Church-based Intervention to Improve Blood Pressure in African Americans

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Heart to Heart

Money Smart

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Rush University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Heart to Heart

Money Smart

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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".

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).

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".

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.

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".

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.

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".

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".

Full Information

NCT ID

NCT05220332

First Posted

January 21, 2022

Last Updated

January 30, 2023

Sponsor

Rush University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05220332

Brief Title

Church-based Intervention to Improve Blood Pressure in African Americans

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 15, 2022 (Actual)

Primary Completion Date

July 2025 (Anticipated)

Study Completion Date

February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rush University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

312 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Heart to Heart

Arm Type

Experimental

Arm Title

Money Smart

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

Heart to Heart

Intervention Description

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

Intervention Name(s)

Money Smart

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Blood pressure

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

Change in Medication adherence

Description

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".

Time Frame

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

Title

Change in DASH diet adherence

Description

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).

Time Frame

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

Title

Change in Self efficacy

Description

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".

Time Frame

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

Title

Change in Quality of life

Description

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.

Time Frame

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

Title

Change in Social support

Description

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".

Time Frame

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

Title

Change in Hypertension knowledge

Description

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.

Time Frame

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

Title

Change in Nutrition knowledge

Description

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".

Time Frame

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

Title

Change in Barriers to medication use

Description

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".

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Elizabeth M Lynch, PhD

Phone

3125632254

Email

elizabeth_lynch@rush.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Yolanda Cartwright, PhD, RD

Phone

3129429697

Email

yolanda_cartwright@rush.edu

Facility Information:

Facility Name

Rush University Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60422

Country

United States

Individual Site Status

Recruiting

Facility Contact: