Physical ActivityCHARGENCT07654868
Self-directed Use of Resources for Physical Activity
A study testing LLM alone, LLM enhanced and Sleep promotion in people with Physical Activity, run by University of Florida.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Physical Activity
- What is being tested?
- LLM alone, LLM enhanced and Sleep promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: CHARGE: Pilot Trial of Self-directed Use of Resources for Physical Activity
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.
Read the 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.
- Conditions
- Physical Activity
- Being tested
- LLM alone, LLM enhanced, Sleep promotion
- Keywords
- exercise, large language model, generative AI, artificial intelligence, physical activity, chatbot
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLM aloneBehavioural
Participants are recommended to use a publicly available, general-purpose LLM for physical activity promotion
LLM enhancedBehavioural
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 promotionBehavioural
Participants are recommended to use publicly available tools to help with sleep (websites with tips for sleep and guided meditation videos)
| Study group | Role | What they receive |
|---|---|---|
| LLM alone | Experimental | Participants are recommended to use a publicly available, general-purpose LLM for physical activity promotion over the next 3 months Receives: Behavioral: LLM alone |
| 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 Receives: Behavioral: LLM enhanced |
| 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 Receives: Behavioral: Sleep promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment feasibility
Ability to meet recruitment goal of 39 participants within an acceptable timeframe
Measured: 6 months
Secondary outcomes (2)
Retention
Ability to retain 80% of participants at 3 month assessment
Measured: 3 month
Physical activity
MET-minutes per week based on international physical activity questionnaire (IPAQ)-short form
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654868
- Sponsor's protocol ID
- IRB202600162
- Acronym
- CHARGE
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHARGE: Pilot Trial of Self-directed Use of Resources for Physical Activity
- ClinicalTrials.gov ID
- NCT07654868
- Acronym / sponsor ID
- CHARGE / IRB202600162
- Conditions
- Physical Activity
- Keywords
- exercise, large language model, generative AI, artificial intelligence, physical activity, chatbot
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LLM alone | Experimental | Behavioral: LLM aloneParticipants are recommended to use a publicly available, general-purpose LLM for physical activity promotion over the next 3 months |
| LLM enhanced | Experimental | Behavioral: LLM enhancedParticipants 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 | Active comparator | Behavioral: Sleep promotionParticipants 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LLM aloneParticipants are recommended to use a publicly available, general-purpose LLM for physical activity promotion | Behavioural | LLM alone |
| LLM enhancedParticipants 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 | Behavioural | LLM enhanced |
| Sleep promotionParticipants are recommended to use publicly available tools to help with sleep (websites with tips for sleep and guided meditation videos) | Behavioural | Sleep promotion |
Primary outcome
Recruitment feasibility
Time frame: 6 months
Ability to meet recruitment goal of 39 participants within an acceptable timeframe
2 secondary outcomes
Retention
Time frame: 3 month
Physical activity
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing LLM alone, LLM enhanced and Sleep promotion in people with Physical Activity, run by University of Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan A McVay, PhD ((352) 294-1638, megan.mcvay@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment feasibility (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.