Clinical trial NCT06730633: Collaborate and Leverage Evidence in African American Rural Network
Official title: Implementation of Heart Matters Evidence-based Program
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Heart health
Behavioral modification
Community-based participatory research
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Project Momentum, Inc.
name: James McFarlin Community Development, Inc.
name: Opportunities Industrialization Center, Inc.
First posted: 2024-12-12
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Non-randomized, propensity-matched-controlled trial. Specifically, 70 participants from the present study will be propensity-matched with 70 participants from NCT02707432.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean change from Baseline, Systolic Blood Pressure
timeFrame: Baseline, 6 Months
measure: Mean change from Baseline, Diastolic Blood Pressure
timeFrame: Baseline, 6 Months
Secondary outcomes:
measure: Number of Participants with Personal History of Cardiovascular Disease
timeFrame: Baseline
measure: Number of Participants with Family History of Cardiovascular Disease
timeFrame: Baseline
measure: Mean Systolic Blood Pressure in mmHg
timeFrame: Baseline, 6 Months, 12 Months
measure: Mean Diastolic Blood Pressure in mmHg
timeFrame: Baseline, 6 Months, 12 Months
measure: Mean Body-mass Index
timeFrame: Baseline, 6 Months, 12 Months
measure: Mean Weight in Pounds
timeFrame: Baseline, 6 Months, 12 Months
measure: Mean Waist Circumference in Centimeters
timeFrame: Baseline, 6 Months, 12 Months
measure: Mean Total Cholesterol in mg/dL
timeFrame: Baseline, 6 Months, 12 Months
measure: Mean High-density Lipoprotein (HDL) Cholesterol in mg/dL
timeFrame: Baseline, 6 Months, 12 Months
measure: Mean Low-density Lipoprotein (LDL) Cholesterol in mg/dL
timeFrame: Baseline, 6 Months, 12 Months
measure: Mean Blood Triglycerides in mg/dL
timeFrame: Baseline, 6 Months, 12 Months
measure: Mean Glycated Hemoglobin (A1C) Score
timeFrame: Baseline, 6 Months, 12 Months
measure: Number of Participants by Categorical Smoking Status
timeFrame: Baseline, 6 Months, 12 Months
measure: Mean Healthy Days
timeFrame: Baseline, 6 Months, 12 Months
measure: Mean Heart Disease Fact Questionnaire Score
timeFrame: Baseline, 6 Months, 12 Months
measure: Mean University of Rhode Island Change Assessment Score
timeFrame: Baseline, 6 Months, 12 Months
measure: Mean Perceived Stress Scale Score
timeFrame: Baseline, 6 Months, 12 Months
measure: Mean Alcohol Use Disorders Identification Test - Consumption (AUDIT-C) Score
timeFrame: Baseline, 6 Months, 12 Months
measure: Mean Minutes of Light, Moderate, and Vigorous Leisure-Time Physical Activity
timeFrame: Baseline, 6 Months, 12 Months
measure: Number of Participants by Categorical Frequency of Dietary Intake of Sweetened Fruit Drinks
timeFrame: Baseline, 6 Months, 12 Months
measure: Number of Participants by Categorical Frequency of Dietary Intake of 100% Pure Fruit Juice
timeFrame: Baseline, 6 Months, 12 Months
measure: Number of Participants by Categorical Frequency of Dietary Intake of Soda
timeFrame: Baseline, 6 Months, 12 Months
measure: Number of Participants by Categorical Frequency of Dietary Intake of Water
timeFrame: Baseline, 6 Months, 12 Months
measure: Number of Participants by Categorical Frequency of Dietary Intake of Fruit
timeFrame: Baseline, 6 Months, 12 Months
measure: Number of Participants by Categorical Frequency of Dietary Intake of Vegetables (Excluding Potatoes)
timeFrame: Baseline, 6 Months, 12 Months
measure: Number of Participants by Categorical Frequency of Dietary Intake of Frozen and Fast Food
timeFrame: Baseline, 6 Months, 12 Months
measure: Number of Participants by Categorical Frequency of Dietary Intake of Processed Meat
timeFrame: Baseline, 6 Months, 12 Months
measure: Number of Participants by Categorical Frequency of Dietary Intake of Whole Grains
timeFrame: Baseline, 6 Months, 12 Months
measure: Number of Participants by Categorical Frequency of Dietary Intake of Candy, Desserts, and Chocolate
timeFrame: Baseline, 6 Months, 12 Months
measure: Number of Participants by Categorical Frequency of Dietary Intake of Chips
timeFrame: Baseline, 6 Months, 12 Months
measure: Number of Participants by Categorical Frequency of Dietary Intake of Sugary Cereals
timeFrame: Baseline, 6 Months, 12 Months
measure: Number of Participants by Categorical Frequency of Dietary Intake of Fish
timeFrame: Baseline, 6 Months, 12 Months
measure: Number of Participants by Categorical Frequency of Dietary Intake of Nuts and Seeds
timeFrame: Baseline, 6 Months, 12 Months
measure: Number of Participants by Categorical Frequency of Dietary Intake of Eggs
timeFrame: Baseline, 6 Months, 12 Months
Other outcomes:
Locations:
city: Enfield
country: United States
facility: A Better Chance, A Better Community
state: North Carolina
city: Nashville
country: United States
facility: The Mercer Foundation, Inc.
state: North Carolina
city: Rocky Mount
country: United States
facility: Marks Chapel Baptist Church
state: North Carolina
city: Rocky Mount
country: United States
facility: Thorne's Chapel Missionary Baptist Church
state: North Carolina
city: Rocky Mount
country: United States
facility: Truth Tabernacle Ministries
state: North Carolina
city: Rocky Mount
country: United States
facility: Girls Making the Grade
state: North Carolina
city: Spring Hope
country: United States
facility: Carolina Hierarchy of Needs
state: North Carolina
city: Stantonsburg
country: United States
facility: St. James United Holy Church
state: North Carolina
city: Warrenton
country: United States
facility: Warren County Health Department
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Gaurav Dave, MBBS, DrPH
role: PRINCIPAL_INVESTIGATOR
References: