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

Haukeland University Hospital80 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Binge Eating Disorder Associated With Obesity Binge Eating Disorder Eating Disorder Binge

Interventions

GLP-1DRUG

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 TherapyBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: Baseline and 12 months

Secondary Outcomes

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

The Composite Harmful Coping Endpoint (CHCE) captures the emergence of new harmful coping behaviors from baseline to 12-month follow-up. It is defined as a binary outcome, scored as positive if any of the following occur: * Deliberate self-harm (DSHI score \> 0) * Alcohol misuse (AUDIT \>= 8 for men, \>= 6 for women) * Drug misuse (DUDIT \> 6 for men, \> 2 for women) Each of the three components is dichotomized using validated clinical thresholds. Participants with no indication at baseline who cross threshold for any of the three domains at 12 months are considered to have developed a new harmful coping strategy (CHCE = 1). The outcome will compare the proportion of participants with CHCE = 1 between Group-GLP and Group-NoMED. DSHI; Deliberate Self-Harm Inventory (range 0-17, higher is worse), AUDIT; Alcohol Use Disorders Identification Test (range 0-40, higher is worse), DUDIT; Drug Use Disorders Identification Test (range 0-44, higher is worse)