Church-based Intervention to Improve Blood Pressure in African Americans

Hypertension Clinical Trial

Official title:

Abundant Living: A Church-based Intervention to Improve Blood Pressure in African Americans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05220332
• Other study ID #: 18050306
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: February 2026

Study information

• Verified date: February 2024
• Source: Rush University Medical Center
• Contact: Elizabeth M Lynch, PhD
• Phone: 3125632254
• Email: elizabeth_lynch[@]rush.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 312
• Est. completion date: February 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Medication adherence	Medication adherence will be measured using the 15-item Adherence to Refills and Medications Scale (ARMS). The items are evaluated on a 4-point scale ranging from "none of the time" to "all of the time".	Measured at baseline and 6 months and 15 months after start of the intervention
Secondary	Change in DASH diet adherence	Adherence to the Dietary Approaches to Stop Hypertension (DASH) diet will be measured using the food frequency questionnaire developed by Viocare (Princeton, NJ). This 156-item graphical, web-based FFQ queries respondents about usual intakes of 156 food and beverage items over the past three months. It also provides food and nutrient analyses to the research team based on the Nutrition Data System for Research 2018 (NDSR, University of Minnesota, Minneapolis, MN).	Measured at baseline and 6 months and 15 months after start of the intervention
Secondary	Change in Self efficacy	Self efficacy will be measured using the Hypertension Self-Care Profile Self-efficacy scale which evaluates self efficacy for 8 common self care recommendations for individuals with hypertension. The items are evaluated on a 4-point scale ranging from "not confident" to "very confident".	Measured at baseline and 6 months and 15 months after start of the intervention
Secondary	Change in Quality of life	Quality of life will be measured using the EuroQual (EQ-5D-5L) questionnaire. The measure evaluates the participant's perception of their "health today" with respect to mobility, self-care, usual activities, pain/discomfort, and anxiety depression. The items are evaluated on a 5-point scale ranging from "no problem" in the area to "extreme problem" in the area.	Measured at baseline and 6 months and 15 months after start of the intervention
Secondary	Change in Social support	Social support for eating a healthy diet will be measured using a 4-item questionnaire which will evaluate the participant's perception of social support received from family members, friends, church members, and their Pastor. The items are evaluated on a 5-point scale ranging from "never" to "always".	Measured at baseline and 6 months and 15 months after start of the intervention
Secondary	Change in Hypertension knowledge	Hypertension knowledge will be evaluated using a 10-item questionnaire adapted from the Hypertension Evaluation of Lifestyle and Management (HELM) Knowledge Scale. Systolic and diastolic blood pressure measurements will be evaluated using the following 4 categories: high, low, normal, and don't know. The frequency with which medication should be taken, lifestyle factors associated with hypertension, and health risks associated with hypertension will also be evaluated.	Measured at baseline and 6 months and 15 months after start of the intervention
Secondary	Change in Nutrition knowledge	Nutrition knowledge will be evaluated using an 18-item survey adapted from the International Food Policy Study 2020 - United States Survey. Common foods and food labels are evaluated on a 10-point scale ranging from "not healthy at all" to "extremely healthy".	Measured at baseline and 6 months and 15 months after start of the intervention
Secondary	Change in Barriers to medication use	Barriers to medication use will be measured using the 15-item BRIGHT study Barriers to Medication Scale. The scale evaluates different reasons why it is difficult for participants to take medications or to take the medications on time. The items are evaluated on a 5-point scale ranging from "never" to "all the time".	Measured at baseline and 6 months and 15 months after start of the intervention