Smartwatch and Exercise for Obesity

(BICEP Trial)

Overseen By Ben O Brenner, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must be taking: GLP-1 RA

Disqualifiers: Pregnancy, BMI <25, Pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a smartwatch can help improve strength and muscle mass. The smartwatch tracks activity and body composition and sends exercise reminders. It targets individuals who have recently started or plan to start using certain medications (liraglutide, semaglutide, tirzepatide, or retatrutide, which are GLP1 agonists for weight management). Participants should have a BMI over 25 and must be able to engage in regular exercise. The trial compares those using the smartwatch with those receiving general exercise advice. As an unphased trial, this study offers participants the chance to explore innovative ways to enhance their fitness journey.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, it focuses on people who have recently started or are planning to start certain medications for obesity, so you may need to continue those.

What prior data suggests that this smartwatch and exercise protocol is safe for improving strength and muscle mass?

Research has shown that GLP-1 agonists, such as liraglutide, semaglutide, tirzepatide, and retatrutide, are generally well-tolerated and have been widely studied. These medications treat type 2 diabetes and aid in weight loss. The FDA has tested and approved them for these uses.

Some individuals may experience side effects, primarily stomach-related, such as nausea or diarrhea. In the U.S., about 16,568 users reported stomach-related issues, indicating that while side effects can occur, they are not very common.

In summary, GLP-1 agonists are considered safe for many people, but awareness of possible stomach-related side effects is important. Always consult a healthcare provider if concerns arise. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores using a smartwatch as a tool to boost physical activity and manage obesity. Unlike traditional methods that rely solely on general exercise advice, this approach leverages technology to provide personalized exercise goals and reminders, which can help increase motivation and adherence. The smartwatch not only tracks activity levels but also monitors body composition, offering real-time feedback that can lead to more effective weight management. This innovative use of technology aims to make exercise more engaging and accessible, potentially improving outcomes for individuals struggling with obesity.

What evidence suggests that this smartwatch and exercise protocol is effective for improving strength and muscle mass in people using GLP-1 RA medications?

Studies have shown that wearable activity trackers, such as smartwatches, can encourage increased activity and modest weight loss. Research indicates that these devices improve fitness and assist in weight management by accurately counting steps and tracking calories burned. These benefits are particularly useful for individuals aiming to enhance their fitness. In this trial, participants in the smartwatch activity monitor group will receive personalized reminders to stay motivated and have exercise goals set with the smartwatch. When paired with exercise goals, smartwatches may boost strength and muscle mass, especially for those using medications like liraglutide or semaglutide. ^{6 7 8 9 10}

Who Is on the Research Team?

Melissa Putman, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have recently started or are about to start GLP-1 RA medications for obesity. Participants should be able to exercise regularly and not have a pacemaker, pregnancy, or plans to become pregnant soon. They must also have a BMI of 25 kg/m2 or higher.

Inclusion Criteria

Able to provide informed consent

I am 18 years old or older.

I have recently started or am about to start incretin therapy.

Exclusion Criteria

Current pregnancy (positive urine hCG) or plans to become pregnant in the next 6 months

Unable to participate in a regular physical exercise program

Implanted pacemaker

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a smartwatch to monitor activity and body composition, with exercise goals and reminders

6 months

Regular monitoring via smartwatch

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GLP1 Agonist

Trial Overview The study tests if using a smartwatch that tracks activity and body composition, along with exercise reminders, can help improve muscle mass and strength in people taking GLP-1 RA medications like liraglutide or semaglutide.

How Is the Trial Designed?

Group I: Smartwatch activity monitor Experimental Treatment 2 Interventions

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.

Group II: Usual guidance Active Control 1 Intervention

Participants will receive general guidance on recommended exercise

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Samsung

Industry Sponsor

Trials

3

Recruited

970+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9034426/

The Effectiveness of Wearable Devices as Physical Activity ... Evidence from this meta-analysis shows that wearable devices as physical activity interventions may be useful for preventing and treating obesity in children ...

2. thelancet.com thelancet.com/journals/landig/article/PIIS2589-75002200111-X/fulltext

Effectiveness of wearable activity trackers to increase ... Wearable activity-tracker interventions are effective in increasing physical activity and supporting modest weight loss in a wide variety of clinical and non- ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1530891X23000460

Effectiveness of Wearable Activity Monitors on Metabolic ... Our results indicate that wearables significantly enhance effectiveness of CR by increasing physical activity, improving exercise capacity, and reducing ...

4. news.northwestern.edu news.northwestern.edu/stories/2025/06/more-accurate-fitness-trackers-for-people-with-obesity

More accurate fitness tracking for people with obesity Scientists at Northwestern University have developed a new algorithm that enables smartwatches to more accurately monitor the calories burned by ...

5. bmcsportsscimedrehabil.biomedcentral.com bmcsportsscimedrehabil.biomedcentral.com/articles/10.1186/s13102-021-00253-9

Exploring use of activity monitors for patients with obesity ... The results of this study suggest that using an activity monitor can either strengthen or undermine patients with obesity attempts to change ...

6. fda.gov fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss

FDA's Concerns with Unapproved GLP-1 Drugs Used for ... FDA has warned companies that have illegally sold unapproved drugs containing semaglutide, tirzepatide or retatrutide that are falsely labeled “for research ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39767190/

Gastrointestinal Safety Assessment of GLP-1 Receptor ... Results: From 2007 to 2023, a total of 187,757 AEs were reported with GLP-1 RAs, and 16,568 were GLP-1 RA-associated GI AEs in the US.

8. diabetesjournals.org diabetesjournals.org/care/article/47/11/1873/156807/Efficacy-and-Safety-of-GLP-1-Medicines-for-Type-2

Efficacy and Safety of GLP-1 Medicines for Type 2 Diabetes ... Tirzepatide produces substantial reductions in HbA1c reduction and weight loss in people with type 2 diabetes and obesity, consistent with the ...

9. jamanetwork.com jamanetwork.com/journals/jama-health-forum/fullarticle/2829222

Marketing and Safety Concerns for Compounded GLP-1 ... Safety concerns are emerging with both brand and compounded GLP-1 RAs, including adverse events related to inappropriate dosing or dosing errors ...

10. nejm.org nejm.org/doi/full/10.1056/NEJMoa2511774

Orforglipron, an Oral Small-Molecule GLP-1 Receptor ... We performed the ATTAIN-1 trial to evaluate the efficacy and safety of orforglipron at doses of 6 mg, 12 mg, and 36 mg in adults with obesity ...