Design of the CHARGE study: A randomized control trial evaluating a novel treatment for Veterans with binge eating disorder and overweight and obesity

Abstract

A large number of Veterans experience binge eating and overweight or obesity, which are associated with significant health and psychological consequences. The gold-standard program for the treatment of binge eating, Cognitive Behavioral Therapy (CBT), results in decreases in binge eating frequency but does not result in significant weight loss. We developed the Regulation of Cues (ROC) program to reduce overeating and binge eating through improvement in sensitivity to appetitive cues and decreased responsivity to external cues, an approach that has never been tested among Veterans. In this study, we combined ROC with energy restriction recommendations from behavioral weight loss (ROC+). This study is a 2-arm randomized controlled trial designed to evaluate the feasibility and acceptability of ROC+, and to compare the efficacy of ROC+ and CBT on reduction of binge eating, weight, and energy intake over 5-months of treatment and 6-month follow-up. Study recruitment completed in March 2022. One hundred and twenty-nine Veterans were randomized (mean age = 47.10 (sd = 11.3) years; 41% female, mean BMI = 34.8 (sd = 4.7); 33% Hispanic) and assessments were conducted at baseline, during treatment and at post-treatment. The final 6-month follow-ups will be completed in April 2023. Targeting novel mechanisms including sensitivity to internal cures and responsivity to external cues is critically important to improve binge eating and weight-loss programs among Veterans.Clinicaltrials.govNCT03678766