Equity in Prevention and Progression of Hypertension by Addressing Barriers to Nutrition and Physical activitY (EPIPHANY)
Primary Purpose
Prehypertension, Hypertension, Blood Pressure
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health Education
Individual-Level Peer Support
Community-Level Peer Support
Sponsored by
About this trial
This is an interventional prevention trial for Prehypertension
Eligibility Criteria
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
Sites / Locations
- University of Alabama At BirminghamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Health Education & Peer Coaching
Health Education Only
Arm Description
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
Participants will have access to online health education materials but will not receive individualized peer support
Outcomes
Primary Outcome Measures
Incident Blood Pressure
Change in systolic blood pressure and diastolic blood pressure
Secondary Outcome Measures
Fruit/Vegetable/Fiber Intake
Change in consumption of fruits, vegetables, and fiber rich foods
Physical Activity
Change in days per week participant participates in moderate and/or vigorous physical activity
Alcohol use
Change in consumption of alcoholic beverages
Smoking
Change in frequency in use of tobacco problems
Full Information
NCT ID
NCT05367544
First Posted
April 12, 2022
Last Updated
June 26, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT05367544
Brief Title
Equity in Prevention and Progression of Hypertension by Addressing Barriers to Nutrition and Physical activitY
Acronym
EPIPHANY
Official Title
Equity in Prevention and Progression of Hypertension by Addressing Barriers to Nutrition and Physical activitY
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 13, 2022 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prehypertension, Hypertension, Blood Pressure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
528 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Health Education & Peer Coaching
Arm Type
Experimental
Arm Description
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
Arm Title
Health Education Only
Arm Type
Active Comparator
Arm Description
Participants will have access to online health education materials but will not receive individualized peer support
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Individual-Level Peer Support
Intervention Description
Participants will receive bi-weekly peer support calls for 6 months, followed by monthly calls for another 6 months.
Intervention Type
Behavioral
Intervention Name(s)
Community-Level Peer Support
Intervention Description
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)
Primary Outcome Measure Information:
Title
Incident Blood Pressure
Description
Change in systolic blood pressure and diastolic blood pressure
Time Frame
Baseline, 6 months,12 months, 24 months
Secondary Outcome Measure Information:
Title
Fruit/Vegetable/Fiber Intake
Description
Change in consumption of fruits, vegetables, and fiber rich foods
Time Frame
Baseline, 6 months,12 months, 24 months
Title
Physical Activity
Description
Change in days per week participant participates in moderate and/or vigorous physical activity
Time Frame
Baseline, 6 months,12 months, 24 months
Title
Alcohol use
Description
Change in consumption of alcoholic beverages
Time Frame
Baseline, 6 months,12 months, 24 months
Title
Smoking
Description
Change in frequency in use of tobacco problems
Time Frame
Baseline, 6 months,12 months, 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Self-identify as Black/African American
Mean systolic blood pressure 120-139mmHg OR diastolic blood pressure 80-89mmHg
Exclusion Criteria:
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 24 months
Not having a cellular phone or landline
Inability to speak English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Cherrington, MD
Phone
2059962885
Email
acherrington@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sh'Nese Holmes, MHA
Phone
2059347157
Email
sholmes@uabmc.edu
Facility Information:
Facility Name
University of Alabama At Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Cherrington
Phone
205-996-2885
Email
cherrington@uab.edu
First Name & Middle Initial & Last Name & Degree
Sh'Nese Holmes
Phone
(205) 934-7157
Email
sholmes@uabmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD with other researchers
Learn more about this trial
Equity in Prevention and Progression of Hypertension by Addressing Barriers to Nutrition and Physical activitY
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