NCT06880315

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started Jan 2027

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 20, 2027

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2027

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

March 11, 2025

Last Update Submit

July 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Physical Activity Levels

    14 days from enrollment

Study Arms (2)

Personalized LLM-Generated Coaching Prompts

EXPERIMENTAL
Behavioral: Pre-Generated Personalized LLM Coaching Impact

Generic Activity Prompts

ACTIVE COMPARATOR
Behavioral: Pre-Generated Personalized LLM Coaching Impact

Interventions

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.

Generic Activity PromptsPersonalized LLM-Generated Coaching Prompts

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow, Cardiovascular Medicine

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 17, 2025

Study Start (Estimated)

January 20, 2027

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

July 23, 2026

Record last verified: 2026-07