About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years old 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
Able to provide informed consent
Disqualifiers
Current pregnancy (positive urine hCG) or plans to become pregnant in the next 6 months
BMI <25 kg/m2 at the time of screening
Unable to participate in a regular physical exercise program
Implanted pacemaker
Trial design
Parallel
Treatments tested in this trial
Smartwatch activity and body composition monitor
DeviceParticipants will be provided a smartwatch to monitor their exercise and body composition
General guidance on recommended exercise
BehavioralParticipants will receive general guidance on recommended exercise
Treatment groups
Trial outcomes
Primary outcomes
Lean mass (kg)
Dual-energy X-ray absorptiometry (DXA) body composition measure
Secondary outcomes
Lean mass index (kg/m2)
Dual-energy X-ray absorptiometry (DXA) body composition measure
Appendicular lean mass index (kg/m2)
Dual-energy X-ray absorptiometry (DXA) body composition measure
Fat mass index (kg/m2)
Dual-energy X-ray absorptiometry (DXA) body composition measure
Fat mass (kg)
Dual-energy X-ray absorptiometry (DXA) body composition measure
Other outcomes
Lumbar spine bone mineral density (g/cm2)
Dual energy Xray absorptiometry
Total hip bone mineral density (g/cm2)
Dual energy Xray absorptiometry
Femoral neck bone mineral density (g/cm2)
Dual energy Xray absorptiometry
Dimensional Anhedonia Scale (DARS)
17 item Self-report scale that measures anhedonia, scores measured from 0-68 with higher scores signifying a better outcome.
Sponsors and contacts
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Massachusetts General Hospital
Lead sponsor
Samsung
Collaborator