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

NCT06915090 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-12-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

Health Coach/Fitbit

Health coach visits (up to 6) will be conducted virtually and include: Session 1: * Assessment, wellness vision, * Habits and goals (Stretching, strength training, cardiovascular PA/walking, Diet) * Motivation, resources, and guidelines * Online program orientation * Set first week's goals Sessions 2-5: -Goal review, successes and challenges, new goal setting (i.e. Increase steps by 1,000/day if consistently meeting goal) Session 6 -Review of progress, maintenance plan, final assessment

Sponsors & Collaborators

  • University of Massachusetts, Worcester

    lead OTHER

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-18
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06915090 on ClinicalTrials.gov