Assessing Follow up Trajectories in Eating, Routines, and Weight After GLP-1
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Percentage of weight loss maintained
研究概览
简要总结
Many people who use GLP-1 medications (such as semaglutide or tirzepatide) achieve meaningful weight loss, but maintaining that weight loss off after stopping the medication can be very challenging. Researchers at Tufts University are conducting a study to learn whether a digital lifestyle program can help people maintain their weight loss after they stop taking a GLP-1 medication.
Adults who have recently stopped a GLP-1 medication may be eligible to participate. Participants will be randomly assigned to either receive access to a digital program or to continue with usual care. The study lasts 12 months and is fully remote. All participants will receive a Bluetooth scale to track weight from home and will complete short online questionnaires several times over the year.
By taking part, participants can help researchers better understand how to support long-term weight maintenance in a way that is affordable, accessible, and sustainable. Participants are compensated for their time, and involvement may help improve care for others with similar experiences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older (no upper limit);
- •ability to read, write, and speak English and/or Spanish;
- •ability to provide informed consent;
- •less than 30-days since GLP-1 RA cessation;
- •willing to participate.
排除标准
- •No clinically significant weight loss (e.g., < 5% body weight) while taking GLP medication;
- •major psychiatric illness, cognitive impairment, or substance misuse that could impair ability to participate;
- •medical conditions that significantly affect weight or make participation unsafe (e.g., pregnancy or breastfeeding, recent bariatric surgery, current use of GLP 1 or other anti-obesity medications, or endocrine disorders that alter weight regulation);
- •inability to use a smartphone or complete remote study procedures;
- •participation in another weight loss or maintenance program or clinical trial judged by investigators to interfere with study involvement;
- •Adults unable to consent (cognitively impaired);
- •Wards of the state;
- •Anyone under age 18.
研究组 & 干预措施
Noom® Smart device Application Subscription
干预措施: Digital Behavioral Application (Behavioral)
Usual care
Usual care for weight loss maintenance includes ongoing nutrition, exercise, and lifestyle counseling. However, the implementation of this standard of care is highly variable and dependent on the provider's discretion and availability. In many cases it is nothing. In some cases, the patient may have 1-2 office or remote visits with a provider or dietitian who educates the patient on nutrition and exercise behaviors. "Usual care" is left to each providers' discretion and will identify how much counseling (if any) participants receive through self-report.
结局指标
主要结局
Percentage of weight loss maintained
时间窗: 12-months
Percentage of weight loss maintained over 12 months following GLP-1 medication cessation measured using study-provided Bluetooth scale.
次要结局
未报告次要终点