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Recruiting

NCT Number: NCT07481305

Lifestyle Change Implementation Research Network at PRC at UMass Chan

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.

Recruiting

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Key information

Conditions

GLP - 1 Behavior Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMass Chan Medical School - Shaw Building

Worcester, Massachusetts, 01605, United States

Location status: Recruiting

Location contact

Jamie Faro, PhD

CONTACT

[email protected]

617-828-8093

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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 Defense program, which provides education on resistance training exercises to prevent muscle loss.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. Physical Activity/Sedentary Time Metrics

    Time frame: Mean counts over 7-days at baseline, 4-, and 8-months.

    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.

  2. Protein, Fruit, and Vegetable Intake

    Time frame: Baseline, 4-, and 8-months

    Proportion of daily intake values for each category will be assessed using two 24-hour dietary recalls.

  3. Lean Body Mass

    Time frame: Baseline, 4-, and 8-months

    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).

  4. Body Weight

    Time frame: Baseline, 4-, and 8-months

    Body weight will be assessed via a seca mBCA 554 bioelectrical impedance scale.

  5. Blood Pressure

    Time frame: Baseline, 4-, and 8-months

    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.

  6. Body Mass Index (BMI)

    Time frame: Baseline, 4-, and 8-months

    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

  7. Muscle Strengthening Activities

    Time frame: Baseline, 4-, and 8-months

    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

  8. Physical Activity Self-Efficacy

    Time frame: Baseline, 4-, and 8-months

    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

  9. Physical Activity Motivation

    Time frame: Baseline, 4-, and 8-months

    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.

  10. Healthy Eating Self-Efficacy

    Time frame: Baseline, 4-, and 8-months

    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

  11. Healthy Eating Motivation

    Time frame: Baseline, 4-, and 8-months

    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

  12. Global Physical Health

    Time frame: Baseline, 4-, and 8-months

    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

  13. Intervention Acceptability

    Time frame: 4-months in Intervention group only

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Joann Wagner, MSW

CONTACT

[email protected]

508-856-6944

Reem Y Najjar, BS

CONTACT

[email protected]

774-275-0890

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Centers for Disease Control and Prevention
  • University of Massachusetts, Lowell

Registry information

Acronym: LCIRN

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 18, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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