COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-18
Study Completion:2025-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06915090

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * BMI ≥27-45
  2. * Prescribed a GLP-1/GIP within the past 6 months
  3. * Currently taking GLP/GIP
  4. * Age 18 years of age and older
  5. * Patient of UMass Medical Group Primary Care Clinic
  6. * Speaks and reads English
  1. * BMI \<27 or ≥45
  2. * Not currently taking GLP-1/GIP
  3. * Under 18 years of age
  4. * Prescribed GLP-1/GIP for less than 6 months
  5. * Not a patient of UMass Medical Group Primary Care Clinic
  6. * Does not speak English

Contacts and Locations

Study Locations (Sites)

UMass Chan Medical School
Worcester, Massachusetts, 01605
United States

Collaborators and Investigators

Sponsor: University of Massachusetts, Worcester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-18
Study Completion Date2025-09-30

Study Record Updates

Study Start Date2025-03-18
Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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