- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07829016
GLP-1 Impacts on Weight Management (GLOW)
GLP-1 Longitudinal Outcomes in Weight Management
The goal of this observational study is to learn about the long-term effects of GLP-1RAs (Ozempic, Wegovy, Rybelsus, Mounjaro, or Zepbound) in adolescents and young adults aged 12-21 who will start taking this drug for weight management. The main question it aims to answer is:
How does starting GLP-1RAs impact eating behaviors and mental health symptoms?
Participants starting to take GLP-1RAs as part of their medical care for weight management will answer online survey questions about their experience taking the drug for 1 year.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Franziska Plessow, PhD
- Numéro de téléphone: 4153532747
- E-mail: Franziska.Plessow@ucsf.edu
Lieux d'étude
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California
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San Francisco, California, États-Unis, 94158
- University of California San Francisco, Mission Bay Campus
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Contact:
- Marissa Raymond-Flesch, MD/MPH
- Numéro de téléphone: 415-353-2747
- E-mail: GLOWStudy@ucsf.edu
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Chercheur principal:
- Marissa Raymond-Flesch, MD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Able to understand and provide informed consent or, for minor participants, able to provide assent with parent/guardian informed consent
- Age 12 and 21 years at the time of consent
- Able to read and write in English; for minor participants, at least one parent/guardian must be able to read and write in English or Spanish
- Willing and able to complete all required in-person and remote study visits and procedures
- Current binge-eating symptomatology
- Initiating first-time GLP-1RA therapy or related incretin-based therapy for weight management (Ozempic, Rybelsus, Wegovy)
- Meets current FDA medication eligibility criteria for prescribed GLP-1RA treatment for weight management: BMI ≥95th percentile OR ≥85th percentile with ≥1 weight-related comorbidity for those <18 years old and a BMI>30 or BMI>26 with ≥1 weight-related comorbidity for those 18 years old and older
- Has reliable access to prescribed GLP1-RA medication through insurance coverage, self-payment, or discount pharmacy plans and is willing to take it as prescribed for the duration of study participation
- On a stable regimen of permitted concomitant medications for at least 1 month prior to GLP-1RA initiation. Participants recently taking prohibited medications may be eligible after an adequate wash-out period as applicable (minimum of 5 half-lives).
- Receiving care in a clinic affiliated with the research study
Exclusion Criteria:
- Current use of Lisdexamfetamine (Vyvanse) or insufficient washout from such medication prior to GLP-1RA initiation
- Anticipated medication changes or planned surgical procedures during the study period that, in the investigator's judgment, could affect study participation of interpretation of outcomes
- Known genetic metabolic or endocrine syndromes associated with obesity, including Prader Willi Syndrome and familial hypercholesterolemia
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- Type 1 or type 2 diabetes
- History of pancreatitis
- Documented uncontrolled thyroid disease
- History of bariatric surgery
- Current pregnancy or known plans to become pregnant within the next 6 months
- Suicidality or any suicide attempts within the past 3 months
- Current severe depressive symptoms at screening
- Any medical, psychiatric, behavioral, or other condition, disorder, or circumstance not otherwise specified in the exclusion criteria that, in the investigator's judgment, may compromise participant safety, study participation, or adherence to the protocol
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
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Adolescents and Young Adults (12-21)
Adolescents and Young Adults who plan to start GLP-1RA treatment for weight management.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in the frequency of Objective Binge Episodes
Délai: 6 months
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Change in the frequency of OBEs over the past 28 days from baseline to 6 months following GLP-1RA initiation, as measured by the Eating Disorder Examination (EDE) Binge-Eating Module
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6 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Frequency of LOC Episodes
Délai: Baseline to 6 months
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Change in the frequency of LOC episodes over the past 28 days from baseline to 6 months following GLP-1RA initiation, as measured by a single-item question (key secondary endpoint)
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Baseline to 6 months
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Change in Frequency of OBEs
Délai: From baseline to 4 months
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Change in the frequency of OBEs over the past 28 days from baseline to 4 months following GLP-1RA initiation, as measured by the EDE Binge-Eating Module
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From baseline to 4 months
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Change in Frequency of LOC Episodes
Délai: Baseline to 4 months
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Change in the frequency of LOC episodes over the past 28 days from baseline to 4 months following GLP-1RA initiation, as measured by a single-item question
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Baseline to 4 months
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Change in Disordered Eating Symptom Severity
Délai: Baseline to 4-6 months
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Change in overall disordered eating symptom severity over the past 28 days from baseline to 4 and 6 months following GLP-1RA initiation, as measured by the Eating Disorder Examination-Questionnaire (EDE-Q) Global score
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Baseline to 4-6 months
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Change in Body Esteem
Délai: Baseline to Month 4 and 6
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Change in body esteem from baseline to 4 and 6 months following GLP-1RA initiation, as measured by the Body Esteem Scale for Adolescents and Adults (BESAA)
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Baseline to Month 4 and 6
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Change in Food Noise
Délai: Baseline to 4 and 6 months
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Change in food noise from baseline to 4 and 6 months following GLP-1RA initiation, as measured by the Food Noise Questionnaire (FNQ) Total score
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Baseline to 4 and 6 months
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Change in Frequency on Purging Behaviors
Délai: Baseline to 4 and 6 Months
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Change in the frequency of purging behaviors over the past 28 days from baseline to 4 and 6 months following GLP-1RA initiation, as measured by the EDE-Q
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Baseline to 4 and 6 Months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Marissa Raymond-Flesch, MD, MPH, University of California, San Francisco
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STUDY00000173
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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