CHARGE: Pilot Trial of Self-directed Use of Resources for Physical Activity

Обзор

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.

Подробное описание

To prepare for a future fully powered RCT, we 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.

Вмешательства

• Поведенческое LLM alone
  Participants are recommended to use a publicly available, general-purpose LLM for physical activity promotion
• Поведенческое 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
• Поведенческое Sleep promotion
  Participants are recommended to use publicly available tools to help with sleep (websites with tips for sleep and guided meditation videos)

Первичные конечные точки

• Recruitment feasibility [Срок оценки: 6 months]

Вторичные конечные точки (2)

• Retention [Срок оценки: 3 month]
• Physical activity [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07654868 · IRB202600162

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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