GLP-1 Impacts on Weight Management
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-21
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Participants will be 12-21 years olds who plan to begin GLP-1RA treatment for weight management. Participants will be current patients receiving care from UCSF affiliated clinics.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Adolescents and Young Adults (12-21)
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 (range: 0-6; higher scores indicate greater eating-disorder psychopathology).
Time frame
Baseline to 4-6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: