Rural Initiative for Inflammatory Screening & Engagement for Women
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Study completion rate (feasibility)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Masking Description
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
RISE-W Intervention
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.
干预措施: RISE-W Micro-Movement Program (Behavioral)
结局指标
主要结局
Study completion rate (feasibility)
时间窗: Baseline through 12 weeks
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)
时间窗: Over the 12-week intervention period
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.
次要结局
- Change in waist circumference(Baseline and 12 weeks)
- Change in blood pressure(Baseline and 12 weeks)
- Change in fasting blood glucose(Baseline and 12 weeks)
- Change in triglycerides(Baseline and 12 weeks)
- Change in HDL cholesterol(Baseline and 12 weeks)
- Change in C-reactive protein (CRP)(Baseline and 12 weeks)
- Change in interleukin-6 (IL-6)(Baseline and 12 weeks)
- Change in body weight and BMI(Baseline and 12 weeks)
- Change in self-reported physical activity(Baseline and 12 weeks)