GLP - 1LCIRNNCT07481305
Lifestyle Change Implementation Research Network at PRC at UMass Chan
A study testing Digital Lifestyle Coaching Program in people with GLP - 1, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GLP - 1
- What is being tested?
- Digital Lifestyle Coaching Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2026to 29 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
- Active diagnosis of Schizophrenia or bipolar disorder
Show all 9Show fewer
- Unable to walk without assistance/assistive device or have restricted walking
- Inability to understand the study and provide informed consent
- Any physical, cognitive, or psychiatric condition that poses a risk or interferes with their ability to participate at the discretion of the study PI (Co-Is: in consultation with PI or if acting as/standing in for PI)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UMass Chan Medical School - Shaw Building
Worcester, Massachusetts, 01605
Jamie Faro, PhD, 617-828-8093, jamie.faro@umassmed.edu
About this study
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.
Read the 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.
- Conditions
- GLP - 1
- Being tested
- Digital Lifestyle Coaching Program
- Keywords
- GLP-1, Physical Activity, Nutrition, Lifestyle Behaviors, Weight, Diabetes, CVD
- Medical subject headings
- Motor Activity, Body Weight, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Lifestyle Coaching ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Digital Lifestyle Coaching Program | Experimental | 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. Receives: Other: Digital Lifestyle Coaching Program |
| Standard Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline, 4, and 8 months
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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).
Measured: Baseline, 4-, and 8-months
Body Weight
Body weight will be assessed via a seca mBCA 554 bioelectrical impedance scale.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 4-months in Intervention group only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start22 Jul 2026
- Primary completion30 Apr 2029 (estimated)
- Study completion29 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GLP - 1Studies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Lowell, Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Jamie Faro, University of Massachusetts, Worcester
- Investigators
- Jamie Faro, PhD, Principal investigator, UMass Chan Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481305
- Sponsor's protocol ID
- STUDY00002809
- Other IDs
- U48DP006955
- Acronym
- LCIRN
- Status last verified
- Sep 2026
- First submitted
- 13 Mar 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Change Implementation Research Network at PRC at UMass Chan
- ClinicalTrials.gov ID
- NCT07481305
- Acronym / sponsor ID
- LCIRN / STUDY00002809
- Conditions
- GLP - 1
- Keywords
- GLP-1, Physical Activity, Nutrition, Lifestyle Behaviors, Weight, Diabetes, CVD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- University of Massachusetts, Lowell, Centers for Disease Control and Prevention
- Study start
- 22 Jul 2026 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 29 Sep 2029 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Lifestyle Coaching Program | Experimental | Other: Digital Lifestyle Coaching ProgramParticipants 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 intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Lifestyle Coaching ProgramParticipants 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. | Other | Digital Lifestyle Coaching Program |
Primary outcome
Primary Outcomes
Time frame: Baseline, 4-, and 8-months
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).
Healthy Eating Index
Time frame: Baseline, 4, and 8 months
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.
13 secondary outcomes
Physical Activity/Sedentary Time Metrics
Time frame: Mean counts over 7-days at baseline, 4-, and 8-months.
Protein, Fruit, and Vegetable Intake
Time frame: Baseline, 4-, and 8-months
Lean Body Mass
Time frame: Baseline, 4-, and 8-months
Body Weight
Time frame: Baseline, 4-, and 8-months
Blood Pressure
Time frame: Baseline, 4-, and 8-months
Body Mass Index (BMI)
Time frame: Baseline, 4-, and 8-months
Muscle Strengthening Activities
Time frame: Baseline, 4-, and 8-months
Physical Activity Self-Efficacy
Time frame: Baseline, 4-, and 8-months
Physical Activity Motivation
Time frame: Baseline, 4-, and 8-months
Healthy Eating Self-Efficacy
Time frame: Baseline, 4-, and 8-months
Healthy Eating Motivation
Time frame: Baseline, 4-, and 8-months
Global Physical Health
Time frame: Baseline, 4-, and 8-months
Intervention Acceptability
Time frame: 4-months in Intervention group only
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jamie Faro, PhD principal investigator
UMass Chan Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Lifestyle Coaching Program in people with GLP - 1, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reem Y Najjar, BS (774-275-0890, Reem.Najjar@umassmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcomes (time frame: Baseline, 4-, and 8-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.