Recruiting

Smartwatch with GLP-1 RA

Sponsor:

Massachusetts General Hospital

Code:

NCT07226947

Conditions

Obesity

Body Composition

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Smartwatch activity and body composition monitor

General guidance on recommended exercise

Study Details

Brief summary:

The goal of this study is to learn if a smartwatch that measures activity level and body composition, combined with exercise reminders, can safely improve strength and muscle mass in people who recently started or are planning to start treatment with incretin therapy (liraglutide, semaglutide, tirzepatide or retatrutide), also known as glucagon-like peptide 1 receptor agonist (GLP-1 RA) medications.

Conditions

Obesity

Body Composition

Study ID

NCT07226947

Start date

Nov 24, 2025

Status verified date

Dec, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria

1. Age ≥ 18 years old at time of signing informed consent
2. Started treatment with incretin therapy (liraglutide, semaglutide, tirzepatide, or retatrutide) within the past 2 months or planning to start this treatment

a. Potential participants switching GLP1-RA therapies due to inadequate response to a prior treatment will be eligible for enrollment
3. Able to provide informed consent

Exclusion Criteria

1. Current pregnancy (positive urine hCG) or plans to become pregnant in the next 6 months
2. BMI <25 kg/m2 at the time of screening
3. Unable to participate in a regular physical exercise program
4. Implanted pacemaker
5. Any factors that, in the opinion of the principal investigator, would interfere with the safe completion of the study

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Smartwatch activity monitor

Participants will be provided a smartwatch to monitor activity and body composition monitor. They will also have exercise goals set with reminders on the watch.

active comparator: Usual guidance

Participants will receive general guidance on recommended exercise

Interventions

Smartwatch activity and body composition monitor

Participants will be provided a smartwatch to monitor their exercise and body composition

General guidance on recommended exercise

Participants will receive general guidance on recommended exercise

Primary outcome measure

  • Lean mass (kg) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Ben O Brenner, BS

617-726-1729bbrenner1@mgb.org

Locations

Diabetes Research Center

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Ben O Brenner, BS

617-726-1729bbrenner1@mgb.org

Grace Kuropatkin, BS

617-726-6537gkuropatkin@mgh.harvard.edu

Principal Investigator:

Melissa S Putman, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Dec 30, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-12-30.