Aim2Be an mHealth intervention for children with overweight and obesity: Study protocol for a randomized controlled trial

Background: The prevalence of overweight and obesity remains high in Canada, and the current standard for the treatment of childhood obesity is in-person family-based multidisciplinary interventions that target lifestyle behaviours (e.g. diet, physical activity, and sedentary behaviours). These programs are costly to operate, have limited success, and report recruitment and retention challenges. With recent advances in technology, mobile health or mHealth has presented as a viable alternative to in-person interventions for behavior change, especially with teens. Purpose: The primary aim of this study is to test the efficacy of Aim2Be, a gamified app based on behavior change theory with health coaching at improving weight outcomes (i.e., decrease in zBMI) and lifestyle behaviours (i.e. improve dietary quality, increase fruit and vegetable intake, reduce sugar-sweetened beverage intake, increase physical activity, and reduce screen time) among 10-17 year old children with overweight or obesity versus their peers randomized into a waitlist control condition. The secondary aims of this study are to: 1) test whether supplementing the Aim2Be program with health coaching increases adherence; and 2) examine the mediators and moderators of adherence to the Aim2Be intervention. Methods: We will employ a randomized controlled trial design and recruit 200 child and parent dyads to participate in the study (2019-2020). Participants will be recruited from Canadian pediatric weight management clinics, and through online advertisements. Child participants must be between the ages of 10-17 years, have overweight or obesity, be able to read English at a grade 5 level, and have a mobile phone or home computer with internet access. Following baseline data collection, participants will be randomized into intervention and waitlist control groups. Intervention participants will receive access to Aim2Be, with access to health coaching. Following 3-month data collection, the control group will gain access to Aim2Be; with no access to health coaching. Participants will control their frequency and duration of app usage to promote autonomy. Discussion: Findings from this study will determine the efficacy of using Aim2Be in improving child weight outcomes and lifestyle behaviours and guide future mHealth interventions for pediatric weight management.