Church-based Intervention to Improve Blood Pressure in African Americans

NCT ID: NCT05220332

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-15

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Heart to Heart

Group Type EXPERIMENTAL

Heart to Heart

Intervention Type BEHAVIORAL

The Heart to Heart intervention will be delivered at the churches over 6 months. The intervention consists of 12 bible study sessions (45 minutes) led by the Senior Pastor and 24 behavior change small group sessions (90 minutes) led by a trained Rush staff interventionist. These sessions are open to the entire church membership and focus on improving diet and physical well being. A community health worker will provide individualized support to participants with uncontrolled blood pressure who do not reduce their blood pressure by participating in small groups.

Money Smart

Group Type ACTIVE_COMPARATOR

Money Smart

Intervention Type BEHAVIORAL

The Money Smart program for adults was developed by the Federal Deposit Insurance Corporation (FDIC). It consists of training modules that cover basic financial topics including deposit and credit services offered by financial institutions, how to obtain and use credit effectively, and the basics of building or repairing credit. This group-based program will be delivered in 14 sessions over 6 months and will be led by a trained instructor.

Interventions

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Heart to Heart

The Heart to Heart intervention will be delivered at the churches over 6 months. The intervention consists of 12 bible study sessions (45 minutes) led by the Senior Pastor and 24 behavior change small group sessions (90 minutes) led by a trained Rush staff interventionist. These sessions are open to the entire church membership and focus on improving diet and physical well being. A community health worker will provide individualized support to participants with uncontrolled blood pressure who do not reduce their blood pressure by participating in small groups.

Intervention Type BEHAVIORAL

Money Smart

The Money Smart program for adults was developed by the Federal Deposit Insurance Corporation (FDIC). It consists of training modules that cover basic financial topics including deposit and credit services offered by financial institutions, how to obtain and use credit effectively, and the basics of building or repairing credit. This group-based program will be delivered in 14 sessions over 6 months and will be led by a trained instructor.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Lynch

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Elizabeth M Lynch, PhD

Role: CONTACT

3125632254

Yolanda Cartwright, PhD, RD

Role: CONTACT

3129429697

Facility Contacts

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Elizabeth Lynch, PhD

Role: primary

312-563-2254

Yolanda Cartwright, PhD, RD

Role: backup

312-942-9697

Other Identifiers

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18050306

Identifier Type: -

Identifier Source: org_study_id

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