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Digital Therapeutics for Obesity and Eating-Related Problems Review Endocrinol Metab 2021;36:220-228 https://doi.org/10.3803/EnM.2021.107 Article pISSN 2093-596X · eISSN 2093-5978 Digital Therapeutics for Obesity and Eating-Related Problems Meelim Kim1,2, Hyung Jin Choi1,2 1Department of Biomedical Sciences, 2BK21 Plus Biomedical Science Project Team, Seoul National University College of Medicine, Seoul, Korea In recent years, digital technologies have rapidly advanced and are being applied to remedy medical problems. These technologies allow us to monitor and manage our physical and mental health in our daily lives. Since lifestyle modification is the cornerstone of the management of obesity and eating behavior problems, digital therapeutics (DTx) represent a powerful and easily accessible treat- ment modality. This review discusses the critical issues to consider for enhancing the efficacy of DTx in future development initia- tives. To competently adapt and expand public access to DTx, it is important for various stakeholders, including health professionals, patients, and guardians, to collaborate with other industry partners and policy-makers in the ecosystem. Keywords: Digital healthcare; Obesity; Feeding behavior INTRODUCTION patients and healthcare providers that provides real-time infor- mation and analysis [3]. There are also other digital healthcare Digital therapeutics (DTx) is “an evidence-based therapeutic in- companies for diabetes and weight control; Noom, Omada, tervention using high-quality software programs to prevent, Livongo, Lark, Voluntis, and so on. In this review, we discuss manage, or treat a medical disorder or disease” [1]. DTx evidence-based therapeutic interventions driven by high-quality emerged as a novel therapeutic approach for the prevention, software programs. Only telephone calls, short message servic- management, or treatment of chronic, behavior-changeable dis- es, or online web-based servers are excluded from the definition eases in recent years. Due to the public health emergency posed of DTx. by coronavirus disease 2019, the Food and Drug Administration Mostly, DTx systems draw upon the evidence-based princi- (FDA) has relaxed its regulations to expand access to digital ples of behavioral or psychological intervention protocols health devices for remote monitoring and management of ill- known as cognitive behavioral therapy (CBT) [2]. CBT uses ness [2]. Currently, DTx products target behavior-modifiable evidence-based techniques to change problematic behaviors and problems such as type 2 diabetes and weight management. For unhelpful cognitive distortions, and to improve emotional regu- example, Welldoc Communications, a system to provide a mo- lation and coping skills to solve the current problems [4]. Fre- bile phone-based diabetes management software connected to quent clinical assessments in the context of diverse psychologi- web-based data analytics, serves as an interactive platform for cal conditions using digital modalities are highly beneficial to Received: 26 January 2021, Revised: 10 February 2021, Copyright © 2021 Korean Endocrine Society Accepted: 17 February 2021 This is an Open Access article distributed under the terms of the Creative Com- mons Attribution Non-Commercial License (https://creativecommons.org/ Corresponding author: Hyung Jin Choi licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribu- Department of Biomedical Sciences, Seoul National University College of tion, and reproduction in any medium, provided the original work is properly Medicine, 103 Daehak-ro, Jongno-gu, Seoul 03080, Korea cited. Tel: +82-2-740-8204, Fax: +82-2-745-9528, E-mail: [email protected] 220 www.e-enm.org Digital Therapeutics for Obesity and Eating-Related Problems Endocrinol Metab 2021;36:220-228 https://doi.org/10.3803/EnM.2021.107 pISSN 2093-596X · eISSN 2093-5978 enhance the efficacy of CBT interventions [5]. In fact, collect- adaptive thinking, and building coping skills related to emotion- ing assessment data in face-to-face conditions is a burdensome al regulation and stress management [8]. These psychological task involving retrospective reports. These reports have high mechanisms contributing to mental health are closely associated risks of being systematically biased by recall and neglecting im- with physical health and contribute to clinical outcomes. portant contextual components or acute changes in certain peri- Mental health should be considered a vital component of DTx ods [5]. In contrast, collecting assessment data using smart- for obesity and eating-related problems. However, most previ- phones and wearables is convenient and time-sensitive, allow- ous self-management DTx studies were limited by only focus- ing the real-time evaluation of context-rich information. Thus, ing on behavioral aspects apart from mental health components, the integration of digital technologies and CBT techniques has such as self-monitoring of glucose and body weight, medication become the cutting-edge approach in DTx components, allow- adherence, logging a food diary, and physical activity [9,10]. ing individualized and stepped-care interventions [6]. The majority of mobile health interventions only showed effec- tive improvements in primary outcomes for physical health DTx FOR OBESITY AND EATING-RELATED measures, such as hemoglobin A1c or body weight [11-14]. PROBLEMS: AN EMPHASIS ON A These interventions were ineffective at improving mental health MULTIDISCIPLINARY APPROACH conditions such as self-efficacy, quality of life, depression, and other measures. We recently showed that motivation, depres- Since obesity and eating behavioral problems are complex dis- sion, anxiety, and self-esteem were predictive markers of suc- eases with a multifactorial etiology, a biopsychosocial approach cessful weight control [15]. Thus, a multidisciplinary approach including medical treatment and lifestyle changes is required to including psychological components is needed to develop prac- treat them effectively [7]. As shown in Fig. 1, both physical and tical DTx for obesity and other eating behavioral problems. mental health conditions are the major components of lifestyle modification. To achieve a healthy lifestyle through a lifestyle RECENT RANDOMIZED CONTROLLED modification intervention, high motivation is mandatory as a TRIALS RELATED TO DTx prerequisite for high adherence. A patient can also attain stimu- lus control capability by manipulating eating-related cues in the To encourage an informed discourse about the efficacy of DTx environment, using cognitive techniques to investigate mal- for obesity and eating-related problems, we review several ran- Clinical outcomes Lifestyle modification Metabolic diseases Physical health Obesity Prediabetes Digital therapeutics Diabetes Hypertension Hyperthyroidism Hypothyroidism Behavior Mental disorders Thoughts Bulimia nervosa Emotions Behaviors Anorexia nervosa Cognitive behavioral Body dysmorphic therapy disorder Avoidant/restrictive food intake disorder Mental health Major depression disorder Fig. 1. Interaction between mental and physical health for lifestyle modification via digital therapeutics. Copyright © 2021 Korean Endocrine Society www.e-enm.org 221 Kim M, et al. 222 Table 1. Randomized Controlled Trials for Digital-Based Interventions for Obesity and Eating Behavior Problems from 2017 to 2020 www.e-enm.org Study design Delivery digital device Outcomes Adherence Study Population (estimated), Intervention Duration Control Smartphone Web Wearable BW Anthropometrics LT BT Psych % Spring et al. (2017) Adults with obesity Technology- 6 mo Self-guided O O X △ ↓↓ - - - O [18] (n=96) supported (SELF), (TECH) standard (STND) Nezami et al. (2018) Mother with Smart group 6 mo Placebo O X X ↓↓ - - - - 85 [16] overweight & (mobile obesity, a child supported) ages 3–5 yr (n=51) Spring et al. (2018) Adults age 18–65 Temporally 12 wk Sequential O X X - - - △ - 82 [19] yr (n=212) simultaneous (digital intervention sham), control Kim et al. (2019) Old adults (mean Mobile-based 24 wk Usual care O X X X X ↓↓ - X - [20] age 60) with glucose diary (paper diabetes (n=136) diary) Fitzsimmons-Craft Women with eating CBT-guided 8 mo Usual care O X X - - - ↓↓ ↓ 31 et al. (2020) [17] disorders Self-help (n=690) Lowe et al. (2020) Women+Men Time-restricted 12 wk Consistent O X O X LBM ↓↓ X - X 84 [21] adults with BMI eating meal timing 27–43 (n=141) Kim et al. (2020) Overweight and Human-based 8 wk Self-help O O X ↓↓ ↓↓ ↓↓ ↓↓ ↓↓ 80 [15] obese women digital CBT using app adults (n=70) (digital sham) BW, body weight; LT, lab test; BT, behavioral test; Psych, psychological assessment; O, used; X, no difference; △, mixed results among the measures; ↓↓, (statistically) significantly decreased; -, not assessed; CBT, cognitive behavioral therapy; ↓, reported decreasing trend; BMI, body mass index; LBM, lean body mass. Copyright © 2021 Korean Endocrine Society Digital Therapeutics for Obesity and Eating-Related Problems domized controlled trials (RCTs) of DTx conducted from 2017 Although obesity and eating behavioral problems are known to 2020 (Table 1). to have complex backgrounds, most studies evaluated clinical Regarding the study population, only one DTx RCT was con- efficacy with only one or two measures [16-19]. A few studies ducted among young children [16]. In fact, the intervention was applied several assessments to validate their intervention effica- not directly delivered to the children, but supported their care- cy, but they did not show significant outcomes in general givers to reduce sugar-sweetened
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