Lifestyle Change Implementation Research Network at PRC at UMass Chan
LCIRN
2 other identifiers
interventional
220
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2026
CompletedFirst Posted
Study publicly available on registry
March 18, 2026
CompletedStudy Start
First participant enrolled
July 22, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 29, 2029
July 28, 2026
July 1, 2026
2.8 years
March 13, 2026
July 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (13)
Physical Activity/Sedentary Time Metrics
Mean counts over 7-days at baseline, 4-, and 8-months.
Protein, Fruit, and Vegetable Intake
Baseline, 4-, and 8-months
Lean Body Mass
Baseline, 4-, and 8-months
Body Weight
Baseline, 4-, and 8-months
Blood Pressure
Baseline, 4-, and 8-months
- +8 more secondary outcomes
Study Arms (2)
Digital Lifestyle Coaching Program
EXPERIMENTALParticipants 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.
Standard Care
NO INTERVENTIONParticipants 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
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.
Eligibility Criteria
You may qualify if:
- 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)
- BMI ≥27 kg/m2
- Age 18 years of age and older
- Speaks and reads English or Spanish
- Willing to enroll in a digital lifestyle intervention for 4-months
- Willing to wear a Fitbit for 8 months
You may not qualify if:
- Was taking a GLP-1 within the 2 months prior to the current GLP-1 start date
- Currently participating in a structured lifestyle change program (receiving structured guidance and counseling on physical activity, diet or weight loss)
- Currently pregnant
- Planning to become pregnant in the next year
- Active diagnosis of an eating disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UMass Chan Medical School - Shaw Building
Worcester, Massachusetts, 01605, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jamie Faro, PhD
UMass Chan Medical School
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 13, 2026
First Posted
March 18, 2026
Study Start
July 22, 2026
Primary Completion (Estimated)
April 30, 2029
Study Completion (Estimated)
September 29, 2029
Last Updated
July 28, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- IPD and supporting information will become available at time of primary results publication.
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.