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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: GLP - 1
• Intervention / Treatment: Other: Digital Lifestyle Coaching Program

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Reem Y Najjar, BS; Phone Number: 774-275-0890; Email: Reem.Najjar@umassmed.edu
• Study Contact Backup: Name: Joann Wagner, MSW; Phone Number: 508-856-6944; Email: joann.wagner@umassmed.edu

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • UMass Chan Medical School

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcomes	Minutes of moderate/vigorous PA per day (over 7 days) assessed via Fitbits on days the participant has sufficient wear time, defined as >10 hours of heart rate data (accumulated of 60-second bouts).	Baseline, 4-, and 8-months
Healthy Eating Index	Healthy Eating Index will be assessed via two 24-hour dietary recalls at each timepoint. The Healthy Eating Index is scored on a scale 0-100, with higher scores indicating better diet quality and alignment with the Dietary Guidelines for Americans.	Baseline, 4, and 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity/Sedentary Time Metrics	Objective metrics of mean step counts (steps/day), light physical activity (minutes/day), sedentary time (hours/day) over 7 days assessed via Fitbit Inspire using Fitbit algorithms and obtained through Fitabase.	Mean counts over 7-days at baseline, 4-, and 8-months.
Protein, Fruit, and Vegetable Intake	Proportion of daily intake values for each category will be assessed using two 24-hour dietary recalls.	Baseline, 4-, and 8-months
Lean Body Mass	Lean body mass will be assessed using a seca mBCA 554 bioelectrical impedance scale. The scale will obtain the results of the patient's body composition (% muscle mass, % water, % body fat, including areas of distribution).	Baseline, 4-, and 8-months
Body Weight	Body weight will be assessed via a seca mBCA 554 bioelectrical impedance scale.	Baseline, 4-, and 8-months
Blood Pressure	Three blood pressure readings will be taken 2 minutes apart after 5 minutes of rest using an automatic oscillometric device, Omron HEM-907. The average of the three readings will be recorded.	Baseline, 4-, and 8-months
Body Mass Index (BMI)	Obtained via two height measurements using a stadiometer and one weight measurement using a Seca scale, using the standard equation (Weight (lbs) x 703) / height (in)2	Baseline, 4-, and 8-months
Muscle Strengthening Activities	Assessed via self-report using the Muscle Strengthening Exercise Questionnaire Short Form, a scale assessing key dimensions of muscle-strengthening exercise, including frequency, session duration, intensity, exercise type, and muscle groups targeted	Baseline, 4-, and 8-months
Physical Activity Self-Efficacy	A self-report assessment using the Self-efficacy for Physical Activity Scale, a 5-question scale assessing how confident a person is that they could be physically active in certain situations	Baseline, 4-, and 8-months
Physical Activity Motivation	A self-report assessment using the 1 question Readiness to Change for Physical Activity, which assess a person's current physical activity habits and readiness to change.	Baseline, 4-, and 8-months
Healthy Eating Self-Efficacy	A self-report assessment using the Eating and Weight Self-efficacy Scale, a 7-question scale assessing a person's confidence to eat healthy in certain situations	Baseline, 4-, and 8-months
Healthy Eating Motivation	A self-report assessment using the 1 question Readiness to Change for Healthy Eating, which assess a person's current eating habits and readiness to change	Baseline, 4-, and 8-months
Global Physical Health	Physical health will be assessed using the PROMIS Global Physical Health, consisting of 4 questions asking about overall health, physical function, pain, and fatigue using Likert scale responses	Baseline, 4-, and 8-months
Intervention Acceptability	The Theoretical Framework of Acceptability (TFA) is an 8-item questionnaire that can be adapted to an intervention to assess the acceptability of healthcare interventions using a Likert scale of 1 to 5 (higher scores indicating greater acceptability).	4-months in Intervention group only

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: Centers for Disease Control and Prevention; University of Massachusetts, Lowell
• Investigators: Principal Investigator: Jamie Faro, PhD, UMass Chan Medical School

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): September 29, 2029

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: GLP-1; Physical Activity; Nutrition; Lifestyle Behaviors; Weight; Diabetes; CVD
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Cardiovascular Diseases; Body Weight; Diabetes Mellitus; Motor Activity
• Other Study ID Numbers: STUDY00002809; U48DP006955 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Participant survey data and participant physiologic data will be shared. This includes a complete, de-identified data set, including survey and clinical/physiologic data (and relevant R or SAS code) through DKnet, the Inter-University Consortium for Political and Social Research, or eScholarship@UMassChan.
• IPD Sharing Time Frame: IPD and supporting information will become available at time of primary results publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

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