An interventional study of Digital Lifestyle Coaching Program in GLP - 1, sponsored by University of Massachusetts, Worcester. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by University of Massachusetts, Worcester · Not applicable, Interventional, and Supportive care
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.
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.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
This study's planned enrollment of 220 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →University of Massachusetts, Worcester is the lead sponsor of 291 studies on the registry; 51 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
Compared within Motor Activity, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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.
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.
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).
Time frame: 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.
Time frame: Baseline, 4, and 8 months
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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline, 4-, and 8-months
Body Weight
Body weight will be assessed via a seca mBCA 554 bioelectrical impedance scale.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 4-months in Intervention group only
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: IPD and supporting information will become available at time of primary results publication.
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Apr 2029, 33 months after the start.
Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 33 months is above that.
Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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