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

NCT06915090 | Completed

• 1 other identifier: STUDY00002177
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Feasibility of enrollment

  The number of enrolled patients in the study.

  6-months

Secondary Outcomes (9)

• Engagement with intervention

  3-months

• Average steps per day

  Baseline, 3-months

• Short-Form 12 Question Health-related Quality of Life

  Baseline, 3-months

• Numeric Pain Rating Scale (NPRS)

  Baseline, 3-months

• Muscle Strengthening Activities

  Baseline, 3-months

Study Arms (1)

GLP-1/Coaching Arm

EXPERIMENTAL

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

Interventions

Health Coach/Fitbit 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

GLP-1/Coaching Arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

UMass Chan Medical School

Worcester, Massachusetts, 01605, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Obesity; Cardiovascular Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 8, 2025
• Study Start: March 18, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1 year afte the study ends.
• Access Criteria: We will share de-identified data upon reasonable request.

Locations

US (1)