Fitbit-Tracked Micromovement for Cardiometabolic Health in Rural Women (NCT07704749) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Fitbit-Tracked Micromovement for Cardiometabolic Health in Rural Women
United States125 participantsStarted 2026-09
Plain-language summary
This pilot study tests whether a low-burden prevention program can be integrated into routine care to identify and reduce cardiometabolic risk in rural women. Rural women face high rates of cardiometabolic syndrome, a cluster of conditions (elevated blood pressure, abdominal obesity, abnormal cholesterol, and high blood sugar) that raises the risk of heart disease and diabetes, yet often face barriers to prevention and screening.
The study enrolls physically inactive adult women with multiple cardiometabolic risk factors who receive care at a rural federally qualified health center. At a baseline visit, participants complete surveys and clinical assessments including inflammatory biomarkers (C-reactive protein and interleukin-6), metabolic labs, blood pressure, waist circumference, menopausal status, and social determinants of health. Participants then take part in a 12-week program of brief, frequent daily movement supported by a wearable activity tracker. Assessments are repeated at 12 weeks.
Because this is a single-group pilot, every participant receives the program and serves as her own comparison. The study evaluates whether the model is feasible to run within routine clinic workflows and examines preliminary changes in cardiometabolic and inflammatory risk indicators. Findings will inform larger studies of scalable prevention strategies for rural women.
Who can participate
Age range
18 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Female, aged 18 to 80 years Physically inactive, defined as less than 150 minutes of moderate-intensity physical activity per week (by self-report) Metabolic syndrome, defined as three or more cardiometabolic risk factors consistent with NCEP ATP III criteria, based on documented diagnosis or clinical history: waist circumference \>88 cm; blood pressure ≥130/85 mmHg; fasting blood glucose ≥100 mg/dL; triglycerides ≥150 mg/dL; HDL cholesterol \<50 mg/dL Access to a personal or household smartphone (Apple iOS 16.4 or higher, or Android OS 11.0 or higher) capable of installing the Fitbit application; no cellular data plan required Working email address Able to understand and provide written informed consent in English or Spanish Receiving care at one of the three Larry Combest Community Health \& Wellness Center sites
Exclusion Criteria:
Current pregnancy or planning to become pregnant during the study period Medical conditions that preclude safe participation in light-to-moderate physical activity (e.g., unstable cardiovascular disease, uncontrolled hypertension, severe musculoskeletal limitations), as determined by the PI through EHR review Participation in another structured lifestyle or cardiometabolic intervention study within the past 6 months (self-report) Use of medications or treatments that significantly alter inflammation or metabolism (e.g., systemic corticosteroids, recent chemotherapy), as determined by the PI through EHR review Inability to …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Study completion rate (feasibility)
Timeframe: Baseline through 12 weeks
2
Adherence to micro-movement intervention (feasibility)
Timeframe: Over the 12-week intervention period
Trial details
NCT IDNCT07704749
SponsorTexas Tech University Health Sciences Center