Church-based Intervention to Improve Blood Pressure in African Americans

NCT05220332 | Recruiting DMC

• 1 other identifier: 18050306
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in Blood pressure

  The primary outcome is systolic blood pressure at 6 months post start of the intervention. The Omron digital blood pressure monitor will be utilized to measure blood pressure (Omron Healthcare, Inc., Lake Forest, IL). The participant will sit quietly for \>5 minutes, 3 readings will be taken 1-2 minutes apart while seated, and an average of the last 2 readings will be taken to evaluate blood pressure.

  Measured at baseline and 6 months and 12 months after start of the intervention

Secondary Outcomes (8)

• Change in Medication adherence

  Measured at baseline and 6 months and 15 months after start of the intervention

• Change in DASH diet adherence

  Measured at baseline and 6 months and 15 months after start of the intervention

• Change in Self efficacy

  Measured at baseline and 6 months and 15 months after start of the intervention

• Change in Quality of life

  Measured at baseline and 6 months and 15 months after start of the intervention

• Change in Social support

  Measured at baseline and 6 months and 15 months after start of the intervention

Study Arms (2)

Heart to Heart

EXPERIMENTAL

Behavioral: Heart to Heart

Money Smart

ACTIVE COMPARATOR

Behavioral: Money Smart

Interventions

Heart to Heart 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.

Heart to Heart

Money Smart 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.

Money Smart

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60422, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Elizabeth M Lynch, PhD

CONTACT

3125632254; elizabeth_lynch@rush.edu

Yolanda Cartwright, PhD, RD

CONTACT

3129429697; yolanda_cartwright@rush.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 2, 2022
• Study Start: March 15, 2022
• Primary Completion: February 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)