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

NCT07042672 | Recruiting FDA Drug

• 1 other identifier: 2025-854686
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in EDE-Q Global Score From Baseline to 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).

  Baseline and 12 months

Secondary Outcomes (1)

• Proportion of Participants With Increase in Composite Harmful Coping Endpoint (CHCE) From Baseline to 12 Months

  Baseline and 12 months

Other Outcomes (11)

• Qualitative Evaluation of Patient Experiences With Combined CBT and GLP-1 Treatment

  12 months

• Mean Difference in Change in AUDIT Score Between Groups From Baseline to 12 Months

  From baseline to 12 months

• Mean Difference in Change in DUDIT Score Between Groups From Baseline to 12 Months

  Baseline and 12 months

Study Arms (2)

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.

Drug: GLP-1; Behavioral: CBTe Group Therapy

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.

Behavioral: CBTe Group Therapy

Interventions

GLP-1 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.

Group-GLP1

CBTe Group Therapy 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-GLP1; Group-NoMED

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with obesity and binge eating disorder. The study will enroll patients with concomitant severe obesity and BED who are referred to the Obesity clinic at Haukeland University Hospital, Norway. All potentially eligible participants will be routinely screened for BED and EDE interview (gold standard) will be used to formally diagnose BED according to the DSM-5.

You may qualify if:

• 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

You may not qualify if:

• Pregnant or lactating women, as well as women planning pregnancy within one year.
• Current use medications with major effects on appetite regulation or weight (including, but not limited to systemic glucocorticoids and antipsychotic medication)
• Renal failure with estimated glomerular filtration rate less than 30 mL/min/1,73m2
• 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
• Active cancer
• Previous medullary thyroid cancer
• Previous pancreatitis
• Active substance abuse (but previous drug abuse accepted)
• Medical or psychological treatment within the specialized health care service for eating disorders within the last 6 months.
• Ongoing severe psychiatric disease that makes them unable to follow the lifestyle treatment program
• 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.
• Previous bariatric surgery
• Use of appetite suppressing drugs (e.g., GLP-1 analogues and/or naltrexone/bupropion) within the last 6 months

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Bergen: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, Vestland, 5021, Norway

RECRUITING

MeSH Terms

Conditions

Binge-Eating Disorder; Feeding and Eating Disorders; Obesity; Overweight

Interventions

Glucagon-Like Peptide 1

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Malin M Kleppe, PhD candidate

CONTACT

+47 99357771; malin.mandelid.kleppe@helse-bergen.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: June 29, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): November 5, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)