Church-based Intervention to Improve Blood Pressure in African Americans

Rush

Status: Enrolling

Conditions: Hypertension

Treatments: Behavioral: Heart to Heart; Behavioral: Money Smart

Study type: Interventional

Funder types: Other

Identifiers

NCT05220332

18050306

Details and patient eligibility

About

This is a 12-month behavioral cluster-randomized trial testing a church-based intervention to reduce blood pressure in African Americans with uncontrolled blood pressure.

Enrollment: 312 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Churches:

• At least 75 members and ability to recruit 15 study participants
• Predominantly African American congregants

Participants:

• Age 18 or older

• Has blood pressure readings with uncontrolled blood pressure, defined as exceeding the blood thresholds for initiation of antihypertensive medication according to the 2017 American College of Cardiology/ American Heart Association (ACC/AHA) guidelines.

  - The thresholds are 140/90 for the general population < 65 years old, and 130/80 for individuals ≥ 65 or with diabetes, chronic kidney disease, or high cardiovascular risk (self-report of prior diagnosis of myocardial infarction, coronary heart disease, stroke or heart failure)

• Attends church (virtually or in-person) at least once per month

• Able to attend weekly Zoom meetings

• Consents and completes all baseline assessments

Exclusion criteria

Churches:

• Pastor unwilling to conduct Bible study

Participants:

• Unable to make dietary changes due to lack of control over their food source (i.e., eat meals at shelter, nursing home)
• Has a medical condition that prohibits or severely restricts ability to eat vegetables (i.e., renal disease, Crohn's disease)
• Has a medical condition with an uncertain 6-month prognosis
• Inability to give informed consent (i.e., cognitive impairment, does not speak Englis
• Plans to move within the 6 months following enrollment
• Participated in prior ALIVE intervention
• Member of household participating in another church

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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312 participants in 2 patient groups

Heart to Heart

Experimental group

Treatment:

Behavioral: Heart to Heart

Money Smart

Active Comparator group

Treatment:

Behavioral: Money Smart