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Self-directed Use of Resources for Physical Activity

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07654868
Acronym
CHARGE
Enrollment
39
Registered
2026-06-17
Start date
2026-09-01
Completion date
2026-12-15
Last updated
2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Activity

Keywords

exercise, large language model, generative AI, artificial intelligence, physical activity, chatbot

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALLLM alone

Participants are recommended to use a publicly available, general-purpose LLM for physical activity promotion

BEHAVIORALLLM 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

BEHAVIORALSleep promotion

Participants are recommended to use publicly available tools to help with sleep (websites with tips for sleep and guided meditation videos)

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Recruitment feasibility6 monthsAbility to meet recruitment goal of 39 participants within an acceptable timeframe

Secondary

MeasureTime frameDescription
Retention3 monthAbility to retain 80% of participants at 3 month assessment
Physical activity3 monthsMET-minutes per week based on international physical activity questionnaire (IPAQ)-short form

Contacts

CONTACTMegan A McVay, PhD
megan.mcvay@ufl.edu(352) 294-1638

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026