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Lifestyle Intervention for High Blood Pressure (EPIPHANY Trial)

N/A

Recruiting

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not taking any antihypertensive medication

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

Must not have

Self-reported history of hypertension outside of pregnancy

Currently taking antihypertensive medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months,12 months, 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing an intervention to lower blood pressure in rural Black adults in Alabama, who have some of the highest rates in the US. The intervention includes group health education, online cooking and exercise classes, and support from health coaches.

Who is the study for?

This trial is for Black/African American adults living in rural Alabama with slightly elevated blood pressure, but not high enough to require medication. Participants should be under 65 years old without a history of heart disease, diabetes, or kidney issues and must speak English. They can't join if they're pregnant, planning to move soon, or don't have a phone.

What is being tested?

The study tests whether health education and peer support interventions delivered through churches can lower blood pressure among rural Black adults. Half the churches offer group education and online resources; the other half adds personalized telephone coaching from trained church members.

What are the potential side effects?

Since this trial focuses on lifestyle changes like diet improvements and increased physical activity rather than medications, side effects are minimal but may include muscle soreness from exercise or changes in digestion due to dietary adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not on any blood pressure medication.

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I have no history of heart disease, diabetes, or kidney problems.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had high blood pressure not related to pregnancy.

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I am currently on medication for high blood pressure.

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I have a history of heart disease.

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I cannot speak English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months,12 months, 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months,12 months, 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months,12 months, 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incident Blood Pressure

Secondary study objectives

Alcohol use

Fruit/Vegetable/Fiber Intake

Physical Activity

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Health Education & Peer CoachingExperimental Treatment3 Interventions

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

Group II: Health Education OnlyActive Control2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Health Education

2014

Completed Phase 3

~4410

0 / 6Eligibility criteria met