FIT-COACH: Fitbit Intervention With Coordinated Health Coaching and PCP Support

Completed · Not applicable

Conditions studied: GLP - 1, Diabetes, Obesity and Obesity-related Medical Conditions, Cardiovascular Diseases

In brief

In individuals with overweight/obesity, increases in physical activity (PA) can improve metabolic and cardiovascular health, independent of weight loss. However, PA levels are often low in individuals with overweight/obesity, and primary care providers (PCPs) are tasked with addressing this issue. The investigative team developed and successfully piloted integrating a Fitbit program into clinical care, where patients were referred by PCPs, and PCPs could view PA data in the Epic electronic health record. Though feasible, PCPs wanted additional support for PA management. We also acknowledge the role of pharmacotherapy (GLP-1 agonists and GIPs) in clinical care for patients with overweighr and obesity, and the added support these patients may need. The investigative team proposes a reimbursable service of a health coach to work collaboratively with PCPs, to deliver a Fitbit-supported PA program to patients with overweight/obesity who have been prescribed a weight loss medication. In Aim 1, the team will enroll PCPs to refer patients to a 12-week health coaching program. In Aim 2, the team will conduct interviews with enrolled patients/PCPs to understand their perspectives on the program, and with new sites to establish relationships for a future R01 submission.

Key facts

Study ID

NCT06915090

Run by

University of Massachusetts, Worcester

People needed

15

Starts

2025-03-18

Expected to finish

2025-09-30

Last updated by the study team

2025-12-18

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• BMI ≥27-45
• Prescribed a GLP-1/GIP within the past 6 months
• Currently taking GLP/GIP
• Age 18 years of age and older
• Patient of UMass Medical Group Primary Care Clinic
• Speaks and reads English

You may not qualify if…

• BMI <27 or ≥45
• Not currently taking GLP-1/GIP
• Under 18 years of age
• Prescribed GLP-1/GIP for less than 6 months
• Not a patient of UMass Medical Group Primary Care Clinic
• Does not speak English

Where it is running

• UMass Chan Medical School — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

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