Body Composition, Obesity
Conditions
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.
Interventions
DEVICESmartwatch activity and body composition monitor
Participants will be provided a smartwatch to monitor their exercise and body composition
BEHAVIORALGeneral guidance on recommended exercise
Participants will receive general guidance on recommended exercise
Sponsors
Samsung
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lean mass (kg) | 6 months | Dual-energy X-ray absorptiometry (DXA) body composition measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fat mass (kg) | 6 months | Dual-energy X-ray absorptiometry (DXA) body composition measure |
| Lean mass/fat mass ratio | 6 months | Dual-energy X-ray absorptiometry (DXA) body composition measure |
| Fat free mass | 6 months | Bioimpedance analysis body composition measure |
| Hand grip strength (kg) | 6 months | Function strength measurement |
| 1-minute sit-to-stand | 6 months | Number of sit-to-stand repetitions in one minute |
| 6-minute walk test | 6 months | Distance walked in six minutes |
| Short Physical Performance Battery frailty score (total points) | 6 months | Physical functioning test consisting of standing balance, gait speed, and repeated chair stands |
| Physical activity score | 6 months | International Physical Activity Questionnaire (IPAQ) |
| Lean mass index (kg/m2) | 6 months | Dual-energy X-ray absorptiometry (DXA) body composition measure |
| Appendicular lean mass index (kg/m2) | 6 months | Dual-energy X-ray absorptiometry (DXA) body composition measure |
| Fat mass index (kg/m2) | 6 months | Dual-energy X-ray absorptiometry (DXA) body composition measure |
| Visceral adipose tissue (kg) | 6 months | Dual-energy X-ray absorptiometry (DXA) body composition measure |
Other
| Measure | Time frame | Description |
|---|---|---|
| Femoral neck bone mineral density (g/cm2) | 6 months | Dual energy Xray absorptiometry |
| Dimensional Anhedonia Scale (DARS) | 6 months | 17 item Self-report scale that measures anhedonia, scores measured from 0-68 with higher scores signifying a better outcome. |
| Patient Health Questionaire-8 (PHQ-8) | 6 months | 8-item scale that measures depressive symptoms over the past two weeks |
| Generalized Anxiety Disorder 7 item scale (GAD-7) | 6 months | 7-item scale that measures anxiety symptoms over the past few days. Scores measured from 0-21 with higher scores signifying a worse outcome. |
| Participant feedback survey | 6 months | Survey with questions to understand participant experience with the study |
| Total hip bone mineral density (g/cm2) | 6 months | Dual energy Xray absorptiometry |
| Lumbar spine bone mineral density (g/cm2) | 6 months | Dual energy Xray absorptiometry |
Countries
United States
Contacts
Primary ContactBen O Brenner, BS
Outcome results
None listed