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

Phase 2

Recruiting

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

• Registration Number: NCT06915090
• Lead Sponsor: University of Massachusetts, Worcester

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. 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 for weight loss for a minimum of 3 months. 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

Aim 1 Procedures:

After the patient has signed consent with the study coordinator, the coordinator will schedule the patient for their baseline in-person visit. They will also let Co-PI Ayyaswami and Co-I Subramanian know via Epic the patient consented to the study. At this point, one of the two clinician investigators will order the Mychart Fitness Tracker flowsheet through the EHR.

During the baseline visit, the study team will conduct standard height and weight assessments. They will also conduct a waist circumference assessment, consisting of two measurements (taking the average of the two). There will be an optional body composition analysis will take place in the Weight Center (UMass Memorial main hospital). The assessment will be done on a seca mBCA 554. The analysis takes 1-2 minutes, and involves the patient standing on a scale/platform and holding onto the hand railings. The analysis will be conducted by a member a member of the study team, who will be trained in using the scale. The scale will then print out the results of the patients body composition (% lean body mass, % water, % body fat, including areas of distribution). This readout of data will be retained by the study team and entered into REDCap, along with scanned into the patients medical record. The paper copy will be destroyed once the data is entered into REDCap. At the conclusion of the visit, the patient will schedule their 3-month follow-up study visit. The 3-month follow-up visit will include the same measurements as listed above. Table 2 provides a broad overview of all data elements to be collected in Aim 1 and AIM 2 for both patients and providers. For specific quantitative data to be collected in REDCap for Aim 1.

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. The participant will receive their Fitbit device at their baseline study visit. 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 also install the Fitbit application and MyChart application as described above and sync the Fitbit with their phone. If patients do not want to use their own email address or do not already have a gmail account for the set up of the Fitbit, a gmail (email) account will be created by the study coordinator for the patient participant. Having the Fitbit synced to the phone and MyChart application, allows the participant to be able to view their own data.

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.

Aim 2 Procedures:

Patient and Provider interview protocol: 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 at least 10 patients 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.

Healthcare Administrator interview protocol: Healthcare administrators will provide verbal consent and be interviewed on their perceptions of the program and implementation at their site, including resources, infrastructure, and potential for sustainability. Interviews will be 30-minutes in length, audio recorded.

Study Timeline

• Study Start: 2025-03-18
• Study First Submitted: 2025-03-25
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-03
• Last Update Submitted: 2025-04-07
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-10
• Primary Completion: 2025-09-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• BMI ≥27-40
• Prescribed a GLP-1/GIP within the past 3 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 ≥40
• Not currently taking GLP-1/GIP
• Under 18 years of age
• Prescribed GLP-1/GIP for less than 3 months
• Not a patient of UMass Medical Group Primary Care Clinic
• Diagnosis of Type 2 diabetes
• Not taking GLP-1/GIC for a minimum of 3 months
• Does not speak English.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of enrollment	6-months	The number of enrolled patients in the study.

Secondary Outcome Measures

Name	Time	Method
Engagement with intervention	3-months	The proportion of scheduled visits the patient completes with the health coach over the 3-month study.
Average steps per day	Baseline, 3-months	The average steps per day over the course of 1-week.
Short-Form 12 Question Health-related Quality of Life	Baseline, 3-months	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.
Numeric Pain Rating Scale (NPRS)	Baseline, 3-months	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.
Short-form Dietary Recall	Baseline, 3-months	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.
Muscle Strengthening Activities	Baseline, 3-months	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.
Self-Report Physical Activity (IPAQ-SF)	Baseline, 3-months	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.
Exercise Self Efficacy	Baseline, 3-months	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.
Eating Self-Efficacy Brief Scale	Baseline, 3-months	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.

Trial Locations

Locations (1)

UMass Chan Medical School; 🇺🇸 Worcester, Massachusetts, United States