Fitbit program with health coaching for weight management
FIT-COACH: Fitbit Intervention With Coordinated Health Coaching and PCP Support
PHASE2; PHASE3 · University of Massachusetts, Worcester · NCT06915090
This study is testing if a Fitbit program combined with health coaching can help people with overweight or obesity who are on GLP-1 medications improve their physical activity and overall health.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Massachusetts, Worcester (other) |
| Locations | 1 site (Worcester, Massachusetts) |
| Trial ID | NCT06915090 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance physical activity levels in individuals with overweight or obesity by integrating a Fitbit program into their clinical care, supported by health coaching and primary care provider (PCP) involvement. Patients who have been prescribed GLP-1 medications for at least three months will be referred by their PCPs to participate in a 12-week health coaching program. The program will include assessments of body composition and regular monitoring of physical activity data through the Fitbit device, with the goal of improving metabolic and cardiovascular health. The study will also involve interviews to gather insights on the program's effectiveness and patient experiences.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a BMI between 27 and 40 who are currently prescribed GLP-1 medications and are patients of UMass Medical Group.
Not a fit: Patients with a BMI below 27 or above 40, those not currently taking GLP-1 medications, or individuals with a diagnosis of Type 2 diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve physical activity levels and overall health outcomes for patients with obesity and related conditions.
How similar studies have performed: Other studies have shown success with similar interventions that combine technology and health coaching to improve physical activity and health outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Worcester, Massachusetts
- UMass Chan Medical School — Worcester, Massachusetts, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: GLP - 1, Diabetes, Obesity and Obesity-related Medical Conditions, Cardiovascular Diseases, GLP-1, Obesity, Health Coach, Physical Activity