NCT07042672

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

Behavioral Therapy With and Without GLP-1 Analogue in Patients With Morbid Obesity and Binge Eating Disorder: A Clinical Prospective Observational Study on Body Weight, Binge Eating Behavior, and Harmful Coping Strategies

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Binge Eating Disorder Associated With Obesity
• Binge Eating Disorder
• Eating Disorder Binge
• Eating Disorders
• GLP-1
• CBT
• Obesity &Amp; Overweight

Interventions

Type	Name	Description
DRUG	GLP-1	Subcutaneous GLP-1 receptor agonist prescribed for weight management according to routine clinical practice. Acceptable agents include liraglutide (up-titrated to ≤ 3.0 mg daily), semaglutide (≤ 2.4 mg weekly), or tirzepatide (≤ 15 mg weekly). Dose escalation and maintenance follow approved product labels and treating-physician judgment. Planned treatment duration: 12 months or longer.
BEHAVIORAL	CBTe Group Therapy	Ten weekly 2-hour group sessions based on Cognitive Behavioral Therapy-Enhanced (CBT-E) plus individualized lifestyle consultations every 4 months over a 12-month period. Content targets eating patterns, weight-management behaviors, and emotion-regulation skills. Delivered by trained multidisciplinary staff at the Obesity Centre.

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-11-05
• Completion: 2028-12-31
• First posted: 2025-06-29
• Last updated: 2025-09-15

Locations

1 site across 1 country: Norway

Regulatory

• FDA-regulated drug study