PrehypertensionEPIPHANYNCT05367544
Equity in Prevention and Progression of Hypertension by Addressing Barriers to Nutrition and Physical activitY
A study testing Health Education, Individual-Level Peer Support and Community-Level Peer Support in people with Prehypertension and Hypertension, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prehypertension, Hypertension, Blood Pressure
- What is being tested?
- Health Education, Individual-Level Peer Support and Community-Level Peer Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2022to 15 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identify as Black/African American
- Mean systolic blood pressure 120-139mmHg OR diastolic blood pressure 80-89mmHg
Who cannot join
- 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
Show all 9Show fewer
- Planning to move out of the county within the next 18 months
- Not having a cellular phone or landline
- Inability to speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama At Birmingham
Birmingham, Alabama, 35205
About this study
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
- Prehypertension, Hypertension, Blood Pressure
- Being tested
- Health Education, Individual-Level Peer Support, Community-Level Peer Support
- Medical subject headings
- Prehypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health EducationBehavioural
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 SupportBehavioural
Participants will receive bi-weekly peer support calls for 6 months, followed by monthly calls for another 6 months.
Community-Level Peer SupportBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Health Education; Behavioral: Community-Level Peer Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident Blood Pressure
Change in systolic blood pressure and diastolic blood pressure
Measured: Baseline, 6 months,12 months, 18 months
Secondary outcomes (4)
Fruit/Vegetable/Fiber Intake
Change in consumption of fruits, vegetables, and fiber rich foods
Measured: Baseline, 6 months,12 months, 18 months
Physical Activity
Change in days per week participant participates in moderate and/or vigorous physical activity
Measured: Baseline, 6 months,12 months, 18 months
Alcohol use
Change in consumption of alcoholic beverages
Measured: Baseline, 6 months,12 months, 18 months
Smoking
Change in frequency in use of tobacco problems
Measured: Baseline, 6 months,12 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start13 Aug 2022
- Primary completion20 Feb 2026
- Study completion15 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehypertensionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Andrea Cherrington, MD, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367544
- Sponsor's protocol ID
- IRB-300009015
- Other IDs
- 878832, UAB
- Acronym
- EPIPHANY
- Status last verified
- Sep 2026
- First submitted
- 12 Apr 2022
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Equity in Prevention and Progression of Hypertension by Addressing Barriers to Nutrition and Physical activitY
- ClinicalTrials.gov ID
- NCT05367544
- Acronym / sponsor ID
- EPIPHANY / IRB-300009015
- Conditions
- Prehypertension, Hypertension, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 13 Aug 2022 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 15 Aug 2026 (actual)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Education & Peer Coaching | Experimental | Behavioral: Health Education, Behavioral: Individual-Level Peer Support, Behavioral: Community-Level Peer SupportParticipants 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 |
| Health Education Only | Active comparator | Behavioral: Health Education, Behavioral: Community-Level Peer SupportParticipants will have access to online health education materials but will not receive individualized peer support |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Self-identify as Black/African American
- Mean systolic blood pressure 120-139mmHg OR diastolic blood pressure 80-89mmHg
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health EducationAll 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 | Behavioural | Health Education & Peer Coaching, Health Education Only |
| Individual-Level Peer SupportParticipants will receive bi-weekly peer support calls for 6 months, followed by monthly calls for another 6 months. | Behavioural | Health Education & Peer Coaching |
| Community-Level Peer SupportChurch 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) | Behavioural | Health Education & Peer Coaching, Health Education Only |
Primary outcome
Incident Blood Pressure
Time frame: Baseline, 6 months,12 months, 18 months
Change in systolic blood pressure and diastolic blood pressure
4 secondary outcomes
Fruit/Vegetable/Fiber Intake
Time frame: Baseline, 6 months,12 months, 18 months
Physical Activity
Time frame: Baseline, 6 months,12 months, 18 months
Alcohol use
Time frame: Baseline, 6 months,12 months, 18 months
Smoking
Time frame: Baseline, 6 months,12 months, 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No. No plan to share IPD with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Education, Individual-Level Peer Support and Community-Level Peer Support in people with Prehypertension and Hypertension, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident Blood Pressure (time frame: Baseline, 6 months,12 months, 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.