Self-directed Use of Resources for Physical Activity (CHARGE)
2026年8月19日 更新者:University of Florida
CHARGE: Pilot Trial of Self-directed Use of Resources for Physical Activity
This is a pilot RCT examining physical activity outcomes at 3 months across 3 conditions: use of large language model (LLM) fully self-directed; use of LLM with guidance; and use of online tools to help with sleep.
研究概览
详细说明
To prepare for a future fully powered RCT, the investigators are conducting a pilot RCT.
The pilot RCT will enroll n=39 insufficiently active primary care patients, and randomize them to one of 3 conditions: LLM alone condition: participants are recommended to use a publicly available, general-purpose LLM for physical activity promotion over the next 3 months (n=13); LLM enhanced condition: participants are recommended to use a publicly available, general-purpose LLM for physical activity promotion over the next 3 months and additionally attend an initial session providing guidance on LLM use and weekly text message with suggestions on using the LLM (n=13); or Control condition: participants are recommended to use publicly available tools to help with sleep (websites with tips for sleep and guided meditation videos) over the next 3 months (n=13).
At study onset, all participants will be given basic information about exercise safety.
At 3 months, moderate-to-vigorous physical activity will be measured with a validated self-report measure.
Feasibility and acceptability outcomes such as recruitment and retention--metrics essential for advancing to a subsequent large-scale trial-will be measured.
研究类型
介入性
注册 (估计的)
39
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Megan A McVay, PhD
- 电话号码:(352) 294-1638
- 邮箱:megan.mcvay@ufl.edu
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Age 18-75
- Reports a desire to increase physical activity level
- Not meeting minimum aerobic PA as indicated by L-CAT endorsement indicating level of activity below moderate (moderate defined as >= 5x/week activity or higher)
- Reports willingness to use LLMs to help with exercise goals.
- Access to internet through phone data plan or home Wi-Fi.
Exclusion Criteria:
Conditions warranting more extensive supervision of physical activity, including:
- Any history of MI or stroke, arrhythmias, or heart failure
- Uncontrolled hypertension
- Type 1 or 2 diabetes
- COPD or asthma
- Recent orthopedic surgery or fracture
- Advanced Parkinson's
- Pregnant or planning to become pregnant in next 9 months
- Active cancer undergoing treatment
- Recent major surgery (<12 weeks)
- Use of assistive devices for ambulation
- History of eating disorder diagnosis
- Dementia diagnosis
- Unable to read on own.
- Hospitalization for mental health reasons in past year
- Has used LLM to support physical activity goals in prior 3 months.
- Currently enrolled in a structured program to promote physical activity or weight loss.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:LLM alone
Participants are recommended to use a publicly available, general-purpose LLM for physical activity promotion over the next 3 months
|
Participants are recommended to use a publicly available, general-purpose LLM for physical activity promotion
|
|
实验性的:LLM enhanced
Participants are recommended to use a publicly available, general-purpose LLM for physical activity promotion over the next 3 months and additionally attend an initial session providing guidance on LLM use and weekly text message with suggestions on using the LLM
|
Participants are recommended to use a publicly available, general-purpose LLM for physical activity promotion over the next 3 months and additionally attend an initial session providing guidance on LLM use and weekly text message with suggestions on using the LLM
|
|
有源比较器:Sleep promotion
Participants are recommended to use publicly available tools to help with sleep (websites with tips for sleep and guided meditation videos) over the next 3 months
|
Participants are recommended to use publicly available tools to help with sleep (websites with tips for sleep and guided meditation videos)
|
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 |
|---|---|---|
|
Recruitment feasibility
大体时间:6 months
|
Ability to meet recruitment goal of 39 participants within an acceptable timeframe
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Retention
大体时间:3 month
|
Ability to retain 80% of participants at 3 month assessment
|
3 month
|
|
Physical activity
大体时间:3 months
|
MET-minutes per week based on international physical activity questionnaire (IPAQ)-short form
|
3 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2026年12月15日
研究完成 (估计的)
2026年12月15日
研究注册日期
首次提交
2026年6月12日
首先提交符合 QC 标准的
2026年6月12日
首次发布 (实际的)
2026年6月17日
研究记录更新
最后更新发布 (实际的)
2026年8月21日
上次提交的符合 QC 标准的更新
2026年8月19日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.