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

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Recruiting
CT.gov ID
NCT05367544
Collaborator
(none)
528
1
2
36.6
14.4

Study Details

Study Description

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 20 churches in rural Alabama. The investigators plan to hold health fairs to find 27 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 10 churches to get group health education and tablets to access online cooking shows and exercise classes. Adults in the other 10 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 10 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Health Education
  • Behavioral: Individual-Level Peer Support
  • Behavioral: Community-Level Peer Support
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
528 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Equity in Prevention and Progression of Hypertension by Addressing Barriers to Nutrition and Physical activitY
Actual Study Start Date :
Aug 13, 2022
Anticipated Primary Completion Date :
Jul 1, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Health Education & Peer Coaching

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

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

Behavioral: Individual-Level Peer Support
Participants will receive bi-weekly peer support calls for 6 months, followed by monthly calls for another 6 months.

Behavioral: 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)

Active Comparator: Health Education Only

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

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

Behavioral: 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)

Outcome Measures

Primary Outcome Measures

  1. Incident Blood Pressure [Baseline, 6 months,12 months, 24 months]

    Change in systolic blood pressure and diastolic blood pressure

Secondary Outcome Measures

  1. Fruit/Vegetable/Fiber Intake [Baseline, 6 months,12 months, 24 months]

    Change in consumption of fruits, vegetables, and fiber rich foods

  2. Physical Activity [Baseline, 6 months,12 months, 24 months]

    Change in days per week participant participates in moderate and/or vigorous physical activity

  3. Alcohol use [Baseline, 6 months,12 months, 24 months]

    Change in consumption of alcoholic beverages

  4. Smoking [Baseline, 6 months,12 months, 24 months]

    Change in frequency in use of tobacco problems

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Self-identify as Black/African American

  • Systolic blood pressure 120-139mmHg OR diastolic blood pressure 80-89mmHg

  • Not taking any antihypertensive medication

  • No history of cardiovascular disease, diabetes, or chronic kidney disease

Exclusion Criteria:
  • Pregnant

  • Have a medical condition with limited life expectancy

  • No telephone

  • Not community-dwelling

  • Expect to move outside of the area within 6 months

  • Cannot speak English

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama At Birmingham Birmingham Alabama United States 35205

Sponsors and Collaborators

  • University of Alabama at Birmingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andrea Cherrington, MD, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT05367544
Other Study ID Numbers:
  • IRB-300009015
First Posted:
May 10, 2022
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2022