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NCT Number: NCT06730633

Collaborate and Leverage Evidence in African American Rural Network

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

A Better Chance, A Better Community, Enfield, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: PREMIER

Primary outcomes

  1. Mean change from Baseline, Systolic Blood Pressure

    Time frame: Baseline, 6 Months

    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.

  2. Mean change from Baseline, Diastolic Blood Pressure

    Time frame: Baseline, 6 Months

    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.

Secondary outcomes

  1. Number of Participants with Personal History of Cardiovascular Disease

    Time frame: Baseline

    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).

  2. Number of Participants with Family History of Cardiovascular Disease

    Time frame: Baseline

    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.

  3. Mean Systolic Blood Pressure in mmHg

    Time frame: Baseline, 6 Months, 12 Months

    Blood pressure is measured as the average of three readings, taken in a seated position using an Omron BP6100 digital blood pressure monitor.

  4. Mean Diastolic Blood Pressure in mmHg

    Time frame: Baseline, 6 Months, 12 Months

    Blood pressure is measured as the average of three readings, taken in a seated position using an Omron BP6100 digital blood pressure monitor.

  5. Mean Body-mass Index

    Time frame: Baseline, 6 Months, 12 Months

    Body-mass index (BMI) will be calculated as weight (pounds) * 703 / height^2 (inches).

  6. Mean Weight in Pounds

    Time frame: Baseline, 6 Months, 12 Months

    Weight will be measured via a digital scale.

  7. Mean Waist Circumference in Centimeters

    Time frame: Baseline, 6 Months, 12 Months

    Waist circumference will be measured using inelastic tape.

  8. Mean Total Cholesterol in mg/dL

    Time frame: Baseline, 6 Months, 12 Months

    Total cholesterol is measured via blood sample using a Cholestech LDX analyzer.

  9. Mean High-density Lipoprotein (HDL) Cholesterol in mg/dL

    Time frame: Baseline, 6 Months, 12 Months

    HDL cholesterol is measured via blood sample using a Cholestech LDX analyzer.

  10. Mean Low-density Lipoprotein (LDL) Cholesterol in mg/dL

    Time frame: Baseline, 6 Months, 12 Months

    LDL cholesterol is measured via blood sample using a Cholestech LDX analyzer.

  11. Mean Blood Triglycerides in mg/dL

    Time frame: Baseline, 6 Months, 12 Months

    Blood triglycerides are measured via blood sample using a Cholestech LDX analyzer.

  12. Mean Glycated Hemoglobin (A1C) Score

    Time frame: Baseline, 6 Months, 12 Months

    A1C is measured via blood sample using A1CNow+ test kits.

  13. Number of Participants by Categorical Smoking Status

    Time frame: Baseline, 6 Months, 12 Months

    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.

  14. Mean Healthy Days

    Time frame: Baseline, 6 Months, 12 Months

    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.

  15. Mean Heart Disease Fact Questionnaire Score

    Time frame: Baseline, 6 Months, 12 Months

    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.

  16. Mean University of Rhode Island Change Assessment Score

    Time frame: Baseline, 6 Months, 12 Months

    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.

  17. Mean Perceived Stress Scale Score

    Time frame: Baseline, 6 Months, 12 Months

    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.

  18. Mean Alcohol Use Disorders Identification Test - Consumption (AUDIT-C) Score

    Time frame: Baseline, 6 Months, 12 Months

    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.

  19. Mean Minutes of Light, Moderate, and Vigorous Leisure-Time Physical Activity

    Time frame: Baseline, 6 Months, 12 Months

    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.

  20. Number of Participants by Categorical Frequency of Dietary Intake of Sweetened Fruit Drinks

    Time frame: Baseline, 6 Months, 12 Months

    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.

  21. Number of Participants by Categorical Frequency of Dietary Intake of 100% Pure Fruit Juice

    Time frame: Baseline, 6 Months, 12 Months

    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.

  22. Number of Participants by Categorical Frequency of Dietary Intake of Soda

    Time frame: Baseline, 6 Months, 12 Months

    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.

  23. Number of Participants by Categorical Frequency of Dietary Intake of Water

    Time frame: Baseline, 6 Months, 12 Months

    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.

  24. Number of Participants by Categorical Frequency of Dietary Intake of Fruit

    Time frame: Baseline, 6 Months, 12 Months

    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.

  25. Number of Participants by Categorical Frequency of Dietary Intake of Vegetables (Excluding Potatoes)

    Time frame: Baseline, 6 Months, 12 Months

    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.

  26. Number of Participants by Categorical Frequency of Dietary Intake of Frozen and Fast Food

    Time frame: Baseline, 6 Months, 12 Months

    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.

  27. Number of Participants by Categorical Frequency of Dietary Intake of Processed Meat

    Time frame: Baseline, 6 Months, 12 Months

    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.

  28. Number of Participants by Categorical Frequency of Dietary Intake of Whole Grains

    Time frame: Baseline, 6 Months, 12 Months

    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.

  29. Number of Participants by Categorical Frequency of Dietary Intake of Candy, Desserts, and Chocolate

    Time frame: Baseline, 6 Months, 12 Months

    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.

  30. Number of Participants by Categorical Frequency of Dietary Intake of Chips

    Time frame: Baseline, 6 Months, 12 Months

    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.

  31. Number of Participants by Categorical Frequency of Dietary Intake of Sugary Cereals

    Time frame: Baseline, 6 Months, 12 Months

    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.

  32. Number of Participants by Categorical Frequency of Dietary Intake of Fish

    Time frame: Baseline, 6 Months, 12 Months

    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.

  33. Number of Participants by Categorical Frequency of Dietary Intake of Nuts and Seeds

    Time frame: Baseline, 6 Months, 12 Months

    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.

  34. Number of Participants by Categorical Frequency of Dietary Intake of Eggs

    Time frame: Baseline, 6 Months, 12 Months

    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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • James McFarlin Community Development, Inc.
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Opportunities Industrialization Center, Inc.
  • Project Momentum, Inc.

Registry information

Official study title

Implementation of Heart Matters Evidence-based Program

Acronym: Co-LEARN

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 12, 2024
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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