Lifestyle change program with GLP-1 medication users

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study enrolls adults who recently started GLP-1 medications and have a BMI of 27 or higher. Participants are randomized to receive a four-month digital lifestyle coaching program or standard care with a Fitbit and lifestyle resources, followed for eight months. Outcomes include physical activity, diet quality, weight, waist circumference, blood pressure, muscle mass, and confidence in maintaining healthy habits, measured at baseline, four months, and eight months. The study also examines real-world implementation aspects such as reach, adoption, and sustainability of the digital intervention. Recruitment is led by the University of Massachusetts and involves collaboration with UMass Lowell and the CDC, with sites in Worcester, MA.

Why it matters

Who can join: the full rules

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. Was taking a GLP-1 within the 2 months prior to the current GLP-1 start date
2. Currently participating in a structured lifestyle change program (receiving structured guidance and counseling on physical activity, diet or weight loss)
3. Currently pregnant
4. Planning to become pregnant in the next year
5. Active diagnosis of an eating disorder
6. Active diagnosis of Schizophrenia or bipolar disorder
7. Unable to walk without assistance/assistive device or have restricted walking
8. Inability to understand the study and provide informed consent
9. 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)

Where it's running

• UMass Chan Medical School - Shaw Building
  Worcester, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Jamie Faro, PhD — UMass Chan Medical School
• Study coordinator: Reem Y Najjar, BS
• Email: Reem.Najjar@umassmed.edu
• Phone: 774-275-0890

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.