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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorMassachusetts General Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Smartwatch activity and body composition monitor

    Device

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

  • General guidance on recommended exercise

    Behavioral

    Participants will receive general guidance on recommended exercise

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Smartwatch activity monitorExperimental treatment 2 interventions
Group B: Usual guidanceActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Lean mass (kg)

Dual-energy X-ray absorptiometry (DXA) body composition measure

Time frame
6 months

Secondary outcomes

1

Lean mass index (kg/m2)

Dual-energy X-ray absorptiometry (DXA) body composition measure

Time frame
6 months
2

Appendicular lean mass index (kg/m2)

Dual-energy X-ray absorptiometry (DXA) body composition measure

Time frame
6 months
3

Fat mass index (kg/m2)

Dual-energy X-ray absorptiometry (DXA) body composition measure

Time frame
6 months
4

Fat mass (kg)

Dual-energy X-ray absorptiometry (DXA) body composition measure

Time frame
6 months

Other outcomes

1

Lumbar spine bone mineral density (g/cm2)

Dual energy Xray absorptiometry

Time frame
6 months
2

Total hip bone mineral density (g/cm2)

Dual energy Xray absorptiometry

Time frame
6 months
3

Femoral neck bone mineral density (g/cm2)

Dual energy Xray absorptiometry

Time frame
6 months
4

Dimensional Anhedonia Scale (DARS)

17 item Self-report scale that measures anhedonia, scores measured from 0-68 with higher scores signifying a better outcome.

Time frame
6 months

Sponsors and contacts

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