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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LLM alone | Experimental | Participants are recommended to use a publicly available, general-purpose LLM for physical activity promotion over the next 3 months |
|
| LLM enhanced | Experimental | 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 |
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| Sleep promotion | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LLM alone | Behavioral | Participants are recommended to use a publicly available, general-purpose LLM for physical activity promotion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment feasibility | Ability to meet recruitment goal of 39 participants within an acceptable timeframe | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Retention | Ability to retain 80% of participants at 3 month assessment | 3 month |
| Physical activity | MET-minutes per week based on international physical activity questionnaire (IPAQ)-short form |
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Inclusion Criteria:
Exclusion Criteria:
Conditions warranting more extensive supervision of physical activity, including:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan A McVay, PhD | Contact | (352) 294-1638 | megan.mcvay@ufl.edu |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| LLM enhanced | Behavioral | 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 |
|
| Sleep promotion | Behavioral | Participants are recommended to use publicly available tools to help with sleep (websites with tips for sleep and guided meditation videos) |
|
| 3 months |