Implementation of Heart Matters Evidence-based Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 9
- 主要终点
- Mean change from Baseline, Systolic Blood Pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Evidence of active or unstable cardiovascular disease
- •Cognitive impairment that limits informed consent
研究组 & 干预措施
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.
干预措施: Heart Matters (Behavioral)
Propensity-matched Control Group (Retrospective)
This group received the Heart Matters intervention, delivered by researchers, under NCT02707432.
干预措施: Heart Matters (Behavioral)
结局指标
主要结局
Mean change from Baseline, Systolic Blood Pressure
时间窗: 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.
Mean change from Baseline, Diastolic Blood Pressure
时间窗: 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.
Mean change from Baseline, Systolic Blood Pressure
时间窗: Baseline, 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. Reporting will compare participants in the present study with propensity-score-matched controls.
Mean change from Baseline, Diastolic Blood Pressure
时间窗: Baseline, 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. Reporting will compare participants in the present study with propensity-score-matched controls.
次要结局
- 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)
- Mean Weight in Pounds(Baseline, 6 Months, 12 Months)
- Mean Waist Circumference in Centimeters(Baseline, 6 Months, 12 Months)
- Mean Total Cholesterol in mg/dL(Baseline, 6 Months, 12 Months)
- Mean High-density Lipoprotein (HDL) Cholesterol in mg/dL(Baseline, 6 Months, 12 Months)
- Mean Low-density Lipoprotein (LDL) Cholesterol in mg/dL(Baseline, 6 Months, 12 Months)
- Mean Blood Triglycerides in mg/dL(Baseline, 6 Months, 12 Months)
- Mean Glycated Hemoglobin (A1C) Score(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Smoking Status(Baseline, 6 Months, 12 Months)
- Mean Healthy Days(Baseline, 6 Months, 12 Months)
- Mean Heart Disease Fact Questionnaire Score(Baseline, 6 Months, 12 Months)
- Mean University of Rhode Island Change Assessment Score(Baseline, 6 Months, 12 Months)
- Mean Perceived Stress Scale Score(Baseline, 6 Months, 12 Months)
- Mean Alcohol Use Disorders Identification Test - Consumption (AUDIT-C) Score(Baseline, 6 Months, 12 Months)
- Mean Minutes of Light, Moderate, and Vigorous Leisure-Time Physical Activity(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Sweetened Fruit Drinks(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of 100% Pure Fruit Juice(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Soda(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Water(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Fruit(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Vegetables (Excluding Potatoes)(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Frozen and Fast Food(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Processed Meat(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Whole Grains(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Candy, Desserts, and Chocolate(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Chips(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Sugary Cereals(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Fish(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Nuts and Seeds(Baseline, 6 Months, 12 Months)
- Number of Participants by Categorical Frequency of Dietary Intake of Eggs(Baseline, 6 Months, 12 Months)
- Mean Systolic Blood Pressure in mmHg(Baseline, 6 Months)
- Mean Diastolic Blood Pressure in mmHg(Baseline, 6 Months)