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

NCT05367544 | Active Not Recruiting DMC

• 3 other identifiers: IRB-300009015878832UAB
• Study Type: interventional
• Target: 528
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Blood Pressure; Prehypertension

Outcome Measures

Primary Outcomes (1)

• Incident Blood Pressure

  Change in systolic blood pressure and diastolic blood pressure

  Baseline, 6 months,12 months, 18 months

Secondary Outcomes (4)

• Fruit/Vegetable/Fiber Intake

  Baseline, 6 months,12 months, 18 months

• Physical Activity

  Baseline, 6 months,12 months, 18 months

• Alcohol use

  Baseline, 6 months,12 months, 18 months

• Smoking

  Baseline, 6 months,12 months, 18 months

Study Arms (2)

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

Behavioral: Health Education; Behavioral: Individual-Level Peer Support; Behavioral: Community-Level Peer Support

Health Education Only

ACTIVE COMPARATOR

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

Behavioral: Health Education; Behavioral: Community-Level Peer Support

Interventions

Health Education BEHAVIORAL

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

Health Education & Peer Coaching; Health Education Only

Individual-Level Peer Support BEHAVIORAL

Participants will receive bi-weekly peer support calls for 6 months, followed by monthly calls for another 6 months.

Health Education & Peer Coaching

Community-Level Peer Support BEHAVIORAL

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)

Health Education & Peer Coaching; Health Education Only

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• American Heart Association: collaborator

Study Sites (1)

University of Alabama At Birmingham

Birmingham, Alabama, 35205, United States

Location

MeSH Terms

Conditions

Prehypertension; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: May 10, 2022
• Study Start: August 13, 2022
• Primary Completion: February 20, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)