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A Randomised Trial Ane Kokkvoll,1 Sameline Grimsgaard,2,3 Rønnaug Ødegaard,4,5 Trond Flægstad,6,7 Inger Njølstad3

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A Randomised Trial Ane Kokkvoll,1 Sameline Grimsgaard,2,3 Rønnaug Ødegaard,4,5 Trond Flægstad,6,7 Inger Njølstad3 ADC Online First, published on December 11, 2013 as 10.1136/archdischild-2012-303571 Arch Dis Child: first published as 10.1136/archdischild-2012-303571 on 11 December 2013. Downloaded from Original article Single versus multiple-family intervention in childhood overweight—Finnmark Activity School: a randomised trial Ane Kokkvoll,1 Sameline Grimsgaard,2,3 Rønnaug Ødegaard,4,5 Trond Flægstad,6,7 Inger Njølstad3 1Department of Paediatrics, ABSTRACT Hammerfest Hospital, Objective To compare a new comprehensive lifestyle What is already known Hammerfest, Norway 2Clinical Research Department, programme performed in groups of families with overweight (included obese) children with a more University Hospital of North ▸ Standard hospital treatment for childhood Norway, Tromsø, Norway conventional single-family programme. The study design 3 obesity has been reported to be ineffective. Department of Community and interim anthropometrical results after 12 months are ▸ Reviews evaluating child obesity interventions Medicine, Faculty of Health presented. Sciences, University of Tromsø, conclude that comprehensive treatment models Design Altogether 97 overweight and obese children Tromsø, Norway appear effective, but underline that the 4 aged 6–12 years with body mass index (BMI) Department of Paediatrics, knowledge base to inform treatment strategies St Olavs Hospital, Trondheim, corresponding to cut-off point ≥27.5 in adults were is limited. Norway included. Study participants were randomised to 5 ▸ Most childhood obesity programmes are Department of Laboratory multiple-family intervention (MUFI) or single-family Medicine, Children’s and performed in hospital settings and there is ’ intervention (SIFI) in a parallel design. MUFI comprised a Women s Health, Norwegian limited data on long-term effects (beyond University of Science and 3-day inpatient programme at the hospital with other 1 year). Technology, Trondheim, families and a multidisciplinary team, follow-up visits in Norway their hometown individually and in groups, organised 6Department of Paediatrics, University Hospital of North physical activity twice weekly and a 4-day family camp Norway, Tromsø, Norway after 6 months. SIFI comprised individual counselling by 7 What this study adds Faculty of Health Sciences, paediatric nurse, paediatric consultant and nutritionist at Paediatric Research Group, the hospital and follow-up by public health nurse in the University of Tromsø, Tromsø, ▸ Norway community. Solution focused approach was applied in A multidisciplinary solution focused obesity both interventions. Primary outcome measures were intervention performed in groups of families Correspondence to change in BMI kg/m2 and BMI SD score (BMI SDS). and in single families showed no Dr Ane Kokkvoll, Department Results BMI increased by 0.37 units in the MUFI between-group effect in body mass index after of Paediatrics, Hammerfest compared to 0.77 units in the SIFI (p=0.18). BMI SDS 12 months. Hospital, Sykehusveien, ▸ Hammerfest N-9600, Norway; decreased by 0.16 units in the MUFI group compared to Children allocated to multiple-family http://adc.bmj.com/ ane.kokkvoll@helse-finnmark. 0.07 units in the SIFI group (p=0.07). Secondary intervention had a significant decrease in waist no endpoint waist circumference decreased 0.94 cm in the circumference compared to the children multiple-family group and increased 0.95 cm in the allocated to single-family intervention. Received 18 December 2012 ▸ Revised 27 September 2013 single-family group, p=0.04. This trial will provide long-term results of a Accepted 9 November 2013 Conclusions Interim analysis after 12 months showed generally applicable treatment programme no between-group difference in terms of BMI or BMI performed in a shared model across primary SDS. The MUFI group had a significant decrease in waist and specialised healthcare. circumference compared to the SIFI group. on September 27, 2021 by guest. Protected copyright. The trial is registered at http://www.clinicaltrials.gov (NCT00872807) latest Cochrane review.5 Cognitive therapy, behav- iour modification and family therapy are the most frequently used approaches to induce lifestyle INTRODUCTION changes. The review5 concluded that there is too Being obese may have negative effects on physical limited quality data to consider one treatment pro- and psychosocial health.1 Therefore, the worldwide gramme better than others and called for long-term increase in childhood overweight and obesity is of studies of obesity intervention in youngsters and great concern.2 Those who are obese in late child- cost-effective programmes for primary care. hood, tend to stay obese as adults,3 and efforts Group intervention has appeared as a method of should be made to stop weight gain in overweight interest for childhood obesity treatment due to the and obese youngsters. possible dual effect of the group facilitator and To cite: Kokkvoll A, Standard hospital treatment of obese children interaction with group participants.6 However, few Grimsgaard S, Ødegaard R, has been reported to be ineffective,4 whereas life- trials investigated the effectiveness of child obesity et al. Arch Dis Child – 7–9 Published Online First: style programmes may be effective after 6 12 group intervention, and the results diverge. The [please include Day Month months if the whole family is included and if the prevalence of combined overweight and obesity Year] doi:10.1136/ intervention consists of dietary, behavioural and among 6-year-old children in Finnmark County archdischild-2012-303571 physical activity components, according to the was 19% in 2007.10 The paediatric service at CopyrightKokkvoll A,Articleet al. Arch author Dis Child 2013;(or 0their:1–7. doi:10.1136/archdischild-2012-303571employer) 2013. Produced by BMJ Publishing Group Ltd (& RCPCH) under licence.1 Arch Dis Child: first published as 10.1136/archdischild-2012-303571 on 11 December 2013. Downloaded from Original article Hammerfest Hospital is the only one in a large rural region, and Subsequently, a paediatric consultant performed a clinical inter- long travelling distances for referred patients stimulated new view and examination (30 min) and outlined definite aims intervention strategies. In a pilot study involving hospital and towards the next consultation. All families met with a nutrition- community health workers, we experienced that intervention ist after 1–2 months. They were followed up by a public health aiming at lifestyle changes in obese children had to take place in nurse in their own municipality at 1, 2, 5, 8, 10, 15 and the municipality where the families live their daily lives. Parents 18 months from baseline, and at the hospital by a paediatric also made us aware of the important provider—family relation- nurse and a paediatric consultant at 3,12, 24 and 36 months. ship and our team became inspired by solution focused work.11 Based on our pilot study and in search for an effective obesity Multiple-family intervention programme, we developed and tested a multidisciplinary inter- Families allocated to MUFI underwent anthropometric measure- vention model to be used in groups of families. In this trial we ments and individual counselling identical to those of the SIFI pro- compare the multiple-family intervention (MUFI) with a more gramme. Additional elements were: (1) a 3-day inpatient conventional model of healthcare for individual families. This programme at the Paediatric Department focusing on physical article describes the study design and interim anthropometrical activity and healthy food, (2) group sessions with other families results after 12 months. and a multidisciplinary hospital team (paediatric and psychiatric nurse, paediatric consultant, nutritionist, physiotherapist, coach MATERIALS AND METHODS and clinical educationalist), (3) municipality follow-up including Study design individual (30 min) and groupwise counselling (1 h) with a public The ‘Finnmark Activity School’ is an ongoing randomised trial health nurse, (4) group-based physical activities twice weekly (each with two parallel arms. The family is the interventional unit and session lasting 1 h, organised by coach and by parents, respect- includes the child, parents and in some cases (n=8), a sibling. ively), (5) family participation in a 4-day camp after 4–6months. Children are randomised to either single-family intervention Table 1 summarises the two intervention programmes. (SIFI) or MUFI. The primary outcome is between-group differ- ences in body mass index (BMI, kg/m2) after 2 years. Secondary Staff and methodology outcomes are between-group differences in physical activity, Both interventions were performed in a shared model across nutrition, and anthropometrical, metabolic and psychological primary and specialised healthcare. Principles from measures. The trial is designed, conducted and reported in Solution-Focused Brief Therapy and Standardised Obesity accordance with Consolidated Standards of Reporting Trials Family Therapy were applied in addition to elements from 12 (CONSORT) guidelines. There has been no deviation from motivational interviewing.11 14 15 Counselling based on the fam- the study protocol other than recruiting in two cycles to obtain ilies’ own resources aiming at increasing physical activity, redu- sufficient number of participants. cing sedentary activity and increasing consumption of healthy food according to national guidelines was the main approach in Participants and settings both intervention arms. The study started in 2009 at the Paediatric
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