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

Sponsor
Haukeland University Hospital
Study ID
NCT07042672
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • GLP-1 — DRUG
    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.
  • CBTe Group Therapy — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Jun 29, 2025
Start date
Jul 1, 2025
Status verified
Sep 2025
Primary completion
Nov 5, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Group-GLP1
    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.
  • Arm: Group-NoMED
    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 Measure

Change in EDE-Q Global Score From Baseline to 12 Months [ Time Frame: Baseline and 12 months ]

Central Contacts

Related Studies