Integrative Intervention Strategies for Binge Eating in Patients With Overweight or Obesity

The main goal of the clinical trial is to compare the short- and long-term outcomes of three 12-week interventions among outpatients with overweight/obesity and binge eating (BE): 1. treatment-as-usual for weight loss (TAU); 2. combined TAU and guided self-help for improving eating behaviors (TAU+GSH); 3. combined TAU, GSH, and biofeedback (TAU+GSH+BF). The primary outcomes will be self-reported reduction of days with objective BE episodes (OBEs). The secondary outcomes will be impulsivity, emotion dysregulation, interoceptive awareness, distress, physiological correlates of arousal (skin conductance and heart rate variability), and inflammatory biomarkers. The TAU+GSH arm is expected to be comparable to the TAU+GSH+BF arm in reducing the number of days with OBEs but is expected to be significantly less effective in improving secondary outcomes (impulsivity, emotional dysregulation, interoceptive awareness, distress, physiological inflammatory markers). The TAU arm is expected to show significant inferiority regarding the primary and secondary outcomes and cost-effectiveness compared to the TAU+GSH and TAU+GSH+BF conditions.

NCT Number	NCT06495619
Lead Sponsor	G. d'Annunzio University
Conditions	Binge Eating, Overweight and Obesity
Enrollment	100 participants
Start Date	2024-08-01
Primary Completion	2024-12-01 (estimated)
Study Completion	2025-06-30 (estimated)
Updated on ClinicalTrials.gov	2024-07-11