NCT06915090Completed
FIT-COACH: Fitbit Intervention With Coordinated Health Coaching and PCP Support
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 25 Mar 2025
- Start date
- 18 Mar 2025
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- University of Massachusetts, Worcester
- Diseases
- Obesity
- NCT number
- NCT06915090
What you commit to
- Study type: Interventional
- Participants enrolled: 15
- From 18 Mar 2025 to the primary completion date, 30 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Not currently taking GLP-1/GIP
Age
- Under 18 years of age
Other
- BMI \<27 or ≥45
- Prescribed GLP-1/GIP for less than 6 months
- Not a patient of UMass Medical Group Primary Care Clinic
- Does not speak English
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UMass Chan Medical School Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.