LLM alone
BehavioralParticipants are recommended to use a publicly available, general-purpose LLM for physical activity promotion
NCT Number: NCT07654868
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants are recommended to use a publicly available, general-purpose LLM for physical activity promotion
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 publicly available tools to help with sleep (websites with tips for sleep and guided meditation videos)
Time frame: 6 months
Ability to meet recruitment goal of 39 participants within an acceptable timeframe
Time frame: 3 month
Ability to retain 80% of participants at 3 month assessment
Time frame: 3 months
MET-minutes per week based on international physical activity questionnaire (IPAQ)-short form
Contact information is provided by the study sponsor or research team.
University of Florida
Other
Acronym: CHARGE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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