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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Marissa Raymond-Flesch, MD
- 电话号码:(416) 562-7034 4153532747
- 邮箱:glowstudy@ucsf.edu
学习地点
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-
California
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San Francisco、California、美国、94158
- University of California San Francisco, Mission Bay Campus
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接触:
- Marissa Raymond-Flesch, MD/MPH
- 电话号码:415-353-2747
- 邮箱:GLOWStudy@ucsf.edu
-
首席研究员:
- Marissa Raymond-Flesch, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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.
描述
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
学习计划
研究是如何设计的?
设计细节
- 观测模型:COHORT
- 时间观点:PROSPECTIVE
队列和干预
团体/队列 |
|---|
|
Adolescents and Young Adults (12-21)
Adolescents and Young Adults who plan to start GLP-1RA treatment for weight management. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in the frequency of Objective Binge Episodes
大体时间:6 months
|
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 |
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Frequency of LOC Episodes
大体时间:Baseline to 6 months
|
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) |
Baseline to 6 months
|
|
Change in Frequency of OBEs
大体时间: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 |
From baseline to 4 months
|
|
Change in Frequency of LOC Episodes
大体时间:Baseline to 4 months
|
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 |
Baseline to 4 months
|
|
Change in Disordered Eating Symptom Severity
大体时间: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 (range: 0-6; higher scores indicate greater eating-disorder psychopathology). |
Baseline to 4-6 months
|
|
Change in Body Esteem
大体时间: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) (subscale score range: 0-4; higher scores indicate greater body esteem). |
Baseline to Month 4 and 6
|
|
Change in Food Noise
大体时间: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 (total score range: 0-20; higher scores indicate greater food noise). |
Baseline to 4 and 6 months
|
|
Change in Frequency on Purging Behaviors
大体时间: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 Eating Disorder Examination Questionnaire (EDE-Q) Global Score: (range: 0-6; higher scores indicate greater eating-disorder psychopathology). |
Baseline to 4 and 6 Months
|
合作者和调查者
调查人员
- 首席研究员:Marissa Raymond-Flesch, MD, MPH、University of California, San Francisco
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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