Actively Recruiting

Age: 18Years - 65Years
All Genders
NCT07042672

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

Led by Haukeland University Hospital · Updated on 2025-09-15

80

Participants Needed

1

Research Sites

182 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

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Severe obesity defined as BMI >40 kg/m2 or >35 kg/m2 with obesity-related conditions such as coronary artery disease, heart failure, hypertension, atrial fibrillation, stroke, venous thromboembolism, obstructive sleep apnea, obesity hypoventilation syndrome, type 2 diabetes, non-alcoholic 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
Not Eligible

You will not qualify if you...

  • Pregnant or lactating women, or women planning pregnancy within one year
  • Current use of medications with major effects on appetite or weight, including systemic glucocorticoids and antipsychotics
  • Renal failure with estimated glomerular filtration rate less than 30 mL/min/1.73m2
  • Liver failure with elevated liver enzymes or clinical signs of decompensation
  • Active cancer
  • Previous medullary thyroid cancer
  • Previous pancreatitis
  • Active substance abuse (previous drug abuse allowed)
  • Medical or psychological treatment for eating disorders within the last 6 months in specialized health care
  • Ongoing severe psychiatric illness preventing participation in the lifestyle program
  • Any illness or prior treatment judged by the investigator to risk participation or study data quality
  • Previous bariatric surgery
  • Use of appetite suppressing drugs such as GLP-1 analogues or naltrexone/bupropion within the last 6 months
  • Participation in another clinical trial with investigational drugs within 1 month prior to inclusion

AI-Screening

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Trial Site Locations

Total: 1 location

1

Haukeland University Hospital

Bergen, Vestland, Norway, 5021

Actively Recruiting

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Research Team

M

Malin M Kleppe, PhD candidate

CONTACT

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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