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

BIA Monitoring and Exercise for the Prevention of Muscle Loss With Incretin Therapy (BICEP Study)

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Body Composition
• Intervention / Treatment: Device: Smartwatch activity and body composition monitor; Behavioral: General guidance on recommended exercise

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ben O Brenner, BS; Phone Number: 617-726-1729; Email: bbrenner1@mgb.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Diabetes Research Center
      • Contact: Ben O Brenner, BS; Phone Number: 617-726-1729; Email: bbrenner1@mgb.org
      • Contact: Grace Kuropatkin, BS; Phone Number: 617-726-6537; Email: gkuropatkin@mgh.harvard.edu
      • Principal Investigator: Melissa S Putman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smartwatch activity monitor; 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.	Device: Smartwatch activity and body composition monitor; Participants will be provided a smartwatch to monitor their exercise and body composition; Behavioral: General guidance on recommended exercise; Participants will receive general guidance on recommended exercise
Active Comparator: Usual guidance; Participants will receive general guidance on recommended exercise	Behavioral: General guidance on recommended exercise; Participants will receive general guidance on recommended exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lean mass (kg)	Dual-energy X-ray absorptiometry (DXA) body composition measure	6 months

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome 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	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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Samsung
• Investigators: Principal Investigator: Melissa Putman, MD, Massachusetts General Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Recruitment website for this study

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: November 6, 2025
• First Submitted That Met QC Criteria: November 10, 2025
• First Posted (Estimated): November 12, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: 2025P001490

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No