ClinicalTrials.gg
CompletedNCT05367544EPIPHANYUpdated Oct 5, 2026

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

An interventional study of Health Education and Individual-Level Peer Support in Prehypertension, Hypertension and Blood Pressure, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Prevention

Updated Oct 5, 2026Now CompletedStudy completion moved+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
416
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Prehypertension
  • Hypertension
  • Blood Pressure
03

In context

Prehypertension

158 studies on the registry are indexed under Prehypertension; 21 are open to participants now.

This study's enrollment of 416 is above the median of 66 across 138 interventional studies indexed under Prehypertension.

Browse Prehypertension studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.

Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
416 participants (actual)

Study arms

  • 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 · Behavioral: Individual-Level Peer Support · Behavioral: Community-Level Peer Support

  • Active comparator
    Health Education Only

    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

  • BehavioralHealth 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

  • BehavioralIndividual-Level Peer Support

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

  • BehavioralCommunity-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)

06

What researchers measure

Primary outcomes

  1. Incident Blood Pressure

    Change in systolic blood pressure and diastolic blood pressure

    Time frame: Baseline, 6 months,12 months, 18 months

Secondary outcomes

  1. Fruit/Vegetable/Fiber Intake

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

    Time frame: Baseline, 6 months,12 months, 18 months

  2. Physical Activity

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

    Time frame: Baseline, 6 months,12 months, 18 months

  3. Alcohol use

    Change in consumption of alcoholic beverages

    Time frame: Baseline, 6 months,12 months, 18 months

  4. Smoking

    Change in frequency in use of tobacco problems

    Time frame: Baseline, 6 months,12 months, 18 months

07

Study locations

1 site
  • University of Alabama At Birmingham
    Birmingham, Alabama 35205, United States
08

References and documents

Individual participant data

Plan to share: No — No plan to share IPD with other researchers

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2022 to primary completion in Feb 2026, 42 months.

Of 56 non-industry interventional studies with no phase under Prehypertension, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 37. This study's 42 months is above that.

Counting every sponsor, half of 60 studies reached it within 20 months; a quarter within 11 and three quarters within 37.

Completion moved once since we started tracking on Sep 25, 2026: Sep 2026 → Aug 2026, on Oct 5, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Apr 12, 2022
First posted
May 10, 2022
StartActual
Aug 13, 2022
Primary completionActual
Feb 20, 2026
CompletionActual
Aug 15, 2026was Sep 2026
Last update
Oct 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Active, not recruiting→Completed
changed Oct 5, 2026
Study completion
Sep 2026→Aug 15, 2026 (actual)
Oct 5, 2026
Enrollment
528 (estimated)→416 (actual)
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    Active, not recruiting→Completed
    Study completion Sep 2026→Aug 15, 2026 (now actual)
    Enrollment 528 (estimated)→416 (actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05367544
Collaborators
American Heart Association
Responsible party
Andrea Cherrington, MD (Professor, University of Alabama at Birmingham) — Principal investigator
First posted
May 10, 2022
Start date
Aug 13, 2022
Primary completion
Feb 20, 2026
Completion
Aug 15, 2026
Last update
Oct 5, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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