Behavioral therapy plus GLP-1 medicines for binge eating and weight in people with 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
Haukeland University Hospital · NCT07042672
This project will try adding GLP-1 medications to a lifestyle program with CBT-E to see if they reduce binge eating and help adults with obesity lose weight and cope better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Haukeland University Hospital (other) |
| Locations | 1 site (Bergen, Vestland) |
| Trial ID | NCT07042672 on ClinicalTrials.gov |
What this trial studies
This is a prospective, non-randomized observational study comparing patients who use GLP-1 analogues with patients who do not while both receive a lifestyle program and 10 weeks of CBT-E group therapy plus individual consultations. About 80 adults with severe obesity and DSM-5 binge eating disorder at Haukeland University Hospital will be followed over time and divided into Group-GLP1 and Group-NoMED. The primary focus is on changes in binge eating symptoms, with secondary evaluations of adoption of harmful coping behaviors, psychological well-being, weight change, and effects on obesity-related comorbidities. Safety and tolerability of GLP-1 use in this population will also be recorded.
Who should consider this trial
Good fit: Adults age 18–65 with severe obesity (BMI >40, or ≥35 with obesity-related comorbidities) and a DSM-5 diagnosis of binge eating disorder who can communicate in Norwegian and are seen at the Haukeland University Hospital obesity clinic are eligible.
Not a fit: Patients who are pregnant or planning pregnancy, taking other medications with major effects on appetite, or with severe renal or liver failure are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, combining GLP-1 medicines with structured behavioral therapy could reduce binge episodes, support weight loss, and improve coping and related health problems.
How similar studies have performed: Previous trials have shown GLP-1 drugs can produce meaningful weight loss and reduce binge episodes, but prospectively pairing GLP-1 treatment with CBT-E in this non-randomized design is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria 1. Severe obesity defined as BMI \>40 kg/m2 or 35 kg/m2 with obesity-related comorbidities: coronary artery disease, heart failure, hypertension, atrial fibrillation, cerebral stroke, venous thromboembolism, obstructive sleep apnea, obesity hypoventilation syndrome, type 2 diabetes mellitus, non-alcoholic fatty liver disease, dyslipidemia, osteoarthritis and polecystic ovary syndrome 2. Age between 18 to 65 years 3. Diagnosis of BED according to DSM-5 criteria 4. Willingness to participate and provide informed consent 5. Able to understand and communicate in Norwegian Exclusion criteria 1. Pregnant or lactating women, as well as women planning pregnancy within one year. 2. Current use medications with major effects on appetite regulation or weight (including, but not limited to systemic glucocorticoids and antipsychotic medication) 3. Renal failure with estimated glomerular filtration rate less than 30 mL/min/1,73m2 4. Liver failure with either ASAT and/or ALAT 5 times upper reference limit, or ALP and/or GT more than 3 times upper reference limit, or clinical signs of liver decompensation 5. Active cancer 6. Previous medullary thyroid cancer 7. Previous pancreatitis 8. Active substance abuse (but previous drug abuse accepted) 9. Medical or psychological treatment within the specialized health care service for eating disorders within the last 6 months. 10. Ongoing severe psychiatric disease that makes them unable to follow the lifestyle treatment program 11. Any illness or prior treatment that in the opinion of the investigator would jeopardize the patient's participation in the study or impact integrity and/or quality of study data. 12. Previous bariatric surgery 13. Use of appetite suppressing drugs (e.g., GLP-1 analogues and/or naltrexone/bupropion) within the last 6 months 14. Participation in another clinical study involving an investigational medicinal product within 1 month prior to study inclusion
Where this trial is running
Bergen, Vestland
- Haukeland University Hospital — Bergen, Vestland, Norway (RECRUITING)
Study contacts
- Study coordinator: Malin M Kleppe, PhD candidate
- Email: malin.mandelid.kleppe@helse-bergen.no
- Phone: +47 99357771
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Binge Eating Disorder Associated With Obesity, Binge Eating Disorder, Eating Disorder Binge, Eating Disorders, GLP-1, CBT, Obesity &Amp, Overweight