Actively Recruiting
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
Led by Haukeland University Hospital · Updated on 2025-09-15
80
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
Sponsors
H
Haukeland University Hospital
Lead Sponsor
U
University of Bergen
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effects of using GLP-1 analogues compared to not using appetite suppressants as part of a lifestyle treatment program for adults with both obesity and binge eating disorder (BED). This prospective observational study aims to evaluate changes in BED symptoms over 12 months and to explore whether participants adopt other harmful coping strategies. The study also examines psychological well-being, weight changes, and their impact on obesity-related health conditions. Participants will be divided into two groups: one group will receive standard lifestyle treatment including cognitive behavioral therapy-enhanced (CBT-E) group sessions and individual consultations every four months along with GLP-1 analogue medication prescribed by their physician. The other group will receive the same lifestyle treatment without any appetite-suppressing drugs. The GLP-1 analogues used may include liraglutide, semaglutide, or tirzepatide, with dosage and duration following routine clinical practice for at least 12 months. During the study, participants will attend 10 weekly CBT-E group therapy sessions and clinical consultations every four months. Evaluations will include patient questionnaires on BED symptoms and coping strategies, as well as measurements of weight and biochemical data at the start and after 12 months. Researchers will monitor changes in BED symptoms using the EDE-Q Global Score and track shifts in harmful coping mechanisms. The total study duration for participants is 12 months, with ongoing follow-up and data collection throughout this period.
CONDITIONS
Brief Title
Behavioral Therapy and GLP-1 Analogue Effects on Binge Eating, Weight, and Coping in Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Severe obesity defined as BMI greater than 40 kg/m2 or greater than 35 kg/m2 with related health conditions such as coronary artery disease, heart failure, hypertension, atrial fibrillation, stroke, venous thromboembolism, sleep apnea, hypoventilation syndrome, type 2 diabetes, fatty liver disease, dyslipidemia, osteoarthritis, or polycystic ovary syndrome
- Age between 18 and 65 years
- Diagnosis of binge eating disorder according to DSM-5 criteria
- Willingness to participate and provide informed consent
- Able to understand and communicate in Norwegian
You will not qualify if you...
- Pregnant or breastfeeding women, or women planning pregnancy within one year
- Current use of medications that affect appetite or weight, including systemic glucocorticoids and antipsychotics
- Kidney failure with estimated filtration rate less than 30 mL/min/1.73m2
- Liver failure indicated by elevated liver enzymes or clinical signs of liver decompensation
- Active cancer
- Previous medullary thyroid cancer
- Previous pancreatitis
- Active substance abuse (previous drug abuse is allowed)
- Medical or psychological treatment for eating disorders within the last 6 months
- Severe psychiatric illness preventing participation in lifestyle treatment
- Any illness or prior treatment judged by the investigator to risk study participation or data quality
- Previous bariatric surgery
- Use of appetite suppressants like GLP-1 analogues or naltrexone/bupropion within the last 6 months
- Participation in another clinical study with investigational drugs within 1 month prior to inclusion
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants engage in ten weekly 2-hour group sessions of Cognitive Behavioral Therapy-Enhanced (CBT-E) targeting eating patterns, weight-management behaviors, and emotion-regulation skills, along with individualized lifestyle consultations every 4 months over a 12-month period.
Weekly group therapy sessions for 10 weeks plus individual consultations every 4 months
Duration - 12 months or longer
Participants prescribed a GLP-1 analogue for weight management according to routine clinical practice. Medication selection, dosage, and duration follow physician judgment and approved product labels over a period of 12 months or longer.
Medication administration as per routine care; visits depend on clinical practice
Trial Site Locations
Total: 1 location
1
Haukeland University Hospital
Bergen, Vestland, Norway, 5021
Actively Recruiting
Research Team
M
Malin M Kleppe, PhD candidate
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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