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.
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.
Study 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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Change in EDE-Q Global Score From Baseline to 12 Months — Baseline and 12 months The Eating Disorder Examination Questionnaire (EDE-Q, version 6.0) global score is a validated measure of core eating disorder psychopathology, ranging from 0 to 6, with higher scores indicating greater symptom severity.
The EDE-Q comprises 28 items and assesses cognitive and behavioral symptoms over the past 28 days, including four subscales: restraint, eating concern, shape concern, and weight concern.
This outcome measures the mean change in global score from baseline to 12-month follow-up, comparing participants receiving GLP-1 analogue treatment (Group-GLP) versus those not receiving appetite suppressants (Group-NoMED).
Trial sites (1)
Facility
City
Region
Status
Haukeland University Hospital
Bergen
Vestland
Recruiting
More Haukeland University Hospital trials in Norway
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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