Lifestyle Change Implementation Research Network at PRC at UMass Chan
Part of paid clinical trials in Worcester, Massachusetts.
- Sponsor
- University of Massachusetts, Worcester
- Study ID
- NCT07481305
- Status
- Not Yet Recruiting
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Conditions
- GLP - 1
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Digital Lifestyle Coaching Program — OTHERParticipants will be enrolled for a 4-month program, in which they will use the Noom app to self-monitor their dietary intake/physical activity, be provided with coaching feedback throughout, and access educational module. Modules include behavior change specific to GLP-1, i.e. higher protein intake than what is prescribed in Noom Weight, Common challenges while taking GLP-1 medications, and weight loss medications and what to expect while taking them. They will also have access to the Muscle Defense program, which provides education on resistance training exercises to prevent muscle loss.
Study Details
The goal of this project is to study how well the Noom digital lifestyle program works for adults who are taking Glucagon-Like Peptide-1 receptor agonist (GLP-1) medications. The study team will assess how the program affects people's behaviors and health outcomes. The team will also look at how digital lifestyle change interventions can be implemented in real-world settings, including how many people it reaches, how well it is put into practice, whether people stick with it over time, and whether it works well for different groups of people.
Key Dates
- Start date
- Apr 15, 2026
- Status verified
- Mar 2026
- Primary completion
- Apr 30, 2029
- Completion
- Sep 29, 2029
Study Design
- Enrollment
- 220 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Digital Lifestyle Coaching ProgramParticipants randomized to the digital LCI arm will participate in a 4-month digital lifestyle intervention consisting of content modules about physical activity, nutrition, and GLP-1 support, nutrition and physical activity tracking, goal-setting, access to a health coach. They will receive a Fitbit and the same resources as the Standard of Care arm.
- No Intervention: Standard CareParticipants in the standard of care arm will receive physical activity and nutrition resources, including those endorsed by the CDC and local resources within UMass Memorial Health and the surrounding communities, as well as Fitbit device. Upon completion of the 8-month study measures, participants will have the opportunity to participate in the 4-month digital LCI program, free of cost.
Primary Outcome Measure
Primary Outcomes [ Time Frame: Baseline, 4-, and 8-months ]
Central Contacts
- Reem Y Najjar, BS774-275-0890
- Joann Wagner, MSW508-856-6944
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UMass Chan Medical School | Worcester | Massachusetts | 01655 | - |
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