Recruiting soon

LCIRNDigital Lifestyle Coaching Program for Adults on GLP-1 Medications

Study Aim

This study aims to evaluate the impact of a digital lifestyle coaching program on the diet quality and physical activity levels of adults using GLP-1 medications, measured by the Healthy Eating Index and minutes of moderate/vigorous physical activity per day.

What is being tested

Digital Lifestyle Coaching Program

Other

Who is being recruted

Behavior+8

+ Body Weight

+ Cardiovascular Diseases

Over 18 Years

+17 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Supportive Care Study

Interventional

Study Start: April 2026

See protocol details

Summary

Principal SponsorUniversity of Massachusetts, Worcester

Study ContactReem Y Najjar, BSMore contacts

Last updated: March 19, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: April 15, 2026

Actual date on which the first participant was enrolled.

This study focuses on adults who have recently begun using GLP-1 medications, often prescribed for weight loss and blood sugar management. The research aims to explore how a digital lifestyle change program, Noom, can enhance physical activity, nutrition, and overall health in these individuals. The ultimate goal is to understand how structured lifestyle guidance can complement these medications. The study targets a group of 220 adults, making it a significant effort to improve care for those using GLP-1 medications. Participants are randomly divided into two groups. One group will engage in a four-month digital lifestyle coaching program, promoting healthy eating, physical activity, and strength-building habits. The other group will receive standard care, including a Fitbit device, resources for physical activity and nutrition, and an opportunity to join the lifestyle program after their 8-month study period. The study measures physical activity levels using Fitbit devices, evaluates diet quality through 24-hour dietary recalls, and examines other health and behavior measures. These include protein, fruit, and vegetable intake, participation in muscle-strengthening activities, confidence in maintaining healthy habits, muscle mass, body weight, waist circumference, and blood pressure.

Official TitleLifestyle Change Implementation Research Network at PRC at UMass Chan

NCT07481305

Principal SponsorUniversity of Massachusetts, Worcester

Study ContactReem Y Najjar, BSMore contacts

Last updated: March 19, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

220 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorBody WeightCardiovascular DiseasesDiabetes MellitusEndocrine System DiseasesMetabolic DiseasesMotor ActivityNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism Disorders

Criteria

9 inclusion criteria required to participate

Began using a GLP-1 within the past 6 months

Currently using GLP-1

Plans to continue GLP-1 use

GLP-1 prescribed by their physician (e.g., not online or 3rd party vendor)

Show More Criteria

8 exclusion criteria prevent from participating

Not currently taking GLP-1

Under 18 years of age

BMI < 27 kg/m2

Began using GLP-1 more than 6 months ago

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants in this group will use the Noom app for 4 months to track diet and physical activity, receive coaching feedback, and access educational modules. The program includes behavior change specific to GLP-1, higher protein intake, common challenges with GLP-1 medications, and weight loss expectations. Participants will also have access to the Muscle Defense program for resistance training exercises to prevent muscle loss. A Fitbit and the same resources as the Standard of Care arm will be provided.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

UMass Chan Medical School

Worcester, United StatesOpen UMass Chan Medical School in Google Maps

Recruiting soonOne Study Center