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.
This prospective single-arm observational study will enroll 100 adolescents and young adults 12 to 21 years of age who are initiating a prescribed glucagon-like peptide-1 receptor agonist (GLP-1RA) therapy or related incretin-based therapy for weight management. The study will assess longitudinal changes in eating behaviors and related clinical features from pre-treatment baseline through 6 months of GLP-1RA treatment, spanning treatment initiation, titration, and maintenance. Exploratory cognitive assessments and biomarker collection will examine behavioral and biological correlates of change. After 6 months, participants will be in follow-up and attend a final study visit at their 12-month mark.
Study Type
OBSERVATIONAL
Enrollment
100
University of California San Francisco, Mission Bay Campus
San Francisco, California, United States
Change in the frequency of Objective Binge Episodes
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
Time frame: 6 months
Change in Frequency of LOC Episodes
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)
Time frame: Baseline to 6 months
Change in Frequency of OBEs
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
Time frame: From baseline to 4 months
Change in Frequency of LOC Episodes
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
Time frame: Baseline to 4 months
Change in Disordered Eating Symptom Severity
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
Time frame: Baseline to 4-6 months
Change in Body Esteem
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)
Time frame: Baseline to Month 4 and 6
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Change in Food Noise
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
Time frame: Baseline to 4 and 6 months
Change in Frequency on Purging Behaviors
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
Time frame: Baseline to 4 and 6 Months