Collaborate and Leverage Evidence in African American Rural Network (Co-LEARN)

Implementation of Heart Matters Evidence-based Program

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Behavioral: Heart Matters

Detailed Description

The research team will use a non-randomized, propensity-matched-controlled design to evaluate the effectiveness of the Heart Matters evidence-based program -- previously evaluated for feasibility and efficacy under NCT02707432 -- in improving cardiovascular health outcomes when scaled in multiple rural, eastern North Carolina counties and implemented by community-based facilitators.

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.

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Enfield, North Carolina, United States, 27823
      • A Better Chance, A Better Community
    • Nashville, North Carolina, United States, 27856
      • The Mercer Foundation, Inc.
    • Rocky Mount, North Carolina, United States, 27801
      • Marks Chapel Baptist Church
    • Rocky Mount, North Carolina, United States, 27801
      • Thorne's Chapel Missionary Baptist Church
    • Rocky Mount, North Carolina, United States, 27801
      • Truth Tabernacle Ministries
    • Rocky Mount, North Carolina, United States, 27804
      • Girls Making the Grade
    • Spring Hope, North Carolina, United States, 27882
      • Carolina Hierarchy of Needs
    • Stantonsburg, North Carolina, United States, 27883
      • St. James United Holy Church
    • Warrenton, North Carolina, United States, 27537
      • Warren County Health Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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 Names: PREMIER
Active Comparator: Propensity-matched Control Group (Retrospective); This group received the Heart Matters intervention, delivered by researchers, under NCT02707432.	Behavioral: 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 Names: PREMIER

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Personal History of Cardiovascular Disease	Personal history of cardiovascular disease is measured via self-report at baseline using an adapted item from My Personal Health Record (MyPHR). Personal history of cardiovascular disease is defined as history of diabetes, heart surgery, high blood cholesterol, high blood pressure, pain or pressure in chest, palpitations, stroke, or other heart condition (including heart attack).	Baseline
Number of Participants with Family History of Cardiovascular Disease	Family history of cardiovascular disease is measured via self-report using an adapted item from the Women's Health Initiative. Family history of cardiovascular disease is defined as having a parent, full-blooded sibling, or child who has ever had a heart condition, such as heart attack, high blood pressure, or stroke.	Baseline
Mean Systolic Blood Pressure in mmHg	Blood pressure is measured as the average of three readings, taken in a seated position using an Omron BP6100 digital blood pressure monitor.	Baseline, 6 Months, 12 Months
Mean Diastolic Blood Pressure in mmHg	Blood pressure is measured as the average of three readings, taken in a seated position using an Omron BP6100 digital blood pressure monitor.	Baseline, 6 Months, 12 Months
Mean Body-mass Index	Body-mass index (BMI) will be calculated as weight (pounds) * 703 / height^2 (inches).	Baseline, 6 Months, 12 Months
Mean Weight in Pounds	Weight will be measured via a digital scale.	Baseline, 6 Months, 12 Months
Mean Waist Circumference in Centimeters	Waist circumference will be measured using inelastic tape.	Baseline, 6 Months, 12 Months
Mean Total Cholesterol in mg/dL	Total cholesterol is measured via blood sample using a Cholestech LDX analyzer.	Baseline, 6 Months, 12 Months
Mean High-density Lipoprotein (HDL) Cholesterol in mg/dL	HDL cholesterol is measured via blood sample using a Cholestech LDX analyzer.	Baseline, 6 Months, 12 Months
Mean Low-density Lipoprotein (LDL) Cholesterol in mg/dL	LDL cholesterol is measured via blood sample using a Cholestech LDX analyzer.	Baseline, 6 Months, 12 Months
Mean Blood Triglycerides in mg/dL	Blood triglycerides are measured via blood sample using a Cholestech LDX analyzer.	Baseline, 6 Months, 12 Months
Mean Glycated Hemoglobin (A1C) Score	A1C is measured via blood sample using A1CNow+ test kits.	Baseline, 6 Months, 12 Months
Number of Participants by Categorical Smoking Status	Smoking status is measured via self-report using excerpted items from wave 1 of the Population Assessment of Tobacco and Health Study. Reporting will include number of participants endorsing ever having smoked a cigarette and (among participants who have endorse ever having smoked) numbers of participants endorsing now smoking every day, some days, or not at all.	Baseline, 6 Months, 12 Months
Mean Healthy Days	Healthy Days measured via self report using the Center for Disease Control (CDC)'s 4-item Healthy Days Core Module (HRQOL-4) with a look-back period of 30 days. HRQOL-4 scores can range from 0 to 30, with 30 indicating maximum number of healthy days.	Baseline, 6 Months, 12 Months
Mean Heart Disease Fact Questionnaire Score	Heart disease knowledge is measured via self-report using the 25-item Heart Disease Fact Questionnaire (HDFQ). HDFQ scores can range from 0 to 25, with higher scores indicating greater knowledge of heart disease.	Baseline, 6 Months, 12 Months
Mean University of Rhode Island Change Assessment Score	Readiness for behavioral change is measured via self-report using the 32-item University of Rhode Island Change Assessment (URICA). URICA scores can range from -2 to +14, with higher scores indicating greater levels of readiness to change.	Baseline, 6 Months, 12 Months
Mean Perceived Stress Scale Score	Perceived stress is measured via self-report using the 10-item Perceived Stress Scale (PSS). PSS scores can range from 0 to 40, with higher scores indicating higher levels of perceived stress.	Baseline, 6 Months, 12 Months
Mean Alcohol Use Disorders Identification Test - Consumption (AUDIT-C) Score	Alcohol use is measured via self-report using the 3-item Alcohol Use Disorders Identification Test - Consumption (AUDIT-C). AUDIT-C scores can range from 0 to 12, with higher scores indicating greater of drinking quantity and/or frequency.	Baseline, 6 Months, 12 Months
Mean Minutes of Light, Moderate, and Vigorous Leisure-Time Physical Activity	Minutes of light, moderate, and vigorous leisure-time physical activity is measured via self-report using an English-language version of Registre Gironí del Cor (REGICOR) with a look-back period of one month.	Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Sweetened Fruit Drinks	Dietary intake of sweetened fruit drinks is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.	Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of 100% Pure Fruit Juice	Dietary intake of 100% pure fruit juice is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.	Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Soda	Dietary intake of soda is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.	Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Water	Dietary intake of water is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.	Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Fruit	Dietary intake of fruit is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.	Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Vegetables (Excluding Potatoes)	Dietary intake of vegetables (excluding potatoes) is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.	Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Frozen and Fast Food	Dietary intake of frozen and fast food is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.	Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Processed Meat	Dietary intake of processed meat is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.	Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Whole Grains	Dietary intake of whole grains is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.	Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Candy, Desserts, and Chocolate	Dietary intake of candy, desserts, and chocolate is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.	Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Chips	Dietary intake of chips is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.	Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Sugary Cereals	Dietary intake of sugary cereals is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.	Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Fish	Dietary intake of fish is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.	Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Nuts and Seeds	Dietary intake of nuts and seeds is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.	Baseline, 6 Months, 12 Months
Number of Participants by Categorical Frequency of Dietary Intake of Eggs	Dietary intake of eggs is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.	Baseline, 6 Months, 12 Months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); James McFarlin Community Development, Inc.; Project Momentum, Inc.; Opportunities Industrialization Center, Inc.
• Investigators: Principal Investigator: Gaurav Dave, MBBS, DrPH, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2025
• Primary Completion (Actual): December 17, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Actual): December 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Community-based participatory research; Heart health; Behavioral modification
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Permadyne Premier
• Other Study ID Numbers: 21-1366; 5R01HL157255 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with The University of North Carolina at Chapel Hill.
• IPD Sharing Time Frame: Beginning 9 and continuing for 36 months following publication
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No