Abundant Living: A Church-based Intervention to Improve Blood Pressure in African Americans
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Change in Blood pressure
研究概览
简要总结
This is a 12-month behavioral cluster-randomized trial testing a church-based intervention to reduce blood pressure in African Americans with uncontrolled blood pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •At least 75 members and ability to recruit 15 study participants
- •Predominantly African American congregants
- •Participants:
- •Age 18 or older
- •Has blood pressure readings with uncontrolled blood pressure, defined as exceeding the blood thresholds for initiation of antihypertensive medication according to the 2017 American College of Cardiology/ American Heart Association (ACC/AHA) guidelines.
- •- The thresholds are 140/90 for the general population < 65 years old, and 130/80 for individuals ≥ 65 or with diabetes, chronic kidney disease, or high cardiovascular risk (self-report of prior diagnosis of myocardial infarction, coronary heart disease, stroke or heart failure)
- •Attends church (virtually or in-person) at least once per month
- •Able to attend weekly Zoom meetings
- •Consents and completes all baseline assessments
排除标准
- •Pastor unwilling to conduct Bible study
- •Participants:
- •Unable to make dietary changes due to lack of control over their food source (i.e., eat meals at shelter, nursing home)
- •Has a medical condition that prohibits or severely restricts ability to eat vegetables (i.e., renal disease, Crohn's disease)
- •Has a medical condition with an uncertain 6-month prognosis
- •Inability to give informed consent (i.e., cognitive impairment, does not speak Englis
- •Plans to move within the 6 months following enrollment
- •Participated in prior ALIVE intervention
- •Member of household participating in another church
研究组 & 干预措施
Heart to Heart
干预措施: Heart to Heart (Behavioral)
Money Smart
干预措施: Money Smart (Behavioral)
结局指标
主要结局
Change in Blood pressure
时间窗: Measured at baseline and 6 months and 12 months after start of the intervention
The primary outcome is systolic blood pressure at 6 months post start of the intervention. The Omron digital blood pressure monitor will be utilized to measure blood pressure (Omron Healthcare, Inc., Lake Forest, IL). The participant will sit quietly for \>5 minutes, 3 readings will be taken 1-2 minutes apart while seated, and an average of the last 2 readings will be taken to evaluate blood pressure.
次要结局
- Change in Medication adherence(Measured at baseline and 6 months and 15 months after start of the intervention)
- Change in DASH diet adherence(Measured at baseline and 6 months and 15 months after start of the intervention)
- Change in Self efficacy(Measured at baseline and 6 months and 15 months after start of the intervention)
- Change in Social support(Measured at baseline and 6 months and 15 months after start of the intervention)
- Change in Quality of life(Measured at baseline and 6 months and 15 months after start of the intervention)
- Change in Hypertension knowledge(Measured at baseline and 6 months and 15 months after start of the intervention)
- Change in Nutrition knowledge(Measured at baseline and 6 months and 15 months after start of the intervention)
- Change in Barriers to medication use(Measured at baseline and 6 months and 15 months after start of the intervention)
研究者
Elizabeth Lynch
Associate Professor
Rush University Medical Center
