Fitbit-Tracked Micromovement for Cardiometabolic Health in Rural Women

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorTexas Tech University Health Sciences Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • RISE-W Micro-Movement Program

    Behavioral

    Brief, frequent bouts of light-to-moderate movement performed each waking hour (target ≥10 hours/day) over 12 weeks, supported by a Fitbit Inspire 3 activity tracker that delivers automated hourly movement reminders and enables self-monitoring.

Treatment groups

125 Participants
are divided into 1 treatment group
Group A: RISE-W InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Study completion rate (feasibility)

Proportion of enrolled participants who complete both baseline and 12-week follow-up assessments. Reported as a percentage; higher indicates greater feasibility.

Time frame
Baseline through 12 weeks
2

Adherence to micro-movement intervention (feasibility)

Adherence measured by the wearable activity tracker as the percentage of hourly movement goals met across the intervention period. Reported as a percentage; higher indicates greater adherence.

Time frame
Over the 12-week intervention period

Secondary outcomes

1

Change in waist circumference

Change in waist circumference measured in centimeters using a non-stretch tape per standardized protocol. A decrease indicates reduced cardiometabolic risk.

Time frame
Baseline and 12 weeks
2

Change in blood pressure

Change in systolic and diastolic blood pressure (mmHg), measured after 5-minute seated rest as the average of two readings. A decrease indicates reduced cardiometabolic risk.

Time frame
Baseline and 12 weeks
3

Change in fasting blood glucose

Change in fasting blood glucose (mg/dL) from a fasting venous sample. A decrease indicates reduced cardiometabolic risk.

Time frame
Baseline and 12 weeks
4

Change in triglycerides

Change in triglycerides (mg/dL) from a fasting venous sample. A decrease indicates reduced cardiometabolic risk.

Time frame
Baseline and 12 weeks

Other outcomes

Sponsors and contacts

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