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 volunteersQualifiers
None
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
RISE-W Micro-Movement Program
BehavioralBrief, 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
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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.
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.
Change in fasting blood glucose
Change in fasting blood glucose (mg/dL) from a fasting venous sample. A decrease indicates reduced cardiometabolic risk.
Change in triglycerides
Change in triglycerides (mg/dL) from a fasting venous sample. A decrease indicates reduced cardiometabolic risk.
Sponsors and contacts
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