A National Eating Disorders Collaboration Report | nedc.com.au

Eating Disorders & Obesity Treatments A systematic review of the physical, psychological and eating disorders outcomes from obesity treatments Prepared for the Commonwealth Department of Health By National Eating Disorders Collaboration Eating Disorders & Obesity Treatments A systematic review of the physical, psychological and eating disorders outcomes from obesity treatments

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Both eating disorders and obesity are complex, chronic conditions with substantial individual and societal consequences and significant shared risk factors.

In Australia, over 60% of the population is currently estimated to be overweight or obese and over 10% are estimated to be suffering from an eating disorder. While often regarded as separate problems, obesity and eating disorders both revolve around unhealthy beliefs and behaviours around weight and eating, and one in five individuals with obesity also presents with comorbid disordered eating. In light of the considerable overlap between conditions at either end of the weight spectrum, there is an urgent need to facilitate evidence-informed dialogue between obesity and eating disorders sectors.

A sizeable literature indicates that prevention initiatives targeting overweight and obesity may inadvertently increase eating disorders risk factors. Public health campaigns that emphasise the desirability of an ideal body weight and shape are associated with increased stigma and body dissatisfaction in individuals of all weights. Whether a similar relationship exists between obesity treatments and eating disorders outcomes has received significantly less attention, but is equally important in ensuring that the benefits of an intervention outweigh the harms.

This report systematically reviews the literature on obesity treatments, including dietary, exercise, behavioural/ psychological, pharmacological and surgical interventions for weight loss. Scientific databases were systematically searched for all treatment studies published within the past five years that included an assessment of treatment impacts on physical, psychological or eating disorders outcomes. The National Health and Medical Research Council guidelines and level of evidence scheme were used as a framework to address key study questions.

In total, 3628 citations were assessed for potential relevance to the study questions and 134 studies (33 systematic reviews and 101 randomised controlled trials) met all criteria and were evaluated in this review.

Obesity Treatment Interventions and Outcomes Numerous treatment strategies have been trialled to assist people to lose weight. As with prior reports, lifestyle interventions incorporating dietary, exercise and behavioural or psychological components were the most commonly recommended first-line approach, with escalation to pharmacotherapy and bariatric surgery in more severe or complicated cases. Bariatric surgery and registered medicines consistently reduced weight but were also associated with adverse effects that ranged from mild to severe, while exercise, dietary and behavioural/ psychological interventions produced mixed weight loss outcomes but had few adverse effects.

The most common measure of psychological outcomes was quality of life, which improved in all cases where it was assessed, across all intervention types. Symptoms of depression also improved in a subset of interventions (behavioural, psychological, pharmacotherapy and surgical interventions). A smaller body of evidence supported improvements in anxiety,

fatigue and confusion (following pharmacotherapy) and psychosocial functioning (following bariatric surgery).

Studies of behavioural and psychological interventions and lifestyle interventions for weight loss reported consistent improvements in cognitive restraint, control over eating and binge eating. In contrast, bariatric surgery resulted in improvements in eating behaviour and body image that were not sustained over the long-term, while pharmacotherapies did not produce clinically significant outcomes in any instance. However, relatively few studies directly assessed the impact of weight loss interventions on psychological and eating disorders outcomes, making it difficult to ascertain whether improvements were a result of the supportive treatment context or weight loss per se.

Concerns have been raised that dieting may precipitate eating disorders in overweight and obese individuals; however, the studies evaluated in this review do not support this suggestion. Rather, we find that professionally administered weight-loss programmes often lead to improvements in quality of life alongside weight loss. At the same time, it is imperative that clinicians are aware of the large and consistent body of evidence reporting harms from unhealthy dieting behaviours, and monitor patients to ensure that healthy diets do not transition into unhealthy diets over time.

There were a number of limitations in the evidence base addressing our key questions that constrain our interpretation of outcomes. Key among these was the scarcity of studies assessing the impacts of weight loss interventions on psychological and eating disorders outcomes, the lack of a well-validated measure to assess eating disorders specifically within the weight loss population, and the overreliance on BMI as a measure of treatment success. Additionally, most studies included only short-term (≤1 year) follow-ups which failed to account for longer-term changes in outcome or relapse.

The Way Forward Overweight and obesity interventions, taken as a whole, are often effective at reducing weight, and for many individuals, weight reduction is associated with significant improvements in health outcomes and quality of life. Since obesity itself is a risk factor for binge eating disorder, weight reduction is also likely to have positive outcomes for eating disorders. Indeed, consistent improvements in eating disorder psychopathology were reported in weight loss interventions that incorporated behavioural and psychological components. These findings underscore the potential gains from multidisciplinary interventions that target psychological well-being alongside measures of physical health.

In consideration of the strengths and limitations of the current evidence base, this review highlights the need for improved clinical tools and practices, greater dialogue and collaboration between sectors, and increased research into the area of overlap between obesity and eating disorders. In particular, the following key areas in research and practice require further attention:

Recommendations for Practice . Better training of health professionals is required to increase awareness about the physical and psychological features of obesity and eating disorders as well as their shared, modifiable risk factors. . Incorporate evidence based treatment strategies into obesity care. Given the benefits of behavioural and psychological interventions on eating disorders outcomes and weight 2

loss, future weight loss interventions should incorporate these components into a more holistic program of care. . Longer-term monitoring and maintenance sessions with a combined emphasis on stabilising weight, well-being, and healthy activity and eating patterns. . Improve postsurgical follow-up care. Bariatric surgery patients present unique challenges that must be carefully monitored, such as the development of disordered eating behaviours with and without concomitant eating disorders psychopathology.

Recommendations for Research . Develop a well-validated psychometric measure of disordered eating for patients seeking weight loss. Current measures targeting traditional eating disorders populations should be adapted to populations seeking weight loss to encompass eating attitudes, cognitions and behaviours that may be unique to this population. . Develop a more comprehensive metric of success that incorporates quality of life, psychological and eating disorders outcomes into existing measures of BMI and weight loss. . Increase research into the psychological and eating disorders outcomes of weight loss interventions.

Taken together, the evidence evaluated in this review provides empirical support for an integrative approach to obesity and eating disorders conceptualisation and care. The overlap between these disorders represents a significant yet underrepresented public health challenge. Urgent dialogue and collaboration between sectors is required to maximise treatment outcomes, minimise harms, and lay the groundwork for an integrated model of care.

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Contents

Executive Summary 1 Contents 2 Table of Tables 6 Glossary and Abbreviations 6 Acknowledgements 7 Objectives of the NEDC 8 1. Background 9 1.1. Overweight and obesity 9 1.2. Dieting, disordered eating and eating disorders 9 1.3. The interface between obesity and eating disorders 10 1.4. Purpose and scope 10 2. Methodology 12 2.1. Criteria for considering studies for this review 12 2.2. Study selection and data extraction 12 2.3. Quality assessment of studies 12 2.4. Methodological limitations 13 3. Obesity treatment interventions and outcomes 14 3.1. Dietary interventions 14 3.1.1. Overview of dietary interventions for weight loss 14 3.1.2. Treatment outcomes of dietary interventions for weight loss 15 3.1.3. Summary of outcomes 15 3.2. Exercise and physical activity 16 3.2.1. Overview of exercise and physical activity interventions for weight loss 16 3.2.2. Treatment outcomes of exercise and physical activity interventions for weight loss 16 3.2.3. Summary of outcomes 17 3.3. Behavioural and psychological interventions 17 3.3.1. Overview of behavioural and psychological interventions for weight loss 17 3.3.2. Treatment outcomes of behavioural and psychological interventions for weight loss 18 3.3.3. Summary of outcomes 19 3.4. Lifestyle interventions 20 3.4.1. Overview of lifestyle interventions for weight loss 20 3.4.2. Treatment outcomes of lifestyle interventions for weight loss 20 3.4.3. Summary of outcomes 21 3.5. Pharmacological interventions 22 3.5.1. Overview of pharmacological interventions for weight loss 22 3.5.2. Treatment outcomes of pharmacological interventions for weight loss 24 3.5.3. Summary of outcomes 26 3.6. Bariatric surgery 27 3.6.1. Overview of bariatric surgery procedures for weight loss 27 3.6.2. Treatment outcomes of bariatric surgery interventions for weight loss 28 3.6.3. Summary of outcomes 29 3.7. Other approaches 30 3.7.1. Overview of other approaches to weight loss 30 3.7.2. Treatment outcomes of other interventions for weight loss 30 3.7.3. Summary of outcomes 31 3.8. Treatment for adolescents 31 3.8.1. Overview of weight loss interventions for adolescents 31

nedc.com.au 3.8.2. Treatment outcomes of interventions for weight loss in adolescents 31 3.8.3. Summary of outcomes 33 3.9. Strengths and limitations 33 4. Summary and discussion 34 4.1. Overview of research findings 34 4.2. Discussion 36 5. The way forward: An integrated approach 38 5.1. Recommendations for Practice 38 5.2. Recommendations for Research 39 Appendices 41 Appendix A: Level of evidence 41 Appendix B: Systematic Review Assessment Procedure 42 Appendix C: RCT assessment procedure 43 Appendix D: Evidence summary procedure 44 References 45 Appendix A: Systematic reviews 60 Appendix B: Randomised controlled trials 70

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Table of Tables Table 3.1. Summary of dietary interventions for weight loss 16 Table 3.2. Summary of exercise & physical activity interventions for weight loss 17 Table 3.3. Summary of behavioural & psychological interventions for weight loss 20 Table 3.4. Summary of lifestyle interventions for weight loss 21 Table 3.5. Summary of pharmacological interventions for weight loss 27 Table 3.6. Summary of surgical interventions for weight loss 30 Table 3.7. Summary of other interventions for weight loss 31 Table 3.8. Summary of weight loss interventions for adolescents 33 Table 4.1. Summary of all weight loss interventions 34 Table 4.2. Summary of all weight loss interventions 35 Table 4.3. Summary of all weight loss interventions 35

Glossary and Abbreviations AN anorexia nervosa BED binge eating disorder BN bulimia nervosa BMI body mass index BPD-DS biliopancreatic diversion-duodenal switch BWL behavioural weight loss CBT cognitive behavioural therapy DSM diagnostic and statistical manual GBP gastric bypass GP general practitioner kKcal kilocalories kg/m2 kilogram per square metre, unit of BMI kJ kilojoule LAGB laparoscopic adjustable gastric band LGB laparoscopic gastric bypass LSG laparoscopic sleeve gastrectomy N number p probability, usually p value SR systematic review SSRI selective serotonin reuptake inhibitor RCT randomised controlled trial RYGB roux-en-y gastric bypass TGA therapeutic goods administration

nedc.com.au Acknowledgements

Collaboration, defined as the act of ‘voluntarily and cooperatively working together to achieve a common goal’ is the core operating principle of the National Eating Disorders Collaboration (NEDC). The work of the NEDC has been based on identifying, analysing and then building on the available evidence. Every voice in the collaboration has been an important one in contributing to the current knowledge base.

The NEDC also acknowledges the considerable work that has already been undertaken by a number of state governments, academic institutions and consumer advocacy groups on identification of gaps and opportunities for improved service for people with eating disorders.

Particular thanks must go to the members of the Steering Committee who have made an extraordinary contribution through their leadership of the NEDC.

The National Eating Disorders Collaboration is funded by the Commonwealth Department of Health.

For specific questions or comments about this report please contact the NEDC on [email protected]

For more information about the National Eating Disorders Collaboration please contact the CEO of the Butterfly Foundation at:

The Butterfly Foundation 103 Alexander Street Crows Nest NSW 2065 T: (02) 9412 4499 F: (02) 8090 8196 E: [email protected]

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Objectives of the NEDC

The National Eating Disorders Collaboration (NEDC) is the second phase of a project initiated and funded by the Commonwealth Government Department of Health in 2009. The primary purpose of the NEDC is to bring together eating disorder stakeholders and experts in mental health, public health, health promotion, education, research, and the media to develop a nationally consistent approach to the prevention and management of eating disorders in Australia.

The project’s objectives are:  To provide or facilitate access to helpful, evidence-based information for young people and their families on the prevention and management of eating disorders and healthy eating;  To promote a consistent evidence-based national approach to eating disorders;  To develop and assist in implementing a comprehensive national strategy to communicate appropriate evidence-based messages to schools, the media and health service providers

In working towards these objectives, the NEDC is actively pursuing the following outcomes that were identified in the first phase of the project:  Eating disorders are a priority mainstream health issue in Australia;  A healthy, diverse and inclusive Australian society acts to prevent eating disorders;  Every Australian at risk has access to an effective continuum of eating disorders prevention, care and ongoing recovery support.

nedc.com.au

1. Background

Obesity and eating disorders are significant public proxy. Body mass index is a standardised and health concerns that are associated with a broad relatively straightforward method for describing range of adverse physical and psychological large populations but is an imperfect measure of conditions. In Australia, more than 60% of adults overall health at the individual level153,201 and may and 25% of children and adolescents are require updating as research progresses148. overweight or obese111,282, with an additional 16% Current definitions ascribe overweight status to presenting with disordered eating behaviours or individuals with BMI ≥ 25 kg/m2 and obesity to eating disorders117. The rate of both eating individuals with BMI>30kg/m2, but a disorders116 and obesity282 is increasing in the straightforward relationship may not apply for all Australian population, and recent evidence groups (such as children, athletes, those at the indicates that the rate of comorbid obesity and extremes of the height distribution and certain eating disorder behaviours has increased more ethnic populations)140,258. rapidly than either disorder alone65. Obesity is a complex, chronic condition that is Healthy body weight is associated with normal accompanied by substantial physical and mental growth and development in young people and health consequences. The prevalence of reduced risk of short- and long-term morbidity overweight and obesity in Australia is among the and mortality among people of all ages50. While highest in the developed world, affecting over the health risks of being overweight are widely 60% of adults and 25% of children and acknowledged, it is imperative to also attend to adolescents111,282. In Australia, the combined the risks associated with being underweight, direct, indirect and social costs of overweight and including decreased immunity, osteoporosis, obesity in 2008 were estimated to be in excess of decreased muscle strength, hypothermia and $58 billion172, and if current trends continue an psychological distress193. estimated 80% of adults will be overweight or obese by 2025111,282. A growing body of evidence highlights the significant shared space between disorders at The major determinants of obesity are complex, both ends of the weight spectrum. Overweight multifaceted and extend beyond simplistic individuals are at increased risk of disordered explanations of overconsumption of calories and eating and eating disorders compared with the insufficient exercise. The early influence of general population42, while individuals who use genetics, intrauterine environment, early infant unhealthy weight-control practices (e.g. fasting, feeding and environmental factors interact to set purging and diet pills) are at increased risk of the stage for weight trajectory throughout life170. overweight and obesity63,186,200. Moreover, Overweight and obesity are associated with individuals with eating disorders are more than overall increased mortality87, as well as risk twice as likely to contact health professionals or factors for cardiovascular disease, type 2 weight loss centres for weight reduction diabetes, sleep apnoea osteoarthritis, assistance116 than they are to seek treatment hypertension, musculoskeletal conditions and specifically for their disorder116. This raises the certain cancers97. Further, overweight and concern that active participation in weight loss obesity have consistently been linked with a may contribute to the development of disordered lower quality of life, including increased risk of eating or eating disorders122. psychological distress157,158, mood and anxiety disorders169, suicidal ideation and attempts53,73 1.1. Overweight and obesity and binge eating disorder1.

The World Health Organisation defines obesity as 1.2. Dieting, disordered eating and a condition of abnormal or excessive body fat that impairs health294. Since measuring body fat eating disorders directly is not always practical, body mass index The term ‘dieting’, as defined here, refers to the (BMI, a ratio of weight by height) is used as a intentional and sustained restriction of calories

9 for the purpose of reducing body weight or and depression83 than obese individuals without changing body shape183. In Western countries, BED. Further, obesity and eating disorders share a approximately 55% of women and 29% of men number of risk factors that apply to a broad range report having dieted to lose weight at some point of eating- and weight-related problems240. These in their lives123. Disordered eating describes include (i) individual factors such as dieting, unhealthy eating behaviours that are not unhealthy weight-control behaviours, weight and sufficient to meet the current criteria for a clinical shape concerns, and self-esteem issues; (ii) social disorder but nonetheless constitute a serious factors, such as parental and peer weight and health problem. Disordered eating differs from shape related behaviours; and (iii) societal dieting in that it describes unhealthy, extreme factors, such as sociocultural norms, media and dangerous dietary and weight control exposure and weight discrimination. Collectively, practices, such as, skipping meals, self-induced these factors place enormous pressure on vomiting, misuse of laxatives and diet pills, and individuals to conform to an ideal weight and binge eating218. Over 10% of Australian women shape, and contribute to body dissatisfaction that and around 8% of Australian men regularly is a predictor of both eating disorders and engage in at least one form of disordered excessive weight gain28. eating119,174. Adolescents are a particularly vulnerable Eating disorders are highly complex and serious demographic for weight-related concerns. The mental and physical illnesses that are peak period of eating disorders onset is between characterised by abnormal eating behaviours and the ages of 12 and 25 years, with a median age of psychological disturbances surrounding shape 18 years115. In the past three decades, obesity in and weight8. Like obesity, eating disorders can adolescents has increased by nearly 75%63, and affect every major organ in the body and cause nearly 25% of Australian children and adolescents significant physiological harms, including are currently overweight17 or obese181. Amongst gastrointestinal illnesses, osteoporosis, kidney young people, dieting is one of the most common failure, heart failure, dental and gum diseases, precursors of eating disorders. Nearly 38% of girls type 2 diabetes, infertility issues and anaemia77. and 12% of boys diet moderately, and nearly 7% of girls and 1% of boys diet at an extreme level212. There are several types of eating disorders Dieting that is not clinically supervised is currently recognised (DSM-58), including anorexia associated with other health concerns including nervosa (AN), bulimia nervosa (BN) and binge depression, anxiety, metabolic problems214, eating disorder (BED). These three disorders each disordered weight control behaviours190 and have specific, formal diagnostic criteria and cause eventual eating disorders213. marked distress. In reference to weight status, individuals with AN are often underweight, Given the relationship between dieting and individuals with BN are typically of average obesity in young people85,187,265 there is reason to weight, and individuals with BED are often be concerned that obesity interventions targeting overweight86. Binge eating disorder is youth could contribute to the development of characterised by recurring episodes of binging eating disorders in later years113. Similar concerns and feelings of lack of control, without have been raised that obesity treatment subsequent compensatory behaviours8. In initiatives may contribute to the onset of comparison, bulimia nervosa (BN) is characterised disordered eating behaviours49,199 in individuals of by frequent episodes of binge eating followed by any age, by increasing anxiety about body shape compensatory behaviours, such as self-induced and weight and the development of unhealthy vomiting or laxatives, to avoid weight gain8. weight loss behaviours283.

1.3. The interface between obesity 1.4. Purpose and scope and eating disorders The physiological benefits of weight loss in The incidence of obesity and eating disorders are overweight and obese adults has been clearly 109,215 interrelated. Obesity is both a risk factor for demonstrated . Many weight loss eating disorders131 and a serious and common interventions focus on strategies to lose weight, outcome for individuals with BN and BED81. and by extension, the most common metric for Individuals with BED are at increased risk of measuring the success of weight loss weight gain and related complications127, and interventions is the amount of weight lost. experience a higher rate of medical problems44 However, overweight and obesity may be

nedc.com.au precipitated by psychological factors as well as increase the risk of psychological consequences161, which may play an important role in modulating treatment outcomes156. Both obesity and eating disorders are associated with low self and body-esteem, depressive symptoms and poor quality of life, among other psychological comorbidities26,65. However the majority of studies exploring the efficacy of weight loss interventions lack assessment of psychological or eating disorders outcomes associated with weight loss156.

Thus, the overall aim of this report was to systematically evaluate the outcomes from weight loss interventions along these three interrelated domains and provide a framework for integrated care going forward. More specifically, the questions guiding this evidence review were: 1. What are the physical health outcomes associated with weight loss interventions? 2. What are the mental health outcomes associated with weight loss interventions? 3. What are the impacts of weight loss interventions on the incidence and symptoms of eating disorders?

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2. Methodology

This study was conducted in the form of a Interventions and Outcome Measures systematic review (SR) of the current literature on The primary interventions evaluated in this overweight and obesity treatment interventions. review were dietary, exercise/physical activity, Searches of the electronic databases Medline, psychological/behavioural, pharmacological and PsycInfo and Cochrane Library were conducted in surgical interventions, while the primary outcome February 2016 using both medical subject measures were standardised anthropometric headings (MeSH) and equivalent free text measures (e.g., BMI and body weight), searches for terms pertaining to obesity standardised body composition measures (e.g., (overweight, overnutrition, hyperphagia), obesity body fat mass), psychological and quality of life interventions (exercise, diet, psychological, measures, and reports of adverse treatment pharmacological, behavioural and surgical), and effects. eating disorders (anorexia nervosa, bulimia nervosa, binge eating disorder, other specified feeding and eating disorders). 2.2. Study selection and data extraction 2.1. Criteria for considering studies The search strategy yielded a total of 3628 for this review citations after removal of duplicates. Following exclusion of studies that did not meet inclusion Studies were included or excluded from this criteria, 134 studies remained, of which 33 were review using the following criteria: SRs and 101 were RCTs. The most common

reasons for exclusion were study foci other than Article Criteria treatment outcomes (N=1478); not being about We considered peer-reviewed SRs or randomised overweight or obesity, or not having overweight controlled trials (RCT) published in 2011 or more or obesity as the primary focus of the study recent, or in the case of SRs or meta-analyses, an (N=1194); reporting primary outcomes measures original or updated search date of 2011 or more not considered in this study (N=241); and recent. These criteria were chosen because of the including participants with physical or volume of available literature, because non- psychological comorbidities (N=48). recent RCTs will be evaluated within recent SRs, and because recent SRs eclipse non-recent SRs. 2.3. Quality assessment of studies Where SRs or RCTs were unavailable, other levels of evidence were sought. We excluded non- All included studies were assessed first English studies, studies reporting primarily individually and second collectively according to qualitative or methodological data, studies treatment intervention. Quality assessment focused on preventative interventions and included appraisal of each of the following: level studies in which the outcomes of an overweight of evidence, study quality, clinical impact, generalisability, applicability and consistency (for or obesity intervention were not the study focus. 191 SRs only; adapted from NHMRC guidelines ). Demographic Each assessment item was scored by one of two reviewers, and a subset of studies (10%) was The target sample included overweight or obese scored by both reviewers to assess accuracy. males and females ranging in age from 12-65 Disagreements were resolved by consensus. years. Adolescents (12-18 years) were assessed separately from adults (18-65 years). Because of Level of Evidence prominent differences in treatment strategies, paediatric and elderly patients were excluded A level of evidence scheme (outlined in Appendix A and developed by the National Health and from consideration. As our aim was to evaluate 191 treatment interventions on a general population, Medical Research Council ) was used to our target sample was otherwise healthy, and organise the study retrieval and selection process, with the exception of BED, had no physical or such that Level I (SRs of level II studies) and II psychological comorbidities. (RCT) studies were targeted first for retrieval for each key question.

nedc.com.au Study Quality Summary of Evidence A quality score of high, moderate or low quality Following the assessment of each individual SR was assigned to each study included in this and RCT, the evidence for each intervention was review. Systematic reviews were assessed using evaluated along the following features: evidence the Overview Quality Assessment base, consistency and clinical impact. The Questionnaire207 (OQAQ, Appendix 1B). The evidence base here refers to the number and OQAQ contains 9 questions that evaluate quality of all studies included for an intervention. whether review authors conducted a Each of the other factors was assessed as comprehensive search, minimised bias in study described above, and assigned a rating of poor, selection and appropriately assessed and pooled satisfactory, good or excellent based on the data for analyses. Randomised controlled trials degree to which relevant criteria were fulfilled. were assessed using the Jadad scale132. The Jadad These methods were adapted from the NHMRC scale, considered the most reliable amongst Body of Evidence Matrix191 (Appendix D). scales of its kind202, contains 7 questions that evaluates whether the study was appropriately 2.4. Methodological limitations randomised and blinded, and whether withdrawals and dropouts were appropriately Reporting of evidence is limited to qualitative accounted for (Appendix 1C). summary of outcomes reported by the original study authors. An important extension of the SR Clinical Impact process is to conduct quantitative meta-analyses of all available evidence from multiple trials, in Clinical impact, in the context of this evidence order to draw more reliable conclusions about a review, refers to the potential benefit that a given topic. However, this was outside the scope study’s outcomes may have for the general of the present review. population. Each study received a clinical impact rating of high, moderate or low based on the Overweight and obese patients receiving statistical precision of the effect, the size of the treatment for weight loss are a demographically effect, and the relevance of the outcome to complex group, often presenting with comorbid patients compared with other treatments or no conditions that may be the cause or consequence treatment. We present a qualitative summary of of their condition. Treatment outcomes are tied key outcomes reported by the original study with the patient’s physical and psychological authors, specifically, whether statistically condition, and patients with multiple significant differences occurred pre- to- post- comorbidities may have a poorer prognosis than intervention or between intervention and control those presenting in better health at the onset of conditions. Statistical significance is partly a treatment. In order to synthesise data that are function of sample size, such that large samples generalisable to the broader population, we may produce a statistically significant difference limited our review to studies assessing primarily that is not clinically meaningful, while small healthy participants free of comorbid diagnoses. samples may fail to find a statistically significant Since individuals with eating disorders often difference despite the occurrence of clinically present with comorbidities that may precede or meaningful outcomes. As such, we additionally follow development of the condition, this review report on measures reflecting the clinical may overlook data on those individuals at relevance of outcomes, when this data is greatest risk. available.

Consistency Systematic reviews were given a consistency rating of high, moderate or low based on how consistent the findings of included studies were. For SRs that also included meta-analyses of RCTs, a high to moderate rating required that statistical heterogeneity between studies was small and/or well accounted for.

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3. Obesity treatment interventions and outcomes

3.1. Dietary interventions Lifestyle interventions that combine diet, exercise and behavioural changes are currently 3.1.1. Overview of dietary interventions for recommended as the first-line approach for the weight loss 135,192 treatment of overweight and obesity . Dietary interventions for overweight and obesity Lifestyle modifications involve dietary and are designed to create a negative energy balance behavioural changes that can be sustained in the (e.g., energy expended is greater than energy long-term to promote health, and are distinct consumed) by a sustained reduction in energy from dieting, which centres on a specific pattern intake below an individual’s unique energy of food intake over a discrete period of time. In requirements80. A variety of dietary approaches this section, we first evaluate the treatment exist to accomplish this, including energy outcomes for each lifestyle component (diet, restricted diets, modified macronutrient diets, exercise and behavioural change) individually, pre-set food portions and meal replacements, or followed by an assessment of strategies that some combination of these components. The combine these. dietary approaches evaluated in this review are briefly discussed below. We subsequently evaluate the treatment outcomes for pharmacotherapies, which are Energy restricted diets include low-energy diets recommended for patients who have attempted and very low-energy diets that restrict kilojoules but not succeeded at attaining weight loss to be below the metabolic expenditure of each through lifestyle interventions100 (or delivered as 107 individual. The general recommendations for low- an adjunct to a lifestyle intervention ), and energy diets is consumption of 4200-5000 kJ for surgery, which is generally reserved for 2 women and 5000-6700 kJ for men, with careful individuals in the higher BMI range (>40 kg/m ). self-monitoring of food intake80. Low-energy diets Adolescents are assessed separately from adults may include structured meal plans or meal and are reported in section 3.8. Each section replacements, both of which increase adherence begins with a brief background on the to energy restriction80. The general intervention, followed by a qualitative assessment recommendations for very low-energy diets is of the treatment outcomes as they pertain to our consumption of 1600-3350 kJ, with large amounts three research questions. Finally, an evidence of protein to preserve lean body mass. Very low- table summarises the body of evidence in each energy diets are normally reserved for patients intervention type in respect to the quantity and with a BMI > 30kg/m2 (or BMI >27 kg/m2) who quality of available studies (evidence base), the have failed to lose weight on a low-energy diet278. degree to which study outcomes are consistent These diets were popular during the 1980s but with each other (consistency) and the statistical are prescribed today on a much more limited and clinical significance of these findings (clinical basis. During the intensive early phase of very impact). The evidence summary table concluding low-energy diets, all meals are replaced with a each intervention section reflects the breadth of specific high protein/low carbohydrate meal the available literature on each intervention. Due replacement formula. The lower levels of to the comparatively small body of literature carbohydrates cause a drop in blood glucose, reporting on mental health and eating disorders which promotes the breakdown of fat as an outcomes, these two areas are summarised only energy source and induces satiety through the briefly in each evidence table, but explored in metabolic process of ketosis107. greater detail (and drawing upon a broader literature base) in section 4. Likewise, outcomes Modified macronutrient diets alter the levels of from treatment targeting adolescents are fat, carbohydrates and proteins relative to each summarised in a single overview table (Tables other. For example, low fat diets require ≤ 10% 3.8) rather than per intervention type. total energy comes from fat; low/high carbohydrate diets require ≤ 40%/ ≥ 65% of total energy comes from carbohydrates; and high

nedc.com.au protein diets require ≥ 35% of total energy comes evening snacks with a ready-to-eat cereal and from protein192. found no effect on weight loss, while another study146 with the meal replacement Optifast One practical means of regulating energy intake is reported reductions in body fat and waist through pre-portioned meals. Food portion sizes circumference that exceeded outcomes from a strongly influence energy intake, such that larger conventional reduced-fat diet. Finally, a portion- portions lead to increased consumption control study224 reported a significant reduction compared with smaller portions231. This portion in BMI at 3-month, but not 12-month, follow-up. size effect has been demonstrated across a range of food items, and is particularly relevant in the What are the mental health outcomes associated current food environment given the with dietary interventions for weight loss? pervasiveness of larger portion sizes286. Only a single RCT146 assessed mental health

outcomes associated with dietary interventions Treatment outcomes of dietary 3.1.2. for weight loss. This study compared the meal interventions for weight loss replacement Optifast to a conventional reduced- Two SRs and 6 RCTs evaluating exclusively dietary fat diet, and reported significant quality of life interventions for weight loss were included in this improvements in both groups. review. These studies ranged from low to moderate quality and reported mixed positive What are the impacts of dietary interventions for and negative outcomes with few adverse effects. weight loss on eating disorders symptomatology?

There were no SRs or RCTs reporting eating What are the physical health outcomes associated disorders outcomes from dietary interventions with dietary interventions for weight loss? for weight loss.

One SR (assessing 7 RCTs)141 evaluated the effects 3.1.3. Summary of outcomes of increased fruit and vegetable consumption on weight loss. This study demonstrated that the Weight loss was reported in studies in which current dietary advice to increase fruit and participants received very-low-calorie ketogenic vegetable consumption, without concomitant diets, high-protein diets or portion-controlled energy restriction, is unfounded. Increased fruit diets, although in most cases this effect was not and vegetable intake produced no discernible sustained over longer (12-month) follow-up effect on body weight. periods. Increased fruit and vegetable consumption, low carbohydrate diets and a One SR (assessing 19 RCTs)184 and 5 ready-to-eat cereal snack replacement were RCTs101,146,168,176,224 evaluated low-energy diets for ineffective as weight loss interventions. Physical weight loss with mixed outcomes. Low adverse effects were reported in only a single carbohydrate diets produced similar reductions in study in which participants received very-low- weight and BMI as balanced diets184, while low- calorie ketogenic diets, and these effects ceased calorie-ketogenic diets produced greater weight when a normal diet was resumed. Only a single loss than standard low-calorie diets but were study assessed mental health outcomes accompanied by a number of short-term side associated with weight loss interventions, and in effects176. High protein diets produced greater this case, an improvement of quality of life was weight and fat loss than high carbohydrate diets demonstrated. There were no SRs or RCTs at 6-month but not 12-month follow-up101. Three reporting eating disorders outcomes from dietary forms of portion control were trialled as a means interventions for weight loss. of restricting energy intake. One study168 replaced

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Table 3.1. Summary of dietary interventions for weight loss Intervention/Outcome Evidence base Consistency Clinical impact Weight loss outcomes Increased fruit & vegetables Satisfactory N/A Poor Low energy diets (overall) Satisfactory Good Poor Low calorie Satisfactory Poor Poor High protein/low carbohydrate Poor N/A Poor Portion controlled meals Satisfactory Satisfactory Satisfactory Mental health outcomes Poor N/A Satisfactory Eating disorders outcomes N/A N/A N/A Note: Evidence base: Excellent = >1 SRs or >2 RCTs with low risk of bias; Good = 1-2 RCTs or 1 SR with low risk of bias; Satisfactory = SRs or RCTs with moderate risk of bias; Poor = SRs or RCTs with high risk of bias. Consistency: Excellent = all studies consistent; Good = mostly consistent; Satisfactory = some inconsistency; Poor = inconsistent; N/A = only 1 RCT. Impact: Excellent = very large; Good= substantial; Satisfactory = moderate; Poor = slight or restricted.

3.2. Exercise and physical activity 3.2.2. Treatment outcomes of exercise and physical activity interventions for weight 3.2.1. Overview of exercise and physical activity loss interventions for weight loss Eight RCTs evaluating exclusively exercise or Exercise and physical activity may be prescribed physical activity interventions for weight loss alone, or in combination with behavioural and were included in this review. These studies dietary interventions within a lifestyle ranged from low to moderate quality and intervention. Physical activity refers to any reported predominantly positive outcomes with physical movement that utilises one or more few adverse effects. large muscles and increases heart rate, while exercise, a type of physical activity, refers to What are the physical health outcomes associated movement within a more structured program with exercise and physical activity interventions for that maintains or enhances overall health, fitness weight loss? and well-being7. The intensity, frequency and 74 duration of the program are important parts of One study compared the effects of aerobic in the exercise prescription. The exercise and males with females when prescribed a low physical activity approaches evaluated in this (400kcal) or high (600kcal) calorie target. Body review are briefly discussed below. weight and fat reductions occurred in all exercise groups compared with no-exercise controls, but All forms of exercise are typically divided into two no differences were observed between low and broad groups: aerobic exercise or resistance high kcal targets or between males and females. exercise296,298. Aerobic exercise, which includes a 238,292 greater variety of forms and is more commonly Two studies assessed the effects of aerobic studied, recruits several large muscle groups and or aerobic plus resistance exercise on body relies on oxygen for fuel. Aerobic exercise is a weight and composition. In both studies, broad category for mild to moderate intensity participants in both the aerobic and aerobic plus activity over a relatively long period of time. resistance groups experienced improvements in 238 Aerobic activities evaluated in this review include body weight or composition. In one study , Pilates, rhythmic movement and active video there was no significant difference between 292 games. Resistance training, on the other hand, groups, while in the other study , the aerobic usually involves short bursts of activity that plus resistance intervention resulted in greater activate single muscle groups to work against a overall fat free mass than the aerobic only resistive load, and use blood sugars rather than intervention. oxygen for fuel (is anaerobic). Resistance exercise 141,251 activities evaluated in this review include strength Two studies assessed the effects of aerobic and endurance training and high-intensity interval high intensity interval training (HIIT) on body 251 training. weight and composition. One study reported weight loss in both HIIT and a moderate exercise control group, with a greater reduction in HIIT participants, while the second study141 found that

16 neither HIIT nor continuous aerobic exercise led What are the impacts of exercise and physical to weight reductions. activity interventions for weight loss on eating disorders symptomatology? Two studies229,234 assessed the effects of varying There were no SRs or RCTs reporting eating intensities of exercise on weight loss. In both disorders outcomes from exercise and physical studies, weight was reduced across exercise activity interventions for weight loss. intensity groups with no significant differences between groups. Lastly, one study51 3.2.3. Summary of outcomes demonstrated that 8 weeks of Pilates exercise was effective at reducing weight in obese women, Weight loss was reported in all but one study although the effect size of this finding was small. assessing aerobic and resistance exercise. A number of these studies also reported favourable What are the mental health outcomes associated changes in body composition, such as reductions with exercise and physical activity interventions for in body fat, and no adverse effects were weight loss? reported. Only a single study assessed mental 229 health outcomes associated with weight loss Only a single RCT assessed mental health interventions, and in this case, an improvement in outcomes associated with exercise interventions quality of life was demonstrated. There were no for weight loss. In this study, quality of life scores studies reporting eating disorders outcomes from improved in moderate- and high-intensity exercise and physical activity interventions for exercise groups compared with no-exercise weight loss. controls.

Table 3.2. Summary of exercise & physical activity interventions for weight loss Exercise & Physical Activity Evidence Base Consistency Clinical Impact Weight loss outcomes Aerobic + resistance Satisfactory Good Good High intensity interval training Satisfactory Poor Good Pilates Poor N/A Poor Mental health outcomes Poor N/A Satisfactory Eating disorders outcomes N/A N/A N/A Note: Evidence base: Excellent = >1 SRs or >2 RCTs with low risk of bias; Good = 1-2 RCTs or 1 SR with low risk of bias; Satisfactory = SRs or RCTs with moderate risk of bias; Poor = SRs or RCTs with high risk of bias. Consistency: Excellent = all studies consistent; Good = mostly consistent; Satisfactory = some inconsistency; Poor = inconsistent; N/A = only 1 RCT. Impact: Excellent = very large; Good= substantial; Satisfactory = moderate; Poor = slight or restricted.

3.3. Behavioural and psychological Behavioural therapy, as applied to weight control, interventions refers to a set of principles and techniques to help individuals adopt and maintain new eating 3.3.1. Overview of behavioural and and activity habits80. These include self- psychological interventions for weight monitoring (recording weight, diet and/or activity loss to increase awareness), stimulus control (altering the environment to contain positive cues), Behavioural and psychological skill building is a problem solving (identifying and generating cornerstone of obesity treatment. These solutions to problems) and cognitive restructuring interventions are usually delivered in group (countering negative thoughts with positive settings, and in combination with other weight thoughts)46. Behavioural therapies evaluated in loss strategies. While traditionally delivered in this review were labelled as behavioural weight person, a number of recent treatment loss, behavioural weight management or programmes have integrated technology as either behavioural counselling, but shared the target of the basis or as an adjunct to in-person treatment. either improving diet, activity or both. The behavioural and psychological interventions evaluated in this review are briefly discussed Other more psychologically focused strategies below. evaluated in this review include cognitive

17 behavioural therapy, motivational interviewing weighing, and pedometer-assisted weight loss are and mindfulness-based interventions. evaluated in this review.

Cognitive behavioural therapies (CBT) are the 3.3.2. Treatment outcomes of behavioural and most commonly used psychological therapies for psychological interventions for weight weight reduction, and focus on helping loss individuals make long-term behavioural changes Seven SRs and 14 RCTs evaluating exclusively in dietary restraint, food intake and physical 192,248 behavioural or psychological interventions for activity . The goal of CBT is to provide the weight loss were included in this review. These individual with coping skills to manage responses studies ranged from low to high quality and to food-related cues and lapses from diet and reported mixed positive and negative outcomes physical activity when they occur. with no adverse effects.

Mindfulness, which originated in the Buddhist What are the physical health outcomes associated concept of mindful meditation, is a mainstay of with behavioural and psychological interventions depression and anxiety interventions but is a for weight loss? relatively new addition to weight loss programmes203. Mindfulness emphasises bringing Five SRs (assessing between 8 and 16 RCTs each) attention to the experiences in the current and 6 RCTs assessed the effects of behavioural moment, without reaction or judgement. In the weight management interventions on weight loss context of weight management, mindfulness and quality of life measures. Outcomes varied trains individuals to become aware of and alter depending on the particular intervention, responses that are inconsistent with their needs outcome variable and duration of follow-up. One and goals, such as awareness of bodily signals of SR300 reported no effect of behavioural weight hunger and satiety to prevent overeating in management on weight loss when delivered by response to social cues. primary care physicians; another36 found a very small, but clinically insignificant, positive effect; Mindful awareness is an important component of and the remaining 3129,136,275 reported reductions acceptance based behavioural therapies, which in weight associated with treatment. Reductions aims to foster the willingness to experience in weight were also observed in 2 RCTs137,222 negative internal experiences rather than reduce assessing the commercially available behavioural the frequency of those experiences90. Acceptance weight loss program Weight Watchers; 1 RCT180 based therapies promote a better ‘meta- assessing the behavioural Camden Weight loss cognitive’ understanding of one’s decision-making program; 1 RCT133 assessing a stepped-care processes285 that supports behaviours that are behavioural weight-loss approach; 1 RCT196 consistent with an individual’s desired goals and assessing a 3 year lifestyle counselling values88. intervention; and 1 RCT128 assessing a gender- sensitised weight loss programme. Motivational interviewing is a person-centred, time-limited counselling approach that focuses on Three studies23,203 evaluated psychological strengthening an individual’s motivation and therapies targeting weight loss and behavioural commitment to behavioural change173. Clinicians change. One SR203 (assessing 8 RCTs) assessed use open-ended questions to help patients mindfulness-based programmes and reported a discuss change, focusing on optimism and intent reduction in weight in most included studies (6 of to change, combined with clinician empathy and 8 RCTs). One SR23 (assessing 24 RCTs) assessed avoidance of confrontation. motivational interviewing and reported a significant reduction in weight in only 9 of 24 Motivation to change and maintain positive included RCTs. One RCT90 assessed an behaviours is an important factor in weight loss acceptance-based behavioural treatment for outcomes266. A number of techniques to enhance weight loss and reported significant reductions in motivation have been trialled to improve weight weight. loss, with self-monitoring at the core of most programmes. Self-monitoring increases Four RCTs incorporated technology into awareness of how behaviours are impacting behavioural or psychological weight loss weight, and creates personal accountability that treatments. Two of these45,263 provided fuels positive behavioural change. The self- participants with personal digital assistants to monitoring methods of diary-keeping, daily self- self-monitor diet and physical activity, and

nedc.com.au reported enhanced weight loss compared with for weight loss, and all reported positive participants receiving standard-care alone. A third outcomes. One study196 reported improved study217 provided participants with a technology- cognitive restraint and control over eating after based system (electronic arm-band, monitor, and participation in a 3-year lifestyle intervention tracking website) with or without standard which included healthy diet and exercise behavioural weight loss and reported a significant counselling. Five studies reported reductions in reduction in weight, but there were no binge eating episodes following standard CBT104, differences between technology-present and self-help CBT105, virtual-reality enhanced CBT56, technology-absent groups. Finally, 1 RCT56 motivational interviewing24 and behavioural delivered enhanced-CBT to obese patients with weight loss36. Behavioural weight loss and BED using virtual-reality technology. Weight standard CBT also led to significantly greater reduction was observed in the enhanced-CBT remission from binge eating compared with group but not standard-CBT or inpatient participants receiving a control intervention. multimodal groups. 3.3.3. Summary of outcomes Four RCTs assessed weight loss in obese patients 56,104 Weight loss was reported, in varying degrees, in with BED. Two studies evaluating cognitive 24 most studies assessing behavioural and behavioural interventions and one study psychological interventions. Interventions evaluating a motivational interviewing producing positive effects on weight loss include intervention reported positive weight loss 105 lifestyle counselling, self-help CBT, and a number outcomes, while one study assessing self-help of technology-based behavioural interventions, delivered in a primary care setting found no while mixed outcomes occurred following effect of treatment on weight. behavioural weight loss or weight management

programmes (including commercially available What are the mental health outcomes associated programmes), mindfulness based interventions with behavioural and psychological interventions and motivational interviewing interventions. A for weight loss? subset of studies targeted obese patients with Three RCTs evaluated mental health outcomes binge eating disorder. Of these, motivational from behavioural or psychological interventions interviewing yielded reductions in weight, while 90 for weight loss. One RCT reported quality of life CBT had mixed outcomes depending on the sub- improvements in participants in standard and type: standard and virtual-reality enhanced CBT, acceptance-based behavioural interventions, with but not self-help CBT, produced weight loss. No no significant difference between groups. Two adverse effects were reported. Three studies RCTs assessed changes in depression symptoms assessed mental health outcomes associated with with weight loss treatments targeting obese weight loss interventions, and of these, one 24 patients with binge eating disorder. One study reported no improvement in quality of life while reported an improvement in depression two reported improvements in depression symptoms with a motivational-interviewing symptoms. Five studies assessed, and reported weight loss intervention that was statistically improvements in, eating disorders outcomes 105 greater than controls, while the second from behavioural and psychological interventions reported a similar improvement with a self-help for weight loss, including improved cognitive CBT intervention, however an improvement was restraint, control over eating and binge eating observed in the control group as well. episodes. A single study reported remission from binge eating following a CBT or behavioural What are the impacts of exercise and physical weight loss program. activity interventions for weight loss on eating disorders symptomatology? Six RCTs evaluated eating disorders outcomes from behavioural and psychological interventions

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Table 3.3. Summary of behavioural & psychological interventions for weight loss Behavioural & Psychological Evidence base Consistency Clinical impact Weight loss outcomes Behavioural weight loss Satisfactory Good Good Cognitive behavioural therapy Good Poor Satisfactory Mindfulness based Satisfactory Poor Poor interventions Acceptance based therapy Satisfactory N/A Satisfactory Motivational interviewing Satisfactory Poor Satisfactory Self-monitoring programmes Satisfactory Satisfactory Satisfactory Mental health outcomes Satisfactory Poor Satisfactory Eating disorders outcomes Satisfactory Good Good Note: Evidence base: Excellent = >1 SRs or >2 RCTs with low risk of bias; Good = 1-2 RCTs or 1 SR with low risk of bias; Satisfactory = SRs or RCTs with moderate risk of bias; Poor = SRs or RCTs with high risk of bias. Consistency: Excellent = all studies consistent; Good = mostly consistent; Satisfactory = some inconsistency; Poor = inconsistent; N/A = only 1 RCT. Impact: Excellent = very large; Good= substantial; Satisfactory = moderate; Poor = slight or restricted.

3.4. Lifestyle interventions groups displayed a small reduction in weight, with no significant difference between groups. 3.4.1. Overview of lifestyle interventions for weight loss The combination of diet and behavioural/ psychological components were assessed in 5 In this section we evaluate the evidence for 167 combinations of diet, exercise or behavioural and RCTs, with mixed outcomes. One study psychological modification. compared weight loss in obese patients with binge eating disorder following 6 months of CBT 3.4.2. Treatment outcomes of lifestyle plus a low-energy density diet to CBT plus general interventions for weight loss nutrition counselling not related to weight loss. Nearly a third of participants lost 5% of body Five SRs and 8 RCTs evaluating lifestyle weight, but weight reduction did not differ interventions for weight loss were included in this between treatment groups. A second study91 review. These studies ranged from low to high reported greater weight reduction, at 6- but not quality and reported predominantly positive 18-months, in overweight and obese adults outcomes with no adverse effects. receiving a hypocaloric almond-enriched diet plus behavioural weight management compared to What are the physical health outcomes associated those receiving a nut-free version of the same with lifestyle interventions for weight loss? intervention. A third study9 compared physical The combination of diet and exercise were activity plus fruit and vegetable meal evaluated in 1 SR (assessing 8 RCTs)21 and 3 RCTs, replacements to usual-care counselling with a and all reported a reduction in weight. The SR dietician. Participants receiving the full compared diet plus exercise to exercise alone, intervention had greater weight loss than usual- care controls at 8, 16 and 24 week follow-ups. A and reported greater reductions in weight in 99 participants receiving the multicomponent fourth study compared a behavioural weight intervention. One RCT151 compared management program plus calorie and fat encouragement to exercise plus meal restricted diet with or without modifications to replacement to supervised exercise plus the home environment. Participants receiving the structured meal plan, and reported greater additional home modification component had reductions in participants receiving the structured significantly greater weight loss than those in the 27 standard program at 6 but not 18 month follow- combination approach. Another RCT study 179 compared a hypocaloric diet plus one of three up. Finally, a fifth study compared weight loss exercise regimes to a control group receiving a in obese women receiving a behavioural hypocaloric diet plus recommendation to intervention plus 1000 calorie diet or 1500 calorie exercise, and reported weight reduction in all diet. While a significant reduction in weight was combination groups compared with controls. observed in both groups, participants receiving Finally, a third RCT6 compared a diet and physical the 1000 calorie diet lost significantly more activity program delivered in full-form via the weight than participants on the 1500 calorie diet. internet or in condensed-form via emails. Both

nedc.com.au The combination of exercise and behavioural/ loss. Two of seven RCTs included in this SR psychological interventions were assessed in 2 assessed quality of life, and both reported an RCTs, with mixed outcomes. One study54 reported overall improvement of quality of life after greater weight reduction in overweight and obese lifestyle weight loss interventions. women receiving an exercise plus behavioural weight management intervention compared to an What are the impacts of lifestyle interventions for education-intervention control. A second study163 weight loss on eating disorders symptomatology? provided standard inpatient medical obesity Only a single RCT167 evaluated eating disorders rehabilitation to all participants, with add-on outcomes from a lifestyle intervention for weight intensive phone after-care for one group. loss. In this study, CBT was prescribed to obese Significant weight reduction was observed in both patients with BED in combination with a low- groups, with no significant difference between energy-density diet or general nutrition groups. counselling. Both groups had significant

reductions in binge eating, and at 12-month The combination of diet, exercise and follow-up, had significant improvements in behavioural/ psychological interventions were behavioural and attitudinal features of BED. assessed in two SRs (assessing 39109 and 722 RCTs) and 1 RCT with positive outcomes. One SR108 3.4.3. Summary of outcomes compared commercial weight loss programs with education or behavioural counselling. The three Lifestyle interventions that include combinations programs that consistently produced greater of diet, exercise and behavioural/ psychological weight loss outcomes than education or components were largely effective at improving counselling controls were Weight Watchers, body weight and related measures in overweight Jenny Craig and Nutrisystem. Similarly, the and obese individuals. Specifically, interventions second SR22 reported reductions in fat mass and that included diet plus exercise or diet plus waist circumference in individuals receiving exercise plus behavioural/ psychological lifestyle interventions compared with education components had consistently positive outcomes. or counselling controls. One RCT58 compared a Mental health was assessed in a single SR, which lifestyle program that included calorie restriction, reported quality of life improvements following a CBT and strengthening exercises to an education- lifestyle intervention. Eating disorders outcomes only control. Participants receiving the lifestyle were assessed in a single RCT, which reported intervention had significantly greater reduction in improvements in binge-eating and behavioural weight, body fat and waist circumference than and attitudinal features of BED. No adverse controls. effects were reported.

What are the mental health outcomes associated with lifestyle interventions for weight loss? Only a single SR22 assessed mental health outcomes from lifestyle interventions for weight

Table 3.4. Summary of lifestyle interventions for weight loss Combined interventions Evidence base Consistency Clinical impact Weight loss outcomes Diet + Exercise Satisfactory Good Good Diet + Behavioural Satisfactory Poor Poor Behavioural + Exercise Satisfactory Satisfactory Good Behavioural + Exercise + Diet Satisfactory Good Good Mental health outcomes Satisfactory Poor Poor Eating disorders outcomes Satisfactory N/A Satisfactory Note: Evidence base: Excellent = >1 SRs or >2 RCTs with low risk of bias; Good = 1-2 RCTs or 1 SR with low risk of bias; Satisfactory = SRs or RCTs with moderate risk of bias; Poor = SRs or RCTs with high risk of bias. Consistency: Excellent = all studies consistent; Good = mostly consistent; Satisfactory = some inconsistency; Poor = inconsistent; N/A = only 1 RCT. Impact: Excellent = very large; Good= substantial; Satisfactory = moderate; Poor = slight or restricted.

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3.5. Pharmacological interventions 3.5.1. Overview of pharmacological cancellation of several CB1-receptor antagonist interventions for weight loss development programmes, the CB1 receptor is still considered a viable therapeutic target for the In Australia, the Therapeutic Goods treatment of obesity and is currently the subject Administration (TGA) classifies most prescription 252 of a number of research programs . and over-the-counter medicines as registered medicines, which carry higher risk and are subject Among registered medicines, Orlistat is the only to thorough evaluation prior to reaching 270 weight-loss agent currently approved for long- market . The TGA classifies low-risk 230 term clinical use . Orlistat, which was approved complimentary medicines, such as herbal in 1999, is an oral inhibitor of pancreatic lipases medicines, vitamins, minerals and other that acts by reducing the absorption of dietary fat supplements, as listed medicines, which contain 37 in the gut . Two new medications, phentermine- only pre-approved low-risk ingredients. A variety topiramate and lorcaserin, have recently been of registered and listed medicines have been approved by the United States Food and Drug trialled for the treatment of overweight and Administration (FDA), but have not yet been obesity, and most of these target weight approved for use by the Therapeutic Goods reduction by decreasing the consumption or Administration (TGA) in Australia (although absorption of food, and/or by increasing energy phentermine is approved for delivery as a short- expenditure. Registered medicines evaluated in 185 107 term monotherapy for obesity ) . this review include weight loss agents (often Phentermine, one of the earliest pharmacological referred to as anorectics or antiobesity agents used for weight loss, is currently the most medications), antidiabetics, anticonvulsants and commonly prescribed antiobesity agent in the antidepressants; listed medicines include 226 United States . It is a centrally-acting vitamins, minerals, enzymes, lipids and dietary amphetamine that triggers the hypothalamic fibres. Pharmacological agents may be delivered release of noradrenaline and dopamine, leading as monotherapies, in multiple-agent compounds, 112 to appetite suppression . Topiramate, which is or as an adjunct to lifestyle interventions. The currently approved for the treatment of medicines evaluated in this review are briefly migraines and seizures, was demonstrated in discussed below. early studies to have an unexpected (and as of yet

unaccounted for) weight-loss benefit. It is In the past decade, several prominent antiobesity frequently prescribed alongside phentermine in a medications were withdrawn from market due to compound that has improved efficacy and side effects and clinical trials were 112 reduced side effects compared to either agent discontinued . For example, a massive (>10000 226 alone . Lorcaserin is a novel selective agonist of enrolled patients) 2010 trial of the withdrawn the serotonin 2C receptor in the hypothalamus anorectic sibutramine demonstrated significant 112 that reduces weight by suppressing appetite . It reductions in weight and waist circumference, but was initially rejected in 2010 due to safety also significant cardiovascular risk concerns which concerns raised in preclinical trials, but was later contraindicated 90% of recruited patients134. reassessed and approved by the FDA. Zonisamide Sibutramine functions by increasing satiety and is a antiepileptic drug that acts on weight through thermogenesis through the inhibition of its dose-dependent actions on dopaminergic and serotonin, noradrenaline and dopamine in the 93 serotonergic activity . hypothalamus. A second anorectic showing initial promise for the treatment of obesity but Other less commonly prescribed anorectics withdrawn from market due to adverse effects is evaluated in this review are the central nervous the cannabinoid CB1 receptor antagonist stimulants diethylpropion, fenproprex and rimonabant. Rimonobant, developed in the mid- mazindol. Diethylpropion and fenproporex 1990s, was licensed in Europe as an anti-obesity suppress appetite through their action on agent in 2006, but subsequently withdrawn in 241 hypothalamic noradrenaline , while mazindol is 2008 over reports of serious psychiatric 230 a sympathomimetic amine that inhibits hunger by problems . The endocannabinoid system plays 288 blocking reuptake of norephinephrine . an important modulatory role in controlling Similarly, ephedrine in combination with caffeine metabolism and energy balance233, and is thought stimulates the central nervous system and leads to be over-active in individuals with obesity253. to weight loss, and has been trialled Despite the withdrawal of rimonabant and the

nedc.com.au independently and in a compound with the evaluated in this review, the evidence base ‘satiety hormone’ leptin159. supporting listed medicines is small, and each of the agents discussed below is evaluated in only Antidepressants may also have a role to play in one or two publications. weight loss. Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) that is indicated for the Dietary fats play a controversial role in obesity291. treatment of depression and bulimia nervosa. A diet high in saturated fat and trans-fatty acids Although it has no formal indication for the favours weight gain, while the digestion of fat into treatment of overweight and obesity2, it is free fatty acids in the small intestine slows gastric occasionally prescribed off-label to promote emptying and suppresses appetite59. Dietary fats weight loss through its appetite suppressing vary substantially in structure and function, and properties247. Bupropion is a dopamine and certain types, such as the long-chain omega-3 noradrenaline reuptake inhibitor that is indicated fatty acids, may facilitate weight loss by mediating for depression and smoking cessation. Similar to fat oxidation, adipose reduction and appetite fluoxetine, it has been prescribed as a weight loss suppression114. The phospholipid N-oleoyl- agent due to its appetite suppressing properties, phophatidyl-ethanolamine (NOPE) may reduce most commonly alongside the opioid antagonist appetite by inhibiting the cannabinoid CB1 naltrexone. Bupropion may also hold promise as a receptor agonist anandamide. Bioavailability and psychopharmacological agent for treating absorption of NOPE can be maximised by overweight people with binge eating disorders delivering it in combination with the green tea who experience food cravings and negative extract epigallocatechin gallate. mood289. Dietary protein is thought to be more satiating Four medications typically prescribed for diabetes than an isoenergetic portion of fat or were evaluated in this review. Metformin is an carbohydrate32. However, most human studies oral antihyperglycemic agent that is currently the investigating the impact of protein on weight most widely used drug for the treatment of type reduction prescribe energy restriction alongside 2 diabetes41. Its primary mode of action is increased protein, which can make it difficult to through the reduction of blood glucose in the separate the effects of diet from those of the liver and the sensitisation to insulin peripherally20. catabolic state induced by an energy deficit19. In It has also been demonstrated to function as a the single study evaluating protein for weight weight-loss agent, and is a particularly popular reduction included in this review19, supplemental choice in the treatment of children and whey or soy protein were added to the diet of adolescents due to its safety profile and multiple overweight and obese adults without metabolic and cardiovascular targets164. Similarly, concomitant energy restriction. canagliflozin is an oral antihyperglcemic that reduces blood glucose by decreasing the Vitamin D and calcium are thought to play an absorption of glucose in the liver. Metformin and important role in body weight and canagliflozin are prescribed both in combination composition259. As a fat soluble vitamin, Vitamin and as monotherapies. The two other antidiabetic D levels are often lower than normal in agents target the gut hormone glucagon-like overweight and obese individuals due to peptide-1 (GLP-1) that enhances insulin sequestering in the expanded adipose tissue secretion112. The GLP-1 analogues exenatide and mass, with adverse effects on calcium liraglutide both improve glycaemic control and absorption295. Calcium is believed to regulate reduce weight, although this has primarily been body weight through the stimulation of whole tested in individuals with type 2 diabetes. While body fat oxidation260. Supplementation of vitamin the more commonly used anti-obesity drugs are D has been suggested as a means of countering centrally acting agents that target nonspecific calcium deficiency and improving weight status in neurotransmitter pathways, leading to multiple overweight and obese individuals. Calcium has adverse effects, the GLP-1 analogues work by also been trialled as a weight loss agent delivered targeting gut hormones directly and are in combination with the polysaccharide sodium considered a novel, but promising direction for alginate. Extracted from brown algae, sodium obesity drug therapies112. alginate is commonly added to food because of its gelling properties, which may hold potential A wide range of listed medicines have been for weight loss due to satiety induced by gelling in trialled for weight loss with varied modes of the stomach96. action. In comparison to the other interventions

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The intestinal microbiota is composed of trillions by increasing levels of norepinephrine, which in of bacteria that play an important role in turn increases energy expenditure and fat metabolism and energy storage. Differences in oxidation220. Green tea for weight loss is normally microbiota composition have been implicated in consumed as a capsule containing a concentrated obesity, with unique species of Lactobacillus extract of catechins and/or caffeine, with highly identified in normal-weight and obese individuals. variable chemical content and pharmacological Probiotics containing specific strains of outcomes139. Lactobacillus may alter the microbiota balance and play a role in weight loss or weight 3.5.2. Treatment outcomes of pharmacological maintenance. interventions for weight loss

Seven SRs and 19 RCTs evaluating exclusively Less common forms of weight loss include the pharmacological interventions and 13 RCTs use of dietary supplements, minerals and evaluating the combination of pharmacological extracts. Glucomannan is a water-soluble, and behavioural/ psychological, dietary or fermentable, fibre supplement extracted from 143 exercise interventions for weight loss were the root of the elephant yam . It passes included in this review. These studies ranged relatively unimpeded into the colon where it can 72 from low to high quality and reported mixed absorb up to 50 times its weight in water . It is positive and negative outcomes with a number of thought to mediate body weight by displacing adverse effects. nutrients and producing satiety as it takes on 84 water and expands in the gastrointestinal tract . What are the physical health outcomes associated

with pharmacological interventions for weight Chromium is an essential trace element that loss? occurs naturally in a wide variety of foods, including cereals, nuts, vegetables and eggs55. Two SRs195,297 (assessing 4 and 20 RCTs) and four Chromium is necessary for fat and carbohydrate RCTs5,12,210,268 assessed the effects of anorectic 3 metabolism , and may reduce body weight by medications on weight loss. Eight different increasing insulin sensitivity10, reducing food anorectic medications were trialled across these cravings16, and increasing metabolic rate206. studies (lorcaserin, phentermine+topiramate, Orlistat, mazindol, sibutramine, fenproporex, Yeast hydrolysate is derived, through hydrolysis, diethylpropion and rimonabant) and all were from the single-celled fungus Saccharomyces reported to be effective at reducing weight and in cerevisiae (commonly known as brewers yeast). most cases, this weight loss was considered The process of hydrolysis breaks down the clinically significant. However, all studies reported complex proteins in yeast to free amino acids physical adverse effects that ranged from mild to which are easy to digest and have been suggested severe, and including gastrointestinal adverse to play a role in fat reduction in obese effects, headache, dizziness, fatigue, dry mouth, individuals138. anxiety, irritability, insomnia and elevated heart rate. Gynostemma pentaphyllum is another natural weight loss product traditionally consumed in Three RCTs assessed the effects of antidepressant Asian countries as a tea. G.pentaphyllum is medications on weight loss with mixed outcomes. thought to mediate weight loss through the One RCT289 prescribed bupropion to overweight activation of the enzyme AMPK, which is involved women with binge eating disorder and reported in regulating metabolism and energy balance. short-term weight loss; one RCT11 prescribed a compound of bupropion and naltrexone to obese Finally, green tea is a natural product made from patients and reported clinically meaningful weight the leaves of the plant Camellia sinensis. Green loss; while a third RCT12 prescribed fluoxetine to tea is most commonly consumed as a social obese patients and reported no effect on weight beverage and to increase alertness, but in more loss. Two of these RCTs11,268 reported adverse recent years has been trialled, with limited effects including nausea, headache, dry mouth, evidence, as a treatment for a variety of insomnia, dizziness and constipation. conditions139. The plant from which green tea is derived contains a complex mix of compounds One RCT249 assessed the efficacy of the known as catechins, which are believed to anticonvulsant medication zonisamide as a weight account for most of green tea’s pharmacological loss agent. Zonisamide led to greater weight loss activity. Catechins are theorised to reduce weight than placebo after 12-months of treatment, but

nedc.com.au also led to greater weight regain than placebo effects. The second study177 supplemented a low- after discontinuation. Zonisamide also produced a energy diet with omega-3 fatty acids and number of side effects, including altered taste, reported no additional weight loss when constipation, diarrhoea, dry mouth, headache, compared to a low-energy diet alone. fatigue and nausea. Thirteen RCTs assessed the combination of Five SRs (assessing 9 to 18 RCTs) and 11 RCTs pharmacological and behavioural/ psychological, assessed the effects of listed “complimentary” dietary and exercise interventions for weight loss. medicines on weight loss with highly variable One study274 compared conventional obesity outcomes. Two studies (1 SR205 evaluating 9 RCTs therapy (including nutritional education and and one RCT144) assessed the efficacy of medical treatment) with an intensive lifestyle glucomannan fiber supplementation on weight intervention that included the addition of loss in overweight and obese adults, and both anorectic or antidepressant medications (as reported no weight loss benefit and adverse required by each patient). Participants receiving short-term effects (including nausea, headache the intensive lifestyle intervention had greater and vomiting). Two studies (1 SR211 assessing 18 weight loss at 1 year follow-up than controls. One RCTs and one RCT237) assessed the efficacy of study94 evaluated weight loss after the addition of Vitamin D on body weight and fat, and while the the anticonvulsant zonisamide (200 or 400mg) to RCT reported fat reduction, the SR reported no lifestyle counselling. Participants receiving benefits of Vitamin D treatment. zonisamide 400mg had significantly greater weight loss than zonisamide 200mg and placebo The remaining 14 compounds were assessed in pill controls. Two studies assessed weight loss only a single study each. Positive weight loss after antidepressant medication and behavioural/ outcomes were reported for chromium psychological therapy. In one study277, bupropion supplementation (in an SR204 assessing 18 RCTs), and naltrexone were prescribed as an adjunct to whey protein19, yeast hydrolysate138, leptin and behaviour modification, which resulted in leptin+caffeine/ ephiderine159, Gynostemma significantly greater weight loss than placebo. In pentaphyllum extract208 and canagliflozin25, while the other102, overweight and obese adults with green tea (in an SR139 assessing 14 RCTs), plant BED were prescribed fluoxetine plus CBT, extracts (in an SR14 assessing 14 RCTs), DHA-rich fluoxetine alone, or CBT plus placebo. None of the fatty acid supplementation114, lipid dietary treatments produced significant weight loss. supplementation165, probiotic supplementation239, calcium232 and soy protein19 Four studies combined anorectic medications produced no significant changes in weight. Of with behavioural/ psychological therapies. One these, physical adverse effects were reported for study106 assessed the combination of Orlistat plus green tea (e.g., mild to moderate nausea, behavioural weight loss therapy (compared with constipation and increased blood pressure), Orlistat + placebo and therapy + placebo) for chromium supplementation (e.g., digestive obese patients with or without BED. The disturbances, dizziness and headaches), plant combination therapy resulted in a significant extracts (e.g., headache, dizziness, nausea, weight reduction in obese patients without BED fatigue), glucomannan (bloating, belching, only. A second study33 assessed the combination stomach fullness), lipid dietary supplement (e.g., of Orlistat plus CBT for obese patients with BED, blurry vision, headache, shakiness) and and reported significantly greater weight cangliflozin (e.g., dizziness, hypoglycaemia, reduction compared with CBT plus placebo poluria, infections). controls. Both studies reported adverse gastrointestinal effects. A third study279 compared Fifteen RCTs evaluated interventions that lifestyle counselling plus Orlistat or sibutramine to combined pharmacotherapy with diet, exercise lifestyle counselling or usual care. At 24 month and behavioural/ psychological components with follow-up, participants receiving combination mixed outcomes. Two RCTs96,177 assessed the therapy (either medication) had greater weight combination of pharmacotherapy and diet. One loss than controls. Adverse events included one study96 reported significantly greater weight loss case of syncope and two patients requiring in individuals receiving alginate supplement plus a gallbladder removal, as well as dropouts due to calorie restricted diet compared with control elevated blood pressure (5 patients receiving participants receiving placebo plus a calorie sibutramine) and gastrointestinal symptoms (5 restricted diet. However, alginate treatment was patients receiving orlistat). Finally, one study103 also associated with gastrointestinal adverse compared combination self-help CBT plus

25 sibutramine to CBT plus placebo or sibutramine contrast, a third study106 reported no only in obese patients with BED. Sibutramine was improvement in psychological outcomes when associated with greater weight loss at 4 but not 6 Orlistat was added to behavioural weight loss. or 12 month follow-up. What are the impacts of pharmacological One study223 combined the antidiabetic interventions for weight loss on eating disorders medication liraglutide with lifestyle modification symptomatology? counselling and reported significantly greater Two RCTs assessed eating disorders outcomes weight loss and body composition at 56 weeks from exclusively pharmacological interventions. than individuals receiving placebo plus lifestyle The first study289 prescribed the antidepressant modification counselling. However, a range of medication bupropion to obese women with BED adverse effects were reported, including nausea, and reported that medication did not improve constipation and nasopharyngitis. In contrast, a binge eating, food cravings or associated eating second study reported no additional weight loss disorders features relative to placebo. The second benefit from the addition of an antidiabetic study210 was the first to prescribe the (metformin) to a lifestyle intervention. Finally, endocannabinoid medication rimonabant to three studies combined listed medicines with obese patient with BED. The treatment group had lifestyle interventions. One study108 reported a a significantly greater reduction in scores on the weight loss benefit from the addition of natural binge eating scale compared with placebo fiber to lifestyle counselling, while the remaining controls; however, this change was not clinically two studies reported no additional gains from the significant. addition of an omega-3 supplement69 or weight loss supplement to lifestyle interventions225. 3.5.3. Summary of outcomes

What are the mental health outcomes associated Registered medicines, including anorectics, with pharmacological interventions for weight antidepressants, anticonvulsants and loss? antidiabetics, are highly effective at reducing weight in overweight and obese individuals. All Three RCTs assessed mental health outcomes studies of registered medicines reported weight associated with exclusively pharmacological 268 loss; however, all but one of these studies also interventions for weight loss. One RCT reported reported adverse effects that ranged from mild to improvements in quality of life, depression and severe. anxiety from treatment with the medications diethylpropion, fenproporex, mazindol, fluoxetine 165 In contrast, listed “complimentary” medicines and sibutramine. Likewise, the second RCT were less effective (less than half of all studies reported a significant improvement in mood, reported positive weight loss outcomes) and also fatigue and confusion from treatment with a lipid 249 reported fewer adverse effects (less than half of dietary supplement. In contrast, the third RCT all studies reported adverse effects). Three reported mild neuropsychiatric adverse events studies assessed mental health outcomes with zonisamide treatment, including anxiety- associated with weight loss. Two studies related and depression-related adverse events, (assessing anorectics, an antidepressant and a along with impaired attention, concentration and lipid dietary supplement) reported improvements memory with zonisamide treatment. However, in quality of life, depression, anxiety, mood, these resolved quickly after the drug was reduced fatigue or confusion, while the third study or discontinued. (assessing an anticonvulsant) reported worsening

attention, concentration and memory. Eating Three RCTs assessed mental health outcomes disorders outcomes from pharmacological associated with combined pharmacological plus interventions for weight loss were assessed in 2 behavioural/ psychological, exercise or dietary 277 RCTs with mixed outcomes: one study reported a interventions. One study reported quality of life reduction in binge eating in patients prescribed improvements from treatment with the endocannabinoid rimonabant, while the bupropion/naltrexone plus behavioural 95 second study reported no improvement in binge modification. A second study reported eating or food cravings in patients prescribed the improvements in depression symptoms in antidepressant bupropion. patients receiving self-help CBT, sibutramine, self- help CBT plus sibutramine or CBT plus placebo, Similar to pharmacotherapy alone, studies that with no significant difference between groups. In included pharmacotherapy as an adjunct to a

nedc.com.au lifestyle intervention generally reported a reported in patients prescribed resulting improvement in weight loss, with the bupropion/naltrexone plus behavioural exception of listed medicines, which again modification (improved quality of life) and in produced ambiguous outcomes. Three studies patients prescribed the now banned assessed mental health outcomes and 2 studies endocannabinoid medication rimonabant assessed eating disorders outcomes with mixed (reduced binge eating). results. Of these, positive outcomes were

Table 3.5. Summary of pharmacological interventions for weight loss Pharmacotherapy Evidence base Consistency Clinical impact Weight loss outcomes Single interventions (overall) Excellent Good Good Registered medicines (overall) Good Good Good Anorectics Good Excellent Good Antidiabetics Satisfactory N/A Good Antidepressants Good Good Good Anticonvulsants Satisfactory N/A Satisfactory Listed medicines (overall) Satisfactory Poor Poor Vitamin D & calcium Satisfactory Poor Poor Sodium alginate Satisfactory N/A Poor Fatty acid supplements Good Good Poor Dietary protein Satisfactory N/A Poor Probiotics Satisfactory N/A Satisfactory Glucomannan supplement Satisfactory Good Poor Chromium supplement Satisfactory N/A Good Yeast hydrolysate Satisfactory N/A Satisfactory Gynostemma pentaphyllum Satisfactory N/A Poor extract Green tea extract Good N/A Poor Combined interventions (overall) Good Satisfactory Satisfactory Pharmacotherapy + Diet Satisfactory Satisfactory Satisfactory Pharmacotherapy + Exercise Satisfactory N/A Poor Pharmacotherapy + Behavioural Good Good Good Pharmacotherapy + Diet + Good Poor Poor Exercise + Behavioural Mental health outcomes Single interventions Satisfactory Poor Poor Combined interventions Satisfactory Poor Poor Eating disorders outcomes Single interventions Satisfactory Poor Poor Combined interventions Poor N/A N/A Note: Evidence base: Excellent = >1 SRs or >2 RCTs with low risk of bias; Good = 1-2 RCTs or 1 SR with low risk of bias; Satisfactory = SRs or RCTs with moderate risk of bias; Poor = SRs or RCTs with high risk of bias. Consistency: Excellent = all studies consistent; Good = mostly consistent; Satisfactory = some inconsistency; Poor = inconsistent; N/A = only 1 RCT. Impact: Excellent = very large; Good= substantial; Satisfactory = moderate; Poor = slight or restricted.

3.6. Bariatric surgery 3.6.1. Overview of bariatric surgery procedures restrictive procedures, that restrict gastric for weight loss volume, and consequently, the amount of food that can be consumed166. In Australia, the three Gastrointestinal surgery for obesity, also called most commonly performed bariatric procedures bariatric surgery, alters normal digestive are Roux-en-Y gastric bypass, laparoscopic sleeve processes to promote weight loss. Bariatric gastrectomy (LSG) and laparoscopic adjustable surgery procedures include two classes of 107 gastric banding (LAGB) . These and the other surgery: malabsorptive procedures, that limit the procedures evaluated in this review are most absorption of calories, proteins and nutrients, and commonly performed laparoscopically, via a

27 minimally invasive keyhole incision61. Bariatric higher complication rates than the alternatives, surgery reduces weight by reducing hunger, and as such, is generally reserved for “super increasing satiety, restricting food intake or obese” patients (BMI > 50kg/m2) or for those for causing a malabsorption of food197 via surgical whom other bariatric procedures have failed. alterations to the gastrointestinal tract61,197. The 182 most commonly used criteria for considering 3.6.2. Treatment outcomes of bariatric surgery 2 bariatric surgery is BMI > 40 kg/m , or BMI >35 interventions for weight loss kg/m2 with obesity related comorbidities171, Nine SRs and 6 RCTs evaluating exclusively although recent positive outcomes in the mild- surgical interventions for weight loss were moderate obesity range have provided support 2 48,221 included in this review. These studies ranged for lowering the BMI cut-off to <30 kg/m . from low to high quality and reported The bariatric procedures evaluated in this review predominantly positive weight loss outcomes. are briefly discussed below. Adverse effects were common across all

procedures. The Roux-en-Y gastric bypass (RYGB) is a combination procedure that restricts food intake What are the physical health outcomes associated via the creation of a small gastric pouch, and with bariatric surgery for weight loss? prevents full nutrient absorption via a bypass of the lower stomach, duodenum and first portion Most SRs (7 of 9) assessed outcomes from of the jujenum257. Collectively, these two surgical multiple surgical procedures, and a subset of components markedly reduce the functional these pooled outcomes across procedures. volume of the stomach61. RYGB is currently the Surgical outcomes, summarised broadly in SRs, most commonly performed surgical procedure for will be presented first, followed by outcomes per treating morbid obesity, representing 70-75% of intervention where this data was available. all bariatric procedures257. Compared with non-surgical interventions, Two procedures evaluated in this review that are bariatric surgery produced significant reductions primarily restrictive in nature are adjustable in body weight, fat mass and BMI across all gastric banding and sleeve gastrectomy. studies, regardless of procedure type. Using these Adjustable gastric banding (LAGB), considered the measures, a large Cochrane SR61 (assessing 22 least invasive purely restrictive procedure, limits RCTs) found that BDDS outperformed RYGB; RYGB food intake by placing an adjustable gastric band outperformed LAGB (over 5 years of assessment); around the top portion of the stomach61,257. The and RYGB, open-RYGB and LSG all produced band can be tightened or loosened over time similar outcomes. Similarly, gastric bypass without the need for additional surgery, allowing procedures (most notably RYGB) outperformed the patient to alter the level of restriction as gastric banding procedures in all 3 other SRs required. Gastric banding is reversible through a assessing these procedures57,152,228, and RYGB second minimally invasive keyhole operation. For produced similar outcomes to LSG in two patients that are considered high risk for bariatric SRs57,228. Complications were reported in all surgery, laparoscopic sleeve gastrectomy (LSG) is studies, and ranged from short-term and minor to often considered as the safest option61,257. This long-term and severe (requiring reoperation or procedure permanently removes a large, vertical causing death). Complications and complication section of the stomach, leaving behind a tube- rates varied with study, population and shaped stomach that is about 25% of its original procedure. Across bariatric surgery procedures, size. For some patients, the stomach may expand roughly 18% of patients developed complications, over time requiring additional (gastric bypass) 7% required rehospitalisation and reoperation surgery for optimal results. and 0.3% died postoperatively57. Gastric bypass procedures (such as the RYGB) were associated In contrast to the previously discussed with amongst the highest complication rates and procedures, the biliopancreatic diversion with postoperative mortality (21% and 4%, duodenal switch (BPD-DS) is primarily respectively), but amongst the lowest reoperation malabsorptive in nature61,257. A portion of the rates (3%). Compared with gastric bypass stomach is removed (via a sleeve gastrectomy) to procedures, LAGB and LSG had lower limit food intake, and a section of the small complication (~13%) and mortality (0.2 and 0.3% intestine is bypassed to reduce surface area for respectively) rates, but higher reoperation rates nutrient absorption. This partially reversible (12 and 9%)57. procedure is considerably more complex and has

nedc.com.au Laparoscopic sleeve gastrectomy was the primary One SR43 (assessing 3 RCTs) and 3 RCTs261,262,302 focus of 1 SR273 (assessing 15 RCTs) and 2 focusing on weight loss outcomes also reported RCTs143,302. These studies all reported significant mental health outcomes following bariatric reductions in weight, body fat and/or BMI. surgery. These studies reported improvements in Overall, these studies reported a complication quality of life across treatment groups (LSG and rate of 3.2302 to 9.2%273 with no mortalities. Both RYGB302; RYGB banded and unbanded43) as well as RCTs compared LSG with RYGB but reported in specific treatment groups (duodenal switch different outcomes: in one RCT302, RYGB outperforming gastric bypass)261. One study262 outperformed LSG in terms of weight loss, while also reported improvements in psychosocial the second RCT143 reported similar outcomes. functioning following gastric bypass and duodenal switch. Finally the remaining studies focused on RYGB, LGB, DS, or some combination of these What are the impacts of surgical interventions for procedures. One SR43 (assessing 3 RCTs) and 1 weight loss on eating disorders symptomatology? RCT301 compared banded to non-banded RYGB Two SRs assessed eating disorders outcomes with mixed outcomes. While the SR reported a from bariatric surgery. The first SR152 (assessing greater weight reduction in patients undergoing 19 RCTs) evaluated the impact of bariatric surgery banded RYGB in the intermediate term, the RCT on psychological functioning in morbidly obese reported no significant difference in weight individuals. This review reported overall reduction outcomes between procedures. Three improvements in eating behaviour and body RCTs120,261,262 compared RYGB to BPD-DS and image following bariatric surgery for weight loss, reported greater weight loss in patients who had but noted that not all bariatric surgery patients undergone BPD-DS. However, patients who had experienced improvements in mental health undergone BPD-DS also experienced significantly (discussed in greater detail in Section 4). The more complications, particularly adverse second SR67 (assessing 3 RCTs) reported a gastrointestinal effects. reduction in binge eating episodes up to 2 years

post-surgery, followed by an increase at further What are the mental health outcomes associated time points. with bariatric surgery loss?

Three SRs67,152,162 focused predominantly on 3.6.3. Summary of outcomes mental health and quality of life in obese patients Bariatric surgery is highly effective at reducing before and after bariatric surgery. One SR67 weight in overweight and obese adults. (assessing 3 RCTs) reported that bariatric surgery Compared with non-surgical interventions, was associated with lower rates and fewer bariatric surgery produced greater reductions in symptoms of mental health conditions. In body weight, fat mass and BMI across all studies, particular, depression was reduced following regardless of procedure type. All studies reported bariatric surgery in 11 of 12 studies (2 of which adverse effects that ranged from mild to severe, were RCTs), while rates of alcohol abuse with rates of complications, reoperation and increased relative to similar populations treated mortality varying with procedure type. Gastric non-operatively. A second SR152 (assessing 19 bypass procedures were generally associated with RCTs) reported a similar decrease in the greatest improvements in weight-related postoperative depressive symptoms along with outcomes, but also had the highest complication improvements in anxiety. However, long-term and mortality rates. Mental health and quality of outcomes were mixed, with some studies life were the primary focus of 3 SRs, and the reporting an improvement in depressive secondary focus of 1 SR and 3 RCTs. Overall, symptoms lasting upwards of 4 years, while other bariatric surgery led to improvements in quality studies reported an initial postoperative benefit of life and depressive symptoms, with some followed by a gradual decline. A third SR and 162 evidence for improvements in anxiety and meta-analysis (assessing 21 RCTs) compared psychosocial functioning. Two SRs reported mental health outcomes of bariatric surgery using overall improvements in eating behaviour, binge a specific assessment tool (the Short-Form 36). eating episodes and body image following This study reported a significant, consistent and bariatric surgery for weight loss. large-magnitude improvement in mental health quality of life following bariatric surgery at 1-year follow-up.

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Table 3.6. Summary of surgical interventions for weight loss Surgical interventions Evidence base Consistency Clinical impact Weight loss outcomes Roux-en-Y gastric bypass Good Satisfactory Good Laparoscopic sleeve Good Good Good gastrectomy Laparoscopic gastric banding Satisfactory Satisfactory Good Duodenal switch Satisfactory Satisfactory Good Mental health outcomes Excellent Good Good Eating disorders outcomes Excellent Satisfactory Good Note: Evidence base: Excellent = >1 SRs or >2 RCTs with low risk of bias; Good = 1-2 RCTs or 1 SR with low risk of bias; Satisfactory = SRs or RCTs with moderate risk of bias; Poor = SRs or RCTs with high risk of bias. Consistency: Excellent = all studies consistent; Good = mostly consistent; Satisfactory = some inconsistency; Poor = inconsistent; N/A = only 1 RCT. Impact: Excellent = very large; Good= substantial; Satisfactory = moderate; Poor = slight or restricted.

3.7. Other approaches 3.7.1. Overview of other approaches to weight a valuable adjunct to exercise and dietary 236 loss interventions for weight loss .

While lifestyle interventions, pharmacotherapy There is a small body of recent evidence that and surgery remain the primary approaches for suggests that bright light therapy, most commonly treating overweight and obesity, recent studies used to enhance mood in seasonal affective have also trialled traditional Chinese medicine disorder sufferers, may enhance the effectiveness (TCM), bright light therapy, and self-motivation of physical activity for weight loss. Bright light for change through the use of pedometers or self- exposure is believed to increase serotonin by weighing. In comparison to the other stimulating the retinohypothalamic tract, a neural interventions evaluated in this review, the pathway between the retina and serotonin- evidence base supporting these alternative producing regions in the brain, such as the dorsal interventions is small, and evaluated in only one raphe nucleus in the brainstem. In addition to or two studies. regulating mood, serotonin plays a role in

regulating body weight by promoting satiety Acupuncture and acupressure are the TCM approaches most commonly explored as 267 3.7.2. Treatment outcomes of other treatments for obesity . From the perspective of interventions for weight loss Western medicine, acupuncture and acupressure are conceptualised to alter neurotransmitter Five RCTs evaluating non-traditional interventions levels in the central nervous system by for weight loss were included in this review. stimulating peripheral nerves at specific These studies ranged from low to moderate ‘acupoints’. These peripheral nerves then relay quality and reported predominantly positive the signal to the spine and onwards to the brain outcomes with no adverse effects. where they stimulate the release of neurotransmitters, and subsequently, What are the physical health outcomes associated physiological changes155. Auricular acupuncture with other interventions for weight loss? and acupressure stimulate five acupoints in and Two RCTs126,147 assessing auricular acupressure around the ear that are thought to modulate reported positive weight outcomes, including appetite and satiety and induce calmness. reductions in weight and waist circumference.

Similarly, 1 RCT299 assessed auricular acupuncture The sympathetic nervous system, which governs and reported reductions in waist circumference the fight or flight response and contributes to and BMI with both five-point and hunger-point regulation of homeostasis, has recently been acupuncture, with no significant difference proposed to play a role in the onset and between groups. One RCT64 assessed the effects development of obesity through its mediation of of bright light therapy on body weight and energy balance and food intake39,235. Hot bathing, composition, and reported a small reduction in in waters above 42°C, activates the sympathetic percentage of body fat but not body weight. nervous system and has been hypothesised to be Finally, one RCT236 assessed the effects of hot

30 bathing on body weight and composition, and 3.7.3. Summary of outcomes found that the addition of hot bathing to a diet Non-traditional weight loss interventions and exercise regimen significantly improved evaluated in this review were acupressure, outcomes. acupuncture, bright light therapy and hot

bathing, which each included only 1-2 low or What are the mental health outcomes associated moderate quality RCTs. Reductions in weight- with other approaches to weight loss? related outcomes were reported in each 147 Only a single RCT assessed mental health intervention. The single RCT assessing a mental outcomes from other interventions for weight health outcome reported improvements in self- loss. This study reported improvements in self- efficacy in participants receiving auricular efficacy (a belief in our own ability to succeed) acupressure. None of the included studies following auricular acupressure for obesity reported on eating disorders outcomes or compared with no-acupressure controls. adverse effects.

What are the impacts of other interventions for weight loss on eating disorders symptomatology? There were no SRs or RCTs reporting eating disorders outcomes from other interventions for weight loss.

Table 3.7. Summary of other interventions for weight loss Other interventions Evidence base Consistency Clinical impact Weight loss outcomes Acupressure Poor Good Satisfactory Acupuncture Satisfactory N/A Good Bright light therapy Satisfactory N/A Poor Hot bathing (+ Diet + Exercise) Satisfactory Poor Satisfactory Mental health outcomes Poor N/A Poor Eating disorders outcomes N/A N/A N/A Note: Evidence base: Excellent = >1 SRs or >2 RCTs with low risk of bias; Good = 1-2 RCTs or 1 SR with low risk of bias; Satisfactory = SRs or RCTs with moderate risk of bias; Poor = SRs or RCTs with high risk of bias. Consistency: Excellent = all studies consistent; Good = mostly consistent; Satisfactory = some inconsistency; Poor = inconsistent; N/A = only 1 RCT. Impact: Excellent = very large; Good= substantial; Satisfactory = moderate; Poor = slight or restricted.

3.8. Treatment for adolescents high quality and reported predominantly positive outcomes with few adverse effects. 3.8.1. Overview of weight loss interventions for adolescents What are the physical health outcomes associated Reduced energy consumption and increased with weight loss interventions for adolescents? physical activity are the basis for obesity Two RCTs assessed dietary interventions for interventions for adolescents, as they are for weight loss in obese adolescents. One study284 adults. Pharmacological and surgical interventions prescribed a high-protein breakfast to obese are considered in more severe or treatment- Chinese adolescents and reported significant resistant cases. Since intervention types parallel weight loss compared with individuals consuming those available for adults and have been a standard breakfast. The second study29 described in the preceding sections, this section prescribed meal replacements (SlimFast shake will focus only on treatment outcomes. consumed 3x daily) and reported significant weight loss at 4 but not 12 months compared 3.8.2. Treatment outcomes of interventions for with conventional-diet controls. weight loss in adolescents Four SRs and 13 RCTs evaluating weight loss Three RCTs evaluated exercise interventions for weight loss in overweight and obese adolescents. interventions for adolescents were included in 250 this review. These studies ranged from low to One study assessed aerobic and resistance training and reported significantly greater weight

31 loss in exercise groups compared with no-exercise The second study68 reported small but significant controls. The second study98 reported no reductions in BMI in obese adolescent females statistical difference in weight loss or body participating in multi-component (diet + exercise composition between overweight or obese + counselling) lifestyle interventions compared adolescents cycling to music or cycling as part of a with usual-care controls. The third study272 video game. The third study280 reported no reported significant reductions in body weight, significant weight reduction in obese adolescents waist and hip circumference in obese adolescents participating in a dance-based exergaming (video participating in a school-based behavioural game exercise) program compared with wait list intervention program consisting of nutritional and controls. exercise education and dietary modification, compared with education-booklet controls. One SR and 1 RCT assessed pharmacotherapy for weight loss in overweight and obese adolescents. Finally, 1 SR38 and 1 RCT30 evaluated the The SR41 reported small but significant weight loss combination of pharmacological and behavioural/ in non-diabetic obese adolescents prescribed the psychological therapy interventions. The SR antidiabetic medication metformin. No adverse reported a significant reduction in BMI in effects were reported. The RCT145 assessed the overweight or obese adolescents prescribed the glucagon-like peptide 1 receptor agonist exanitide antidiabetic metformin as part of a lifestyle in severely obese adolescents, and reported intervention. Similarly, the RCT reported a significantly greater weight and BMI reductions significant reduction in BMI in overweight or compared with placebo pill controls. A number of obese adolescents prescribed the anorectic adverse effects were reported, including short sibutramine plus behavioural counselling, term nausea, abdominal pain, diarrhoea, compared with behavioural-counselling plus headache, and vomiting. placebo controls. Weight loss was comparable between individuals with and without binge Two SRs assessed bariatric surgery for weight loss eating during the 12 months of treatment. in obese adolescents. One SR31 reported significant short-term weight loss in adolescents What are the mental health outcomes associated following bariatric surgery. The second SR290 with weight loss interventions for adolescents? reported significant reductions in BMI following One SR and 5 RCTs evaluated mental health LAGB. However, both studies included only a outcomes associated with weight loss single RCT each which limits interpretation of interventions for adolescents. Improvements in results. Both studies reported adverse effects, quality of life were reported following LAGB290 including nutrient deficiencies, hernias, wound and combined CBT and exercise125, while infections, small bowel obstructions and ulcers. improvements in psychosocial functioning

(improved perception of self and social The remaining studies included combinations of competence) were reported following exercise dietary, exercise, behavioural/ psychological and interventions (cycling exercise98 and dance based pharmacological interventions. One RCT124 exergaming280). Combined diet, exercise and evaluated the combination of exercise and behavioural/ psychological interventions led to behavioural/ psychological therapies. This study improvements in depressive symptoms272, reported a long-term reduction in BMI compared improved body satisfaction and decreased with usual-care controls. Another RCT150 internalisation of female norms68. evaluated the combination of diet and behavioural/ psychological therapies. This study What are the eating disorders outcomes reported reductions in weight, BMI and waist associated with weight loss interventions in circumference in participants receiving dietary adolescents? counselling and a low glycaemic index diet compared with standard-diet controls. Three RCTs evaluated eating disorders outcomes from weight loss interventions for adolescents. Three RCTs evaluated the combination of diet, One study98 prescribed twice weekly aerobic exercise and behavioural/ psychological fitness (stationary or interactive video game therapies. The first study40 reported significant cycling) to obese adolescents and observed a weight loss in overweight and obese adolescents positive association between changes in fitness participating in CBT interventions that included and psychosocial functioning, including motivational interviewing, diet and exercise improvements in body image and social advice, compared with no-treatment controls. competence. The second study68 assigned

nedc.com.au overweight and obese girls to a primary-care weight or a related measure was dance-based based, multi-component lifestyle intervention exergaming. A number of studies reported specifically targeting overweight adolescent significant short-term results that dissipated at females, and reported significant improvements longer-term follow-ups. Adverse effects, ranging in body image compared with usual-care controls. from mild to severe, were reported in 2 SRs on The third study30 assigned behavioural weight loss bariatric surgery and 1 RCT prescribing the plus an anorectic (sibutramine) to ethnically glucagon-like peptide 1 receptor agonist exanitide diverse obese adolescents with and without binge to severely obese patients. Mental health was eating behaviours, and reported an improvement assessed in a 1 SR and 4 RCTs, which reported in cognitive restraint and disinhibition (loss of improvements in quality of life, psychosocial control over eating) in individuals with and functioning, depressive symptoms, body without initial binge eating behaviours. satisfaction and internalisation of female norms. Improvements in eating disorders outcomes were 3.8.3. Summary of outcomes reported in 3 RCTs, including improvements in body image, social competence, cognitive Weight loss interventions targeting overweight restraint and disinhibition. and obese adolescents were largely effective at improving body weight and related measures. The only trialled intervention that did not reduce

Table 3.8. Summary of weight loss interventions for adolescents Summary Assessment Evidence base Consistency Clinical impact Weight loss outcomes Diet Satisfactory Good Satisfactory Exercise (aerobic) Satisfactory Poor Satisfactory Behavioural (CBT) Satisfactory N/A Satisfactory Pharmacological (antidiabetics) Satisfactory Good Good Surgical Good Satisfactory Satisfactory Lifestyle (diet, exercise and/or Satisfactory Good Satisfactory behavioural) Lifestyle + Pharmacological Satisfactory N/A Satisfactory Mental health outcomes Satisfactory Good Satisfactory Eating disorders outcomes Satisfactory Good Good Summary of outcomes from weight loss treatments for adolescents. Evidence base: Excellent = >1 SRs or >2 RCTs with low risk of bias; Good = 1-2 RCTs or 1 SR with low risk of bias; Satisfactory = SRs or RCTs with moderate risk of bias; Poor = SRs or RCTs with high risk of bias. Consistency: Excellent = all studies consistent; Good = mostly consistent; Satisfactory = some inconsistency; Poor = inconsistent; N/A = only 1 RCT. Impact: Excellent = very large; Good= substantial; Satisfactory = moderate; Poor = slight or restricted

3.9. Strengths and limitations that they reviewed or inconsistent outcomes23,57,139. Second, some studies contained To our awareness, this is the first review to a moderate to high risk of bias due to lack of systematically examine physical, psychological double-blinding and inappropriate or poorly and eating disorders outcomes from weight loss described methods of randomisation. Studies that interventions. This study evaluated a large are not double-blinded contain a higher risk of number of high quality SRs and RCTs using being influenced by the placebo effect132, and structured methods for article retrieval and their results should be interpreted with an added evaluation. However, there were limitations in level of caution. Third, many studies used small the studies evaluated in this review that must be sample sizes and samples tended to be gendered taken into account when interpreting outcomes (predominantly female) and racialised (e.g., see Tables 3.1-3.11 for a summary of the (predominantly Caucasian), limiting breadth, quality, consistency and clinical impact generalisability of the conclusions drawn. Finally, of the evidence base for each intervention type). although many studies and reviews reported First, the heterogeneity RCTs included in statistically significant results for the impact of evaluated SRs was often high enough to preclude 139 various treatments on obesity, the size of this data pooling for meta-analysis . A number of effect, and therefore the clinical relevance, was SRs reported either inconsistency in the studies often small.

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4. Summary and discussion

4.1. Overview of research findings Lifestyle interventions included various combinations of diet, exercise and behavioural/ Physical health outcomes from weight loss psychological components and produced mixed interventions outcomes. Combinations including diet plus The most common measure of obesity exercise and diet plus exercise plus behavioural/ intervention success is the amount of weight lost. psychological components produced consistent In this review, and consistent with the large reductions in weight, but behavioural/ literature on the topic, the amount of weight lost psychological components combined with diet or varied considerably with intervention type. exercise yielded mixed weight loss outcomes. No Surgical interventions consistently resulted in adverse effects were reported. significant weight loss across all procedures and demographics (adolescents and adults), but also Pharmacological interventions were broadly consistently resulted in adverse effects which divided into registered medicines and listed (or ranged from relatively minor (e.g., nausea) to ‘complimentary’) medicines, and assessed more severe (requiring reoperation or causing individually as well as in combination with the mortality). above mentioned interventions. Registered medicines, including anorectics, antidepressants, Dietary interventions produced mixed weight-loss anticonvulsants and antidiabetics, were highly outcomes. The most positive results were and consistently effective at reducing weight, reported in studies in which participants received however, in all but one study also produced very-low-calorie ketogenic diets, high-protein adverse effects that ranged from mild to severe. diets or portion-controlled diets, although in most One study prescribed an anorectic plus cases this effect was not sustained, and in the behavioural weight loss to obese individuals with case of ketogenic diets, also produced temporary and without BED, and reported improvements in adverse effects. Exercise interventions produced individuals without BED only. In contrast, listed more positive outcomes (weight loss in all but “complimentary” medicines produced fewer one trial) and no adverse effects were reported. adverse effects but were considerably less Likewise, behavioural and psychological effective, with less than half of all studies interventions produced weight reductions in the resulting in weight reduction. Similarly, the majority of studies assessing behavioural weight addition of pharmacotherapy to lifestyle loss (commercial and non-commercial interventions typically improved weight loss programmes), mindfulness-based programmes, outcomes for registered medicines and had and acceptance-based behavioural programmes. ambiguous outcomes for listed medicines. Mixed outcomes were observed for motivational interviewing and technology-based interventions.

Table 4.1. Summary of all weight loss interventions Summary Assessment Evidence Base Consistency Clinical Impact Diet Satisfactory Good Satisfactory Exercise Good Good Good Behavioural Good Good Satisfactory Pharmacotherapy Excellent Good Good Surgical Excellent Good Excellent Lifestyle (diet, exercise and/or Satisfactory Satisfactory Good behavioural)Lifestyle + Pharmacotherapy Good Satisfactory Satisfactory Note: Evidence base: Excellent = >1 SRs or >2 RCTs with low risk of bias; Good = 1-2 RCTs or 1 SR with low risk of bias; Satisfactory = SRs or RCTs with moderate risk of bias; Poor = SRs or RCTs with high risk of bias. Consistency: Excellent = all studies consistent; Good = mostly consistent; Satisfactory = some inconsistency; Poor = inconsistent; N/A = only 1 RCT. Impact: Excellent = very large; Good= substantial; Satisfactory = moderate; Poor = slight or restricted.

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Mental health outcomes from weight loss confusion (following pharmacotherapy) and interventions psychosocial functioning (following bariatric surgery). The majority of research exploring the efficacy of weight loss interventions lacked assessment of While the psychological outcomes were largely psychological changes associated with weight positive across intervention types, very few loss. In studies that did include a measure of studies directly assessed the relationship mental health, the outcomes were predominantly between actual weight loss and degree of positive. The most common outcome observed in improvement in psychological outcomes. Mood all intervention types was an improvement in improvements in clinical trials may be due to a quality of life, followed by improvements in number of factors, such as the supportive depression symptoms (in behavioural and treatment context or behavioural and psychological interventions, pharmacotherapy psychological changes brought on by the and surgery only). A smaller body of evidence treatment rather than weight loss per se130. supported improvements in anxiety, fatigue and

Table 4.2. Summary of all weight loss interventions Summary Assessment Evidence Base Consistency Clinical Impact Diet Poor N/A Satisfactory Exercise Poor N/A Satisfactory Behavioural Satisfactory Poor Satisfactory Pharmacotherapy Satisfactory Poor Poor Surgical Excellent Good Good Lifestyle (diet, exercise and/or Satisfactory Poor Poor behavioural)Lifestyle + Pharmacotherapy Satisfactory Poor Poor Other interventions Poor N/A Poor Note: Evidence base: Excellent = >1 SRs or >2 RCTs with low risk of bias; Good = 1-2 RCTs or 1 SR with low risk of bias; Satisfactory = SRs or RCTs with moderate risk of bias; Poor = SRs or RCTs with high risk of bias. Consistency: Excellent = all studies consistent; Good = mostly consistent; Satisfactory = some inconsistency; Poor = inconsistent; N/A = only 1 RCT. Impact: Excellent = very large; Good= substantial; Satisfactory = moderate; Poor = slight or restricted.

Impacts of obesity treatment on eating disorders produce clinically significant outcomes in any instance. No studies of dietary and exercise The impact of weight loss interventions on eating interventions reported on eating disorders disorders outcomes was rarely assessed. Studies outcomes. of behavioural and psychological interventions and lifestyle interventions for weight loss Due to the shortage of high quality SRs and RCTs reported consistent improvements (across 5 assessing eating disorders outcomes from weight RCTs) in cognitive restraint, control over eating or loss interventions, we draw upon a broader binge eating. In contrast, bariatric surgery literature base to further explore this key resulted in improvements in eating behaviour and question in section 4.2. body image that were not sustained over the long-term, while pharmacotherapies did not

Table 4.3. Summary of all weight loss interventions Summary Assessment Evidence Base Consistency Clinical Impact Diet N/A N/A N/A Exercise N/A N/A N/A Behavioural Satisfactory Good Good Pharmacotherapy Satisfactory Poor Poor Surgical Excellent Satisfactory Good Lifestyle (diet, exercise and/or Satisfactory N/A Satisfactory behavioural)Lifestyle + Pharmacotherapy Poor N/A N/A Other interventions N/A N/A N/A Note: Evidence base: Excellent = >1 SRs or >2 RCTs with low risk of bias; Good = 1-2 RCTs or 1 SR with low risk of bias; Satisfactory = SRs or RCTs with moderate risk of bias; Poor = SRs or RCTs with high risk of bias. Consistency: Excellent = all studies consistent; Good = mostly consistent; Satisfactory = some inconsistency; Poor = inconsistent; N/A = only 1 RCT. Impact: Excellent = very large; Good= substantial; Satisfactory = moderate; Poor = slight or restricted.

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4.2. Discussion Numerous treatment strategies exist to assist However, this benefit is not universal, and people in losing weight. As with prior approximately 20% of patients undergoing reports87,157,229, lifestyle interventions bariatric surgery fail to achieve clinically incorporating dietary, exercise and behavioural or significant weight loss or experience a worsening psychological components were the most in psychological outcomes152,254,255. For certain commonly recommended first-line approach, individuals who lose large amounts of weight, with escalation to pharmacotherapy and bariatric loose, sagging and excess skin may contribute to surgery in more severe or treatment-resistant worsening body image. For example, one study cases. Bariatric surgery and registered medicines found that over two thirds of post-bariatric consistently reduced weight but were also surgery patients viewed the development of associated with adverse effects that ranged from excess skin to be a negative outcome of mild to severe, while exercise, dietary treatment, and for some, a motivator to seek interventions and behavioural/ psychological plastic surgery242. Further, a growing literature interventions produced mixed weight loss demonstrates that bariatric surgery patients have outcomes but had few adverse effects. significantly higher suicide rates than the general Improvements in quality of life, and in some cases population121,219,271. depression, where reported in a subset of studies of all intervention types, while improvements in A recent Australian study of bariatric surgery eating disorders symptoms were reported candidates reported that 13.5% of individuals consistently only in interventions incorporating met the DSM-IV criteria for BED178, while other behavioural or psychological treatments. Given studies reported subthreshold disordered eating the reciprocal relationship between obesity and behaviours (such as Night Eating Syndrome, mental health and the benefits of behavioural grazing and uncontrolled eating) in the pre- and psychological interventions on eating surgical population that were likely to exceed disorders outcomes, overweight and obesity these rates60,243. Since binge eating disorder and interventions that incorporate these components disordered eating pre-surgery are associated with would provide a more balanced approach than increased disordered eating post-surgery244, poor the traditional focus on weight loss alone. weight loss outcomes, surgical complications and psychological distress60,71,160,194, it is vital that Special consideration should be given to clinicians are informed about the overlap evaluations of adolescent obesity treatment. between these populations. Overweight and obese young people are more vulnerable to a range of physical and The prevalence of disordered eating symptoms psychological co-morbidities than their normal- such as specialised diets, episodic vomiting and weight peers98 and obesity during childhood nutrient deficits is often seen in post-bariatric increases the probability of obesity during surgery patients303, and certain postoperative adulthood40. Young people who engage in weight symptoms may lead patients to engage in loss behaviours are at increased risk of restrictive or compensatory behaviours to developing eating pathologies in later life142, mitigate the discomfort from consuming foods including a higher risk of binge eating and that are difficult to tolerate post-surgery303. For associated weight gain75. Consequently, weight example, post-operative patients may adopt loss interventions for young people play an vomiting behaviour after meals as a means to important role in improving health in the present reduce discomfort from consuming newly as well as reducing the burden of disease indigestible foods, or as a means of accelerating associated with obesity in adulthood98. weight loss303. Together, these factors make it challenging to distinguish between normal post- In Australia, the use of surgical procedures to surgery eating behaviours and eating pathology, treat obesity has risen dramatically in recent since many such changes in eating behaviour are years18. Consistent with recent obesity guidelines necessitated by the surgery and even encouraged (NHMRC, 2013192) our review found bariatric by clinicians62,166. Further, it is possible that surgery to be the most effective intervention for disordered eating that has developed as a sustained weight loss, and the majority of studies response to gastrointestinal symptoms may that included an assessment of psychological eventually trigger the onset of an eating outcomes reported improvements, primarily in disorder110. In light of these behaviours and the quality of life and depression symptoms. increased vulnerability of the post-surgical

36 population, clinicians should ensure that long- term follow-ups include an assessment of the motivations for abnormal eating behaviours, separating behaviours motivated by physical discomfort from behaviours motivated by weight and shape concerns.

Concerns have previously been raised that dieting may precipitate eating disorders in overweight and obese individuals293, however, the studies evaluated in this review do not support this suggestion. Our finding are in line with previous reviews122,183 which conclude that professionally administered weight-loss programmes do not increase the risk or symptoms of eating disorders. However, a large body of evidence52,66,131 reports harms from unhealthy dieting behaviours, which confer a 5- to 18-fold risk for the development of eating disorders. It is important that clinicians are aware of the increased risk for harm in individuals engaging in unhealthy dietary practices, and monitor individuals to ensure that healthy diets do not transition into unhealthy diets.

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5. The way forward: An integrated approach

Numerous factors contribute to the development physical exercise35,158,227. In doing so, these and maintenance of overweight and obesity, campaigns may inadvertently stigmatise the including genetic, metabolic, biochemical, individuals they intend to help, and may be a risk physiological, psychological and environmental factor in the development of eating factors78. The presence of disordered eating and disorders79,246. eating disorders in a significant portion of the obese population complicates the situation Both obesity and eating disorders would benefit further1. These complex causal features make it from a reduction in the stigma and negativity that unlikely that researchers or clinicians will identify obesity attracts. Stigma increases levels of body a weight-loss panacea that will be successful for dissatisfaction, which in turn increases depressive all obese patients. Rather, the way forward symptomatology and can play a determining role requires a multidisciplinary approach that takes in both quality of life and treatment into account the various factors underlying outcomes76,92,264. A collaborative approach to obesity and eating disorders, as well as the overweight and obesity reduction that addresses factors confounding treatment outcomes. weight stigma and promotes healthy eating practices without encouraging dieting or weight Recent studies indicate that comorbid eating preoccupation would be a valuable first step to disorders and obesity are on the rise. A recent improving the health of individuals of all population survey in South Australia reported weights188. Conscientious prevention that comorbid obesity and eating disorders interventions that integrate media literacy, body- behaviours have increased 4.5 times between satisfaction and self-esteem with messaging on 1995 to 2005, with one in five individuals with general healthy eating and physical activity for obesity also presenting with comorbid disordered enjoyment may improve outcomes while eating. Further, cross-sectional and longitudinal reducing weight stigma and other unintentional studies indicate that individuals may progress harms. On a practical level, integrated campaigns from one weight-related problem to another over aimed at preventing the spectrum of eating- and time86,186,193. Both obesity and eating disorders weight-related problems would be time- and carry a significant personal and public health cost-effective130,187, would improve coherence in burden, in terms of decreased health and quality messaging (and reduce harms from conflicting of life and increased use of health messaging)188, and would create a valuable services4,118,154,175, which is compounded for avenue for discourse between sectors. individuals with comorbid obesity and eating disorders. These individuals face the added 5.1. Recommendations for Practice difficulty of receiving care for both the medical There is an increased need for prevention and complications associated with obesity and the treatment interventions that target the broad psychosocial functioning difficulties associated 65 spectrum of weight-related disorders. This with eating disorders . necessarily requires dialogue and collaboration between professionals in obesity and eating The reasons for such a large increase in comorbid disorders sectors, as well as the involvement of obesity and eating disorders in a relatively short stakeholders at all levels of community and period of time are unclear, but media and weight- government. Existing and new treatments should reduction campaigns have been suggested as 65 be grounded in evidence and should include long- precipitating factors . The media plays an term follow ups which incorporate routine important role in propagating sociocultural assessments of psychological well-being alongside pressures to attain an ideal body image, and weight-related measures. numerous studies have demonstrated a causal link between levels and types of media exposure Better training of health professionals and body dissatisfaction189,256,287. Likewise, weight-reduction campaigns in the form of Awareness by all health professionals of shared community-based interventions and social risk factors would help mitigate harms. For marketing often emphasise the desirability of an example, the identification of an effective ideal body weight or shape through dieting and pharmacological weight loss agent would be a

nedc.com.au positive development for the obesity sector but common forms of disordered eating following may be a cause for concern for eating disorders bariatric surgery, may resurface two years after professionals, as such an agent carries the the procedure216. These findings highlight the potential for abuse by individuals with eating need for long-term monitoring and maintenance disorders122. Health professionals interacting with sessions, which are initiated earlier following eating disorders or overweight populations completion of a treatment program, to ensure should be informed about the physical and that individuals maintain healthy behaviours. psychological features of both conditions, as well as the significant shared space between them. Improve postsurgical follow-up care Cross-training between specialists in both sectors, The development of eating disorders following such as through shared conferences or bariatric surgery is an uncommon but serious workshops, would ensure that those in the postoperative issue that requires special obesity field learn about eating disorders and vice attention by practitioners recommending or versa190. performing these procedures166. A small body of

literature supports the use of behavioural and Certain individuals, such as young women82, will cognitive approaches for patients who develop be at greater eating disorders risk, and health symptoms of anorexia nervosa or bulimia professionals should be able to identify nervosa13,149,245, but clinicians should be aware of vulnerable overweight or obese individuals and the difficulties they may encounter when treating adapt treatment appropriately. Further, some post-bariatric eating pathologies. These include signs and symptoms of eating disorders may the challenges of navigating healthy eating initially present as treatment benefits. For behaviours in patients facing postsurgical food example, increased physical activity and control intolerance and discomfort, fear of gaining and discipline over biological urges may be weight, and intense management of weight and viewed as positive outcomes from weight body image concerns15. Additionally, since reduction interventions, but are also a sign of repeated vomiting, laxative abuse and fasting can increasing disease severity for individuals with all have severe medical repercussions, clinicians anorexia nervosa269. should be knowledgeable of the signs of

symptoms of disordered eating and ensure that Incorporate evidence based treatment strategies post bariatric patients are informed and have into obesity care access to help should they require it. Treatment strategies for obesity should be evidence based and comprehensive, taking into 5.2. Recommendations for Research account a broader range of health outcomes than weight or BMI alone34. Given the benefits of There is significant overlap between weight- behavioural and psychological interventions on related disorders that warrants increased eating disorders outcomes and weight loss, research. Future studies should endeavour to weight loss interventions should incorporate improve study quality and consistency these components into a more holistic program (particularly between outcome measures), and of care. Treatments should follow a chronic adopt a multidisciplinary approach that integrates disease model of care that progresses from the perspectives from specialists across sectors. use of micro-environmental and lifestyle interventions through to more intensive Develop a well-validated psychometric measure of interventions alongside the severity of obesity281. disordered eating for patients seeking weight loss Importantly, psychological and physical There is considerable variability in the range of comorbidities should be managed concurrently diagnostic criteria and eating disorders measures with weight to maximise outcomes in both currently employed. The validation of a 107 physical health and quality of life , and when psychometric tool is dependent on the population disordered eating is detected, stabilisation of of interest and the purpose of assessment, and a eating disorders symptoms should precede and measure validated in one context may not be run alongside the weight loss program. valid in another. Current measures targeting traditional eating disorders populations should be Although psychological outcomes often improve adapted to populations seeking weight loss to following weight loss, there are reports that risk encompass eating attitudes, cognitions and of suicide is increased following bariatric behaviours that may be unique to this population. 242 surgery , and binge eating, one of the most Since outcomes can vary with measure type, care

39 must be taken to select the appropriate comprehensive metric of success following measures. These measures should be openly obesity interventions should include measures of disseminated, and importantly, should be overall mental health alongside measures of integrated into a routine screening procedure weight reduction and changes in body during patient follow-ups. composition190.

Develop a more comprehensive metric for Increase research into the psychological and treatment success eating disorders outcomes of weight loss interventions Overweight and obesity are normally measured by weighing individuals and recording BMI. The evidence evaluated in this review highlights However, BMI is an imperfect measure153,201 and the need for more research into the psychological there is currently a lack of consensus about what outcomes of weight loss interventions and the an ‘ideal’ BMI is, particularly for individuals losing significant overlap between obesity and eating large amounts of weight70,148. The emphasis that disorders. In particular, research focusing on the is currently placed on external measures of health development of standardised tools for eating such as BMI may also detract from other disorders assessment in the weight loss context important measures of health, such as physical and the identification of shared modifiable risk activity and well-being47. Additionally, the factors for both conditions would contribute to a suitability of a measure in one context does not more holistic model of care. Future studies should imply suitability in all contexts. For instance, target a wider population base (studies were psychological outcomes may be of greater predominantly female and Caucasian) and include importance than physiological outcomes when longer-term follow-ups since both weight and determining the success of behavioural weight mental health are susceptible to relapse once loss programs156. The development of a more removed from the supportive treatment context.

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Appendices

Appendix A: Level of evidence

Level I A systematic review of randomised controlled trials Level II At least one well-designed randomised controlled trial Level III-1 A well-designed pseudo-randomised controlled trial Level III-2 A comparative study with concurrent controls: ● Non-randomised experimental trial ● Cohort study ● Case-control study ● Interrupted time series with a control group Level III-3 A comparative study without concurrent controls: ● Historical control study ● Two or more single arm study ● Interrupted time series without a parallel control group Level IV Case series with either post-test or pre-test and post-test outcomes The level of evidence scheme adopted a priori for this review was developed by the National Health and Medical Research Council191. This review contains only Level 1 and Level II items.

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Appendix B: Systematic Review Assessment Procedure

Overview quality assessment questionnaire (OQAQ) Items 1. Were the search methods reported? 2. Was the search for evidence reasonably comprehensive? 3. Were the study inclusion criteria reported? 4. Was selection bias avoided? 5. Were the criteria for assessing study validity reported? 6. Was assessment of study validity appropriate? 7. Were methods to combine studies reported? 8. Were the findings of studies combined appropriately? 9. Were the conclusions supported by the data/analysis?

Scoring: We adapted the scoring of the OQAQ207 to produce a quality rating of high (all criteria were met), moderate (>5 criteria were met items), or low (<5 criteria were met).

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Appendix C: RCT assessment procedure

Jadad Scale 1. Was the study described as randomised (this includes words such as randomly, random, and randomisation)? (+1) 2. Was the method used to generate the sequence of randomisation described and appropriate (table of random numbers, computer-generated, etc)? (+1) 3. Was the study described as double blind? (+1) 4. Was the method of double blinding described and appropriate (identical placebo, active placebo, dummy, etc)? (+1) 5. Was there a description of withdrawals and dropouts? (+1) 6. Deduct one point if the method used to generate the sequence of randomisation was described and it was inappropriate (e.g. patients were allocated alternately, or according to date of birth, hospital number, etc). (+1) 7. Described but inappropriate (-1) 8. Deduct one point if the study was described as double blind but the method of blinding was inappropriate (e.g. comparison of tablet vs. injection with no double dummy). (+1) 9. Described but inappropriate (-1)

Scoring: We adapted the scoring of the Jadad scale132 to produce a quality rating of high (score of 5), moderate (score of 3-4) or low (score of 0-2).

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Appendix D: Evidence summary procedure

NHMRC Body of Evidence Matrix

Excellent Good Satisfactory Poor

SRs/RCTs with Several high quality 1-2 high quality SRs/RCTs with low moderate quality SRs/RCTs with low SRs/RCTs studies quality and/or Evidence base and/or moderate risk of bias with low risk of bias high risk of bias risk of bias Some Most studies inconsistency, Inconsistent All studies consistent and reflecting genuine evidence Consistency consistent inconsistency uncertainty accounted for around question Clinical impact Very large Moderate Slight Restricted

The evidence summary procedure was adapted from the NHMRC Levels of evidence and grades for recommendations for developers and guideliens191. SR= Systematic review; RCT= randomised controlled trial. When only a single RCT was available for an intervention, consistency was scored as N/A. When a single SR was available, consistency was scored based on the consistency between RCTs evaluated in the SR.

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Appendix A: Systematic reviews

Systematic reviews meeting inclusion criteria for the evidence review

Study Features Objective & Interventions Summary of outcomes Adverse effects

First author: Astell Study questions/objective:  The evidence reviewed for the Adverse events Publication/Search year: 2013/2012  To determine the impact of efficacy of plant extracts in included disturbance N studies: 14 (all RCTs) natural supplements on appetite weight loss was inconclusive of skin sensation, Demographic: Obese adults and subsequent weight loss  The only exceptions were headache, dizziness, Caralluma fimbriata extract nausea, flushing, Inclusion criteria: Double-blind RCTs Interventions included and a combination supplement vomiting, fatigue, with n>20; 2+ week interventions;  Appetite suppressant plant containing Garcinia cambogia flatulence, bloating, measurable outcomes on appetite or extracts plus Gymnema sylvestre, which injury/poisoning and food intake and anthropometry had promising short-term respiratory infection results

Notes and/or limitations: No assessment of study validity reported; no attempt to pool data in meta-analyses; weak quality of include studies.

First author: Baillot Study questions/objective:  Combined diet + exercise is None reported Publication/Search year: 2014/2012  To determine the impact of more effective than diet alone N studies: 40 (8 RCTs) physical activity on body at reducing weight, waist Demographic: Obese adults composition and quality of life circumference and body fat outcomes  Regular physical activity is Inclusion criteria: Obese adults  To identify the research gaps and positively associated with waiting to undergo bariatric surgery; priorities regarding the impact of health outcomes studies with a physical activity regular physical activity intervention; reporting of  Due to the limited quantity and quality of studies in this anthropometric parameters, body Interventions included review, no strong conclusions composition, cardiometabolic risk  Any physical activity/exercise can be drawn from this study factors, QOL or psychological intervention parameters Exclusion criteria: Studies with weight-loss as the only outcome

Notes and/or limitations: Data could not be pooled for meta-analyses due to high heterogeneity and small sample sizes.

First author: Baillot Study questions/objective:  Lifestyle interventions led to None reported Publication/Search year: 2015/2012  To determine the impact of significant improvements in fat N studies: 56 (7 RCTs) lifestyle interventions (exercise, mass and waist circumference Demographic: Adults with class II and counselling and education) on  Improvements were greater III obesity physical and psychological for long-term interventions outcomes Inclusion criteria: Reported on either than intermediate- or short- term interventions a physical or psychological outcomes. Interventions included  Lifestyle interventions did not Exclusion criteria: None reported  Physical activity and exercise have a significant impact on  Counselling and education quality of life

Notes and/or limitations: The study methods and outcomes were highly heterogeneous.

First author: Barnes Study questions/objective:  The evidence reviewed for the None reported Publication/Search year: 2015/2014  To determine the impact of efficacy of motivational N studies: 24 RCTs motivational interviewing on interviewing for weight loss Demographic: Overweight or obese weight loss was inconsistent adults  Half of the included studies Interventions included reported no weight loss in Inclusion criteria: RCTs of  Motivational interviewing participants receiving motivational interviewing in a primary motivational interviewing care setting where weight was an (compared with controls), outcome variable while the remainder showed Exclusion criteria: Studies that only some or significant weight loss included baseline data; studies that did not include post treatment data; studies set in specialty care rather than primary care; studies that included paediatric or adolescent samples

Notes and/or limitations: No assessment of study validity; few studies reported treatment fidelity; high variability in outcomes.

nedc.com.au Study Features Objective & Interventions Summary of outcomes Adverse effects

First author: Black Study questions/objective:  Bariatric surgery led to Adverse effects were Publication/Search year: 2013  To determine the impact of significant short-term weight specific to the type of N studies/subjects: 23 (1 RCT)/637 (50 bariatric surgery on children loss in children and bariatric surgery in RCT) adolescents overall performed. These Interventions included Demographic: Children and  In the single RCT included included nutrient  Bariatric surgery 198 adolescents (6-18 years) here , weight loss was deficiencies, hernias,

significantly higher in wound infections, Inclusion criteria: Assessed weight participants randomised to small bowel within 6 months of receiving bariatric surgery than control (lifestyle obstructions and surgery program) ulcers Exclusion criteria: Non-sequential case series and studies with less than 10 individuals

Notes and/or limitations: Only one RCT of adolescent bariatric surgery with small sample size (N=50) was included in this SR. This RCT had a high attrition in the non-surgical arm (28% withdraw post-randomisation, possibly introducing bias).

First author: Booth Study questions/objective:  Behavioural interventions led None reported Publication/Search year: 2014  To determine the impact of to very small reductions in N studies/subjects: 15 RCTs/4539 behavioural interventions body weight which were Demographic: Overweight or obese delivered in a primary care unlikely to be clinically adults setting on body weight significant

Inclusion criteria: RCTs conducted in a Interventions included primary care setting; studies in which  Behavioural interventions weight loss was measured as an targeting diet and exercise outcome Exclusion criteria: Studies using drug treatment

First author: Bouza Study questions/objective:  Metformin, when combined There was no evidence Publication/Search year: 2012/2011  To determine the impact and with lifestyle interventions, is for adverse effects N studies/subjects: 9 RCTs/498 safety of metformin on BMI and effective for reducing BMI in Demographic: Overweight or obese adverse effects obese adolescents adolescents Interventions included Inclusion criteria: RCTs that compared  metformin to a lifestyle intervention Metformin or placebo; studies that measured BMI, weight, or adverse side effects as outcomes Exclusion criteria: Participants presenting with comorbidities

Notes and/or limitations: The positive findings of this study reflect short-term outcomes. Further research is required to clarify long-term effects of metformin treatment.

First author: Brufani Study questions/objective:  Metformin resulted in small None reported Publication/Search year: 2014/2013  To determine the effectiveness but significant weight loss in N studies: 11 (7 RCTs) of metformin on weight loss in obese children in the short- Demographic: Obese non-diabetic non-diabetic children compared term, but this outcome was children and adolescents with lifestyle interventions considered to be clinically small Inclusion criteria: Double-blind RCTs Interventions included

Exclusion criteria: Studies that were  Metformin short in duration (<6 months)  Lifestyle interventions

Notes and/or limitations: Authors do not assess bias or validity of included studies. The quality of this S.R. was somewhat limited.

First author: Buchwald Study questions/objective:  B-RYGB resulted in significant NB-RYGB (but not B- Publication/Search year: 2014/2013  To determine the outcomes of intermediate-term weight loss RYGB) produced N studies/subjects: 15 (3 RCTs)/8707 banded Roux-en-Y gastric bypass that surpassed the adverse outcomes Demographic: Obese adults (B-RYGB) intermediate-term weight loss such as dumping outcomes of NB-RYGB syndrome and Inclusion criteria: Full length research Interventions included  There were no significant postoperative leak articles published after January 1  B-RYGB differences in QOL in patients 1990 about RYGB; reporting of weight  Non-banded Roux-en-Y-Gastric receiving B-RYGB and NB-RYGB and complications Bypass (NB-RYGB)

Exclusion criteria: Studies with a follow-up period > 3 yrs; case studies

Notes and/or limitations: The current review was limited by a shortage of experimental studies, lower-quality observational studies, no standardised B-RYGB procedure, and no specific bariatric surgery data-reporting requirements

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Study Features Objective & Interventions Summary of outcomes Adverse effects

First author: Chang Study questions/objective:  Bariatric surgery resulted in Reoperation rates Publication/Search year: 2014  To determine the risks and significant long-term weight were ~7%. N studies/subjects: 164 (37 RCTs)/ benefits associated with bariatric loss that was clinically relevant Complication rates 161756 surgery  Bariatric surgery was were ~10% - 17% and Demographic: Obese adults associated with low rates of included bleeding, Interventions included post-surgery mortality vomiting, reflux, Inclusion criteria: RCTs and  Gastric bypass gastrointestinal observational studies of bariatric  Adjustable gastric banding symptoms, and surgery; inclusion of at least one  Vertical banded gastroplasty nutritional and outcome criteria: weight change,  Control (non-surgical electrolyte surgery mortality, complications and interventions) abnormalities impact on diseases

Exclusion criteria: Studies that did not look at surgical interventions; studies of children/adolescents

Notes and/or limitations: Only a subset of included studies were RCTs; outcome reporting was highly heterogeneous across studies.

First author: Colquitt Study questions/objective: The most commonly  Surgical interventions Publication/Search year: 2014/2013  To assess the effects of bariatric cited adverse events resulted in significantly N studies: 22 (7 RCTs)/1798 surgery for overweight and after bariatric surgery greater reductions in body Demographic: Overweight or obese obesity were iron deficiency mass compared with non- adults anaemia and Interventions included surgical interventions reoperations, although Inclusion criteria: RCTs comparing  Surgical procedures in current  Individuals with higher BMIs many other less surgical interventions to other (non- use (≥40) lost significantly more common adverse surgical or surgical interventions) for  Non-surgical treatment (usual weight than those with events were reported the management of overweight care, no treatment or medical lower BMIs and/or obesity; assessed relevant management) clinical outcomes; minimum duration  Surgery led to greater of 12 months improvements in quality of Exclusion criteria: Open versus life than non-surgical laparoscopic procedures; procedures interventions, although this no longer in current use outcome was derived from only a few studies

Notes and/or limitations: Heterogeneity among studies was very high and results were based on a small number of studies and individuals with only short-term (<2 years) follow-up.

First author: Dawes Study questions/objective:  The most common mental  None reported Publication/Search year: 2016  To estimate the prevalence of health conditions among N studies: 68 mental health conditions in patients seeking bariatric Demographic: Overweight or obese patients seeking and undergoing surgery were depression and adults bariatric surgery BED   Depression and BED were not Inclusion criteria: Studies that To evaluate the association between preoperative mental consistently associated with addressed 1 specific study aim; report 2 health conditions and weight loss differences in weight outcomes data for adults with BMI ≥35kg/m ; report data from primary research surgery  Bariatric surgery was  Exclusion criteria: Studies that asked To evaluate the association consistently associated with a patients to recall their preoperative between surgery and clinical decrease in postoperative health status course of mental conditions depression

Interventions included  Bariatric surgery

Notes and/or limitations: Included studies had variation in their scales, thresholds and definitions of outcomes. Most included studies reported data from a single institution, which may reduce the generalisability of this report.

First author: Gloy Study questions/objective:  Bariatric surgery produced The most commonly Publication/Search year: 2013  To compare surgical (bariatric) significantly greater cited adverse events N studies/subjects: 11 RCTs/ 796 and non-surgical interventions improvements in body mass after bariatric surgery Demographic: Obese individuals with for obesity and QOL than non-surgical were iron deficiency BMI ≥ 30 interventions anaemia and Interventions included  Individuals with higher BMIs reoperations, although Inclusion criteria: RCTs of bariatric  Bariatric surgery (≥40) lost significantly more many other less surgeries with a non-surgical  Non-surgical comparator (diet, weight than those with lower common adverse treatment comparison weight reducing drugs, BMIs events were reported. behavioural therapy, or any

combination thereof)

Notes and/or limitations: Heterogeneity among studies was very high and results were based on a small number of studies and individuals with only short-term (<2 years) follow-up.

nedc.com.au Study Features Objective & Interventions Summary of outcomes Adverse effects

First author: Gudzune Study questions/objective:  The 3 programs that dominate Very-low-calorie diets Publication/Search year: 2015/2014  To examine the benefits, the weight-loss service may increase the risk N studies: 45 (39 RCTs) adherence, and harms of industry (Weight Watchers, for gallstones Demographic: Overweight and obese commercial or proprietary Jenny Craig and Nutrisystem) adults weight-loss programs compared consistently produced greater with control/education or weight loss than control Inclusion criteria: RCTs of ≥12 week behavioural counselling interventions duration that compared a commercial  The 3 programs that promote or proprietary weight-loss program to Interventions included weight loss through very-low- an education or behavioural  Commercial or proprietary calorie meal replacements counselling control weight loss programs (11 (HMR, Medifast and Optifast) Exclusion criteria: Programs that included) produced short-term weight focused on components other than  Education or behavioural loss compared with controls weight loss; promoted medications or counselling  5 self-directed programs supplements, were not available in the US or were residential programs offered support through the internet. The Atkins program had the greatest short-term weight loss compared with controls

Notes and/or limitations: Many studies assessed outcomes only over the short-term, the clearest exceptions being Weight Watchers and Jenny Craig, which provide consistent evidence for longer-term benefits. Studies often did not provide data on adherence or adverse outcomes and frequently lacked adequate blinding procedures.

First author: Hutchesson Study questions/objective:  eHealth weight loss None reported Publication/Search year: 2015/2014  To evaluate the effectiveness of interventions resulted in N studies/Subjects: 84 RCTs/24010 eHealth interventions for the modest weight loss compared Demographic: Overweight and obese prevention and treatment of to no or minimal treatment adults overweight and obesity  Interventions with evidence- based features (self- Inclusion criteria: RCTs assessing Interventions included monitoring, personalised eHealth weight loss interventions  Electronic interventions using the feedback) resulted in compared to control, standard care, Internet, email, text messages, significantly greater weight loss another delivery mode or another monitoring devices, mobile eHealth intervention; weight-related applications, computer primary outcomes programs, podcasts and personal digital assistants

Notes and/or limitations: Although the meta-analyses conducted in this review were large, robust, and resulted in statistically significant weight loss, it is worth noting that the clinical significance of the average weight loss (1.4-2.7kg) is lower than traditional behavioural weight 276 loss interventions (i.e., weekly group-based lifestyle counselling resulted in an average weight loss of 10.7kg) .

First author: Hutchesson Study questions/objective:  Most (5/8) included studies  None reported Publication/Search year: 2013/2011  To evaluate behavioural weight reported significant N studies/subjects: 8 RCTS/452 management interventions improvements in weight status Demographic: Young women 18-35 targeting young women of participants receiving years intervention as compared with Interventions included minimal/no-intervention Inclusion criteria: RCTs about weight  controls management (weight loss, Behavioural weight gain prevention interventions maintenance and prevention) with at least one intervention study arm; reported weight –related outcomes Exclusion criteria: Surgical interventions and drug trials; pregnant or postpartum women; participants with a recent history of major health conditions

Notes and/or limitations: The overall effectiveness of weight management interventions described here is difficult to ascertain due to the following study features: the intervention types, components and durations where highly heterogeneous; the sample sizes were small; the risk of bias was high and the included studies were rated as poor to moderate in quality.

63

Study Features Objective & Interventions Summary of outcomes Adverse effects

First author: Johns Study questions/objective:  In the short-term, combined None reported Publication/Search year: 2014/2012  To evaluate whether BWMPs BWMPs result in similar weight N studies/subjects: 8 RCTs/1022 involving both diet and physical loss as diet-only interventions Demographic: Overweight or obese activity lead to greater weight  In the long-term, weight-loss is (BMI≥25) adults (≥18 years) loss in the long-term (>12 greatest for combined BWMPs months) than programs involving Inclusion criteria: Clearly defined  Interventions based on diet or physical activity alone behavioural weight management physical activity alone are less effective than combined program (BWMP) that included diet Interventions included BWMPs in both the short and and physical activity compared to a  Combined BWMP (diet + long term diet and/or physical activity-only physical activity) program; a measure of weight change  Diet only at ≥12 months  Physical activity only Exclusion criteria: Pregnant women, people with eating disorders; weight loss targeted to medical disorders; weight loss by surgery or medication

Notes and/or limitations: High heterogeneity in some analyses; unclear allocation concealment in most studies. However, all but one study indicated high compliance.

First author: Jurgens Study questions/objective:  Green tea preparations induce Of the 8 studies that Publication/Search year: 2012/2011  To evaluate the efficacy of green a clinically small, non- reported on adverse N studies: 14 RCTs/754 tea for weight loss significant reduction in weight events, half reported Demographic: Overweight and obese in overweight and obese adults mild to moderate Interventions included adults adverse events  Green tea preparations including nausea, Inclusion criteria: RCTs comparing constipation, green tea preparations to a control in abdominal discomfort overweight or obese adults; 12+ and increased blood weeks duration pressure Exclusion criteria: None reported

Notes and/or limitations: Due to the high level of heterogeneity among studies, data were divided into two groups: studies conducted within Japan and studies conducted outside Japan. Even within these groups, heterogeneity was too high for data pooling in most cases.

First author: Kaiser Study questions/objective:  Increased fruit and vegetable None reported Publication/Search year: 2014/2013  To evaluate the effectiveness of intake had a small, clinically N studies: 7 RCTs the general recommendation to insignificant effect on weight Demographic: Not reported eat more fruits/vegetables for loss weight loss or the prevention of  The current recommendations Inclusion criteria: ≥15 subjects weight gain to increase fruit and vegetable randomised to each treatment arm; intake, without concomitant ≥8 week intervention period; body Interventions included energy restriction, is weight or composition as a outcome  Dietary change of increased fruit unsupported variable; intervention goal was weight and vegetable intake or fat loss or prevention of weight or fat gain; the prescription of a variety of minimally processed fruits and vegetables Exclusion criteria: Interventions that added only one specific fruit, vegetable or nuts to the diet; populations with medical or genetic conditions affecting body weight

Notes and/or limitations: The number of studies included in analyses was small (2 in primary analyses and 7 in secondary analyses).

First author: Kubik Study questions/objective:  There were overall None reported Publication year: 2013  To evaluate the impact of improvements in N studies: 9 bariatric surgery on psychological psychopathology, depressive Demographic: Not reported outcomes symptoms, eating behavior, body image, and HRQoL Interventions included Inclusion criteria: Bariatric procedures following bariatric weight loss  Any bariatric procedure Exclusion criteria: None reported surgery  A subset of patients did not improve at all

nedc.com.au Study Features Objective & Interventions Summary of outcomes Adverse effects

First author: Magallares Study questions/objective:  Physical and mental health (as None reported Publication year: 2015  To evaluate mental and physical measured by the SF-36 QOL N studies: 21 health-related quality of life in questionnaire) were Demographic: Not reported obese patients following bariatric considerably higher in the surgery post-surgery group compared Inclusion criteria: Obese patients to the pre-surgery group undergoing bariatric surgery; Interventions included  These effects were very large application of the SF-36 health-  Any bariatric procedure in magnitude* related quality of life questionnaire; longitudinal studies with follow-up  Improvements in HRQoL were measures up to one year observed up to one year Exclusion criteria: Other following bariatric surgery questionnaires or measurement tools; non-empirical studies

Notes and/or limitations: Short follow-up periods (max one-year) that may not be long enough to capture long-term maintenance of HQRoL. Approximately 15% of participants did not complete the post-surgery assessment, which may have biased outcomes. *High heterogeneity should temper our interpretation of pooled data.

First author: Naude Study questions/objective:  There were no significant None reported Publication/Search year: 2012/2011  To evaluate the beneficial and differences in weight loss N studies: 14 RCTs/754 harmful effects of low between low carbohydrate and Demographic: Overweight and obese carbohydrate diets on weight in balanced diets adults comparison to balanced diets  Reductions in weight or BMI, when noted, occurred in both Inclusion criteria: RCTs comparing Interventions included low and balanced diet groups green tea preparations to a control in  Low carbohydrate diets  Weight loss was therefore the overweight or obese adults; 12+  Balanced diets result of a reduction in dietary weeks duration Exclusion criteria: None reported energy intake rather than manipulations of macronutrient components

Notes and/or limitations: Many of the included trials were deemed to have high risk of bias with inter-trial variation in the type and quantity of fat consumed; adherence to dietary goals was low; and trials were small with short duration.

First author: Nigro Study questions/objective:  A significantly higher Adverse events Publication/Search year: 2013  To evaluate the clinical data on proportion of patients associated with N studies: 4 RCTs(1 Stage 2; 3 Stage 3 lorcaserin for obesity receiving lorcaserin lost >5% lorcaserin include trials) management body weight compared with nausea, dizziness, Demographic: None reported those receiving placebo headache, upper Interventions included  Patients receiving lorcaserin respiratory tract Inclusion criteria: In-vitro or in-vivo  The anti-obesity agent lorcaserin also had greater weight loss infections and evaluations of lorcaserin (a novel serotonin 2C agonist) compared those receiving nasopharyngitis Exclusion criteria: None reported placebo (6 and 3kg, respectively)

Notes and/or limitations: Although lorcaserin resulted in significantly greater weight loss than placebo in all 3 Stage 2 trials, this reduction met FDA standards (≥5% reduction compared with placebo) on only two trials, and by a small margin (5.8% in both cases). Trial participants received behavioural counselling and daily exercise instruction that may explain all or some of the reported treatment outcomes.

First author: Olson Study questions/objective:  Significant weight loss was None reported Publication/Search year: 2015  To evaluate the current evidence reported in 3 of 8 RCTs N studies/subjects: 19 (8 RCTs) for MBIs for weight loss comparing MBIs to control Demographic: Overweight or obese interventions Interventions included adults  Effect sizes (and therefore the  MBIs clinical significance of the Inclusion criteria: Evaluation of a  Acceptance-based weight-loss treatment effect) among these mindfulness-based intervention (MBI) interventions studies ranged from weak to for weight management; weight strong measured as an outcome at baseline 89 and completion  Only a single study applied an Exclusion criteria: Studies including empirical assessment of the children or adolescents; studies of relationship between post-bariatric surgery patients mindfulness and weight change. This study found no association between increased mindfulness and weight loss at program completion

Notes and/or limitations: The measurement and assessment of mindfulness itself is important in determining the validity and efficacy of mindfulness as an intervention for weight loss, however, most studies do not include any specific measure of mindfulness. Since nearly all reviewed programs are multi-component (including education, diet, physical activity and self-monitoring components), it remains unclear whether mindfulness actively influences weight loss.

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Study Features Objective & Interventions Summary of outcomes Adverse effects

First author: Onakpoya Study questions/objective:  Chromium supplementation Adverse events were Publication/Search year: 2013/2012  To evaluate the efficacy of led to significant reductions in reported with daily N studies/subjects: 20 RCTs/1038 (18 chromium supplements on body body weight and percent body doses exceeding 1000 RCTs/974 patients included in meta- weight and related parameters in fat, but not BMI, waist µg, including watery analysis) overweight and obese patients circumference or waist to hip stools, vertigo, Demographic: Overweight or obese ratio weakness, nausea, Interventions included individuals  Maximum weight loss was vomiting, dizziness and  Chromium supplements achieved with dosages of 400 head- aches. Inclusion criteria: RCTs testing the µg chromium, although the efficacy of orally administered These events stopped amount of weight lost was chromium on body weight or when chromium was highly variable composition; minimum program withdrawn and duration of 8 weeks reappeared when Exclusion criteria: Trials testing chromium was chromium as part of a combination reintroduced supplement

Notes and/or limitations: The included studies were variable along a number of quality parameters (i.e., randomisation, allocation concealment, blinding, etc), and the data included in meta-analyses were highly heterogeneous. Although reductions in weight and fat were significant, the magnitude of the effect in each case was small.

First author: Onakpoya Study questions/objective:  Glucomannan intake did not Most RCTs reported Publication/Search year: 2014/2012  To evaluate the efficacy of the significantly influence body adverse events. The N studies/subjects: 9 RCTs/273 soluble fibre glucomannan in weight or BMI when compared most commonly Demographic: Overweight or obese body weight reduction with placebo reported were related individuals to the gastrointestinal Interventions included system and included Inclusion criteria: RCTs testing orally  Glucomannan supplements diarrhea, constipation, administered glucomannan for body abdominal discomfort, weight reduction in overweight or and mild meteorism obese patients Exclusion criteria: Trials testing glucomannan alongside other dietary interventions

Notes and/or limitations: The included studies were variable along a number of quality parameters (small sample size, failure to report attrition, lack of intention-to-treat analyses) and the results of the meta-analyses should therefore be interpreted with caution.

First author: Pathak Study questions/objective:  Vitamin D supplementation did None reported Publication/Search year: 2014/2013  To evaluate whether vitamin D not reduce body weight or N studies/subjects: 18 RCTs; 605 supplementation reduced body body fat in the absence of Demographic: Adult women weight and fat in the absence of caloric restriction caloric restriction Inclusion criteria: High quality RCTs using non-pregnant, non-lactating Interventions included women; vitamin-D use in at least one  Vitamin D arm of the RCT; inclusion of some measure of body weight or fat distribution Exclusion criteria: None reported

First author: Puzziferi Study questions/objective:  RYGB resulted in greater Long-term Publication/Search year: 2014  To assess the effectiveness of weight loss than LAGB in both complication rates N studies/subjects: 29 (10 RCTs)/ bariatric surgeries for weight loss the short (<2 years) and long- were relatively low 7971 2 years post-procedure term (2-5 years) overall (≤3% after Demographic: Severely obese adults  Weight loss from RYGB was RYGB and ≤6% after Interventions included substantial and sustained over LAGB), including Inclusion criteria: RCTs and  RYGB the long-term deaths, hernia, ulcer, observational studies with 50+ adult  LAGB anaemia, iron patients with BMI≥35; patients deficiency and undergoing gastric bypass (RYGB) or reoperation laparoscopic adjustable gastric banding (LAGB) for weight loss; 2+ years of follow-up of ≥80% patients Exclusion criteria: Articles on jujunoileal bypass, vertical banded gastroplasty, biliopancreatic diversion, mini-gastric bypass and gastric plication

nedc.com.au Study Features Objective & Interventions Summary of outcomes Adverse effects

First author: Magallares Study questions/objective:  Physical and mental health (as None reported Publication year: 2015  To evaluate mental and physical measured by the SF-36 QOL N studies: 21 health-related quality of life in questionnaire) were Demographic: Not reported obese patients following bariatric considerably higher in the surgery post-surgery group compared Inclusion criteria: Obese patients; to the pre-surgery group. bariatric surgery; application of the Interventions included These effects were very large SF-36 health-related quality of life  Any bariatric procedure in magnitude*. questionnaire; longitudinal studies  with follow-up measures up to one Improvements in hrQOL were observed up to one year year following bariatric surgery Exclusion criteria: Other questionnaires or measurement tools; non-empirical studies

Notes and/or limitations: Included only one-year follow-up, which may not be long enough to capture long-term maintenance of hrQOL. *High heterogeneity should temper our interpretation of pooled data. Approximately 15% of participants did not complete the post-surgery assessment, which may have biased outcomes.

First author: Naude Study questions/objective:  There were no significant None reported Publication/Search year: 2014  To evaluate the beneficial and differences in weight loss N studies: 19 RCTs/3209 harmful effects of low between low carbohydrate and Demographic: Overweight or obese carbohydrate diets on weight in balanced diets adults comparison to balanced diets  Reductions in weight or BMI, when noted, occurred in both Inclusion criteria: RCTs providing Interventions included low and balanced diet groups macronutrient dietary goals; low carb  Low carbohydrate diets  Weight loss ws therefore the weight loss diets compared to  Balanced diets result of a reduction in dietary balanced weight loss diet plans with similar energy content energy intake rather than Exclusion criteria: Pregnant or manipulations of macronutrient components lactating women; < 18years; <10 participants per group; diets combined with other interventions

Notes and/or limitations: Many of the included trials had high risk of bias with high variation in the type and quantity of fat consumed; adherence to dietary goals was low; and trials were small with short duration.

First author: Nigro Study questions/objective:  Significantly more patients Adverse events Publication/Search year: 2013  To evaluate the clinical data on receiving lorcaserin lost >5% associated with N studies: 4 RCTs(1 Stage 2; 3 Stage 3 lorcaserin for obesity body weight compared with lorcaserin included trials) management those receiving placebo nausea, dizziness, Demographic: None reported  Patients receiving lorcaserin headache, upper Interventions included also had greater weight loss respiratory tract Inclusion criteria: In-vitro or in-vivo  The anti-obesity agent lorcaserin compared those receiving infections and evaluations of lorcaserin (a novel serotonin 2C agonist) placebo (6 and 3kg, nasopharyngitis Exclusion criteria: None reported respectively)

Notes and/or limitations: Reductions in weigh met FDA standards (≥5% reduction compared with placebo) on only two trials, and by a small margin. Participants received behavioural counselling and daily exercise instruction, which may have contributed to a portion of this reduction independent of the medication.

First author: Olson Study questions/objective:  Significant weight loss was None reported Publication/Search year: 2015  To evaluate the current evidence reported in 3 of 8 RCTs N studies/subjects: 19 (8 peer for MBIs for weight loss comparing MBIs to control reviewed RCTs) interventions Interventions included Demographic: Overweight or obese  Effect sizes (and the clinical  MBIs adults significance of the treatment  Acceptance-based weight-loss effect) among these studies Inclusion criteria: Evaluation of a interventions ranged from weak to strong mindfulness-based intervention (MBI) 89 for weight management; weight  Only a single study applied an measured as an outcome at baseline empirical assessment of the and completion relationship between Exclusion criteria: Studies including mindfulness and weight children or adolescents; studies of change. This study found no post-bariatric surgery patients association between increased mindfulness and weight loss at program completion

67

Study Features Objective & Interventions Summary of outcomes Adverse effects

First author: Trastulli Study questions/objective:  LSG led to a reduction in % LSG was deemed to Publication/Search year: 2013/2012  To evaluate the effictiveness and excessive weight loss and % have high feasibility N studies/subjects: 15 RCTs/1191 safety of LSG for weight loss excess BMI, without any and acceptable safety, Demographic: Obese adults (BMI ≥40 significant differences with a mortality rate of 2 Interventions included kg/m ; aged ≥18 years) compared to alternative 0% and a mean  LSG surgical procedures (such as complication rate of Inclusion criteria: RCTs reporting 1+ LGB or LAGB) 9.2% (lower than rates outcome of interest; 1+ comparison for LGB) arms including adult obese patients undergoing laparoscopic sleeve gastrectomy (LSG) Exclusion criteria: Studies reporting on LSG data pooled with other data; data on single-incision LSG

Notes and/or limitations: RCT data included in this study reflect short-term (≤3 year) outcomes only. These data reflect the extent of the current literature on this procedure: recent observational and non-randomised study data evaluating long-term effects exists, but RCT data evaluating 3+ years post-operative is lacking. Since corrective procedures for weight loss failure or weight regain (such as resleeve, gastric bypass and duodenal switch) are normally performed 3+ years postoperatively, the positive surgical outcomes reported here must be interpreted with caution.

First author: Wadden Study questions/objective:  There were no RCTs in which None reported Publication/Search year: 2014  To evaluate behavioural primary care practitioners N studies/subjects: 12 RCTs/3893 counselling delivered by primary delivered intensive behavioural Demographic: Overweight and obese care practitioners for weight loss counselling following CMS patients (BMI ≥25 kg/m2) guidelines (14 sessions over 6 Interventions included months) Inclusion criteria: RCTs that recruited  Behavioural weight loss  Clinically meaningful weight participants from primary care counselling loss was demonstrated in some settings; included behavioural weight  Lifestyle interventions (including RCTs following other delivery loss counselling or lifestyle diet, physical activity and protocols (different number of interventions; 3+ months of behavioural components) sessions/period of delivery) intervention and 6+ months follow- and delivered outside of up; delivered by primary care primary care practitioners; weight as outcome; sample of 15+ participants per group Exclusion criteria: weight gain prevention interventions or pharmacological agents

Notes and/or limitations: No meta-analyses conducted to pool result; no studies located addressing original study queries

First author: Willcox Study questions/objective:  LAGB reduced BMI in all Post-operative Publication/Search yr: 2014/2013  To determine the impact of LAGB studies complication rates N studies/subjects: 11 (1 RCT)/453 on weight loss and psychosocial  LAGB improved quality of life ranged from 4-25% Demographic: Adolescents outcomes (in the 4 studies that reported (reported in 5 studies) this outcome) Most complications Interventions included Inclusion criteria: adolescents occurred post-  LAGB (<18yrs); pre- and post-op outcome discharge data presented Exclusion criteria: obesity resultant from an underlying medical condition, not reported in English, studies had less than 10 participants

Notes and/or limitations: Data could not be pooled for meta-analysis; only 1 RCT included.

First author: Yanovski Study questions/objective:  Orlistat, lorcaserin,and Orlistat: mainly Publication/Search year: 2014/2013  To evaluate currently approved phentermine+ topiramate, gastrointestinal N studies: 21 (20 RCTs) obesity medications used alongside lifestyle adverse effects Demographic: Obese adults interventions, all increase the Lorcaserin: headache, Interventions included probability that patient will dizziness, fatigue, Inclusion criteria: Primary or  Orlistat achieve clinically meaningful nausea, dry mouth, secondary outcome of body weight  Lorcaserin (≥5%) 1-year weight loss cough, constipation change; 50+ participants per group;  Phentermine + topiramate (ranging from 35-70% of Phentermine: 50%+ retention; reported intention- patients) dizziness, taste to-treat results  Weight loss varies based on alterations, insomnia, Exclusion criteria: None reported demographic factors as well as constipation, dry gastric plication the intensity of the associated mouth, elevation in lifestyle intervention heart rate, memory or cognitive changes

Notes and/or limitations: Many included studies had high attrition rates. Approved medications refer to approval by the FDA (USA).

nedc.com.au Study Features Objective & Interventions Summary of outcomes Adverse effects

First author: Yoong Study questions/objective:  High-intensity weight-loss None reported Publication/Search year: 2013/2011  To evaluate the effectiveness of counselling did not result in N studies: 16 RCTs behavioural weight-loss clinically significant weight loss Demographic: Overweight or obese interventions delivered by when delivered by primary adults in primary care (BMI ≥25 primary-care physicians care physicians 2 kg/m )  High-intensity weight-loss Interventions included counselling resulted in clinically Inclusion criteria: Adult overweight or  Behavioural interventions significant weight loss when obese primary-care patients; delivered by primary care delivered by non-physicians, behavioural weight-loss interventions physicians incorporated meal delivered in primary-care; weight loss replacements alongside or BMI reductions as outcomes dietician counselling and Exclusion criteria: Surgical and participation in commercial pharmacological interventions weight-loss programmes with regular monitoring

Notes and/or limitations: The methodological qualities of some included studies were poor, and the number of studies addressing the SR questions was limited.

Outcomes reflect all studies included in a review, however note that in some cases these may include study types other than RCTs. While many types of outcome variables may be reported in the above studies, only data on outcome variables of interest are included here. The number of subjects listed reflects the total number of subjects across all study types, unless otherwise indicated

69

Appendix B: Randomised controlled trials

Randomised controlled trials meeting inclusion criteria for the evidence review

Study Features Interventions Summary of outcomes Adverse effects

First author, year: Allison, 2013 Intervention: Pharmacological . Tx A had statistically and Adverse effects were Country: USA . Tx A: Phentermine/Topiramate clinically greater weight loss most commonly Population: Obese adults (mean age: 3.75/23mg (N=241) than Tx B experienced by Tx B, 43, 83% female) . Tx B: Phentermine/Topiramate . Both Tx groups had statistically including paresthesia, Total Participants: N=1267 15/92mg (N=512) and clinically greater dry mouth, Setting: Not reported . Control: Placebo pill (N=514) reductions in weight and waist constipation, Follow-up duration: 56 weeks circumference than controls dysgeusia, and insomnia. Most Inclusion criteria: See population adverse effects were Exclusion criteria: Not reported mild in severity

First author: Almeida, 2015 Intervention: Lifestyle . Participants both Tx and None reported Country: USA . Tx: Internet-based INCENT control groups displayed a Population: Overweight and obese program: Weight loss support via small reduction in weight (1kg adults employed at a participating diet and physical activity program and 0.6kg, respectively) and worksite (mean age: 46, 80% female) delivered via email. Included BMI (0.4 and 0.2 kg/m2, Total Participants: N= 1001 monetary incentive (N=789) respectively), however, there Setting: Outpatient . Control: Email-based Livin’ My were no significant differences Follow-up duration: 6 months Weigh minimal intervention between groups control program: Provided a Inclusion criteria: Employment at a condensed version of the Incent participating worksite; have access to program without tailoring the internet (emails) or monetary incentive Exclusion criteria: Medical conditions (N=495) (including pregnancy), participating in a weight loss program

First author: Anderson, 2011 Study questions/objective:  Participants receiving Tx had None reported Country: USA  Tx: Standardised behavioural significantly greater weight loss Population: Overweight adults (mean intervention using meal than controls at 8, 16 and 24 age: 51, 77% female) replacements, fruits and week follow-ups Total Participants: N= 22 vegetables + increased physical  The frequency and severity of Setting: Outpatient activity (N=8) adverse events were similar in Follow-up duration: 24 weeks  Control: Usual-care counselling both groups with registered dietician (N=16) Inclusion criteria: BMI of 30- 39.9kg/m2; in good health Exclusion criteria: Pregnant or planning pregnancy; current or recent participants of another trial; use of medications that can effect weight or use of anticoagulants or oxcarbazepine; diagnosis of diabetes mellitus

First author: Apovian, 2013 Intervention: Pharmacological . Individuals receiving Tx had Participants receiving Country: USA  Tx: Naltrexone/bupropion: 32 significantly greater weight loss treatment reported Population: Overweight and obese mg/day naltrexone + 360 mg/day at week 28 (-6.5% vs. -1.9%) greater incidence of adults (mean age: 44, 85% female) bupropion, twice daily (N=506) and 56 (-6.4% vs. -1.2%) than adverse events Total Participants: N= 1001  Control: Placebo pill (N=495) controls compared with Setting: Outpatient  The Tx group had significant placebo, including mild Follow-up duration: 28 and 56 weeks improvements in physical to moderate nausea, function, self-esteem and headache and Inclusion criteria: See population sexual life constipation. Exclusion criteria: Diabetes; vascular, hepatic or renal disease; weight change of >4kg 3 months prior to study; history of seizures or serious psychiatric illness

nedc.com.au Study Features Interventions Summary of outcomes Adverse effects

First author, year: Aronne, 2013 Intervention: Behavioural +  Combined with lifestyle The only significant Country: USA pharmacological counselling, Tx C and Tx F were adverse effect was Population: Obese adults (mean age:  Tx A: Phentermine 7.5mg the most effective treatments impairment in 45, 72% female) (N=109) for weight loss, resulting in a attention, which was Total Participants: N= 756  Tx B: Topiramate ER 46mg statistically and clinically found among all Setting: Not specified (N=106) greater weight loss (-8.5% and treatment groups vs. Follow-up duration: 28 weeks  Tx C: Phentermine/Topiramate -9.2% respectively) compared the control group to all other treatment groups Inclusion criteria: See population ER 7.5mg/46mg (N= 106)  Tx D: Phentermine 15mg (N=108) and placebo Exclusion criteria: Patients who had used phentermine or topiramate  Tx E: Topiramate ER 92mg within 3 months leading up to study; (N=107) patients who had recently gained or  Tx F = Phentermine/Topiramate lost more than 5kg; patient who had ER 15/92mg (N= 108) participated in formal weight loss  Control: Placebo pill (N=109) program All participants received lifestyle intervention counselling

First author: Baer, 2011 Intervention: Pharmacological  Tx A produced significantly None reported Country: USA  Tx A: Whey Protein supplement greater weight loss compared Population: Overweight and obese (N=30) than control Tx, but the size of adults (mean age: 51, 53% female)  Tx B: Soy Protein supplement this effect was small (-1.8kg Total Participants: N= 90 (N=30) difference) Setting: Not specified  Control: Isoenergetic amount of  There were no significant Follow-up duration: 23 weeks carbohydrate (N=30) weight loss differences between Tx B and control or Inclusion criteria: Non smokers; BMI 2 between Tx A and Tx B 28 – 38kg/m Exclusion criteria: Participants with co-morbid diseases or cancers

First author: Barnes, 2014 Intervention: Behavioural  Participants receiving Tx B had None reported Country: USA  Tx A: Motivational interviewing, 5 significantly greater weight loss Population: Overweight and obese sessions over 12 weeks (N=30) than controls adults (mean age: 49)  Tx B: Nutrition psycho-education,  Participants receiving both Txs Total Participants: N= 89 5 sessions over 12 weeks (N=29) had significantly reduced Setting: University-based medical  Control: Usual care (N=30) symptoms of depression and healthcare centre BED compared with controls Follow-up duration: 3 months . There was no significant

Inclusion criteria: Access to phone difference in weight loss between Tx A and Tx B or and Internet between participants with and Exclusion criteria: Severe psychiatric without BED problems, severe medical problems, pregnancy and breastfeeding

First author: Bays, 2014 Intervention: Pharmacological  Weight was significantly Modest adverse Country: USA and Puerto Rico  Tx A: Canagliflozin 50mg (N=98) reduced in all Tx groups effects including Population: Overweight and obese  Tx B: Canagliflozin 100mg (N=93) compared with controls. genital mycotic adults, (mean age: 45, 86% female)  Tx C: Canagliflozin 300mg (N=96)  The size of this effect was small infections, osmotic Total Participants: N=376  Control: Placebo pill (N=89) and unlikely to be clinically dieresis, polyuria and Setting: Not specified significant reduced intravascular Follow-up duration: 12 weeks volume (e.g. dizziness), and hypoglycemia Inclusion criteria: See population Exclusion criteria: Not specified

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Study Features Interventions Summary of outcomes Adverse effects

First author: Benito, 2015 Intervention: Exercise + Diet  All forms of exercise None reported Country: Madrid, Spain  Tx A: Strength training, 3x/ week resulted in statistically and Population: Overweight and obese using a circuit (N=30) clinically significant weight adults (50% female)  Tx B: Endurance training, loss, but there were no Total participants N= 120 running, cycling or optional significant differences Setting: Not specified activities 3x/week (N=30) between groups Follow-up duration: 22 weeks  Tx C : Strength + endurance

Inclusion criteria: No history of training 3x/week (N=30) important concomitant illness; non-  Control: General physical activity recommendations (N=30) smokers Exclusion criteria: Taking medication; All groups were placed on a physical and psychological diseases hypocaloric diet

First author: Berkowitz, 2011 Intervention: Pharmacological  Tx was effective for short- but None reported Country: USA  Tx: Meal replacement SlimFast not long-term weight loss Population: Overweight and obese shake consumed 3x/day (N=71)  Tx produced statistically and adolescents (mean age: 15, 81%  Control: Conventional diet of clinically significant reductions female) 1,300 – 1,500kcal/day (N=42) in BMI after 4 but not 12 Total Participants: N=113 months compared to the Setting: Not specified control group Follow-up duration: 4 and 12 months

Inclusion criteria: BMI 28 – 50kg/m2 Exclusion criteria: Physical or medical disorders; pre-study weight loss; smokers

First author: Bishop-Gilyard, 2011 Intervention: Behavioural + . Participants receiving Tx had None reported Country: USA pharmacological significantly greater reductions Population: Overweight and obese  Tx = Sibutramine 15mg/day + in BMI at 12 months compared adolescents (mean age: 14.1, 67% behavioural counselling (N=43) to the control group females)  Control: Placebo pill + . There was no significant Total Participants: N= 82 behavioural counselling (N=39) difference in weight loss Setting: Not specified between participants identified Follow-up duration: 1, 6 and 12 with BED and participants months identified without BED . Both groups had statistically Inclusion criteria: See population and clinically significant Exclusion criteria: Psychiatric reductions in binge eating disorders; patients with high blood symptoms but there were no pressure; patients on anti depressant differences between the medication treatment and control group

First author: Blomquist, 2011 Intervention: Behavioural +  Tx significantly reduced binge Adverse effects Country: USA pharmacological eating symptoms compared to included Population: Obese adults (mean age:  Tx: Orlistat 120mg, 3 x day + 12 the placebo at 12 weeks, but gastrointestinal 47, 88% female) weeks of CBT (N=25) not at the 3 month follow up symptoms were Setting: Not specified  Control: Placebo pill, 3 x a day +  The combination of CBT+ experienced by some Total Participants: N=82 12 weeks of CBT (N=25) orlistat was more effective for participants in the Follow-up duration: Post-treatment reducing weight compared to treatment group (12 weeks) and 3 months after CBT alone (control group) treatment ended

Inclusion criteria: BED diagnosis Exclusion criteria: Patients receiving treatment for eating or weight- related illnesses; patients with medical conditions that effect weight; pregnancy; severe psychiatric conditions

nedc.com.au Study Features Interventions Summary of outcomes Adverse effects

First author: Brennan, 2013 Intervention: Behavioural  The Tx group had significantly None reported Country: Australia  Tx: CBT Choose Health Program greater weight loss than the Population: Overweight and obese that includes motivational control group, but the size of adolescents (mean age: 14.3, 82% interviewing and diet and this effect was small (partly the female) exercise advice (N=34) result of poor compliance rates Total Participants: N= 63  Control: No treatment (N=29) in the treatment group) Setting: RMIT University, Melbourne and RMIT University, Bundoora campus Follow-up duration: 6 months

Inclusion criteria: See population Exclusion criteria: Disability or illness that prevented participation

First author: Burke, 2011 Intervention: Behavioural + . Weight was significantly None reported Country: USA technology reduced in all groups at 6 Population: Overweight and obese  Tx A: Personal Digital Assistant - months, but there were no adults (mean age: 47, 85% female) no feedback (N=68) significant differences between Total Participants: N= 210  Tx B: PDA with feedback (N=70) groups Setting: Not specified  Control: Paper record (N=72) Follow-up duration: 6 months

Inclusion criteria: BMI 27- 43kg/m2 Exclusion criteria: Recent participation in weight loss program; medical conditions requiring diet + exercise treatment

First author: Cakmakci, 2011 Intervention: Exercise . There were no significant None reported Country: Turkey . Tx: Pilates sessions of 1 hour in differences between Tx and Population: Obese women (mean age: duration 4x/week (N=34) control groups 36) . Control: No treatment (N=27) Total Participants: N= 63 Setting: KOMEK (Vocational Training Course) Follow-up duration: 8 weeks

Inclusion criteria: Not reported Exclusion criteria: Not reported

First author: Carraca, 2012 Intervention: Behavioural . The weight management None reported Country: Portugal . Tx: Weight management intervention, which included Population: Overweight and obese intervention that included an the promotion of regular women (mean age: 38) exercise component (N=114) exercise, resulted in Total Participants: N= 225 . Control: General health statistically and clinically Setting: Not specified education (N=111) greater weight loss compared Follow-up duration: 24 months to the control group . Both groups reported Inclusion criteria: Female; BMI 25 – 2 statistically significant 40kg/m ; premenopausal improvements in body image, Exclusion criteria: Major illness; taking but there was no significant medication that effects weight differences between groups

First author: Cayir, 2015 Intervention Technology . The Tx group lost a statistically None reported Country: Turkey . Tx: Pedometer + low calorie diet and clinically greater amount Population: Obese women (mean age: + exercise prescription (N=50) of weight compared to 40) . Control: No pedometer + low controls Total Participants: N=100 calorie diet + exercise Setting: Not reported prescription (N=50) Follow-up duration: 3 months

Inclusion criteria: See population Exclusion criteria: Comorbiditities; medication for weight loss

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Study Features Interventions Summary of outcomes Adverse effects

First author: Cesa, 2011 Intervention: Behavioural . Weight was reduced in all None reported Country: Italy . Tx A: Enhanced CBT including treatment groups, but there Population: Adult women (mean age: virtual reality protocol (N=31) was no difference between 32) . Tx B: Standard CBT (N=30) groups Total Participants: N=90 . Control: Inpatient treatment Setting: Outpatient and inpatient (N=29) Follow-up duration: 1 year

Inclusion criteria: BED diagnosis for 6 months prior to study Exclusion criteria: Comorbidity of severe psychiatric disorders; other treatment for BED including medication; medical condition unrelated to disorder

First author: Chambliss, 2011 Intervention: Behavioural + . Both Tx groups had None reported Country: USA technology significantly greater weight loss Population: Overweight adults (mean . Tx A: Computerised self- after 12 weeks than controls age: 45, 83% female) monitoring with basic feedback. . There were no significant Total Participants: N= 120 Participants recorded their daily differences Tx groups Setting: Not specified food intake and exercise in a Follow-up duration: 12 weeks program and received generic feedback (N=45) Inclusion criteria: Computer + email . Tx B: Computerised self- access; BMI 25-35kg/m2 monitoring with enhanced Exclusion criteria: Participation in behavioural feedback. another weight loss program; major Participants recorded their daily health problems food intake and exercise in a program and received feedback that was individually tailored (N=45) . Control: No treatment waitlist (N=30)

First author: Christen, 2011 Intervention: (FINALE) lifestyle . Participants in the Tx group None reported Country: Denmark program: diet + behavioural + had statistically and clinically Population: Female overweight health exercise significant reductions in care workers (mean age: 46) . Tx: Calorie restricted diet plan + weight, fat and waist Total Participants: N=98 strengthening exercise + CBT circumference compared with Setting: Health care work place (N=54) controls Follow-up duration: 3 months . Control: Monthly oral lecture (N=44) Inclusion criteria: Employees working minimum of 15hrs/week; BMI 25+ Exclusion criteria: Not specified

First author: Danilenka, 2013 Intervention: Other . There was no significant None reported Country: Russia . Tx: 3 weeks of daily bright light difference in weight loss Population: Overweight adult women treatment using a device of light- between participants in the Tx (mean age: 37) emitting diodes (N=not specified) group and those in the control Total Participants: N=39 . Control: Identical placebo: group Setting: Not specified imitation light-emitting device . Tx resulted in a statistically Follow-up duration: 3 and 10 weeks using a deactivated ion generator greater reduction in for 3 weeks (N=not specified) participants’ percentage of Inclusion criteria: 20–54 yrs; BMI 25– 2 body fat compared to controls 30kg/m ; stable medication (if (minimal clinical significance) suffering from chronic disease) Exclusion criteria: Attempt to lose weight 3 months prior; acute illness 2 months prior; previous use of light therapy

nedc.com.au Study Features Interventions Summary of outcomes Adverse effects

First author: DeBar, 2012 Intervention: Lifestyle: diet + . Participants receiving Tx had None reported Country: USA behavioural + exercise significantly greater reductions Population: Adolescent females . Tx: Multi-component lifestyle in BMI than controls (small (mean age: 14) intervention which includes effect size) Total Participants: N=208 dietary advice (restricted . Psychological outcomes Setting: Primary care calories), the promotion of (improved body satisfaction Follow-up duration: 6 and 12 months regular exercise and counselling and decreased internalisation

th (N=105) of female norms) were Inclusion criteria: BMI in 90 . Control: Usual primary care significantly greater in the Tx percentile or above (N=103) than controls Exclusion criteria: Significant cognitive impairment; severe obesity; medications that effect weight; pregnancy

First author: DeFina, 2011 Intervention: Pharmacological . When combined with a calorie None reported Country: USA . Tx: Omega-3 supplements + controlled diet and exercise Population: Overweight and obese calorie controlled diet + an prescription Omega-3 adults(68% female) exercise prescription (N=64) supplements were not found Total Participants: N= 128 . Control: Placebo pill + calorie to be any more effective for Setting: Not specified controlled diet + an exercise reducing weight compared to Follow-up duration: 6 months prescription (N=64) the placebo group. . All participants lost more than Inclusion criteria: BMI 26 – 40kg/m2; 5% of their body weight sedentary however this effect was Exclusion criteria: Severe comorbidity; attributed to the calorie weight loss medication; oral controlled and exercise contraceptive promotion element of the study

First author: Donnelly, 2013 Intervention: Exercise . All forms of aerobic exercise None reported Country: USA . Tx A: Male aerobic exercise resulted in statistically Population: Overweight and obese burning 400kcal/session, 5 days a significant reductions in weight adults (mean age: 23, 50% female) week for 10 months (N=18) and body fat compared to the Total Participants: N=141 . Tx B: Female aerobic exercise control groups, with no Setting: Not specified burning 400kcal/session, 5 days a significant difference between Follow-up duration: 10 months week for 10 months (N=19) groups . Tx C: Male aerobic exercise . There was no significant Inclusion criteria: Sedentary adults burning 600kcal/session, 5 days a difference between males and Exclusion criteria: History of chronic week for 10 months (N=19) females disease; smoking; medication . Tx D: Female aerobic exercise effecting exercise performance; burning 600kcal/session (N= 18) planned physical activity . Control A: Male no exercise, 5 days a week for 10 months (N=9) . Control B: Female no exercise (N=9)

First author: Forman, 2013 Intervention: Behavioural . Both groups had significant None reported Country: USA . Tx: Acceptance-based improvements in weight and Population: Overweight and obese behavioural Tx weekly for 40 quality of life post Tx and at 6 adults (mean age: 46) weeks (N=48) months, with no significant Total Participants: N= 128 . Control: Standard behavioural Tx, differences between groups Setting: Not specified weekly for 40 weeks (N=54) Follow-up duration: Post Tx (40 weeks) and 6 months

Inclusion criteria: BMI 27 – 40kg/m2 Exclusion criteria: Significant medical or psychiatric conditions; pregnancy or planned pregnancy; medication that effects weight

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First author: Foster, 2012 Intervention: Diet + behavioural . When combined with None reported Country: USA . Tx: Hypocaloric almond-enriched behavioural methods of weight Population: Overweight and obese diet + behavioural methods of control, participants adults(mean age: 47, 91% female) weight control (N=61) consuming the almond- Total Participants: N= 123 . Control: Hypocaloric nut free diet enriched diet had significantly Setting: Hospital outpatient + behavioural methods of weight greater weight loss than to Follow-up duration: 6 and 18 months control (N=62) controls (small effect size),

2 however, there was no effect Inclusion criteria: BMI 27 - 40kg/m at 18 months Exclusion criteria: Comorbidity of major diseases; medications that effect weight

First author: Gadde, 2011 Intervention: Behavioural + . At 12 months participants Gastrointestinal issues; Country: USA pharmacological receiving Tx B had statistically nervous system Population: Obese adults (mean age: . Tx A: 200mg zonisamide/day + and clinically greater weight problems; adverse 43, 60% female) diet and lifestyle counselling loss than those in Tx A or psychiatric effects Total Participants: N= 225 (N=76) control groups including memory Setting: Not specified . Tx B: 400mg zonisamide/day + . There were no significant impairment, Follow-up duration: 12 months diet and lifestyle counselling differences in the 12 month heightened anxiety

2 (N=75) weight loss between Tx A and and depression Inclusion criteria: BMI 30–50kg/m . Control: Placebo pill + diet and control associated with both Exclusion criteria: Major medical or lifestyle counselling (N=74) treatment groups psychiatric illness; medication the effects weight

First author: Georg, 2012 Intervention: Diet + pharmacological . All forms of aerobic exercise Gastrointestinal Country: Denmark  Tx: Alginate supplement + calorie resulted in statistically symptoms Population: Obese adults restricted diet (N=48) significant reductions in weight Total Participants: N=96  Control: Placebo supplement + and body fat compared to the Setting: Not specified calorie restricted diet (N=48) control groups, with no Follow-up duration: 12 weeks significant difference between groups or between males and Inclusion criteria: See population females Exclusion criteria: Chronic disease; medications; other supplements; smoking

First author: Goldfield, 2013 Intervention: Exercise  No statistical difference was None reported Country: USA  Tx: Cycling as part of a video found within or between the Population: Overweight or obese game twice a week, 2x60 minute impact of cycling to music and adolescents (54% female) sessions per week for 10 weeks cycling as part of a video game Total Participants: N= 30 (N=15) in terms of weight loss or body Setting: Laboratory  Control: Cycling to music twice a composition Follow-up duration: 10 weeks week, 2x60 minute sessions per  However, across both groups

th week for 10 weeks (N=15) cycling was found to improve Inclusion criteria: BMI top 95 percentile social competence, and body image Exclusion criteria: Diabetes; medication or supplements; significant weight change 2 months prior; psychiatric illness

First author: Gorin, 2013 Intervention: Diet + behavioural  When combined with a calorie Gastrointestinal Country: USA  Tx: Standard behavioural weight and fast restricted diet, Tx symptoms Population: Overweight and obese loss + calorie and fat restricted resulted in a statistically adults (mean age: 49; 78% female) diet + changes to home greater weight loss at 6 month, Total Participants: N=201 environment (N=102) but not 18 months, compared Setting: Clinic and home . Control: Standard behavioural to the control group Follow-up duration: 6 and 18 months weight loss + calorie and fat  This effect was only observed restricted diet (N=99) in women; there was no Inclusion criteria: See population treatment effect for men Exclusion criteria: Heart condition; medication for weight loss; weight loss program; pregnancy

nedc.com.au Study Features Interventions Summary of outcomes Adverse effects

First author: Griffin, 2013 Intervention: Diet  Tx resulted in statistically and None reported Country: Australia  Tx: High protein (N=36) clinically significant weight loss Population: Overweight young  Control: High carbohydrate diet and % of fat loss compared to women (N=35) controls at 6 months but not at Total Participants: N=71 12 months Setting: Not specified Follow-up duration: 6 and 12 months

Inclusion criteria: See population Exclusion criteria: Significant medical and psychiatric conditions

First author: Grilo, 2011 Intervention: Behavioural  All behavioural treatments None reported Country: USA  Tx A: CBT (N=45) resulted in clinically significant Population: Obese adults with BED  Tx B: Behavioural weight loss BED remission but there were (mean age: 45) therapy (N=45) no statistical differences Total Participants: N= 125  Tx C: CBT + BWL (N=35) between the remission rates of Setting: Not specified  All treatments were administered the 3 types of treatments Follow-up duration: 6 and 12 months via 16 x 60 minute sessions over  Tx A resulted in statistically and clinically significant reductions Inclusion criteria: See population 24 weeks in occurrences of binge eating Exclusion criteria: Treatment of compared to Tx B eating/weight problems; medical conditions influencing weight; severe  Tx B and C resulted in psychiatric problems; pregnancy statistically greater weight loss than CBT alone at 6 months but there was no statistical difference in weight loss among the 3 treatment groups at 12 months

First author: Grilo, 2012 Intervention: Behavioural +  At 6 months both groups None reported Country: USA pharmacological receiving CBT (Tx B and Population: Overweight and obese  Tx A: Fluoxetine alone (N=27) control) had statistically and adults with BED (mean age: 44, 75%  Tx B: Fluoxetine + CBT (N=26) clinically higher rates of BED female)  Control: CBT + placebo (N=28) symptom remission compared Total Participants: N=81 to Tx A, but there was no Setting: Not specified significant difference between Follow-up duration: 6 and 12 months these groups  At 12 months BED symptom Inclusion criteria: Individuals who are remission rates differed 100–200% of ideal weight for height significantly for all groups; 4% Exclusion criteria: Treatment for of participants receiving Tx A weight, eating or psychiatric were assessed as being in problems; medical conditions; severe remission, compared to 27% psychiatric conditions; for Tx B, and 36% of pregnancy/lactation participants in the control group  None of the treatments were effective for inducing significant weight loss

First author: Grilo, 2013 Intervention: Behavioural +  Overall, adding Orlistat to BWL Minor gastrointestinal Country: USA pharmacological did not impact on events including Population: Obese Spanish-speaking  Tx A: BED receiving Orlistat + psychological outcomes flatulence and Latino adults with and without BED behavioural weight loss (BWL) compared with controls fatty/oily stools from economically disadvantaged (N=20)  However the addition of backgrounds (82% female)  Tx B: Non BED receiving Orlistat + Orlistat to BWL resulted in Total Participants: N=79 BWL (N=20) significantly greater weight loss Setting: Not specified  Control A: BED receiving BWL + in obese patients without BED Follow-up duration: 6 months placebo (N=20) (but not with BED)

Inclusion criteria: 21–65 years  Control B: Non BED receiving Exclusion criteria: Serious mental Orlistat + placebo (N=19) illness; changing medication regimes; antipsychotic medication; cardiac disease

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Study Features Interventions Summary of outcomes Adverse effects

First author: Grilo, 2013 Intervention: Behavioural . Participants in both groups had None reported Country: USA  Tx: Self help CBT over 16 weeks significant reductions in Population: Obese adults with BED, (N=24) episodes of binge eating, mean age (46, 79% female)  Control: Usual care over 16 eating disorder Participants: N=48 weeks (N=24) psychopathology and Setting: Primary care depressive symptoms, Follow-up duration: 4 months although there were no differences between groups Inclusion criteria: See population  There was no significant Exclusion criteria: BMI 50+; current reduction in BMI for either use of medication or weight loss group treatment; severe medical problems

First author: Grilo, 2014 Intervention: Behavioural +  There were no significant None reported Country: USA pharmacological group differences in BED Population: Obese adults with BED  Tx A: Self help CBT for 4 months remission rates at 6 or 12 (mean age: 44, 70% female) (N=27) months Total Participants: N =104  Tx B: Sibutramine 15mg/day for 4  Individuals receiving Tx B had Setting: Primary care months (N=26) significantly greater weight loss Follow-up duration: Post treatment  Tx C: CBT + siburamine 15mg/day than controls at 4 but not at 6 (4 months), 6 and 12 months for 4 months (N=26) or 12 months

Inclusion criteria: See population  Control: CBT + placebo for 4  All groups displayed decreased months (N=25) symptoms of depression over Exclusion criteria: Anti depressant medication; medication effecting the course of the study, but weight; severe medical or psychiatric there were no significant differences between these problems groups

First author: Grube, 2013 Intervention: Diet + exercise +  When combined with advice None reported Country: Germany pharmacological on a calorie restricted diet and Population: Overweight and obese . Tx: Litramine supplement + exercise prescription, Litramine adults (mean age: 45) advice on calorie restricted diet supplement was statistically Total Participants: N=125 plan + exercise advice (N=62) and clinically effective for Setting: Not reported  Control: Placebo pill + advice on weight loss, BMI reduction, Follow-up duration: 12 weeks calorie restricted diet plan + reduction in body fat and waist

2 exercise advice (N= 63) circumference compared to a Inclusion criteria: BMI 25-35kg/m placebo combined with advice Exclusion criteria: History of an eating on a calorie restricted diet and disorder; gastrointestinal issues; exercise prescription medication effecting gastrointestinal function; medical problems; pregnant/lactating

First author: Harden, 2014 Intervention: Pharmacological  Both treatments resulted in None reported Country: U.K.  Tx A: Docosahexaenoic significant weight loss with no Population: Overweight and obese supplement (N=not reported) significant differences between women (mean age: 45)  Tx B: Oleic Acid (N=not reported) groups Total Participants: N=40 Setting: Not specified Follow-up duration: 12 weeks

Inclusion criteria: See population Exclusion criteria: BMI 40+; not able to eat fish; gastrointestinal disorders; food allergy/intolerance; weight instability 3 months prior; drug consumption; fish oil; medication effecting appetite

First author: Hedberg, 2012 Intervention: Surgery  Both surgeries resulted in Gastrointestinal issues Country: Sweden  Tx: Duoedenal switch (N=24) statistically and clinically (diarrhea and Population: Morbidly obese adults significant reduction in BMI at flatulence),  Control: Roux-en-Y gastric bypass (mean age: 40, 53% male) 4 years reoperation (for 3 (N= 23) Total Participants: N=47  The difference in weight loss participants) Setting: Hospital between these groups was Follow-up duration: 4 years post- statistically significant operation

Inclusion criteria: BMI 48+ Exclusion criteria: Not reported

nedc.com.au Study Features Interventions Summary of outcomes Adverse effects

First author: Grilo, 2013 Intervention: Behavioural . Participants in both groups had None reported Country: USA  Tx: Self help CBT over 16 weeks significant reductions in Population: Obese adults with BED, (N=24) episodes of binge eating, mean age (46, 79% female)  Control: Usual care over 16 eating disorder Participants: N= 48 weeks (N=24) psychopathology and Setting: Primary care depressive symptoms, Follow-up duration: 4 months although there were no differences between groups Inclusion criteria: See population  There was no significant Exclusion criteria: BMI 50+; current reduction in BMI for either use of medication or weight loss group treatment; severe medical problems

First author: Grilo, 2014 Intervention: Behavioural +  There were no significant None reported Country: USA pharmacological group differences in BED Population: Obese adults with BED  Tx A: Self help CBT for 4 months remission rates at 6 or 12 (mean age: 44, 70% female) (N=27) months Total Participants: N =104  Tx B: Sibutramine 15mg/day for 4  Individuals receiving Tx B had Setting: Primary care months (N=26) significantly greater weight loss Follow-up duration: Post treatment  Tx C: CBT + siburamine 15mg/day than controls at 4 but not at 6 (4 months), 6 and 12 months for 4 months (N=26) or 12 months

Inclusion criteria: See population  Control: CBT + placebo for 4  All groups displayed decreased months (N=25) symptoms of depression over Exclusion criteria: Anti depressant medication; medication effecting the course of the study, but weight; severe medical or psychiatric there were no significant differences between these problems groups

First author: Grube, 2013 Intervention: Diet + exercise +  When combined with advice None reported Country: Germany pharmacological on a calorie restricted diet and Population: Overweight and obese . Tx: Litramine supplement + exercise prescription, Litramine adults (mean age: 45) advice on calorie restricted diet supplement was statistically Total Participants: N=125 plan + exercise advice (N=62) and clinically effective for Setting: Not reported  Control: Placebo pill + advice on weight loss, BMI reduction, Follow-up duration: 12 weeks calorie restricted diet plan + reduction in body fat and waist

2 exercise advice (N= 63) circumference compared to a Inclusion criteria: BMI 25 - 35kg/m placebo combined with advice Exclusion criteria: History of an eating on a calorie restricted diet and disorder; gastrointestinal issues; exercise prescription medication effecting GI function; medical problems; pregnant/lactating

First author: Harden, 2014 Intervention: Pharmacological  Both treatments resulted in None reported Country: U.K.  Tx A: Docosahexaenoic significant weight loss with no Population: Overweight and obese supplement (N=not reported) significant differences between women (mean age: 45)  Tx B: Oleic Acid (N=not reported) groups Total Participants: N=40 Setting: Not specified Follow-up duration: 12 weeks

Inclusion criteria: See population Exclusion criteria: BMI 40+; not able to eat fish; gastrointestinal disorders; food allergy/intolerance; weight instability 3 months prior; drug consumption; fish oil; medication effecting appetite

First author: Hedberg, 2012 Intervention: Surgery  Both surgeries resulted in Gastrointestinal issues Country: Sweden  Tx: Duodenal switch (N=24) statistically and clinically (diarrhoea and Population: Morbidly obese adults  Control: Roux-en-Y gastric bypass significant reduction in BMI at flatulence), (mean age: 40, 53% male) (N= 23) 4 years reoperation (for 3 Total Participants: N= 47  The difference in weight loss participants) Setting: Hospital between these groups was Follow-up duration: 4 years post- statistically significant operation

Inclusion criteria: BMI 48+ Exclusion criteria: Not reported

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Study Features Interventions Summary of outcomes Adverse effects

First author: Grilo, 2013 Intervention: Behavioural . Participants in both groups had None reported Country: USA  Tx: Self help CBT over 16 weeks significant reductions in Population: Obese adults with BED, (N=24) episodes of binge eating, mean age (46, 79% female)  Control: Usual care over 16 eating disorder Participants: N= 48 weeks (N=24) psychopathology and Setting: Primary care depressive symptoms, Follow-up duration: 4 months although there were no differences between groups Inclusion criteria: See population  There was no significant Exclusion criteria: BMI 50+; current change in BMI for either group use of medication or weight loss treatment; severe medical problems

First author: Grilo, 2014 Intervention: Behavioural +  There were no significant None reported Country: USA pharmacological group differences in BED Population: Obese adults with BED  Tx A: Self help CBT for 4 months remission rates at 6 or 12 (mean age: 44, 70% female) (N=27) months Total Participants: N =104  Tx B: Sibutramine 15mg/day for 4  Individuals receiving Tx B had Setting: Primary care months (N=26) significantly greater weight loss Follow-up duration: Post treatment  Tx C: CBT + sibutramine than controls at 4 but not at 6 (4 months), 6 and 12 months 15mg/day for 4 months (N=26) or 12 months

Inclusion criteria: See population  Control: CBT + placebo for 4  Depression symptoms months (N=25) decreased for all groups, but Exclusion criteria: Anti depressant medication; medication effecting there were no significant weight; severe medical or psychiatric differences between these groups problems

First author: Grube, 2013 Intervention: Diet + exercise +  When combined with advice None reported Country: Germany pharmacological on a calorie restricted diet and Population: Overweight and obese . Tx: Litramine supplement + exercise prescription, Litramine adults (mean age: 45) advice on calorie restricted diet supplement was statistically Total Participants: N=125 plan + exercise advice (N=62) and clinically effective for Setting: Not reported  Control: Placebo pill + advice on weight loss, BMI reduction, Follow-up duration: 12 weeks calorie restricted diet plan + reduction in body fat and waist

2 exercise advice (N= 63) circumference compared to a Inclusion criteria: BMI 25 - 35kg/m placebo combined with advice Exclusion criteria: History of an eating on a calorie restricted diet and disorder; gastrointestinal issues; exercise prescription medication effecting GI function; medical problems; pregnant/lactating

First author: Harden, 2014 Intervention: Pharmacological  Both treatments resulted in None reported Country: U.K.  Tx A: Docosahexaenoic significant weight loss with no Population: Overweight and obese supplement (N=not reported) significant differences between women (mean age: 45)  Tx B: Oleic Acid (N=not reported) groups Total Participants: N=40 Setting: Not specified Follow-up duration: 12 weeks

Inclusion criteria: See population Exclusion criteria: BMI 40+; not able to eat fish; gastrointestinal disorders; food allergy/intolerance; weight instability 3 months prior; drug consumption; fish oil; medication effecting appetite

First author: Hedberg, 2012 Intervention: Surgery  Both surgeries resulted in Gastrointestinal issues Country: Sweden  Tx: Duodenal switch (N=24) statistically and clinically (diarrhoea and Population: Morbidly obese adults significant reduction in BMI at flatulence),  Control: Roux-en-Y gastric bypass (mean age: 40, 53% male) 4 years reoperation (for 3 (N= 23) Total Participants: N= 47  The difference in weight loss participants) Setting: Hospital between these groups was Follow-up duration: 4 years post- statistically significant operation

Inclusion criteria: BMI 48+ Exclusion criteria: Not reported

nedc.com.au Study Features Interventions Summary of outcomes Adverse effects

First author: Hofsteeng, 2013 Intervention: Behavioural  There were small but None reported Country: Amsterdam, Netherlands  Tx: Go4it lifestyle intervention statistically significant benefits Population: Obese adolescents (mean that includes dietary and exercise from Tx compared to control, age: 15, 62% female) advice (N=71) including improvements in Total Participants: N= 122  Control: Usual care (N= 51) physical health and QOL Setting: Outpatient university clinic Follow-up duration: 6 months

Inclusion criteria: See population Exclusion criteria: Non-Dutch speaking; diabetes; physical or mental disability

First author: Hofsteeng, 2014 Intervention: Behavioural  Tx led to a modest reduction in None reported Country: Amsterdam, Sweden  Tx: Go4it lifestyle intervention BMI compared with controls Population: Obese adolescents (mean that includes dietary and exercise  These reductions were greater age: 15, 62% female) advice (N=71) for non-Western participants Total Participants: N = 122  Control: Usual care (N= 51) Setting: Outpatient Follow-up duration: 18 months

Inclusion criteria: See population Exclusion criteria: Non-Dutch speaking; diabetes; physical or mental disability

First author: Hsieh, 2011 Intervention: Other  Tx resulted in statistically and None reported Country: North Taiwan  Tx: Acupressure with Japanese clinically significant reduction Population: Overweight Asian young Magnetic Pearl (N=27) in weight and waist adults (91% female)  Control: Placebo (N=28) circumference compared the Total Participants: N= 55 control group Setting: Not reported Follow-up duration: 8 weeks

Inclusion criteria: Waist circumference > 80cm (for females); > 90cm (for males) Exclusion criteria: Not specified

First author: Huerta, 2015 Intervention: Pharmacological +  All groups had a significant None reported Country: Spain diet reduction in weight, waist and Population: Overweight and obese  Tx A: Eicosapentaenoic acid + hip circumference, and waist women energy restricted diet (N=20) to hip ratio Setting: Not reported  Tx B: Alpha-lipoic acid + energy  Tx B and Tx C produced in Total Participants: N= 97 restricted diet (N=26) statistically and clinically Follow-up duration: 10 weeks  Tx C: Eicosapentaenoic acid + significant reductions in weight

Inclusion criteria: Regular menstrual Alpha-lipoic acid + energy and waist and hip circumference compared to Tx cycle; unchanged weight for previous restricted diet (N=26)  Control: Placebo + energy and control 3 months Exclusion criteria: Significant or restricted diet (N=31) chronic physical or mental health problems

First author: Hunt, 2014 Intervention: Lifestyle  Tx resulted in statistically Gall bladder removal Country: U.K.  Tx: Weight loss program which greater reduction in weight, (1 participant); rupture Population: Overweight or obese men included dietary and exercise waist circumference and of Achilles tendon (1 (mean age: 47, 98% Caucasian) advice (N=374) percentage of body fat participant) Total Participants: N=747  Control: Wait list (N=374) compared to the WL group Setting: Not specified  The clinical significance of Follow-up duration: 12 months these changes are moderate

Inclusion criteria: See population Exclusion criteria: Had previously completed FFF-IT; high blood pressure

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Study Features Interventions Summary of outcomes Adverse effects

First author: Jakicic, 2012 Intervention: Behavioural + diet  Participants in both significant None reported Country: USA  Tx: Stepped-care weight loss amounts of weight by 18- Population: Overweight and obese intervention that included a low month follow-up adults (mean age: 43, 83% female) calorie diet and weekly to Total Participants: N=363 monthly counselling sessions Setting: Not reported (N=198) Follow-up duration: 18 months  Control: Standard behavioural weight loss (N=165) Inclusion criteria: See population

Exclusion criteria: medical conditions effecting exercise and dietary change; cardiovascular disease; medication effecting weight; exercise of 20mins +/day

First author: Johnston, 2013 Intervention: Behavioural  Tx resulted in a statistically and None reported Country: USA  Tx: Weight watchers programme clinically greater percentage of Population: Overweight and obese which included a food and weight loss at 3 and 6 months adults (mean age: 47, 90% female) exercise plan, skills to change compared controls Total Participants: N= 292 behaviour and access to group  Participants in the Tx group Setting: Not reported support (N=147) who used all 3 components of Follow-up duration: 3 and 6 months  Control: Self-help weight loss the weight loss intervention methods in which the (web access, WW app and who Inclusion criteria: See population participants received publicly attended meetings) lost Exclusion criteria: Dieting or taking available material explaining statistically and clinically weight loss medication; severe basic weight-loss concepts greater amounts of weight medical illness or condition; thyroid (N=145) compared to participants who problems; pregnancy accessed only one or two components of the program

First author: Jung, 2014 Intervention: Pharmacological  After 10 weeks the Tx group None reported Country: Korea  Tx: Yeast hydrolysate had statistically and clinically Population: Overweight and obese supplement taken daily (N=27) greater reductions in weight, adults  Control: Placebo pill (N=27) body fat mass and abdominal Total Participants: N=54 fat mass than controls Setting: Not reported Follow-up duration: 10 weeks

Inclusion criteria: See population Exclusion criteria: Significant medical illnesses or conditions; anti-obesity medication; weight loss program

First author: Keating, 2014 Intervention: Exercise  There were no significant Fainting was reported Country: Australia  Tx A: High intensity interval changes in body mass in any by one participant in Population: Overweight adults (mean training for 20–24 minutes, group Tx B age: 43; 82% female) 3x/week (N=13)  Tx B resulted in significant Total Participants: N=38  Tx B: Continuous aerobic exercise reductions in body fat Setting: Not specified training for 36–48 minutes, Follow-up duration: 12 weeks 3x/week (N=13)

Inclusion criteria: BMI 25–29.9kg/m2  Control: Placebo exercise which Exclusion criteria: significant medical included stretching, using a fit condition; lipid-lowering medication ball and self massage (N=12)

First author: Kehagias, 2011 Intervention: Surgery  Statistically and clinically Intestinal obstruction; Country: Greece  Tx A: Laparoscopic sleeve significant weight loss was ventral hernia; Population: Morbidly obese adults gastrectomy (N=30) found as the result of both enterocutaneous (73% female)  Tx B: Roux-en-Y Gastric bypass types of surgery fistula; acid Total Participants: N=60 (N=30)  Tx A resulted in statistically regurgitation, Setting: Not reported greater weight loss after 2 heartburn, and Follow-up duration: 3 years years, but there was no vomiting; 1 difference between the reoperation; Inclusion criteria: See population surgeries at the 3 year follow abdominal abscess Exclusion criteria: Chronic medical or up psychiatric illness; previous surgery

nedc.com.au Study Features Interventions Summary of outcomes Adverse effects

First author: Keithley, 2013 Intervention: Pharmacological  Neither treatment resulted in Belching, bloating and Country: USA  Tx: Glucomannan supplement significant weight loss or stomach fullness were Population: Overweight – moderately (N=26) improvements in body more commonly obese adults (mean age: 41, 85%  Control: Placebo pill (N=27) composition at 8 weeks present in the female) treatment group Participants: N=53 Setting: Not reported Follow-up duration: 8 weeks

Inclusion criteria: BMI 25-35kg/m2 Exclusion criteria: Currently using fibre supplements; unstable medical conditions that effect weight; gastrointestinal problems; medications that effect weight; psychiatric conditions

First author: Kelly, 2013 Intervention: Pharmacological  Tx resulted in a statistically Short term nausea, Country: USA  Tx: Glucagon-like peptide-1 greater absolute weight loss abdominal pain, Population: Severely obese receptor agonist (N=13) and BMI reduction compared diarrhoea, headache, adolescents (mean age: 15, 62%  Control: Placebo pill (N=13) to the placebo pill, although and vomiting female the size of this effect was Total Participants: N=26 modest Setting: Outpatient Follow-up duration: 3 months

Inclusion criteria: BMI over 35 Exclusion criteria: Diabetes; psychiatric disorders; bariatric surgery; significant medical conditions

First author: Khoo, 2014 Intervention: Pharmacological  Both groups experienced None reported Country: Singapore  Tx: Optifast Meal replacements, 2 significant weight loss at 40 Population: Obese Asian males (mean sachets/ day (N=24) weeks but only the Tx group age 40)  Control: (N=24) Conventional had significantly reduced waist Total Participants: N=48 reduced-fat diet (N=24) circumference Setting: Not specified  The Tx group had significant Follow-up duration: 40 weeks reductions in percentage of body fat compared with Inclusion criteria: BMI 27.5+ and waist controls circumference > 90 Exclusion criteria: cardiovascular  Both groups experienced disease; treatment for sexual or significant improvements in urinary problems QOL

First author: Kim, 2014 Intervention: Other  Tx resulted in a statistically and None reported Country: South Korea  Tx: Auricular acupressure using clinically significant reduction Population: Overweight or obese Sinapsis alba seeds (N=29) in body weight and BMI female college students (mean age:  Control: Placebo (N=29) compared to placebo 21)  There was no difference Total Participants: N=58 between the treatment and Setting: Not specified control group regarding Follow-up duration: 4 weeks changes in percentage of body fat or waist-to-hip ratio Inclusion criteria: No ear injury or surgery in the previous 6 months; no  Self-efficacy improved significant medical conditions; no significantly for participants history of treatment for Obesity receiving Tx, whereas self- Exclusion criteria: Not specified efficacy decreased for participants receiving the placebo treatment

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Study Features Interventions Summary of outcomes Adverse effects

First author: Kong, 2014 Intervention: Diet + behavioural  When combined with dietary None reported Country: Hong Kong  Tx: Low glycemic index diet + counselling, individuals Population: Obese adolescents (mean fortnightly dietary counselling receiving Tx had a statistically age: 17, 57% female) (N=52) significant reduction in obesity Total Participants: N=104  Control: Conventional Chinese indices including BMI, body Setting: Not specified diet based on the standard food weight and waist Follow-up duration: 6 months pyramid promoted by the Hong circumference compared with Kong Department of Health controls Inclusion criteria: See population (N=52) Exclusion criteria: Major medical illness; long-term medication

First author: Kreider, 2011 Intervention: Exercise + Diet  At 10 weeks participants in None reported Country: USA  Tx A: Meal replacement (Special both groups had significant Population: Overweight and obese K) + encouragement to increase reductions in weight, but this sedentary women (mean age: 41) exercise (N=45) reduction was greater for Tx B Total Participants: N=90  Tx B: Structured meal plan diet +  Similar results were found at Setting: University clinic supervised exercise regime 34 weeks Follow-up duration: 10 and 34 weeks (N=45)  Participants in Tx A also

Inclusion criteria: See population experienced improvements in Exclusion criteria: Recent QOL scores, although the participation in diet or exercise statistical significance of this was not reported program; recent weight loss; significant medical illness or co- morbidity

First author: Lim, 2011 Intervention: Pharmacological  Tx B resulted in significantly Gastrointestinal Country: Australia  Tx A: Metformin + lifestyle greater reductions in weight discomfort, rash, Population: Overweight and obese intervention (N=65) and waist circumference than dizziness, chest pain – young women (mean age: 28)  Tx B: Lifestyle intervention Tx or control groups experienced by a small Total Participants: N=203 (N=99) number of participants Setting: Not reported  Control: Placebo + lifestyle (<10) Follow-up duration: 12 weeks intervention (N=79)

Inclusion criteria: Access to Internet Exclusion criteria: Significant medical illnesses or co-morbidities; pregnant or lactating; current weight loss

First author: Liu, 2013 Intervention: Pharmacological  Tx A and C, but not B, had None reported Country: USA  Tx A: 200mg caffeine/20mg significant reductions in weight Population: Overweight and obese ephedrine, 3x/day (N=30) at 24 week follow-up adults  Tx B: Leptin daily (N= 30)  The difference in weight loss Total Participants: N=90  Tx C: Caffeine/ephedrine + leptin between participants receiving Setting: Not reported daily (N=30) Tx A and C, compared to Follow-up duration: 24 weeks participants receiving Tx B, was attributed by study authors to Inclusion criteria: See population a statistically greater reduction Exclusion criteria: Pregnancy/ in overall fat mass lactating; regular use of medication; recent weight loss; co-morbidity

First author: Maddison, 2011 Intervention: Lifestyle  Tx resulted in a significantly No adverse effects Country: New Zealand  Tx: Active video game, 60 greater reduction in both body related to the Population: Overweight and obese minutes every day of the week weight and percentage of intervention were children (mean age: 12, 27% female) (N=160) overall body fat compared with reported Participants: N=322  Control: Sedentary video game, control, but this treatment Setting: Not specified playing times left to the effect was small Follow-up duration: 24 weeks discretion of the participants (N=162) Inclusion criteria: Owns a PlayStation2 or 3 consol; no active video games Exclusion criteria: Medical conditions effecting physical activity

nedc.com.au Study Features Interventions Summary of outcomes Adverse effects

First author: Malkina-Pykh, 2012 Intervention: Behavioural  Tx A resulted in statistically and None reported Country: Russia  Tx A: Rhythmic movement clinically improved symptoms Population: Overweight or obese therapy (N=30) of obesity and eating disorders adults (mean age: 38, 69% female)  Tx B: CBT (N=28) including; a reduction in BMI, a Total Participants: N=58  Control: No treatment (N=18) reduction in restrained and Setting: Not specified emotional eating, body Follow-up duration: 12 weeks dissatisfaction, and emotional dysfunction Inclusion criteria: Self-referred  Participants in Tx B and control participants or patients referred by their GP group had no significant differences between pre- and Exclusion criteria: Not specified post-treatment symptoms

First author: Mangine, 2012 Intervention: Pharmacological  Both groups experienced a Blurry vision, Country: USA  Tx: 40mg N-oleyl- reduction in body weight from headache, Population: Overweight and obese phosphatidylethanolamine + baseline, however no increased appetite, adults (70% female) 35mg epigallocatechin-3-gallate, significant differences were shakiness, and Total Participants: N=50 3x/day (N=25) found between groups re: disrupted Setting: Not specified  Control: Placebo pill, 3x /day changes in body mass, alertness Follow-up duration: 4 and 8 weeks (N=25) percentage of body fat or waist circumference Inclusion criteria: Daily energy intake  at or above recommended guidelines At week 8 participants in the Tx group reported a statistically Exclusion criteria: Not reported significant, but modest reduction in tension

First author: Masheb, 2011 Intervention: Behavioural + Diet  26% of all participants None reported Country: USA  Tx: CBT + low energy density achieved a weight loss of Population: Obese adults with BED diet (N=25) greater than 5% at 6 months (mean age: 46, 76% female)  Comparator: CBT + general but there was no significant Total Participants: N= 50 nutrition counselling (N=25) differences between groups Setting: Not specified  30% of participants achieved Follow-up duration: 6 and 12 months a similar weight loss at 12 months but, again, there Inclusion criteria: See population was no significant difference Exclusion criteria: Psychiatric co- between groups morbidities; receiving any treatment  that effects weight; medical co- Both groups had a morbidities; pregnant/lactating significant improvement in the behavioural and attitudinal features of BED

First author: Mathews, 2012 Intervention: Diet  No significant weight loss or None reported Country: U.K.  Tx: Ready to eat Kellogg’s body composition differences Population: Overweight adults (mean breakfast cereal (N=36) were found between groups age: 40, 75% female)  Control: Usual evening snack  There was, however, a Total Participants: N=70 (N=34) statistically significant Setting: Not specified reduction in waist Follow-up duration: 2, 4 and 6 weeks circumference for participants

2 in the Tx group at 6 weeks Inclusion criteria: BMI 25-32kg/m although the size of this effect Exclusion criteria: Significant illness or was minimal medical condition; smoking; eating disorder traits; medication effecting weight; significant weight fluctuation in previous 6 months; night shift workers

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Study Features Interventions Summary of outcomes Adverse effects

First author: Morena, 2014 Intervention: Diet  At all monthly evaluations The Tx diet induced a Country: Spain  Tx: Very low-calorie-ketogenic there was a statistically and range of short-term Population: Obese adults (mean age: diet as part of a commercial clinically significant difference side effects in many 45, 89% female) weight loss program - Pronokal in weight loss between Tx and participants including Total Participants: N=79 Method. This was based on a control groups constipation, Setting: Not specified high-biological-value protein  The maximum weight loss was headache, asthenia, Follow-up duration: monthly for a preparations diet and natural observed at 8 months hyperuricemia and total of 12 months foods (N=39)  Additionally the Tx diet was fatigue  Control: Standard low calorie diet Inclusion criteria: Stable body weight seen to induce a weight loss of in previous 3 months; history of failed with a caloric value of 10% below more than 10% in body weight the total metabolic expenditure diet attempts in 96% of its participants, of each individual (N=40) Exclusion criteria: Significant illness or compared to only 3% of medical condition; psychiatric participants achieving this conditions weight loss in the control group. This difference was seen at 2,3, 4 and 12 month evaluations.

First author: Munro, 2013 Intervention: Pharmacological +  Supplementing a low energy None reported Country: Australia diet diet with omega 3 fatty acids Population: Obese adults (69%  Tx: Fatty acid supplement + low was not shown to induce extra female) energy diet (N=17) weight loss Total Participants: N=35  Control: Placebo + low energy  Participants in both groups Setting: Not specified diet (N=18) experienced statistically and Follow-up duration: 12 weeks clinically significant weight loss at 12 weeks, however there Inclusion criteria: See population Exclusion criteria: Significant medical were no significant differences between groups condition or illness; current energy restriction; pregnant/lactating

First author: Nackers, 2013 Intervention: Diet + behavioural  Both treatment groups had a None reported Country: USA  Tx A: 1,000 calorie diet + statistically and clinically Population: Obese women, aged 25– behavioural treatment (N=65) significant reduction in weight 75 years, mean age: 52, 74% female  Tx B: 1,500 calorie diet + at 6 and 12 months Total Participants: N=125 behavioural treatment (N= 60)  Between 7–12 months Setting: Not specified participants in Tx A had Follow-up duration: 6 and 12 months significant weight re-gain, and

at the 12 month assessment Inclusion criteria: Basic English were not statistically different reading skills than Tx B Exclusion criteria: Psychiatric conditions; significant weight loss in previous 6 months; previous participation in behavioural weight loss program

First author: Nanchahal, 2012 Intervention: Behavioural  A statistically and clinically None reported Country: U.K.  Tx: 1 to 1 behavioural weight loss higher proportion of Population: Overweight and obese program that included dietary participants in the Tx group adults (mean age: 49, 71% female) and exercise advice (N=191) lost more than 5% of their Total Participants: N= 381  Control: Usual care (N=190) baseline body weight and Setting: Primary care experienced a reduction in Follow-up duration: 12 months waist circumference than the proportion of participants in Inclusion criteria: See population the control group Exclusion criteria: Pregnancy; significant medical illness; participation in another study

nedc.com.au Study Features Interventions Summary of outcomes Adverse effects

First author: Napolitano, 2013 Intervention: Behavioural +  Overall FB + personalised text None reported Country: USA technology messaging was effective for Population: Overweight and obese  Tx A: Facebook (FB): participants encouraging short term weight students (mean age: 21, 87% female) were part of a private FB group loss Total Participants: N= 52 through which they could access  At 4 weeks participants in Tx B Setting: Not specified content about weight loss lost significantly more weight Follow-up duration: 4 and 8 weeks interventions (N=17) than Tx A or controls  Inclusion criteria: mobile phone plan Tx B: FB + text messaging:  The size of this effect was participants were part of a including unlimited text messaging; modest active Facebook user private FB group through which they received access to the same Exclusion criteria: Significant medical content as participants in the FB illness or condition; medication group. Participants in FB+ also effecting weight; unstable psychiatric received additional theoretically- disorder; eating disorder driven intervention targets: goal setting, self-monitoring, and social support communicated via text messaging (N=18)  Control: Waiting List (N=17)

First author: Park, 2014 Intervention: Pharmacological  Tx was statistically and None reported Country: Korea  Tx: Gynostemma pentaphyllum clinically more effective for Population: Obese adults (mean age: extract 450mg/day (N=40) reducing abdominal fat and 41)  Control: Placebo pill, taken once body weight compared to the Total Participants: N= 80 daily (N=40) control group Setting: Not specified  The effect size for reduced Follow-up duration: 12 weeks body weight, BMI and overall percentage of body fat was Inclusion criteria: See population small Exclusion criteria: Significant medical illnesses or conditions; morbidly obese patients’ weight variation 3 months prior to study

First author: Pataky, 2013 Intervention: Pharmacological  Participants receiving Tx had a Nausea, Country: Multiple  Tx: Rimonabant 20mg/day statistically and clinically nasopharyngitis, Population: Obese adults with BED (N=143) significant reduction in weight, diarrhoea and (mean age: 43)  Control: Placebo pill, daily waist circumference and binge insomnia were more Total Participants: N=289 (N=146) eating compared with controls significant in the Tx Setting: Not specified groups Follow-up duration: 6 months

Inclusion criteria: BMI 30–45kg/m2; diagnosed BED Exclusion criteria: Previous surgery for weight loss; cannabis use; substance abuse problems in the previous 6 months; medication the effects weight; co-morbidities

First author: Pellegrini, 2012 Intervention: Behavioural  All treatment interventions None reported Country: USA  Tx A: Technology based weight resulted in significant Population: Overweight and obese loss system (N=17) reductions in body weight, wait adults (mean age: 44)  Tx B: Standard behavioural circumference, hip Total Participants: N=51 weight loss system + a circumference and percentage Setting: Not specified technology based element of body fat, with no significant Follow-up duration: 6 months (N=17) differences between groups

Inclusion criteria: Sedentary; access to  Control: Standard behavioural phone and internet weight loss system (N=17) Exclusion criteria: Significant illnesses or medical conditions; medications that effect weight; limitations of exercise

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First author: Pinto, 2013 Intervention: Behavioural  Adding fundamental None reported Country: USA  Tx A: Standard behavioural principles of BWL treatment Population: Overweight and obese weight loss treatment (N=48) to the weight watchers adults (mean age: 50, 90% female)  Tx B: Fundamental principles program (Tx B) did not Total Participants: N=144 of BWL + weight watchers enhance weight loss Setting: Not specified program (N=47)  Participants in all treatment Follow-up duration: 24 and 48 weeks  Comparator: Weight watchers groups lost statistically and clinically significant amounts Inclusion criteria: See populations program (N=49) of weight at 12, 24 and 48 Exclusion criteria: Weight loss medication or participation in a weeks, with no significant differences between groups weight loss program within previous 12 months; participated in weight watchers program in previous 2 years; significant medical illness or co-morbidity

First author: Pi-Sunyer, 2015 Intervention: Pharmacological  In conjunction with lifestyle A range of adverse Country: 27 countries  Tx A: 3mg Liraglutide injection, modification counselling, effects were noted Population: Obese adults, aged 18 + once daily + lifestyle Liraglutide Tx resulted in with the most years, mean age: 45, 79% women modification counselling statistically and clinically common being Total Participants: N=3731 (N=2487) greater weight loss and nausea, diarrhoea, Setting: Not specified  Control: Placebo injection + reduction in waist constipation and Follow-up duration: 56 weeks lifestyle modification circumference at 56 weeks nasopharyngitis counselling (N=1244) compared to the placebo Inclusion criteria: Stable body weight group Exclusion criteria: Type 1 or 2 diabetes; medications effecting weight’ previous bariatric surgery; significant medical illness; psychiatric disorder

First author: Poelman, 2015 Intervention: Behavioural  Tx resulted in a significant None reported Country: Netherlands  Tx: PortionControl@Home reduction in BMI at 3 Population: Overweight and obese program that aims to modify months compared to the adults (mean age: 46, 85% female) dietary behaviours (N=142) control group, however Total Participants: N= 278  Control: Wait List (N= 142) there was no difference at Setting: Not specified 12 months Follow-up duration: 3, 6 and 12 months

Inclusion criteria: Participant required to be the gatekeeper of the family (e.g. the person who had the most significant influence on food) Exclusion criteria: Co-morbidities; clinical depression; significant medical illness

First author: Poole, 2011 Intervention: Exercise +  Adding Tx to an exercise None reported Country: USA pharmacological regime does not enhance Population: Overweight college  Tx: Weight loss supplement + weight loss students (mean age: 22) exercise (N=12)  There were no significant Total Participants: N=24  Control: Placebo pill + exercise differences in BMI or body Setting: Not specified (N=12) composition in either group or Follow-up duration: 8 weeks between groups

Inclusion criteria: See population Exclusion criteria: Co-morbidities; medication effecting weight

nedc.com.au Study Features Interventions Summary of outcomes Adverse effects

First author: Reichkendl, 2014 Intervention: Exercise  Both Tx groups had statistically None reported Country: Denmark  Tx A: Moderate exercise, 3x/ and clinically significant Population: Overweight Caucasian week (N=21) reductions in weight and waist men  Tx B: High intensity of exercise, circumference compared with Total Participants: N=64 3x/ week (N=22) controls Setting: Not specified  Control: No exercise (N=18)  QOL scores also improved for Follow-up duration: 11 weeks Tx A and Tx B groups, and remained statistically greater Inclusion criteria: Sedentary; stable in Tx B compared with controls weight Exclusion criteria: Significant medical condition; regular medication

First author: Ross, 2015 Intervention: Exercise  At 24 weeks all treatment None reported Country: Canada  Tx A: Low amount, low intensity groups experienced statistically Population: Abdominally obese adults of exercise – exercise was significant reductions in body (mean age: 51) walking or jogging, 5x/week weight and waist Total Participants: N=300 (N=73) circumference, compared to Setting: Not specified  Tx B: High amount, low intensity the control group but there Follow-up duration: 24 weeks of exercise - exercise was walking were no significant differences or jogging, 5x/week (N=76) between the types of exercise Inclusion criteria: See population  Tx C: High amount, high intensity performed Exclusion criteria: Illness preventing exercise; 2 + exercise sessions per - exercise was walking or jogging, week; diabetes 5x/week (N=76)  Control: No prescribed exercise (N=75)

First author: Sukarai, 2013 Intervention: Diet + exercise +  Participants who hot bathed, None reported Country: Japan other dieted and exercised regularly Population: Overweight older adults  Tx A: Dietary modification (Tx A) experienced significantly (mean age: 62, 77% female) consisting of a series of 4x 75- greater weight reduction, BMI Total Participants: N=66 min nutrition guidance classes + and body fat percentage Setting: Not specified 75 minutes of exercise 2x/week + compared to all other Follow-up duration: 3 months hot bathing for 20 minutes after treatment groups and the each period of exercise (N=17) control group Inclusion criteria: Seen population  Tx B: 75 minutes of exercise Exclusion criteria: Significant medical 2x/week + dietary modification condition; mental disorder or consisting 4 nutrition guidance cognitive impairment classes (N=16)  Tx C: Hot bathing for 20 minutes 2x/week (N=16)  Control: No treatment (N=17)

First author: Sanal, 2013 Intervention: Exercise  Both groups had significant None reported Country: Turkey  Tx A: Aerobic exercise for 20–45 reductions in body weight, BMI Population: Overweight and obese minutes a day, 3-5 days per week and waist circumferences but adults (mean age: 39) (N=46) there were no significant Total Participants: N=92  Tx B: Aerobic resistance exercise, differences between groups Setting: Not specified same exercise prescription as Tx  Significant differences were Follow-up duration: 12 weeks A + resistance training twice a found in changes to body week (N=46) composition. Overall Tx B was Inclusion criteria: See population Exclusion criteria: Significant medical significantly more effective at increasing the fat free mass of condition; aerobic program 12 in all regions of the body, and months prior to study; medication the body overall compared to effecting the musculoskeletal system Tx A  There was a significant gendered difference in response to the different types of exercise; Tx B was more effective for increasing the fat free mass of the arms, trunk and the whole body for men, whereas Tx B was more effective for reducing fat mass in the trunk region in women

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First author: Salenpour, 2012 Intervention: Pharmacological  The Tx group experienced None reported Country: Iran  Tx: Vitamin D supplement 25 statistically and clinically Population: Overweight and obese μg/day (N=42) greater reductions in overall women (mean age: 38)  Control: Placebo pill 25 μg/day body mass compared to those Total Participants: N= 85 (N=42) taking the placebo Setting: Not specified  There were no significant Follow-up duration: 12 weeks differences within or between groups in relation to body Inclusion criteria: See population weight, waist circumference or Exclusion criteria: Significant medical illness; consuming medication or hip circumference other vitamin supplements; recent fluctuations in body weight; smoking and alcohol consumption

First author: Sanchez, 2014 Intervention: Pharmacological  Overall, there was no None reported Country: Canada  Tx: Lactobacillus rhamnosus statistical difference Population: Obese adults, aged 18 – supplement, 2x/day + between the weight loss of 55 years (mean age: 36, 62% female) moderate energy restricted participants receiving the Tx Total Participants: N=125 diet (N=62) compared to those Setting: Not reported  Control: Placebo pill, 2x/day + receiving the placebo, but Follow-up duration: 12 and 24 weeks moderate energy restricted there was a significant diet (N=63) difference between the Inclusion criteria: Stable body weight weight loss of women taking 3 months prior the Tx and those taking the Exclusion criteria: Pregnancy; placebo pill at both 12 and menopause; co-morbidities and 24 week follow-ups significant medical conditions; medication effecting body weight

First author: Shapiro, 2012 Intervention: Behavioural  Neither group experienced None reported Country: USA  Tx: Text4Diet a daily interactive weight loss at either follow- Population: Overweight and obese weight loss programme up assessment adults (mean age: 42, 65% female) consisting of personalised text Total Participants: N= 170 messages + monthly e-newsletter Setting: Not specified (N=81) Follow-up duration: 6 and 12 months  Control: Monthly e-newsletter (N=89) Inclusion criteria: Access to Internet and owns and uses a cell phone Exclusion criteria: Eating disorder; non-English speaking persons

First author: Shin, 2014 Intervention: Pharmacological  At 12 months Tx B resulted in Altered taste, Country: USA  Tx A: Zonisamide 200mg/day + statistically and clinically constipation, Population: Obese adults (60% diet and lifestyle counselling greater weight loss compared diarrhoea, dry mouth, female) (N=76) to Tx A and placebo. There headache, fatigue, Setting: Not specified  Tx B: Zonisamide 400mg/day + were no significant differences nausea/vomiting, Total Participants: N=225 diet and lifestyle counselling between the weight loss of somnolence, Follow-up duration: 12, 18 and 24 (N=75) participants consuming Tx A language/speech months  Control: Placebo pill + diet and and the placebo. These problems, impaired differences were maintained at attention/ Inclusion criteria: See population lifestyle counselling (N=74) the 18 months follow up concentration, Exclusion criteria: Diabetes; co-  memory problems, morbidities; significant illness; At 24 months (6 months after the study was discontinued) and anxiety-related psychiatric diagnoses; psychotic patients receiving Tx B and depression- medication treatment had regained the related adverse events most weight

nedc.com.au Study Features Interventions Summary of outcomes Adverse effects

Country: Canada Intervention: Exercise  All exercise groups None reported Population: Obese adolescents (mean  Tx A: Aerobic training 4x/week experienced significant age: 6, 70% female) (N=75) reductions in percentage of Total Participants: N=304  Tx B: Resistance training 4x/week body fat compared to the Setting: Not specified (N=78) control group, but there were Follow-up duration: 6 months  Tx C: Combination of Tx A, B and no significant differences between the three exercise Inclusion criteria: Post-pubertal; C 4x/week (N=75) groups and the size of these sedentary for 4 months prior to study  Control: No exercise (N=76) reductions were modest. Exclusion criteria: Regular exercise of  more than 2 days a week; significant All exercise groups had significant reductions in waist medical illness or condition circumference, but not the control. There were no differences between groups regarding waist circumference measurements at 6 months.

First author: Sijie, 2012 Intervention: Exercise  Participants in both exercise None reported Country: China  Tx A: Moderate intensity groups experienced statistically Population: Overweight young continuous training, 5x/week and clinically significant women (mean age: 20) (N=16) reductions in body mass, BMI, Total Participants: N=60  Tx B: High intensity interval body fat percentage and waist- Setting: Not specified training, 5x/week (N=17) to-hip ratio Follow-up duration: 12 weeks  Control: No training (N=19)  The reduction in body fat was significantly greater for Inclusion criteria: Normal menstrual participants in Tx B, than the Tx cycle A and control group Exclusion criteria: Significant medical conditions

First author: Sovik, 2011 Intervention: Surgery  Both procedures led to Participants who Country: Norway and Sweden  Tx A: Duodenal switch (N=29) statistically and clinically received Tx A Population: Morbidly obese adults  Tx B: Gastric bypass (N=31) improved outcomes for experienced Total Participants: N=60 participants, but participants significantly more Setting: Not reported receiving Tx A had significantly adverse effects Follow-up duration: 12 and 24 greater reductions in BMI, total compared to those months weight loss, waist who underwent Tx B, circumference and hip including readmission, Inclusion criteria: See population circumference compared to requiring new surgery, Exclusion criteria: BMI greater than participants who underwent Tx vomiting and other 60; history of bariatric surgery; B gastric problems significant illness  Participants in both surgical groups reported significant improvements in health related QOL, with statistically greater improvements in QOL in individuals who underwent Tx B

First author: Sovik, 2013 Intervention: Surgery  24 months after surgery See Sovik, 2011 Country: Sweden and Norway  Tx A: Duodenal switch (N=29) participants who underwent Tx Population: Morbidly obese adults  Tx B: Gastric bypass (N=31) A had significantly more Total Participants: N=60 adverse gastrointestinal effects Setting: Not specified compared to participants who Follow-up duration: 24 months underwent Tx B, for example diarrhoea, anal leakage of stool Inclusion criteria: See population and more day time defecation Exclusion criteria: BMI greater than  60; history of bariatric surgery; Psychosocial functioning improved significantly after significant illness surgery for both groups – there was no significant difference in these scores between surgery groups

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First author, yr: Spring, 2013 Intervention: Behavioural +  Participants who received their None reported Country: USA technology usual physician care with the Population: Overweight and obese  Tx: Usual physician care + mobile addition of mobile phone adults (mean age: 58, 86% male) phone technology which technology (Tx) experienced Total Participants: N=69 participants used as a decision statistically greater weight loss Setting: Primary care support tool to self-regulate compared to participants who Follow-up duration: 3, 6, 9 and 12 energy intake (N=35) received only physician care months  Control: Usual care (N=35) (control)  The size of this effect was Inclusion criteria: Weight less than 181.4kg moderate

Exclusion criteria: Psychiatric hospitalization; BED

First author: Steinberg, 2013 Intervention: Other  At both 3 and 6 months, Tx None reported Country: USA  Tx: Daily self-weighing program resulted in statistically and Population: Overweight and obese which included use of a ‘‘smart’’ clinically greater weight loss adults (mean age: 44, 75% female) scale for daily weighing; a web- compared to the group that Total Participants: N=91 based graph of weight trends delayed weigh-ins Setting: Not specified over time; weekly tailored Follow-up duration: 3 and 6 months feedback via e-mail on self- weighing frequency and weight Inclusion criteria: Access to internet loss progress; and 22 weekly Exclusion criteria: significant medical lessons on behavioural weight condition; psychiatric disorder other control via e-mail (N=46) than depression; eating disorder;  Comparator: Delayed weighing, participation in weight loss program where participants were given in past 6 months scales at baseline for evaluation purposes only and instructed to maintain their current self- weighing habits (N=44)

First author: Strobl, 2013 Intervention: Behavioural  Weight reduction was None reported Country: Germany  Tx: Standard inpatient medical observed in both groups Population: Obese adults (mean age: obesity rehabilitation + Intensive  The difference in weight loss 48, 55% male) after-care consisting of a between the two groups was Total Participants: N=467 combined planning and not statistically significant Setting: After-care telephone aftercare intervention Follow-up duration: 12 months (N=228)  Control: Standard inpatient Inclusion criteria: Had started medical obesity rehabilitation inpatient treatment for obesity; could speak and understand German (N=239) Exclusion criteria: Type 1 diabetes; medical condition that effects ability to participate in sport; bariatric surgery; psychiatric disorders

First author: Suplicy, 2014 Intervention: Pharmacological  Participants receiving all drug Medically treated Country: Brazil  Tx A: Diethylpropion 75mg/day treatments, with the exception groups experienced Population: Obese premenopausal (N=28) of those receiving Tx D, more adverse effects women (mean age: 37)  Tx B: Fenproporex 25mg/day experienced significant weight than the placebo Total Participants: N=174 (N=29) loss compared to participants group, including dry Setting: Academic institution  Tx C: Mazindol 2mg/day (N=29) receiving placebo mouth, constipation, Follow-up duration: 52 weeks  Tx D: Fluoxetine 20mg/day  There were no significant anxiety, and irritability. differences found between the These side effects Inclusion criteria: Stable weight (N=29) drugs that resulted in were reported as mild previous 3 months  Tx E: Sibutramine 15mg/day significant weight loss to moderate in Exclusion criteria: Males; previous (N=30) severity. bariatric surgery; significant medical  Control: Placebo pill (N=29)  A statistically and clinically illness; psychiatric disorders including greater proportion of participants receiving Tx A, B, C diagnosed eating disorder and D lost 5 or more percent of their body weight and had reductions in waist circumference at 52 weeks, than participants receiving either Tx D or placebo . All Tx groups had significant improvements in QOL scores, depression and anxiety

nedc.com.au Study Features Interventions Summary of outcomes Adverse effects

First author, yr: Toulabi, 2012 Intervention: Behavioural  There was a statistically and None reported Country: Iran  Tx: School-based behavioural clinically significant reduction Population: Obese adolescents (mean intervention program consisting in body weight, BMI, waist and age: 16) of nutritional education, hip circumference of Total Participants: N=152 modifying dietary habits, participants of the school- Setting: Public high school teaching exercise programs, based behavioural program Follow-up duration: 6 weeks teaching nutritional facts to the compared to the control parents, and performing  Inclusion criteria: Participation of at Participants in both the school- exercises 3 days a week (N=76) based behavioural program least one parent  Exclusion criteria: drugs effecting Control: Education booklets and those in the control group containing information about reported improved levels of body weight; consuming special diets; healthy eating and exercise depressive symptoms, with no comorbidities (N=76) differences between the groups on this measure

First author: Tur, 2013 Intervention: Behavioural  At 1 year there was a None reported Country: Spain  Tx: Intensive lifestyle significantly greater Population: Morbidly obese adults intervention including regular proportion of participants (mean age: 47, 69% female) group meetings focused on who received Tx who Total Participants: N=106 dietary habits and food achieved a weight loss of Setting: Not specified choices, exercise prescription more than 2, 10 and 20% of Follow-up duration: 1 year and the option of receiving body weight compared to weight loss medication (N=60) the proportion of Inclusion criteria: See population  Control: Conventional obesity participants receiving Exclusion criteria: Enrolment in therapy which included the conventional obesity another obesity program; prior standard nutritional therapy (control) bariatric surgery; significant medical education, medical treatment conditions; psychiatric disorders and follow-up available for patients with morbid obesity (N=46)

First author: Wadden, 2011a Intervention: Behavioural +  Participants in the Tx group Nausea, constipation, Country: USA pharmacological lost a statistically greater dizziness, abdominal Population: Overweight and obese  Tx: Naltrexone SR 32 mg/day proportion of their body pain and depressed adults combined with bupropion SR 360 weight compared to those in mood were Total Participants: N=793 mg/day + behavioural the placebo group statistically greater Setting: Not specified modification (N=591)  Nearly twice as many side effects in the Tx Follow-up duration: 56 weeks  Control: Placebo pill + individuals receiving Tx lost group compared with behavioural modification (N=202) ≥10% and nearly three times as control Inclusion criteria: See population many lost ≥15% of initial Exclusion criteria: Significant medical weight compared with controls illness; treatment with bupropion or . Tx also resulted in statistically naltrexone within the previous 12 and clinically enhanced QOL months; history of drugs or alcohol compared placebo (including within previous 12 months; enhanced self-esteem and psychiatric disorder; smokers reduced levels of public distress)

First author: Wadden, 2011b Intervention: Lifestyle  Tx B resulted in statistically Two Country: USA  Tx A: Brief lifestyle counselling greater weight loss at 24 cholecystectomies and Population: Obese adults (mean age: (N=131) months compared to Tx A and one case of syncope 52, 80% female)  Tx B: Enhanced brief lifestyle control. The maximum weight were reported. Total Participants: N=390 counselling + either a meal loss for all groups was Sibutramine was Setting: Primary care replacement or Orlistat or recorded at 12 months discontinued in 5 Follow-up duration: 24 months sibutramine (N=129)  Participants in Tx B could participants due to choose to enhance their increased blood Inclusion criteria: See population  Control: Usual primary care lifestyle counselling with meal pressure and Orlistat Exclusion criteria: Significant medical (N=130) replacements, Orlistat or was discontinued in condition; recent weight loss; sibutramine. There were no five participants due to medications effecting weight; significant between outcomes gastrointestinal psychiatric disorders with these additions symptoms.

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First author, yr: Spring, 2013 Intervention: Behavioural +  Participants who received their None reported Country: USA technology usual physician care with the Population: Overweight and obese  Tx: Usual physician care + mobile addition of mobile phone adults (mean age: 58, 86% male) phone technology which technology (Tx) experienced Total Participants: N=69 participants used as a decision statistically greater weight loss Setting: Primary care support tool to self-regulate compared to participants who Follow-up duration: 3, 6, 9 and 12 energy intake (N=35) received only physician care months  Control: Usual care (N=35) (control)  The size of this effect was Inclusion criteria: Weight less than 181kg moderate

Exclusion criteria: Psychiatric hospitalization; BED

First author: Steinberg, 2013 Intervention: Other  At both 3 and 6 months, Tx None reported Country: USA  Tx: Daily self-weighing program resulted in statistically and Population: Overweight and obese which included use of a ‘‘smart’’ clinically greater weight loss adults (mean age: 44, 75% female) scale for daily weighing; a web- compared to the group that Total Participants: N=91 based graph of weight trends delayed weigh-ins Setting: Not specified over time; a) weekly tailored Follow-up duration: 3 and 6 months feedback via email on self- weighing frequency and weight Inclusion criteria: Access to internet loss progress; and 22 weekly Exclusion criteria: significant medical lessons on behavioural weight condition; psychiatric disorder other control via email (N=46) than depression; eating disorder;  Comparator: Delayed weighing, participation in weight loss program where participants were given in past 6 months scales at baseline for evaluation purposes only and instructed to maintain their current self- weighing habits (N=44)

First author: Strobl, 2013 Intervention: Behavioural  Weight reduction was None reported Country: Germany  Tx: Standard inpatient medical observed in both groups Population: Obese adults (mean age: obesity rehabilitation + Intensive  The difference in weight loss 48, 55% male) after-care consisting of a between the two groups was Total Participants: N=467 combined planning and not statistically significant Setting: After-care telephone aftercare intervention Follow-up duration: 12 months (N=228)  Control: Standard inpatient Inclusion criteria: Had started medical obesity rehabilitation inpatient treatment for obesity; could speak and understand German (N=239) Exclusion criteria: Type 1 diabetes; medical condition that effects ability to participate in sport; bariatric surgery; psychiatric disorders

First author: Suplicy, 2014 Intervention: Pharmacological  Participants receiving all drug Medically treated Country: Brazil  Tx A: Diethylpropion 75mg/day treatments, with the exception groups experienced Population: Obese premenopausal (N=28) of those receiving Tx D, more adverse effects women (mean age: 37)  Tx B: Fenproporex 25mg/day experienced significant weight than the placebo Total Participants: N=174 (N=29) loss compared to participants group, including dry Setting: Academic institution  Tx C: Mazindol 2mg/day (N=29) receiving placebo mouth, constipation, Follow-up duration: 52 weeks  Tx D: Fluoxetine 20mg/day  There were no significant anxiety, and irritability. differences found between the These side effects Inclusion criteria: Stable weight (N=29) drugs that resulted in were reported as mild previous 3 months  Tx E: Sibutramine 15mg/day significant weight loss to moderate in Exclusion criteria: Males; previous (N=30) severity. bariatric surgery; significant medical  Control: Placebo pill (N=29)  A statistically and clinically illness; psychiatric disorders including greater proportion of participants receiving Tx A, B, C diagnosed eating disorder and D lost 5 or more percent of their body weight and had reductions in waist circumference at 52 weeks, than participants receiving either Tx D or placebo . All Tx groups had significant improvements in QOL scores, depression and anxiety

nedc.com.au Study Features Interventions Summary of outcomes Adverse effects

First author, yr: Wagener, 2012 Intervention: Exercise  Exergaming was not None reported Country: USA  Tx: Exergaming, a supervised 10- statistically effective for weight Population: Obese adolescents (mean week group dance-based (N=21) loss or improving psychological age: 14, 67% female) exergame exercise programme outcomes, with the exception Total Participants: N=41  Control: Wait list control (N=20) of a statistically greater Setting: Not specified improvement in participants’ Follow-up duration: 10 weeks perceptions of competence (which was higher from base Inclusion criteria: See population line at 10 weeks compared to Exclusion criteria: Significant medical the control group) illness; smoking; participation in 30+ minutes of exercise per day

First author: Wang, 2015 Intervention: Diet  Participants that followed a None reported Country: China  Tx: High protein breakfast diet high protein diet for Population: Obese Chinese (N=not reported) breakfast lost a statistically adolescents (mean age: 15, 51%  Control: Standard breakfast and clinically greater male) diet (N=not reported) proportion of body weight Total Participants: N=156 compared to participants Setting: Not specified that consumes a standard Follow-up duration: 3 months diet for breakfast

Inclusion criteria: See population Exclusion criteria: Chronic illness; participation in weight loss program

First author: White, 2013 Intervention: Pharmacological  Bupropion Tx resulted in a None reported Country: USA  Tx: Bupropion (anti-depressant) statistically and clinically Population: Overweight and obese 300mg taken daily (N=31) greater reduction of body women with BED (mean age: 44)  Control: Placebo pill taken daily weight after eight weeks Total Participants: N=61 (N=30) compared to those taking the Setting: Not specified placebo pill Follow-up duration: 8 weeks  There were no significant differences in psychological Inclusion criteria: BED outcomes between groups Exclusion criteria: Significant medical illness; psychoactive medications; serious psychiatric disorders; history of anorexia or bulimia

First author: Willis, 2012 Intervention: Exercise  Participants in Tx B and C None reported Country: USA  Tx A: Resistance training, experienced statistically Population: Overweight and obese 3x/week (N=44) significant reductions in overall sedentary results (57% female)  Tx B: Aerobic training, of about body weight, fat mass and Total Participants: N= 119 12 miles/week (N=38) waist circumference Setting: Not specified  Tx C: Aerobic and resistance  Lean body mass increased Follow-up duration: 10 weeks training (AT/RT), AT of about 12 significantly for participants in

miles/week + RT 3x/week (N=37) Tx A and C Inclusion criteria: Sedentary lifestyle; mild to moderate dyslipidemia Exclusion criteria: Smokers; significant medical illness or comorbidities

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First author, yr: Yeo, 2014 Intervention: Other  Both acupuncture Txs resulted None reported Country: Korea  Tx A: 5 point acupuncture, once a in statistically and clinically Population: Overweight and obese week for 8 weeks (N=31) significant reductions in BMI at Koreran adults (mean age: 39, 82%  Tx B: Hunger point acupuncture, 8 weeks, with no significant female) once a week for 8 weeks (N=30) difference between groups Total Participants: N= 91  Control: Placebo acupuncture,  Waist circumference reduced Setting: Not reported once a week for 8 weeks (N=30) significantly in all 3 groups Follow-up duration: 8 weeks from baseline, and waist circumference reduction was Inclusion criteria: Sedentary lifestyle; stable body weight statistically greater for participants receiving Tx A Exclusion criteria: Pregnancy; significant medical illness; current treatment for weight loss

First author: Zarate, 2013 Intervention: Surgery  At 5 years post-surgery Occasional dysphagia Country: Mexico  Tx A: Banded Roux-en-Y gastric participants in both groups had and nausea Population: Morbidly obese adults bypass (RYGB) (N=21) lost a statistically and clinically (mean age: 37, 89% female)  Tx B: Unbanded RYGB (N= 22) significant proportion of body Total Participants: N=43 weight, with no significant Setting: Not reported differences between groups Follow-up duration: 5 years

Inclusion criteria: See population Exclusion criteria: Not specified

First author: Zhang, 2014 Intervention: Surgery  Maximum weight loss in both None reported Country: China  Tx A: Laparoscopic sleeve groups was achieved at 1 year Population: Obese adolescents and gastrectomy (N=32) post-surgery, with participants adults (mean age: 29, 59% female)  Tx B: Roux-en-Y gastric bypass in both groups gradually Total Participants: N= 64 (N=32) regaining weight over the Setting: Not specified following 4 years. Follow-up duration: Every 12 months  At 5 years post-surgery for 5 years participants who underwent Tx B had a statistically and Inclusion criteria: See population clinically lower BMI compared Exclusion criteria: chronic medical or to those who underwent Tx A psychiatric condition; previous  Overall, participants in both gastrointestinal surgery groups reported statistically and clinically significant improvements in QoL over the 5 years post-surgery, with no significant difference between groups  Improvements in QOL were correlated with the percentage of weight loss

Abbreviations used: BED: binge eating disorder; BMI: body mass index; ER: extended release; RCT: randomised controlled trial; QOL: quality of life. All other abbreviations used are described first within the text for that entry.

General notes: While many types of outcome variables may be reported in the above studies, only data on outcome variables of interest are included here. Clinical and statistical significance, where reported, reflect the analysis of the study authors.

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The National Eating Disorders Collaboration 103 Alexander Street Crows Nest NSW 2065 Phone: +61 2 9412 4499 Fax: +61 2 8090 8196 Email: [email protected]

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