Primary-Care Strategies to Enhance Weight Management (PRISM) After Discontinuation of Anti-Obesity Medications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
The goal of this clinical trial pilot is to determine the feasibility of an intervention to enhance weight management in patients who have stopped taking anti-obesity/weight management medications in primary care. The main questions it aims to answer are:
- Can patients be recruited into the study efficiently?
- Is the program acceptable to patients?
- Can the study be conducted efficiently?
The new program will be compared to usual care.
详细描述
The goal of this clinical trial pilot is to determine the feasibility of an intervention to enhance weight management in patients who have stopped taking anti-obesity/weight management medications in primary care. The main questions it aims to answer are:
- Can patients be recruited into the study efficiently?
- Is the program acceptable to patients?
- Can the study be conducted efficiently?
The new program will be compared to usual care.
Participants will be asked to 1) complete short surveys about their medication use while taking the weight management medication, 2) complete online visits using study-provided scales, and 3) complete video visits with study staff monthly and online check-ins weekly, if assigned to the active treatment group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •For run-in: prescribed liraglutide, semaglutide, or tirzepatide or newer medication approved by the FDA for long-term use for obesity treatment for the purpose of weight managment by a primary care provider at Rush University System for Health and have received at least one dose of the medication concurrent with enrollment in the study.
- •For randomization: discontinue their prescribed anti-obesity medication.
排除标准
- •Not fluent in English
- •Diagnosis of diabetes (type 1 or type 2)
- •Current or planned pregnancy
- •Bariatric surgery in the past 2 years or planned bariatric surgery.
- •Body mass index ≥60 kg/m2, due to increased injury risk with exercise
- •Body weight ≥ 375 pounds (scale capacity with a margin for regain)
- •No access to home WIFI or a smartphone with data available
- •Medical contraindications to treatment, including significant cognitive impairment, active substance abuse based on the World Health Organization's ASSIST screener, or serious medical illness (e.g., stage 3 or 4 heart failure, cancer, renal failure, etc.)
- •Concurrent engagement with other behavioral treatments for obesity (for randomized phase only).
- •Medication obtained from online/compound pharmacies or prescription from specialty clinic without a prescription from primary care team at the time of enrollment
- •Another member of the household is enrolled in the study
研究组 & 干预措施
Usual Care
Participants will continue to receive their regular, usual primary care.
PRISM Program
This is a novel, remotely delivered, self-tailored intervention for post-anti-obesity medication discontinuation weight management.
干预措施: PRISM Program (Behavioral)
结局指标
主要结局
Recruitment rate
时间窗: Baseline
The recruitment rate will be defined as the number of participants randomized into the clinical trial per month.
Acceptability of the Intervention
时间窗: 3 and 6 months post randomization
Self-reported Likert scale items will assess the overall satisfaction with the program, the likelihood participants would recommend the program to others, and their satisfaction with individual treatment components (e.g., the online check-ins).
次要结局
- Medication adherence duration questions(From consent to reported discontinuation, up to 22 months)
- Reasons for Discontinuation questions(Baseline)