Clinical trial NCT06915090: FIT-COACH: Fitbit Intervention With Coordinated Health Coaching and PCP Support
Official title: FIT-COACH: Fitbit Intervention With Coordinated Health Coaching and PCP Support
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: GLP - 1
Diabetes
Obesity and Obesity-related Medical Conditions
Cardiovascular Diseases
Keywords: GLP-1
Diabetes
Obesity
Health Coach
Physical Activity
Body Composition
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of enrollment
timeFrame: 6-months
Secondary outcomes:
measure: Engagement with intervention
timeFrame: 3-months
measure: Average steps per day
timeFrame: Baseline, 3-months
measure: Short-Form 12 Question Health-related Quality of Life
timeFrame: Baseline, 3-months
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Baseline, 3-months
measure: Muscle Strengthening Activities
timeFrame: Baseline, 3-months
measure: Short-form Dietary Recall
timeFrame: Baseline, 3-months
measure: Self-Report Physical Activity (IPAQ-SF)
timeFrame: Baseline, 3-months
measure: Exercise Self Efficacy
timeFrame: Baseline, 3-months
measure: Eating Self-Efficacy Brief Scale
timeFrame: Baseline, 3-months
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Chan Medical School
state: Massachusetts
Study officials:
References: