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.
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
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
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.
Cohort
Prospective
GLP-1
DrugSubcutaneous 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
BehavioralTen 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.
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).
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)
Qualitative Evaluation of Patient Experiences With Combined CBT and GLP-1 Treatment
A subset of study participants (n = 12) receiving GLP-1 analogue treatment will be invited to participate in structured in-depth interviews at 12-month follow-up. Interviews will explore patient experiences related to appetite regulation, eating habits, emotion regulation, and coping strategies during the treatment period. Interviews will be audio-recorded, transcribed, and analyzed using thematic content analysis. This qualitative outcome complements quantitative endpoints by providing insight into subjective treatment experiences.
Mean Difference in Change in AUDIT Score Between Groups From Baseline to 12 Months
The Alcohol Use Disorders Identification Test (AUDIT) is a 10-item screening tool developed by the WHO to assess alcohol consumption, drinking behaviors, and alcohol-related problems. Each item is scored from 0 to 4, yielding a total score range of 0 to 40. Higher scores indicate more severe alcohol-related problems. This outcome assesses the mean difference in AUDIT score change from baseline to 12-month follow-up between participants receiving GLP-1 analogues (Group-GLP) and those not receiving appetite suppressants (Group-NoMED).
Mean Difference in Change in DUDIT Score Between Groups From Baseline to 12 Months
The Drug Use Disorders Identification Test (DUDIT) is an 11-item screening tool for drug misuse, with total scores ranging from 0 to 44. Higher scores indicate greater severity of drug-related problems. This outcome assesses the mean difference in DUDIT score change from baseline to 12-month follow-up between participants receiving GLP-1 analogues (Group-GLP) and those not receiving appetite suppressants (Group-NoMED).
Mean Difference in Change in DSHI Score Between Groups From Baseline to 12 Months
The Deliberate Self-Harm Inventory (DSHI) is a 17-item self-report questionnaire assessing the presence of specific self-injurious behaviors. Each item is scored 0 (absent) or 1 (present), yielding a total score ranging from 0 to 17. Higher scores reflect a greater number of different self-harm methods. This outcome assesses the mean difference in DSHI score change from baseline to 12-month follow-up between participants receiving GLP-1 analogues (Group-GLP) and those not receiving appetite suppressants (Group-NoMED).
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Haukeland University Hospital
Lead sponsor
University of Bergen
Collaborator
