Lifestyle Change Implementation Research Network at PRC at UMass Chan (LCIRN)

University of Massachusetts, Worcester

Status: Begins enrollment this month

Conditions: GLP - 1

Treatments: Other: Digital Lifestyle Coaching Program

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07481305

U48DP006955 (U.S. NIH Grant/Contract)

STUDY00002809

Details and patient eligibility

About

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.

Full description

This study will examine how a digital lifestyle change program (Noom) may support adults who have recently started taking GLP-1 medications, which are commonly prescribed for weight loss and blood sugar control. The goal is to better understand how structured lifestyle guidance may improve physical activity, nutrition, and overall health while people are using these medications.

A total of 220 adults will participate in the study. Participants will be randomly assigned to one of two groups. One group will receive a four-month digital lifestyle coaching program designed to support healthy eating, physical activity, and strength-building habits. The other group will receive standard of care, a Fitbit device, resources for physical activity and nutrition, and the opportunity to participate in the lifestyle program at the completion of their 8-months in the study.

Participants will be assessed at the start of the study, after four months, and again at eight months. Throughout the study, the team will measure levels of physical activity using Fitbit devices. They will also evaluate overall diet quality using 24- hour dietary recalls of foods and beverages consumed. In addition, the team will examine other health and behavior measures, including intake of protein, fruits, and vegetables; participation in muscle-strengthening activities; confidence in maintaining healthy habits; muscle mass; body weight; waist circumference; and blood pressure.

In the 2nd Aim, the study team will evaluate implementation factors, such as how many participants were reached, how the program was implemented, engagement within the program, and how well how well the lifestyle coaching program can be delivered within real-world healthcare settings. Information will be gathered from patients, lifestyle change program leaders, healthcare providers, and healthcare systems. Data sources will include medical records, program records, and interviews.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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. Not currently taking GLP-1
2. Under 18 years of age
3. BMI <27 kg/m2
4. Began using GLP-1 more than 6 months ago
5. Does not speak or read English or Spanish
6. Not willing to follow study procedures, including digital LCI enrollment
7. Currently pregnant
8. Does not consent

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Digital Lifestyle Coaching Program

Experimental group

Description:

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.

Treatment:

Other: Digital Lifestyle Coaching Program

Standard Care

No Intervention group

Description:

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.