跳至主要内容
临床试验/NCT05367544
NCT05367544进行中(未招募)不适用

Equity in Prevention and Progression of Hypertension by Addressing Barriers to Nutrition and Physical activitY

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 528 人开始时间: 2022年8月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
528
试验地点
1
主要终点
Incident Blood Pressure

研究概览

简要总结

The goal of this study is to test an intervention to prevent high blood pressure among rural, Black adults living in Alabama. Black adults in this region have one of the highest rates of high blood pressure in the US. Eating fruits and vegetables and exercising daily lowers the chance of getting high blood pressure. Many problems get in the way of eating a healthy diet and exercising like a lack of grocery stores with fresh foods, few gyms, little money, lack of transportation, and limited support for keeping healthy habits. One place where many Black adults in rural Alabama meet weekly and feel supported is their church. The investigators will connect with 30 churches in rural Alabama. The investigators plan to hold health fairs to find 12 Black adults from each church with blood pressure that is higher than normal but not high enough to need blood pressure lowering medications. The investigators will randomly select 15 churches to get group health education and tablets to access online cooking shows and exercise classes. Adults in the other 15 churches will get support from a health coach over the telephone to help set and meet diet and physical activity goals as well as the group health education and tablets to access online cooking shows and exercise classes. In this study, the investigators will ask church members to sign up to be a health coach. These 15 churches will also get money to help bring healthy foods and/or physical activity opportunities to their communities. The investigative team will train 2 to 3 of their church members to learn how to coach others to eat more healthy food and be more physically active. This study answers two questions. 1) Will this intervention designed to reduce barriers to a healthy lifestyle lower blood pressure among rural, Black adults? 2) Can churches and participants complete the whole two-year study, and can the intervention be used in other communities in a cost-effective way to improve blood pressure? This project will add to the health equity mission of the American Heart Association by finding out if an intervention using health coaches lowers blood pressure among rural Black adults.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Self-identify as Black/African American
  • Mean systolic blood pressure 120-139mmHg OR diastolic blood pressure 80-89mmHg

排除标准

  • Mean systolic blood pressure greater than or equal to140 mm Hg, or mean diastolic blood pressure greater than or equal to 90 mm Hg
  • Currently taking antihypertensive medication
  • Self-reported history of hypertension outside of pregnancy
  • Known pregnancy
  • Self-reported history of cardiovascular disease
  • Age ≥65 years or self-reported history of chronic kidney disease, or diabetes, if systolic blood pressure ≥ 130 mm Hg or diastolic blood pressure ≥ 80
  • Planning to move out of the county within the next 18 months
  • Not having a cellular phone or landline
  • Inability to speak English

研究组 & 干预措施

Health Education & Peer Coaching

Experimental

Participants will have access to online health education materials and will also be matched with a community health worker who will offer support through peer coaching

干预措施: Health Education (Behavioral)

Health Education & Peer Coaching

Experimental

Participants will have access to online health education materials and will also be matched with a community health worker who will offer support through peer coaching

干预措施: Individual-Level Peer Support (Behavioral)

Health Education & Peer Coaching

Experimental

Participants will have access to online health education materials and will also be matched with a community health worker who will offer support through peer coaching

干预措施: Community-Level Peer Support (Behavioral)

Health Education Only

Active Comparator

Participants will have access to online health education materials but will not receive individualized peer support

干预措施: Health Education (Behavioral)

Health Education Only

Active Comparator

Participants will have access to online health education materials but will not receive individualized peer support

干预措施: Community-Level Peer Support (Behavioral)

结局指标

主要结局

Incident Blood Pressure

时间窗: Baseline, 6 months,12 months, 18 months

Change in systolic blood pressure and diastolic blood pressure

次要结局

  • Fruit/Vegetable/Fiber Intake(Baseline, 6 months,12 months, 18 months)
  • Physical Activity(Baseline, 6 months,12 months, 18 months)
  • Smoking(Baseline, 6 months,12 months, 18 months)
  • Alcohol use(Baseline, 6 months,12 months, 18 months)

研究者

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

Andrea Cherrington, MD

Professor

University of Alabama at Birmingham

研究点 (1)

Loading locations...

相似试验