Identifying Strategies to Curtail Weight Regain After GLP-1 Receptor Agonist Treatment Cessation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Intervention Satisfaction
研究概览
简要总结
Longitudinal studies show there is a steep increase in weight regain in the first 3-4 months after stopping GLP-1 receptor agonist medications (GLP-1s) and most patients regain most of their weight within a year. Insurers now question the utility of GLP-1s for weight loss as they are hesitant to cover these costs long-term (~$833 per person per month). Some patients would also prefer not to take these medications in perpetuity and are likely to struggle with lifelong adherence. These challenges present an opportunity to test alternative interventions, such as meal replacements and behavioral treatments, to support weight maintenance after successful weight loss with GLP-1s. This regimen would allow patients to benefit from significant weight loss in the first year of taking GLP-1s and use more cost effective and sustainable strategies for long-term maintenance.
详细描述
In the proposed study the investigators will execute a pilot randomized controlled trial to identify whether medically tailored meals (MTM, Group 1, N=20) and/or Noom®, a mobile application (Group 2, N=20) are associated with greater treatment adherence and satisfaction than usual care (Group 3, N=20) after GLP-1 Receptor Agonist cessation. The investigators will enroll adults 18 and older that have lost more than 10% of their bodyweight taking GLP-1 Receptor Agonist and ceased treatment within the past 30-days. For four-months, Group 1 will receive 40 MTM per month, Group 2 will receive a Noom® subscription, and Group 3 will receive lifestyle counseling per standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Complete masking is not feasible given the nature of the interventions - the program coordinator and participants will know if the participant receives home delivered medically tailored meals, a smart device application subscription, or usual care. The care provider will not be told the participants group assignment, but the participant may reveal it themselves in discussions with the provider.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Medically tailored meals
Participants will receive 10 medically tailored meals per week (40 meals per month) for four-months.
干预措施: Medically tailored meals (Other)
Noom®
Participants will receive a paid Noom® subscription for four-months. Noom® is a subscription-based mobile application that provides food intake and exercise tracking and uses principles from psychology to motivate behavior change.
干预措施: Usual care (Other)
Usual care
Participants will receive usual care from their provider.
干预措施: Usual care (Other)
Medically tailored meals
Participants will receive 10 medically tailored meals per week (40 meals per month) for four-months.
干预措施: Usual care (Other)
Noom®
Participants will receive a paid Noom® subscription for four-months. Noom® is a subscription-based mobile application that provides food intake and exercise tracking and uses principles from psychology to motivate behavior change.
干预措施: Noom® (Behavioral)
结局指标
主要结局
Intervention Satisfaction
时间窗: 4-months
The Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) will be used to measure satisfaction, and be adapted for the interventions understudy. Responses are provided on a 7-point Likert scale ranging from extremely satisfied to extremely dissatisfied. Scores are then transformed to a 0-100 scale with a higher score indicating greater treatment satisfaction.
Intervention Adherence
时间窗: 4-months
Adherence will be measured using the Perceived Behavior subscale (6-items) from the validated Treatment Adherence Perception Questionnaire (TAPQ).
次要结局
- Percent weight loss maintained(4-months)
- Diet quality(4-months)
研究者
Kelseanna Hollis-Hansen
Assistant Professor
University of Texas Southwestern Medical Center