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

Louise C Mâsse, Janae Vlaar, Janice Macdonald, Jennifer Bradbury, Tom Warshawski, E Jean Buckler, Jill Hamilton, Josephine Ho, Annick Buchholz, Katherine M Morrison, Geoff D C Ball, Louise C Mâsse, Janae Vlaar, Janice Macdonald, Jennifer Bradbury, Tom Warshawski, E Jean Buckler, Jill Hamilton, Josephine Ho, Annick Buchholz, Katherine M Morrison, Geoff D C Ball

Abstract

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 behaviors (e.g., diet, physical activity, and sedentary behaviors). 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 been 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 to improve weight outcomes (i.e., decrease in standardized body mass index (zBMI)) and lifestyle behaviors (i.e., improve dietary quality, increase fruit and vegetable intake, reduce sugar-sweetened beverage intake, increase physical activity, and reduce screen time) among children 10- to 17-years old 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 and 17 years, have overweight or obesity, be able to read English at least 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. After having their data collected for 3 months, 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 behaviors and guide future mHealth interventions for pediatric weight management.

Trial registration: ClinicalTrials.gov, NCT03651284. Registered 29 August 2018.

Keywords: Childhood obesity, Gamification, mHealth, Behavior change, Lifestyle intervention.

Conflict of interest statement

The Childhood Obesity Foundation (COF) (Janice Macdonald, Director of LiGHT Program; Jennifer Bradbury, COF Executive Director; and Tom Warshawski, COF Chair of the Board of Directors) owns the content of LiGHT and Aim2Be. The Aim2Be app features are built on Ayogo Health Inc.’s Empower™ Platform and Goal Store architecture, which are owned by Ayogo. As Aim2Be was developed, in part, with funds from the Public Health Agency of Canada (PHAC), the app can only be commercialized outside of Canada, and as such, both Ayogo Health Inc. and the Childhood Obesity Foundation own intellectual property and have financial interests.

PHAC has mandated that the evaluation be separated from the administration of the intervention. The COF staff will be involved in recruiting participants for the evaluation but will not be involved with any other evaluation activities. The evaluation of Aim2Be is conducted by the BC Children’s Hospital Research Institute (BCCHRI)/School of Population and Public Health (SPPH), University of British Columbia (UBC) under the supervision of Dr. Louise C. Mâsse. Dr. Mâsse has provided scientific expertise in the development of Aim2Be but does not own any of the intellectual property or have any financial interests in Aim2Be. All reports prepared by UBC will be reviewed by a Faculty member from the School of Population and Public Health (SPPH) at UBC to ensure an impartial peer review is completed prior to submission. BCCHRI/SPPH/UBC will maintain the rights to publish the evaluation data regardless of the outcomes of the evaluation and own the data collected as part of the evaluation.

Figures

Fig. 1
Fig. 1
Study flow chart
Fig. 2
Fig. 2
Conceptual framework of Aim2Be
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SPIRIT Figure

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