An evidence-based gamified mHealth intervention for overweight young adults with maladaptive eating habits: study protocol for a randomized controlled trial

Podina, Ioana R.; Fodor, Liviu A.; Cosmoiu, Ana; Boian, Rareș · 2017 · DOAJ

DOI: 10.1186/s13063-017-2340-6

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Summary

This paper presents the study protocol for a randomized, placebo-controlled trial evaluating the efficacy of SIGMA (Self-help, Integrated, and Gamified Mobile-phone Application), an mHealth intervention designed for overweight young adults (BMI 25–29.9 kg/m²) with maladaptive eating habits such as emotional eating, binge eating, and food cravings. The intervention is grounded in Cognitive Behavior Therapy (CBT) principles, specifically targeting maladaptive beliefs and attentional biases that contribute to weight gain. The motivation for this study stems from the high prevalence of obesity, the limited accessibility of in-person CBT, and the high dropout rates associated with existing non-gamified mHealth applications. SIGMA aims to improve long-term adherence by integrating game-like elements, including a storyline, reward systems, and an embedded pedometer that supplements in-game points with points earned through physical activity. The trial design involves a 2-week baseline calibration period, a 2-month active intervention phase, and a 3-month follow-up. Participants will be randomized into either the SIGMA intervention group or an attention placebo control group. The control group receives a modified version of the app that includes all modules except the active gamified cognitive-behavioral and attention-training components, thereby isolating the specific active ingredients of the intervention. The SIGMA app comprises four main modules: psycho-education, a gamified intervention module (split into explicit cognitive-behavioral tasks and implicit attention-training tasks), a crisis and relapse prevention module, and a self-monitoring and feedback module. The explicit module uses 300 scenarios to train users in identifying and replacing sabotaging thoughts, while the implicit module employs attention bias modification techniques to redirect focus from unhealthy to healthy food stimuli. Primary outcomes include changes in self-reported maladaptive thoughts and behaviors related to eating, as well as biased attentional processing of food items measured by reaction times. Secondary outcomes assess changes in weight, Body Mass Index, general mood, and physical activity levels (steps per day). The study targets a sample size of 104 participants (52 per arm) to account for an anticipated 40% dropout rate, aiming to detect a medium effect size (Cohen’s d = 0.50). Recruitment will occur through universities and online platforms, with strict inclusion criteria requiring Android smartphone ownership and exclusion of individuals with clinical eating disorders, pregnancy, or current participation in other weight management programs. The significance of this research lies in its potential to provide a cost-effective, scalable, and preventive self-help tool for a demographic at high risk for chronic disease. By combining evidence-based CBT with gamification, the SIGMA intervention addresses the specific barriers of motivation and adherence that limit the utility of traditional digital health interventions. If successful, this approach could offer a viable strategy for managing maladaptive eating habits in young adults, reducing the societal and economic burden of obesity without requiring direct therapist contact.

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• gamification driving