Rural Initiative for Inflammatory Screening & Engagement for Women
| Registry | NCT07704749, acronym RISE-W |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, prevention |
| Enrollment | 125 (Estimated) |
| Sponsor | Texas Tech University Health Sciences Center (Other) |
| Conditions | Cardiometabolic Risk Factors |
| Interventions | RISE-W Micro-Movement Program (Behavioral) |
| Dates | start 2026-09-01 (estimated), primary completion 2027-02-01 (estimated), completion 2027-05-01 (estimated), first posted 2026-07-15, last updated 2026-07-15 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Cardiometabolic Risk Factors All trials of RISE-W Micro-Movement Program
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.
Thought process Thought process Here are both, written to PRS conventions and ready to paste. Brief Summary is lay-facing and concise; Detailed Description carries the technical detail.
Brief 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.
Detailed Description Background. Cardiometabolic syndrome (CMS) substantially increases the risk of cardiovascular disease, type 2 diabetes, and early mortality. Rural women experience disproportionately high rates of CMS due to structural and social barriers, and risk is often identified only after disease has progressed. Systemic inflammation contributes to CMS development, and biomarkers such as C-reactive protein (CRP) and interleukin-6 (IL-6) can rise before metabolic abnormalities appear, offering an opportunity for earlier risk identification. Physical inactivity and prolonged sedentary time contribute to metabolic dysregulation; brief, frequent bouts of movement supported by wearable trackers may help interrupt sedentary behavior.
Purpose. This pilot evaluates the feasibility of the Rural Initiative for Inflammatory Screening and Engagement for Women (RISE-W), a pragmatic prevention model designed to support early identification and reduction of cardiometabolic risk among physically inactive rural women receiving care at a federally qualified health center.
Design. Prospective, single-group, pre-post pilot interventional design. All enrolled participants receive the RISE-W intervention and serve as their own control, with outcomes assessed at baseline and at the conclusion of the 12-week intervention.
Objectives.
Evaluate the feasibility of integrating inflammatory biomarkers, metabolic screening, and cardiometabolic risk assessment into routine care.
Implement and assess the acceptability of and adherence to a low-burden prevention strategy incorporating micro-movement physical activity.
Examine preliminary changes in cardiometabolic risk indicators (inflammatory biomarkers, metabolic markers, blood pressure, and waist circumference) over 12 weeks.
Assess the feasibility of embedding the model within existing clinic workflows without increasing clinician workload.
Intervention. A 12-week pragmatic prevention strategy consisting of micro-movement physical activity: brief bouts of light-to-moderate movement each hour during waking hours (target of at least 10 hours per day), supported by a wearable activity tracker (Fitbit Inspire 3) providing automated hourly movement reminders and self-monitoring.
Assessments. At baseline, participants complete demographic and health questionnaires, a social determinants of health questionnaire, and menopausal staging, along with anthropometric measurements (waist circumference, height, weight), blood pressure, and fasting blood samples for metabolic indicators (fasting glucose, triglycerides, HDL) and inflammatory biomarkers (CRP, IL-6). Post-intervention assessments at 12 weeks (study day 84 ± 14 days) repeat anthropometric measures, blood pressure, and biomarker collection, and include a self-report follow-up survey and download of the full activity-tracker dataset.
Outcomes. Primary outcomes are change from baseline to 12 weeks in cardiometabolic risk indicators (waist circumference, systolic and diastolic blood pressure, fasting glucose, triglycerides, HDL) and inflammatory biomarkers (CRP, IL-6), together with feasibility and adherence metrics (assessment completion and adherence to micro-movement activity). Secondary outcomes include anthropometric change (weight, BMI), self-reported physical activity, and exploratory associations of menopausal status and social determinants of health with adherence and outcomes.
Sample size. A target of 125 participants was selected to evaluate feasibility metrics and provide preliminary estimates of effect size and variability to inform future larger trials; the study is not powered for formal hypothesis testing.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| RISE-W Intervention | Experimental | Behavioral: RISE-W Micro-Movement Program | Participants receive the 12-week RISE-W micro-movement prevention program: brief bouts of light-to-moderate movement each waking hour (target ≥10 hours/day), supported by a wearable activity tracker that provides hourly movement reminders and enables self-monitoring. |
Sex: Female, ages: 18 Years to 80 Years
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 comply with study procedures, including wearing the activity tracker or completing follow-up assessments No access to a smartphone, or a smartphone unable to run the Fitbit application due to operating system incompatibility
| Facility | City | Country | Status |
|---|---|---|---|
| Texas Tech University Health Sciences Center Clinical Research Institute | Lubbock, Texas | United States |