Beta
Trial Radar KI
Eine Studie entspricht den Filterkriterien
Kartenansicht
Zurück zur Suche

Behavioral Therapy and GLP-1 Analogue Effects on Binge Eating, Weight, and Coping in Obesity (BETTER-GLP1) 80 Randomisiert Beobachtend Lebensstil

Offene Rekrutierung
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT07042672 (BETTER-GLP1) ist eine beobachtungsstudie zur Untersuchung von Binge Eating Disorder Associated With Obesity, Binge-Eating-Störung, Essstörung Binge, Essstörungen, GLP-1, KVT (Kognitive Verhaltenstherapie), Obesity &Amp; Overweight und hat den Status offene rekrutierung. Die Studie startete am 1. Juli 2025 und soll 80 Teilnehmer aufnehmen. Durchgeführt von Haukeland University Hospital ist der Abschluss für 31. Dezember 2028 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 15. September 2025 aktualisiert.
Kurzbeschreibung
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 ...

Mehr anzeigen
Offizieller Titel

Behavioral Therapy With and Without GLP-1 Analogue in Patients With Morbid Obesity and Binge Eating Disorder: A Clinical Prospective Observational Study on Body Weight, Binge Eating Behavior, and Harmful Coping Strategies

Erkrankungen
Binge Eating Disorder Associated With ObesityBinge-Eating-StörungEssstörung BingeEssstörungenGLP-1KVT (Kognitive Verhaltenstherapie)Obesity &Amp; Overweight
Weitere Studien-IDs
  • BETTER-GLP1
  • 2025-854686
NCT-Nummer
NCT07042672
Studienbeginn (tatsächlich)
2025-07-01
Zuletzt aktualisiert
2025-09-15
Studienende (vorauss.)
2028-12-31
Geplante Rekrutierung
80
Studientyp
Beobachtungsstudie
Status
Offene Rekrutierung
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
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.
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.
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.
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.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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)
Baseline and 12 months
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  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

  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
Haukeland University Hospital logoHaukeland University Hospital
University of Bergen logoUniversity of Bergen
Zentrale Studienkontakte
Kontakt: Malin M Kleppe, PhD candidate, +47 99357771, [email protected]
1 Studienstandorte in 1 Ländern

Vestland

Haukeland University Hospital, Bergen, Vestland, 5021, Norway
Malin M Kleppe, MSc, Kontakt, 99357771, [email protected]
Paal Methlie, MD, PhD, Kontakt, 97677930, [email protected]
Paal Methlie, MD, PhD, Hauptprüfer
Offene Rekrutierung