Collaborate and Leverage Evidence in African American Rural Network
NCT ID: NCT06730633
Last Updated: 2026-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
173 participants
INTERVENTIONAL
2025-02-22
2026-05-31
Brief Summary
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Detailed Description
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This study aims to recruit 210 participants, 70 of whom will be propensity-score-matched with participants from NCT02707432. Propensity-score-matching will allow for flexibility in recruitment, statistical rigor, and resource efficiency. The research team hypothesizes that matched participants in the present study will show significant improvements in health outcomes (systolic blood pressure, diastolic blood pressure) compared to the matched NCT02707432 controls.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention Group
This group will receive the Heart Matters intervention, delivered by community-based facilitators. All participants consenting to the present study will be assigned to this arm.
Heart Matters
Heart Matters is a lifestyle modification intervention guided by the theory of planned behavior. Designed to mitigate cardiovascular disease risk factors, the program strives to help participants consume nutritious foods, engage in a more active lifestyle, lose weight and lower their systolic or diastolic blood pressure. Lifestyle modifications can include weight loss, a reduction in percent calorie fat consumption and total sodium intake, improving diet and increasing physical activity, and reducing daily alcoholic beverage consumption.
Propensity-matched Control Group (Retrospective)
This group received the Heart Matters intervention, delivered by researchers, under NCT02707432.
Heart Matters
Heart Matters is a lifestyle modification intervention guided by the theory of planned behavior. Designed to mitigate cardiovascular disease risk factors, the program strives to help participants consume nutritious foods, engage in a more active lifestyle, lose weight and lower their systolic or diastolic blood pressure. Lifestyle modifications can include weight loss, a reduction in percent calorie fat consumption and total sodium intake, improving diet and increasing physical activity, and reducing daily alcoholic beverage consumption.
Interventions
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Heart Matters
Heart Matters is a lifestyle modification intervention guided by the theory of planned behavior. Designed to mitigate cardiovascular disease risk factors, the program strives to help participants consume nutritious foods, engage in a more active lifestyle, lose weight and lower their systolic or diastolic blood pressure. Lifestyle modifications can include weight loss, a reduction in percent calorie fat consumption and total sodium intake, improving diet and increasing physical activity, and reducing daily alcoholic beverage consumption.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Reside in rural, eastern North Carolina
* Self-report at least one cardiovascular disease risk factor, such as pre-diabetes, pre-hypertension or stage one hypertension, obesity, or family history of early heart disease
Exclusion Criteria
* Cognitive impairment that limits informed consent
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Project Momentum, Inc.
INDUSTRY
James McFarlin Community Development, Inc.
OTHER
Opportunities Industrialization Center, Inc.
UNKNOWN
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Gaurav Dave, MBBS, DrPH
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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A Better Chance, A Better Community
Enfield, North Carolina, United States
The Mercer Foundation, Inc.
Nashville, North Carolina, United States
Marks Chapel Baptist Church
Rocky Mount, North Carolina, United States
Thorne's Chapel Missionary Baptist Church
Rocky Mount, North Carolina, United States
Truth Tabernacle Ministries
Rocky Mount, North Carolina, United States
Girls Making the Grade
Rocky Mount, North Carolina, United States
Carolina Hierarchy of Needs
Spring Hope, North Carolina, United States
St. James United Holy Church
Stantonsburg, North Carolina, United States
Warren County Health Department
Warrenton, North Carolina, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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21-1366
Identifier Type: -
Identifier Source: org_study_id
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