CHARGE: Pilot Trial of Self-directed Use of Resources for Physical Activity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 39
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
LLM alone
Participants are recommended to use a publicly available, general-purpose LLM for physical activity promotion over the next 3 months
干预措施: LLM alone (Behavioral)
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
干预措施: LLM enhanced (Behavioral)
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
干预措施: Sleep promotion (Behavioral)