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临床试验/NCT05220332
NCT05220332招募中不适用

Abundant Living: A Church-based Intervention to Improve Blood Pressure in African Americans

Rush University Medical Center1 个研究点 分布在 1 个国家目标入组 312 人开始时间: 2022年3月15日最近更新:
适应症
干预措施

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

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

Experimental

干预措施: Heart to Heart (Behavioral)

Money Smart

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Lynch

Associate Professor

Rush University Medical Center

研究点 (1)

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