NCT07654868

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Jun 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Jun 2026Dec 2026

First Submitted

Initial submission to the registry

June 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

June 22, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 12, 2026

Last Update Submit

June 12, 2026

Conditions

Keywords

exerciselarge language modelgenerative AIartificial intelligencephysical activitychatbot

Outcome Measures

Primary Outcomes (1)

  • Recruitment feasibility

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

    6 months

Secondary Outcomes (2)

  • Retention

    3 month

  • Physical activity

    3 months

Study Arms (3)

LLM alone

EXPERIMENTAL

Participants are recommended to use a publicly available, general-purpose LLM for physical activity promotion over the next 3 months

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

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

Behavioral: Sleep promotion

Interventions

LLM aloneBEHAVIORAL

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

LLM alone
LLM enhancedBEHAVIORAL

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

LLM enhanced
Sleep promotionBEHAVIORAL

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

Sleep promotion

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Megan A McVay, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2026

First Posted

June 17, 2026

Study Start

June 22, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

June 17, 2026

Record last verified: 2026-06