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

NCT ID: NCT06915090

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-18
• Study Completion Date: 2025-09-30

Brief 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.

Detailed Description

In Aim 1, after the patient has signed consent with the study coordinator, the coordinator will schedule the patient for their baseline in-person visit, and a flowsheet for the fitness tracker will be placed in the EHR by the study clinicians. During the baseline visit, the study team will assess height and weight, waist circumference assessment, and body composition. The 3-month follow-up visit will include the same measurements as listed above. Once baseline measures are completed, patients without a Fitbit device will be provided one for the duration of the study, which they get to keep. The same option will be available for patients who already have a Fitbit but would like one provided by the study team anyway. Patients will also install the Fitbit application and MyChart application (if needed) and sync the Fitbit with their patient portal with direction from the study team. Participants will also be instructed to wear their Fitbit for a total of 12 weeks. They will be provided a suggested step count to be accomplished from the health coach once they meet for the first session

Patients will have their first meeting scheduled with the health coach (up to 60-minutes in length, remotely). Patients will then meet with the health coach up to 5 more times (remotely) for up to 30-minutes per session over the course of the 12 weeks in the study. Health coaches will schedule meetings with the patients and communicate via Mychart. All sessions will be telehealth, conducted and recorded over Zoom. Patients will participate in the study for up to 12 weeks. Patients will receive support from the study team during the study period to troubleshoot any device related issue.

In Aim 2, patients and providers will provide verbal consent and be interviewed by the study research coordinator to assess workflow acceptability, perceptions, areas for workflow modification, preferences for initial training, preferences for frequency of review of remote monitoring data, and health coach interactions. The study team will interview patients during and at the completion of their 12 weeks to understand their perceptions on the program and supports needed, such as activity goals, feedback etc. Interviews will be 30-minutes in length, audio recorded only.

Conditions

GLP - 1; Diabetes; Obesity and Obesity-related Medical Conditions; Cardiovascular Diseases

Keywords

GLP-1; Diabetes; Obesity; Health Coach; Physical Activity; Body Composition

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

GLP-1/Coaching Arm

Patients enrolled in this arm will complete assessments at baseline and 3-months, and receive a 12-week health coaching intervention (up to 6 virtual sessions with health coach) in addition to a Fitbit wearable device.

Group Type: EXPERIMENTAL

Health Coach/Fitbit

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Jamie Faro

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UMass Chan Medical School

Worcester, Massachusetts, United States

Countries

United States

Other Identifiers

STUDY00002177

Identifier Type: -

Identifier Source: org_study_id