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

Not Applicable

Not yet recruiting

• Conditions: Binge Eating; Overweight and Obesity

• Registration Number: NCT06495619
• Lead Sponsor: G. d'Annunzio University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-03
• Study First Submitted QC: 2024-07-03
• Last Update Submitted: 2024-07-03
• Study First Posted: 2024-07-11
• Last Update Posted: 2024-07-11
• Study Start: 2024-08-01
• Primary Completion: 2024-12-01
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
objective BE episodes (OBEs)	12-week follow-up-1 4-month follow-up-2 (after the end-of-treatment)	The primary outcomes will be self-reported reduction of days with objective BE episodes (OBEs)

Secondary Outcome Measures

Name	Time	Method
physiological correlates of arousal	(T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment)	The secondary outcomes will be skin conductance and heart rate variability.
psychological variables	(T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment)	The secondary outcomes will be impulsivity, emotion dysregulation, interoceptive awareness, distress.
inflammatory biomarkers	(T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment)	The secondary outcomes will be ClpB protein and IgG