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NCT Number: NCT07654868

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LLM alone

Behavioral

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

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)

Primary outcomes

  1. Recruitment feasibility

    Time frame: 6 months

    Ability to meet recruitment goal of 39 participants within an acceptable timeframe

Secondary outcomes

  1. Retention

    Time frame: 3 month

    Ability to retain 80% of participants at 3 month assessment

  2. Physical activity

    Time frame: 3 months

    MET-minutes per week based on international physical activity questionnaire (IPAQ)-short form

Study contacts

Contact information is provided by the study sponsor or research team.

Megan A McVay, PhD

CONTACT

[email protected]

(352) 294-1638

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Acronym: CHARGE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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