Effectiveness of Integrative Intervention Strategies for Binge Eating in Patients With Overweight or Obesity: A Multidisciplinary Approach
| Registry | NCT06495619, acronym BE-side |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 100 (Estimated) |
| Sponsor | G. d'Annunzio University (Other) |
| Conditions | Binge Eating, Overweight and Obesity |
| Interventions | treatment-as-usual, combined TAU and guided self-help, combined TAU, GSH, and biofeedback (Behavioral) |
| Dates | start 2024-08-01 (estimated), primary completion 2024-12-01 (estimated), completion 2025-06-30 (estimated), first posted 2024-07-11, last updated 2024-07-11 |
Related Papers Related Patents Related Grants Related Experts
All trials for Binge Eating All trials for Overweight and Obesity All trials of treatment-as-usual All trials of combined TAU and guided self-help
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| (1)TAU | Active comparator | Behavioral: treatment-as-usual | treatment-as-usual for weight loss (TAU) |
| (2)TAU+GSH | Active comparator | Behavioral: combined TAU and guided self-help | combined TAU and guided self-help for improving eating behaviors (TAU+GSH) |
| (3)TAU+GSH+BF | Active comparator | Behavioral: combined TAU, GSH, and biofeedback | combined TAU, GSH, and biofeedback (TAU+GSH+BF) |
Sex: All, ages: 18 Years to 65 Years
Inclusion Criteria:(1) age 18-65 years; (2) BMI≥25 kg/m2; (3) ability to read and write in Italian; (4) Binge Eating Disorder (BED) or subthreshold BED status. \- Exclusion Criteria: (1) current treatment for BE with a registered psychologist; (2) severe psychiatric disorders; (4) cognitive impairment; (5) pregnancy; (6) severe medical comorbidity. \-