Collaborate and Leverage Evidence in African American Rural Network

NCT06730633 | Active Not Recruiting

• 2 other identifiers: 21-13665R01HL157255
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 9

Brief Summary

The goal of this non-randomized, propensity-matched-controlled study is to assess the effectiveness of the Heart Matters evidence-based program -- previously evaluated for feasibility and efficacy in NCT02707432 -- in improving cardiovascular health outcomes (change in systolic and diastolic blood pressure, primary outcomes) when implemented by community-based facilitators.

Conditions

Cardiovascular Diseases

Keywords

Heart health; Behavioral modification; Community-based participatory research

Outcome Measures

Primary Outcomes (2)

• Mean change from Baseline, Systolic Blood Pressure

  Blood pressure is measured as the average of three readings, taken in a seated position using an Omron BP6100 digital blood pressure monitor. Reporting will compare participants in the present study with propensity-score-matched controls.

  Baseline, 6 Months

• Mean change from Baseline, Diastolic Blood Pressure

  Blood pressure is measured as the average of three readings, taken in a seated position using an Omron BP6100 digital blood pressure monitor. Reporting will compare participants in the present study with propensity-score-matched controls.

  Baseline, 6 Months

Secondary Outcomes (34)

• Number of Participants with Personal History of Cardiovascular Disease

  Baseline

• Number of Participants with Family History of Cardiovascular Disease

  Baseline

• Mean Systolic Blood Pressure in mmHg

  Baseline, 6 Months, 12 Months

• Mean Diastolic Blood Pressure in mmHg

  Baseline, 6 Months, 12 Months

• Mean Body-mass Index

  Baseline, 6 Months, 12 Months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Heart Matters

Propensity-matched Control Group (Retrospective)

ACTIVE COMPARATOR

This group received the Heart Matters intervention, delivered by researchers, under NCT02707432.

Behavioral: Heart Matters

Interventions

Heart Matters BEHAVIORAL

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.

Also known as: PREMIER

Intervention Group; Propensity-matched Control Group (Retrospective)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Identify as Black or African American
• 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

You may not qualify if:

• Evidence of active or unstable cardiovascular disease
• Cognitive impairment that limits informed consent

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Project Momentum, Inc.: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• James McFarlin Community Development, Inc.: collaborator
• Opportunities Industrialization Center, Inc.: collaborator

Study Sites (9)

A Better Chance, A Better Community

Enfield, North Carolina, 27823, United States

Location

The Mercer Foundation, Inc.

Nashville, North Carolina, 27856, United States

Location

Marks Chapel Baptist Church

Rocky Mount, North Carolina, 27801, United States

Location

Thorne's Chapel Missionary Baptist Church

Rocky Mount, North Carolina, 27801, United States

Location

Truth Tabernacle Ministries

Rocky Mount, North Carolina, 27801, United States

Location

Girls Making the Grade

Rocky Mount, North Carolina, 27804, United States

Location

Carolina Hierarchy of Needs

Spring Hope, North Carolina, 27882, United States

Location

St. James United Holy Church

Stantonsburg, North Carolina, 27883, United States

Location

Warren County Health Department

Warrenton, North Carolina, 27537, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Permadyne Premier

Study Officials

• Gaurav Dave, MBBS, DrPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomized, propensity-matched-controlled trial. Specifically, 70 participants from the present study will be propensity-matched with 70 participants from NCT02707432.

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: February 22, 2025
• Primary Completion: December 17, 2025
• Study Completion: May 1, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with The University of North Carolina at Chapel Hill

Locations

US (9)