An addiction-based mobile health weight loss intervention: protocol of a randomized controlled trial

Abstract

Background: The notion of obesity as an addictive process is controversial. However, studies show that between 5.9 and 30.7% of adolescents with obesity report food or eating addiction. Few weight management interventions have tested techniques based on addiction medicine principles.

Methods: This multi-center randomized control trial (RCT) is designed to test the effectiveness of a mobile health (mHealth) weight-loss intervention based on addiction principles, such as withdrawal and tolerance, in a sample of 180 adolescents (ages 14-18) recruited from four pediatric weight management clinics in Southern California. Akin to a Multiphase Optimization Strategy (MOST) design evaluating multicomponent behavioral interventions, we will compare the combination of an app + phone coaching (App+Coach) to app alone (App) and in-clinic multi-disciplinary (Clinic) intervention arms. The primary outcome is mean change in zBMI and %BMIp95 over 18 months. We hypothesize that youth who receive App+Coach will have a greater reduction in body weight over the 18-month study period at a lower cost than standard of care models. Secondary outcomes include adherence to treatment regimen, intervention satisfaction, effect of the intervention on metabolic factors and activity level. We will also explore potential moderators of intervention effectiveness such as addictive eating habits, self-regulation and executive functioning.

Conclusions: New and creative approaches are needed to address pediatric obesity. If successful, this RCT may provide an innovative and cost-effective mHealth approach, based on addiction methods, for weight loss among adolescents with overweight and obesity.

Trial registration: ClinicalTrials.gov NCT03500835.

Keywords: Coaching; Eating addiction; Mobile health; Obesity; Pediatrics; Weight loss.

Copyright © 2019 Elsevier Inc. All rights reserved.

Figures

Fig. 1.

Enrollment flow.

Fig. 2.

Recruitment flow.

Fig. 3.

Study visit outline by intervention arm.

Fig. 4.

Coach training paradigm.