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

Hypertension Clinical Trial

— EPIPHANY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05367544
• Other study ID #: IRB-300009015
• Status: Recruiting
• Phase: N/A
• Start date: August 13, 2022
• Est. completion date: September 2025

Study information

• Verified date: June 2024
• Source: University of Alabama at Birmingham
• Contact: Andrea Cherrington, MD
• Phone: 2059962885
• Email: acherrington[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 528
• Est. completion date: September 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension
• Prehypertension

Intervention

Behavioral:
• Health Education
All participants will receive education regardless of randomization status. On the day of enrollment, participants will be invited to attend education modules focused on HTN risk, diet, physical activity, stress management, and goal setting. Participants will also have access to culturally relevant, weekly online sessions, alternating between cooking shows and exercise
• Individual-Level Peer Support
Participants will receive bi-weekly peer support calls for 6 months, followed by monthly calls for another 6 months.
• Community-Level Peer Support
Church Leadership in churches randomized to intervention will identify 2-3 Peer Health Advocates from the church who will receive training on ways to promote a culture of health, encouraging church members to attend on-line cooking shows and exercise sessions. After training, these individuals will also work with Church Leadership to form a committee that will develop a project (e.g., community food pantry, farmer's market, Zumba instruction, small church gym) aimed at overcoming structural barriers to healthy behaviors. Each church will receive a small stipend for their project. Churches randomized to education alone will receive the community-level intervention after 12 months of participation in the study (delayed intervention)

Locations

Country	Name	City	State
United States	University of Alabama At Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incident Blood Pressure	Change in systolic blood pressure and diastolic blood pressure	Baseline, 6 months,12 months, 18 months
Secondary	Fruit/Vegetable/Fiber Intake	Change in consumption of fruits, vegetables, and fiber rich foods	Baseline, 6 months,12 months, 18 months
Secondary	Physical Activity	Change in days per week participant participates in moderate and/or vigorous physical activity	Baseline, 6 months,12 months, 18 months
Secondary	Alcohol use	Change in consumption of alcoholic beverages	Baseline, 6 months,12 months, 18 months
Secondary	Smoking	Change in frequency in use of tobacco problems	Baseline, 6 months,12 months, 18 months