Recruiting

Noom with GLP-1

Sponsor:

University of Massachusetts, Worcester

Code:

NCT07481305

Conditions

GLP - 1

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Digital Lifestyle Coaching Program

Study Details

Brief summary:

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.

Conditions

GLP - 1

Study ID

NCT07481305

Start date

Jul 22, 2026

Status verified date

Jul, 2026

Completion date

Sep 29, 2029

Anticipated

Primary completion date

Apr 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Began using a GLP-1 within the past 6 months
2. Currently using GLP-1
3. Plans to continue GLP-1 use
4. GLP-1 prescribed by their physician (e.g., not online or 3rd party vendor)
5. BMI ≥27 kg/m2
6. Age 18 years of age and older
7. Speaks and reads English or Spanish
8. Willing to enroll in a digital lifestyle intervention for 4-months
9. Willing to wear a Fitbit for 8 months

Exclusion Criteria:

1. Was taking a GLP-1 within the 2 months prior to the current GLP-1 start date
2. Currently participating in a structured lifestyle change program (receiving structured guidance and counseling on physical activity, diet or weight loss)
3. Currently pregnant
4. Planning to become pregnant in the next year
5. Active diagnosis of an eating disorder

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Digital Lifestyle Coaching Program

Participants 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 Care

Participants 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.

Interventions

Digital Lifestyle Coaching Program

Participants 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.

Primary outcome measure

  • Primary Outcomes [ Time Frame: Baseline, 4-, and 8-months ]
  • Healthy Eating Index [ Time Frame: Baseline, 4, and 8 months ]

Central Contacts and Locations

Central contacts

Reem Y Najjar, BS

774-275-0890Reem.Najjar@umassmed.edu

Joann Wagner, MSW

508-856-6944joann.wagner@umassmed.edu

Locations

UMass Chan Medical School - Shaw Building

Recruiting

Worcester, Massachusetts, United States, 01605

Contacts

Jamie Faro, PhD

617-828-8093jamie.faro@umassmed.edu

More Information

Sponsor

University of Massachusetts, Worcester

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Keywords

  • GLP-1
  • Physical Activity
  • Nutrition
  • Lifestyle Behaviors
  • Weight
  • Diabetes
  • CVD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Massachusetts, Worcester on 2026-07-28.