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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
173
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.
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
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.
Time frame: Baseline, 12 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.
Time frame: Baseline, 12 Months
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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 Months
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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
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.
Time frame: Baseline, 6 Months
Mean Body-mass Index
Body-mass index (BMI) will be calculated as weight (pounds) \* 703 / height\^2 (inches).
Time frame: Baseline, 6 Months, 12 Months
Mean Weight in Pounds
Weight will be measured via a digital scale.
Time frame: Baseline, 6 Months, 12 Months
Mean Waist Circumference in Centimeters
Waist circumference will be measured using inelastic tape.
Time frame: Baseline, 6 Months, 12 Months
Mean Total Cholesterol in mg/dL
Total cholesterol is measured via blood sample using a Cholestech LDX analyzer.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 Months, 12 Months
Mean Blood Triglycerides in mg/dL
Blood triglycerides are measured via blood sample using a Cholestech LDX analyzer.
Time frame: Baseline, 6 Months, 12 Months
Mean Glycated Hemoglobin (A1C) Score
A1C is measured via blood sample using A1CNow+ test kits.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 Months, 12 Months