Abstract
IMPORTANCE: Cognitive behavioral therapy (CBT) has the most empirical support for treatment of binge eating. Appetitive traits, including food responsiveness and satiety responsiveness, impact how individuals interact with the current obesogenic environment. The regulation of cues (ROC) plus behavioral weight loss (BWL) intervention was specifically developed to target food responsiveness, satiety responsiveness, and energy reduction. OBJECTIVE: To evaluate the feasibility and efficacy of ROC+BWL and CBT over 5 months of treatment and 6 months of follow-up and to explore whether clinical binge eating was a moderator of outcomes. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial was conducted from March 2019 to April 2023 among veterans at a university clinic. Eligible participants were veterans who met criteria for Binge Eating Disorder (BED) or subthreshold BED, had a body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 25 to 45, were aged 18 to 65 years, and were free of other exclusionary criteria. Data were analyzed from January 2024 to June 2025. INTERVENTION: The ROC+BWL intervention uniquely targets food responsiveness, satiety responsiveness, and energy reduction. CBT focuses on disrupting the dietary restraint/binge eating cycle by changing maladaptive thoughts and behaviors. Participants were randomized to receive either ROC+BWL or CBT for 5 months. MAIN OUTCOMES AND MEASURES: The main outcomes were feasibility and change in binge eating (measured as loss of control) and body weight, assessed at midtreatment (2.5 months), posttreatment (5 months), and a 6-month follow-up (11 months). RESULTS: A total of 1853 veterans inquired about participation and 1724 were excluded or declined to participate. The final sample included 129 veterans (mean [SD] age, 47.1 [11.3] years; 76 [59%] male; mean [SD] BMI, 34.8 [4.7]), with 63 randomized to ROC+BWL and 66 to CBT. A total of 123 veterans (95%) provided data posttreatment, and 115 veterans (89%) provided data at the 6-month follow-up. Attendance and acceptability ratings did not differ between treatments. ROC+BWL resulted in a greater reduction in risk of binge eating than CBT at midtreatment (difference in probability, -0.20; 95% credible interval [CrI], -0.30 to -0.11), posttreatment (difference in probability, -0.23; 95% CrI, -0.22 to -0.19), and at the 6-month follow-up (difference in probability, -0.21; 95% CrI, -0.21 to -0.18). ROC+BWL also resulted in greater weight loss at midtreatment (difference in BMI change, -0.68; 95% CrI, -1.23 to -0.12) and posttreatment (difference in BMI change, -0.71; 95% CrI, -1.40 to -0.01) assessments than CBT, but significant differences were no longer observed at the 6-month follow-up (difference in BMI change, -0.22; 95% CrI, -0.98 to 0.54). Results were more pronounced among veterans with BED. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial among veterans with binge eating and obesity, ROC+BWL resulted in greater decreases in binge eating compared with CBT. Although ROC+BWL resulted in greater weight loss compared with CBT during treatment, these differences were not maintained. Thus, ROC+BWL could be an alternate model to treat BED among veterans, but effects on weight need further research. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03678766.