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

NCT ID: NCT07042672

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2028-12-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

GLP-1

Intervention Type: 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

Intervention Type: 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.

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.

CBTe Group Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bergen

OTHER

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Haukeland University Hospital

Bergen, Vestland, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Malin M Kleppe, PhD candidate

Role: CONTACT

malin.mandelid.kleppe@helse-bergen.no

+47 99357771

Facility Contacts

Malin M Kleppe, MSc

Role: primary

malin.mandelid.kleppe@helse-bergen.no

99357771 ext. +47

Paal Methlie, MD, PhD

Role: backup

paal.methlie@uib.no

97677930 ext. 47

Other Identifiers

2025-854686

Identifier Type: -

Identifier Source: org_study_id