Clinical trial NCT05367544: Equity in Prevention and Progression of Hypertension by Addressing Barriers to Nutrition and Physical activitY
Official title: Equity in Prevention and Progression of Hypertension by Addressing Barriers to Nutrition and Physical activitY
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prehypertension
Hypertension
Blood Pressure
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 528
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Mean systolic blood pressure greater than or equal to140 mm Hg, or mean diastolic blood pressure greater than or equal to 90 mm Hg
2. Currently taking antihypertensive medication
3. Self-reported history of hypertension outside of pregnancy
4. Known pregnancy
5. Self-reported history of cardiovascular disease
6. 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
7. Planning to move out of the county within the next 18 months
8. Not having a cellular phone or landline
9. Inability to speak English

Primary outcomes:
measure: Incident Blood Pressure
timeFrame: Baseline, 6 months,12 months, 18 months
Secondary outcomes:
measure: Fruit/Vegetable/Fiber Intake
timeFrame: Baseline, 6 months,12 months, 18 months
measure: Physical Activity
timeFrame: Baseline, 6 months,12 months, 18 months
measure: Alcohol use
timeFrame: Baseline, 6 months,12 months, 18 months
measure: Smoking
timeFrame: Baseline, 6 months,12 months, 18 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama At Birmingham
state: Alabama
Study officials:
References: