- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06880315
LLM-Generated Coaching Prompts
January 21, 2026 updated by: Euan Ashley, Stanford University
Enhancing Physical Activity With LLM-Generated Coaching Prompts: A My Heart Counts Study
This pilot study aims to evaluate whether personalized coaching prompts generated by a large language model (LLM) can effectively increase physical activity levels among participants.
The study will involve 50 participants who will receive daily text messages, either personalized by the LLM or generic, over a 14-day period.
Participants will share their HealthKit data for analysis.
The findings will inform the development of future versions of the My Heart Counts application, enhancing user engagement and health outcomes.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age: Participants must be 18 years or older.
- Health Status: Participants must be healthy enough to engage in physical activity.
- Language Proficiency: Participants must be able to read, understand, and consent in English or Spanish (dependent on which is being studied).
- Device Ownership: Participants must possess an iPhone and an Apple Watch.
- Data Sharing: Participants must be willing to share their HealthKit data via secure upload.
Exclusion Criteria:
- Age: Participants under the age of 18.
- Health Status: Participants who are not healthy enough to engage in physical activity.
- Language Proficiency: Participants who cannot read, understand, or consent in English or Spanish.
- Device Ownership: Participants who do not have both an iPhone and an Apple Watch.
- Data Sharing: Participants unwilling to share their HealthKit data via secure upload.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Personalized LLM-Generated Coaching Prompts
|
After the initial 7 days, participants will switch to the other type of prompting for another 7 days.
This means that participants who initially received personalized LLM-generated prompts will then receive generic activity prompts, and vice versa.
This crossover design allows for each participant to experience both types of interventions, providing a within-subject comparison of the effectiveness of personalized versus generic prompts in increasing physical activity levels.
|
|
Active Comparator: Generic Activity Prompts
|
After the initial 7 days, participants will switch to the other type of prompting for another 7 days.
This means that participants who initially received personalized LLM-generated prompts will then receive generic activity prompts, and vice versa.
This crossover design allows for each participant to experience both types of interventions, providing a within-subject comparison of the effectiveness of personalized versus generic prompts in increasing physical activity levels.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Physical Activity Levels
Time Frame: 14 days from enrollment
|
14 days from enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 20, 2026
Primary Completion (Estimated)
July 30, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
March 11, 2025
First Submitted That Met QC Criteria
March 11, 2025
First Posted (Actual)
March 17, 2025
Study Record Updates
Last Update Posted (Actual)
January 23, 2026
Last Update Submitted That Met QC Criteria
January 21, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 79946
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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