Reducing Cardiovascular Disease Risk Factors in Rural Communities in North Carolina

Study Overview
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Brief Summary
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The study will determine the feasibility and efficacy of adapting an evidence-based intervention (EBI) to reduce cardiovascular disease (CVD) risk factors in rural African American communities and determine the acceptability of mobile technology in these communities to support behavior change.

Detailed Description
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Cardiovascular disease (CVD), the leading cause of death in the United States (US), disproportionately burdens rural communities. CVD prevalence rates for residents of rural areas (13.1%) is higher compared to those in urban areas (11.2%) of the US. The proposed settings for this research report similar trends in CVD prevalence, where CVD and stroke are among the top three leading causes of death. In community health assessments conducted in the last three years CVD risk factors such as obesity and hypertension were among the top 10 health priorities in our target counties. Compared to residents of metropolitan areas, rural residents have higher rates of cigarette smoking, obesity, mortality from ischemic heart disease, and are physically inactive. These disparities are likely to widen; at the current rate, its estimated 50% of individuals in the US will have CVD by 2030. Using a community-based participatory research (CBPR) approach, our specific aims for the study are to: Expand and sustain a coalition of community and academic stakeholders to develop successful CVD risk prevention strategies in rural communities; Conduct a mixed-method community needs and assets assessment based on: a) assemble, review and assess existing sources of CVD data; b) identification of community strengths and resources using a web-based survey of community, faith based, social service and healthcare organizations; c) determine the acceptability of components of CVD risk reduction EBIs and community members' perceptions of possible targets for intervention using focus group interviews; d) determine specific family influences (barriers and facilitators) on acceptability of EBI acceptability; Adapt PREMIER, a multi-component EBI using intervention mapping; Conduct a small-scale randomized control trial to assess a) efficacy; and, b) feasibility and adaption of implementing adapted PREMIER in rural settings.

Official Title
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Reducing Cardiovascular Disease Risk Factors in Rural Communities in North Carolina

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: Heart Matters


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: African American Aged 21 and older Has at least one of the following cardiovascular disease (CVD) risk factors: pre-diabetes, hypertension, obesity, family history of early CVD, prior CVD Reside in Nash or Edgecombe counties of North Carolina Exclusion Criteria: Evidence of active or unstable CVD Cognitive impairment that limits informed consent

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Time 1 (T1) Intervention Group<br>This group will be the first to receive the adapted intervention, Heart Matters (adapted from the PREMIER intervention). The intervention will be 12 months long. | Behavioral: Heart Matters<br>* Heart Matters is an intervention adapted from PREMIER, an evidence-based, comprehensive lifestyle intervention that focuses on blood pressure as the primary outcome. To assess the feasibility and efficacy of adapting PREMIER for rural African Americans, Heart Matters will be delivered to multiple intervention groups, but at two different stages.<br>* Other names: PREMIER;|
| Experimental: Time 2 (T2) Intervention Group<br>This delayed intervention group will receive the adapted intervention, Heart Matters, six months after the T1 Intervention group. The intervention will be 12 months long. | Behavioral: Heart Matters<br>* Heart Matters is an intervention adapted from PREMIER, an evidence-based, comprehensive lifestyle intervention that focuses on blood pressure as the primary outcome. To assess the feasibility and efficacy of adapting PREMIER for rural African Americans, Heart Matters will be delivered to multiple intervention groups, but at two different stages.<br>* Other names: PREMIER;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight | Measured in pounds | Baseline and 6 months after initiated treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Systolic Blood Pressure | Blood pressure as measured in mmHg | Baseline, Month 6 | 
| Change in Diastolic Blood Pressure | As measured in mmHg | Baseline, Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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African Americans, Cardiovascular Diseases, Community-Based Participatory Research