Behavioral Therapy and GLP-1 Analogue Effects on Binge Eating, Weight, and Coping in Obesity

Recruiting

• Conditions: Binge Eating Disorder Associated With Obesity; Binge Eating Disorder; Eating Disorder Binge; Eating Disorders; GLP-1; CBT; Obesity &Amp; Overweight
• Interventions: Drug: GLP-1; Behavioral: CBTe Group Therapy

• Registration Number: NCT07042672
• Lead Sponsor: Haukeland University Hospital

Brief Summary

This study is a clinical, longitudinal, non-randomized, prospective observational study that seeks to compare the treatment effects and safety of using GLP-1 analogues versus not using appetite suppressants during a lifestyle treatment program that includes individual consultations every fourth month and 10 weeks of CBT-E group therapy in patients with both obesity and BED.

The primary objective of this study is to evaluate the impact on BED symptomatology, while the secondary objectives include examining the potential adoption of alternative harmful coping mechanisms. Additionally, the study will assess psychological well-being and weight changes and their consequent influence on obesity-associated comorbid conditions.

Adult patients with coexisting obesity and BED presenting at the Obesity clinic at Haukeland University Hospital, Bergen, Norway, will be included Patients will be divided into two groups: Group-GLP1 (n = 40), who will use GLP-1 analogues, and Group-NoMED (n = 40), who will not use appetite suppressants. Both groups will otherwise follow the routine standardized patient care pathway with follow-up controls every four months and participation in CBT group therapy sessions.

Changes in symptoms of BED, alternative harmful coping strategies and mental health will be recorded at baseline and 12 months using patient-reported questionnaires, as well as anthropometric and biochemical data.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-03
• Study First Submitted QC: 2025-06-27
• Study First Posted: 2025-06-29
• Study Start: 2025-07-01
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-09
• Last Update Posted: 2025-09-15
• Primary Completion: 2027-11-05
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group-GLP1	GLP-1	Participants receiving standard lifestyle treatment including CBT-E group therapy and individual clinical consultations, in combination with a GLP-1 analogue prescribed by their physician (e.g., liraglutide, semaglutide, or tirzepatide) for weight management. GLP-1 analogue selection, dosage, and duration follow routine clinical practice.
Group-GLP1	CBTe Group Therapy	Participants receiving standard lifestyle treatment including CBT-E group therapy and individual clinical consultations, in combination with a GLP-1 analogue prescribed by their physician (e.g., liraglutide, semaglutide, or tirzepatide) for weight management. GLP-1 analogue selection, dosage, and duration follow routine clinical practice.
Group-NoMED	CBTe Group Therapy	Participants receiving standard lifestyle treatment including CBT-E group therapy and individual clinical consultations, but without use of GLP-1 analogues or other appetite-suppressing medications.

Primary Outcome Measures

Name	Time	Method
Change in EDE-Q Global Score From Baseline to 12 Months	Baseline and 12 months	The Eating Disorder Examination Questionnaire (EDE-Q, version 6.0) global score is a validated measure of core eating disorder psychopathology, ranging from 0 to 6, with higher scores indicating greater symptom severity.; The EDE-Q comprises 28 items and assesses cognitive and behavioral symptoms over the past 28 days, including four subscales: restraint, eating concern, shape concern, and weight concern.; This outcome measures the mean change in global score from baseline to 12-month follow-up, comparing participants receiving GLP-1 analogue treatment (Group-GLP) versus those not receiving appetite suppressants (Group-NoMED).

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants With Increase in Composite Harmful Coping Endpoint (CHCE) From Baseline to 12 Months	Baseline and 12 months	The Composite Harmful Coping Endpoint (CHCE) captures the emergence of new harmful coping behaviors from baseline to 12-month follow-up. It is defined as a binary outcome, scored as positive if any of the following occur: * Deliberate self-harm (DSHI score \> 0); * Alcohol misuse (AUDIT \>= 8 for men, \>= 6 for women); * Drug misuse (DUDIT \> 6 for men, \> 2 for women); Each of the three components is dichotomized using validated clinical thresholds. Participants with no indication at baseline who cross threshold for any of the three domains at 12 months are considered to have developed a new harmful coping strategy (CHCE = 1). The outcome will compare the proportion of participants with CHCE = 1 between Group-GLP and Group-NoMED.; DSHI; Deliberate Self-Harm Inventory (range 0-17, higher is worse), AUDIT; Alcohol Use Disorders Identification Test (range 0-40, higher is worse), DUDIT; Drug Use Disorders Identification Test (range 0-44, higher is worse)

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Vestland, Norway