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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Diabetes; GLP - 1; Obesity and Obesity-related Medical Conditions
• Intervention / Treatment: Behavioral: Health Coach/Fitbit

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • Umass Chan Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of enrollment	The number of enrolled patients in the study.	6-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement with intervention	The proportion of scheduled visits the patient completes with the health coach over the 3-month study.	3-months
Average steps per day	The average steps per day over the course of 1-week.	Baseline, 3-months
Short-Form 12 Question Health-related Quality of Life	12-item self-report survey assessing quality of life. Scores range from 0-100 with a higher score indicating more positive health-related quality of life.	Baseline, 3-months
Numeric Pain Rating Scale (NPRS)	6-questions regarding pain in body parts and doing activities of daily living using a Likert Scale from 0 to 10. Scores range from 0 (minimum) to 50 (maximum) with higher scores indicating greater levels of pain.	Baseline, 3-months
Muscle Strengthening Activities	The Muscle-Strengthening Exercise Questionnaire (MSEQ) is a 4-item questionnaire assessing the weekly frequency, session duration and intensity, types of MSE (e.g., weight machines, bodyweight exercise) and muscle groups targeted. Scores range from 0 (minimum) to 7 (maximum), with higher scores indicating higher frequency of muscle strengthening activities.	Baseline, 3-months
Short-form Dietary Recall	A short-form 15-item Food Frequency Questionnaire (FFQ) is a dietary assessment tool designed to estimate an individual's usual intake of specific food groups over a given period. The scores range from 15 (minimum) to 75 (maximum), with higher scores indicating consumption of a healthier diet.	Baseline, 3-months
Self-Report Physical Activity (IPAQ-SF)	The Physical Activity Questionnaire - Short Form (PAQ-SF) is a brief, self-reported questionnaire designed to assess an individual's physical activity levels over a specified period, typically the past 7 days. It is a condensed version of longer physical activity questionnaires, making it practical for use in research, clinical settings, and population health surveys. The minimum score is 0 (no minutes per week), and there is no maximum. Higher scores indicate higher levels of physical activity.	Baseline, 3-months
Exercise Self Efficacy	A 24-item tool assessing barriers that get in the way of physical activity on a Likert scale of 1 to 5. The scores range from 24 (minimum) to 168 (maximum) with a higher score indicating greater exercise self-efficacy.	Baseline, 3-months
Eating Self-Efficacy Brief Scale	Designed to assess an individual's confidence in their ability to control eating behaviors across different situations. It is rooted in self-efficacy theory, which emphasizes the role of belief in one's capability to perform specific behaviors. Consists of 7 items using a Likert scale of 1 to 5 for responses. The total score range is 10 (minimum) to 70 (maximum), with a higher score indicating greater eating self-efficacy.	Baseline, 3-months

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2025
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: March 25, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Diabetes; Physical Activity; Obesity; GLP-1; Body Composition; Health Coach
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Overweight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Cardiovascular Diseases; Diabetes Mellitus; Motor Activity
• Other Study ID Numbers: STUDY00002177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share de-identified data upon reasonable request.
• IPD Sharing Time Frame: 1 year afte the study ends.
• IPD Sharing Access Criteria: We will share de-identified data upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No