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
Location: See location...
Intervention Type: Behavioral, Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

• Age between 18 to 65 years

• Diagnosis of BED according to DSM-5 criteria

• Willingness to participate and provide informed consent

• Able to understand and communicate in Norwegian

Locations
Other Locations
Norway
Haukeland University Hospital
RECRUITING
Bergen
Contact Information
Primary
Malin M Kleppe, PhD candidate
malin.mandelid.kleppe@helse-bergen.no
+47 99357771
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 80
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Bergen
Leads: Haukeland University Hospital

This content was sourced from clinicaltrials.gov