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| Name | Class |
|---|---|
| Samsung | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smartwatch activity monitor | Experimental | 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. |
|
| Usual guidance | Active Comparator | Participants will receive general guidance on recommended exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartwatch activity and body composition monitor | Device | Participants will be provided a smartwatch to monitor their exercise and body composition |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lean mass (kg) | Dual-energy X-ray absorptiometry (DXA) body composition measure | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lean mass index (kg/m2) | Dual-energy X-ray absorptiometry (DXA) body composition measure | 6 months |
| Appendicular lean mass index (kg/m2) | Dual-energy X-ray absorptiometry (DXA) body composition measure |
| Measure | Description | Time Frame |
|---|---|---|
| Lumbar spine bone mineral density (g/cm2) | Dual energy Xray absorptiometry | 6 months |
| Total hip bone mineral density (g/cm2) | Dual energy Xray absorptiometry |
Inclusion Criteria
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
a. Potential participants switching GLP1-RA therapies due to inadequate response to a prior treatment will be eligible for enrollment
Able to provide informed consent
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ben O Brenner, BS | Contact | 617-726-1729 | bbrenner1@mgb.org |
| Name | Affiliation | Role |
|---|---|---|
| Melissa Putman, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes Research Center | Recruiting | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38687506 | Background | Locatelli JC, Costa JG, Haynes A, Naylor LH, Fegan PG, Yeap BB, Green DJ. Incretin-Based Weight Loss Pharmacotherapy: Can Resistance Exercise Optimize Changes in Body Composition? Diabetes Care. 2024 Oct 1;47(10):1718-1730. doi: 10.2337/dci23-0100. | |
| 16685058 | Background | Cesari M, Leeuwenburgh C, Lauretani F, Onder G, Bandinelli S, Maraldi C, Guralnik JM, Pahor M, Ferrucci L. Frailty syndrome and skeletal muscle: results from the Invecchiare in Chianti study. Am J Clin Nutr. 2006 May;83(5):1142-8. doi: 10.1093/ajcn/83.5.1142. |
| Label | URL |
|---|---|
| Recruitment website for this study | View source |
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Individual participant data will not be available to other researchers.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| General guidance on recommended exercise | Behavioral | Participants will receive general guidance on recommended exercise |
|
| 6 months |
| Fat mass index (kg/m2) | Dual-energy X-ray absorptiometry (DXA) body composition measure | 6 months |
| Fat mass (kg) | Dual-energy X-ray absorptiometry (DXA) body composition measure | 6 months |
| Visceral adipose tissue (kg) | Dual-energy X-ray absorptiometry (DXA) body composition measure | 6 months |
| Lean mass/fat mass ratio | Dual-energy X-ray absorptiometry (DXA) body composition measure | 6 months |
| Fat free mass | Bioimpedance analysis body composition measure | 6 months |
| Hand grip strength (kg) | Function strength measurement | 6 months |
| 1-minute sit-to-stand | Number of sit-to-stand repetitions in one minute | 6 months |
| 6-minute walk test | Distance walked in six minutes | 6 months |
| Short Physical Performance Battery frailty score (total points) | Physical functioning test consisting of standing balance, gait speed, and repeated chair stands | 6 months |
| Physical activity score | International Physical Activity Questionnaire (IPAQ) | 6 months |
| 6 months |
| Femoral neck bone mineral density (g/cm2) | Dual energy Xray absorptiometry | 6 months |
| Dimensional Anhedonia Scale (DARS) | 17 item Self-report scale that measures anhedonia, scores measured from 0-68 with higher scores signifying a better outcome. | 6 months |
| Patient Health Questionaire-8 (PHQ-8) | 8-item scale that measures depressive symptoms over the past two weeks | 6 months |
| Generalized Anxiety Disorder 7 item scale (GAD-7) | 7-item scale that measures anxiety symptoms over the past few days. Scores measured from 0-21 with higher scores signifying a worse outcome. | 6 months |
| Participant feedback survey | Survey with questions to understand participant experience with the study | 6 months |
| 26949037 | Background | Srikanthan P, Horwich TB, Tseng CH. Relation of Muscle Mass and Fat Mass to Cardiovascular Disease Mortality. Am J Cardiol. 2016 Apr 15;117(8):1355-60. doi: 10.1016/j.amjcard.2016.01.033. Epub 2016 Feb 2. |
| 27266673 | Background | Tyrovolas S, Haro JM, Mariolis A, Piscopo S, Valacchi G, Bountziouka V, Anastasiou F, Zeimbekis A, Tyrovola D, Foscolou A, Gotsis E, Metallinos G, Tur JA, Matalas A, Lionis C, Polychronopoulos E, Panagiotakos D. Skeletal muscle mass and body fat in relation to successful ageing of older adults: The multi-national MEDIS study. Arch Gerontol Geriatr. 2016 Sep-Oct;66:95-101. doi: 10.1016/j.archger.2016.04.017. Epub 2016 May 9. |
| Background | Tempia Valenta S, Nicastri A, Marcolini F, Petroni ML, Perazza F, Beghelli V, et al. The Impact of GLP-1 Receptor Agonists (GLP-1 RAs) on Mental Health: A Systematic Review. Current Treatment Options in Psychiatry. 2024 Sep 18;11(4):310-57. |
| 37366315 | Background | Jastreboff AM, Kaplan LM, Frias JP, Wu Q, Du Y, Gurbuz S, Coskun T, Haupt A, Milicevic Z, Hartman ML; Retatrutide Phase 2 Obesity Trial Investigators. Triple-Hormone-Receptor Agonist Retatrutide for Obesity - A Phase 2 Trial. N Engl J Med. 2023 Aug 10;389(6):514-526. doi: 10.1056/NEJMoa2301972. Epub 2023 Jun 26. |
| 37385275 | Background | Garvey WT, Frias JP, Jastreboff AM, le Roux CW, Sattar N, Aizenberg D, Mao H, Zhang S, Ahmad NN, Bunck MC, Benabbad I, Zhang XM; SURMOUNT-2 investigators. Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2023 Aug 19;402(10402):613-626. doi: 10.1016/S0140-6736(23)01200-X. Epub 2023 Jun 26. |
| 35658024 | Background | Jastreboff AM, Aronne LJ, Ahmad NN, Wharton S, Connery L, Alves B, Kiyosue A, Zhang S, Liu B, Bunck MC, Stefanski A; SURMOUNT-1 Investigators. Tirzepatide Once Weekly for the Treatment of Obesity. N Engl J Med. 2022 Jul 21;387(3):205-216. doi: 10.1056/NEJMoa2206038. Epub 2022 Jun 4. |
| 33567185 | Background | Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |