What is this study trying to find out about body composition and obesity?

This study is evaluating if a smartwatch that tracks activity and body composition with exercise reminders can safely improve muscle strength and mass in people using incretin therapy for obesity. The research is conducted by Massachusetts General Hospital to learn how to support patients starting these medications. Participants can expect to use a device or receive exercise guidance while researchers monitor their progress.

Who may be eligible for this obesity clinical trial?

Adults aged 18 to 99 who have started or plan to start incretin therapy such as liraglutide, semaglutide, tirzepatide, or retatrutide are eligible. Participants must have a BMI of 25 kg/m2 or higher and be able to exercise regularly. People who are pregnant or have a pacemaker may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this obesity clinical trial?

Study-related care, including the smartwatch or exercise guidance and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for visits.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 99Years

All Genders

ID07226947

Study of Smartwatch Monitoring and Exercise to Prevent Muscle Loss in Adults Using Incretin Therapy for Obesity

Led by Massachusetts General Hospital · Updated on 2025-12-30

100

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying whether using a smartwatch that tracks activity levels and body composition, along with exercise reminders, can safely help improve strength and muscle mass in people who have recently started or plan to start treatment with incretin therapy medications called GLP-1 receptor agonists liraglutide, semaglutide, tirzepatide, or retatrutide. These medications are used to manage conditions such as obesity and body composition changes. Participants will be randomly assigned to one of two groups. One group will receive a smartwatch to monitor their exercise and body composition, with exercise goals set and reminders provided on the device. The other group will receive general guidance on recommended exercise without the smartwatch. This study does not use blinding and follows participants over six months. During the study, participants will have their lean mass and other body composition measures checked at six months. Assessments will include hand grip strength, physical performance tests like the 1-minute sit-to-stand and 6-minute walk test, and physical activity scores. Researchers will monitor these outcomes to evaluate changes in muscle and fat mass and overall physical function throughout the study period.

CONDITIONS

Brief Title

Body Composition and Exercise to Prevent Muscle Loss With GLP1 Agonist Treatment

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	Smartwatch Monitoring (GLP1-RA)	General Guidance (GLP1-RA)
What it is	Participants use a smartwatch to monitor their physical activity and body composition while undergoing GLP1-RA therapy for weight management.	Participants receive general recommendations on exercise and activity while on GLP1-RA therapy for weight management.
Role in the trial	Intervention arm evaluating effects of smartwatch-based activity and composition tracking combined with GLP1-RA therapy.	Active comparator arm receiving standard guidance on exercise paired with GLP1-RA therapy.
Primary use or goal	To test whether continuous activity and body composition monitoring can help preserve or increase muscle mass during weight loss with GLP1-RA medicines.	To examine the effect of general exercise recommendations, without enhanced monitoring, on muscle mass in people taking GLP1-RA medicines.
How it is given or performed	Participants wear a smartwatch device for the duration of the study and are monitored for both activity and changes in body composition. They continue with prescribed GLP1-RA therapy.	Participants receive standard written or verbal recommendations for exercise, with no additional device-based monitoring, while continuing GLP1-RA therapy.
Evidence status	The combined effect of smartwatch-monitored exercise and GLP1-RA therapy on muscle preservation is under investigation; results are not yet available. Literature suggests resistance exercise may help counterbalance muscle loss seen with weight loss drugs.	General exercise recommendations are standard of care. Studies suggest GLP1-RA therapies alone often reduce both fat and lean mass, so additional strategies may be needed to maintain muscle during weight loss.
Important limitations	The benefit of smartwatch-facilitated exercise monitoring for preserving muscle is not yet proven, especially when used with GLP1-RA therapy. Not all patients may have equal access or ability to use wearable technology.	General exercise advice may not offer sufficient support to preserve muscle mass during intentional weight loss with GLP1-RA medications. Implementation may vary across individuals, and some may struggle to maintain adequate activity.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 18Years - 99Years

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older at time of signing informed consent
Started treatment with incretin therapy (liraglutide, semaglutide, tirzepatide, or retatrutide) within the past 2 months or planning to start this treatment
Switching GLP1-RA therapies due to inadequate response to prior treatment are eligible
Able to provide informed consent

You will not qualify if you...

Current pregnancy or plans to become pregnant in the next 6 months
Body mass index (BMI) less than 25 kg/m2 at screening
Unable to participate in a regular physical exercise program
Implanted pacemaker
Any factors deemed by the principal investigator to interfere with safe study completion

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 6 months

Participants receive either a smartwatch to monitor activity and body composition with exercise goals and reminders or general guidance on recommended exercise while undergoing incretin therapy.

Regular visits during the 6 months of treatment