Lifestyle Change Implementation Research Network at PRC at UMass Chan
Study tests digital coaching with GLP-1 meds for weight management
Plain English Summary
Lifestyle Change Implementation Research Network at PRC at UMass Chan is a Not Applicable clinical trial sponsored by University of Massachusetts, Worcester studying GLP - 1. This study tests how well a digital lifestyle program called Noom works for adults taking GLP-1 medications. It is for adults who are 18 or older, have a BMI of 27 or higher, and have started taking a GLP-1 medication in the last 6 months. Participants will use the Noom app for 4 months, track their food and activity, and wear a Fitbit for 8 months. Alternatives include standard medical advice and other weight management programs not specifically integrated with GLP-1 medications. The trial aims to enroll 220 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 18 or older and have a BMI of 27 or higher. You must have started taking a GLP-1 medication within the last 6 months and plan to continue it. You need to be able to read and speak English or Spanish and be willing to use a digital program and wear a fitness tracker. You cannot join if you are under 18, have a BMI below 27, started GLP-1 more than 6 months ago, are pregnant, or are not willing to follow study instructions. This trial is studying GLP - 1, so participants generally need a confirmed diagnosis.
What They're Measuring
The study will measure changes in eating habits and physical activity over 8 months to see if the digital program helps people improve their health while on GLP-1 medication. The specific primary outcome measures are: Primary Outcomes (Baseline, 4-, and 8-months); Healthy Eating Index (Baseline, 4, and 8 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it explores how digital tools can support people using GLP-1 medications, addressing a growing need for effective weight management strategies. This research targets GLP - 1, where improved treatment options are needed.
Investor Insight
This trial signals a growing interest in combining digital health solutions with popular weight-loss medications, potentially expanding the market for digital health platforms in chronic disease manag
Is This Trial Right for Me?
Ask your doctor if this study is a good fit for you and what the potential benefits and risks are. You will use the Noom app daily to log meals and exercise, and wear a Fitbit to track your activity for the study duration. The study involves regular check-ins and data collection over 8 months, with a focused 4-month digital coaching program. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 220 participants
Interventions
- 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 De
Primary Outcomes
- Primary Outcomes (Baseline, 4-, and 8-months)
- Healthy Eating Index (Baseline, 4, and 8 months)
Secondary Outcomes
- 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)
Full Eligibility Criteria
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 Locations
- UMass Chan Medical School, Worcester, Massachusetts, United States
Frequently Asked Questions
What is clinical trial NCT07481305?
NCT07481305 is a Not Applicable INTERVENTIONAL study titled "Lifestyle Change Implementation Research Network at PRC at UMass Chan." It is currently not yet recruiting and is sponsored by University of Massachusetts, Worcester. The trial targets enrollment of 220 participants.
What conditions does NCT07481305 study?
This trial investigates treatments for GLP - 1. The primary condition under study is GLP - 1.
What treatments are being tested in NCT07481305?
The interventions being studied include: Digital Lifestyle Coaching Program (OTHER). 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 De
What does Not Applicable mean for NCT07481305?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07481305?
This trial is currently "Not Yet Recruiting." It started on 2026-04-15. The estimated completion date is 2029-09-29.
Who is sponsoring NCT07481305?
NCT07481305 is sponsored by University of Massachusetts, Worcester. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07481305?
The trial aims to enroll 220 participants. The trial has not yet started recruiting.
How is NCT07481305 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07481305?
The primary outcome measures are: Primary Outcomes (Baseline, 4-, and 8-months); Healthy Eating Index (Baseline, 4, and 8 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07481305 being conducted?
This trial is being conducted at 1 site, including Worcester, Massachusetts (United States).
Where can I find official information about NCT07481305?
The official record for NCT07481305 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07481305. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07481305 testing in simple terms?
This study tests how well a digital lifestyle program called Noom works for adults taking GLP-1 medications. It is for adults who are 18 or older, have a BMI of 27 or higher, and have started taking a GLP-1 medication in the last 6 months.
Why is this trial significant?
This trial is important because it explores how digital tools can support people using GLP-1 medications, addressing a growing need for effective weight management strategies.
What are the potential risks of participating in NCT07481305?
Potential side effects of GLP-1 medications can include nausea, vomiting, diarrhea, or constipation. Using a digital program and fitness tracker may lead to frustration or feeling overwhelmed for some participants. There's a risk that the digital program may not be effective for everyone, and individual results can vary. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07481305?
Ask your doctor if this study is a good fit for you and what the potential benefits and risks are. You will use the Noom app daily to log meals and exercise, and wear a Fitbit to track your activity for the study duration. The study involves regular check-ins and data collection over 8 months, with a focused 4-month digital coaching program. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07481305 signal from an investment perspective?
This trial signals a growing interest in combining digital health solutions with popular weight-loss medications, potentially expanding the market for digital health platforms in chronic disease manag This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will use the Noom app for 4 months, track their food and activity, and wear a Fitbit for 8 months. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More GLP - 1 Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.