Clinical trial NCT05220332: 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
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Blood pressure
timeFrame: Measured at baseline and 6 months and 12 months after start of the intervention
Secondary outcomes:
measure: Change in Medication adherence
timeFrame: Measured at baseline and 6 months and 15 months after start of the intervention
measure: Change in DASH diet adherence
timeFrame: Measured at baseline and 6 months and 15 months after start of the intervention
measure: Change in Self efficacy
timeFrame: Measured at baseline and 6 months and 15 months after start of the intervention
measure: Change in Quality of life
timeFrame: Measured at baseline and 6 months and 15 months after start of the intervention
measure: Change in Social support
timeFrame: Measured at baseline and 6 months and 15 months after start of the intervention
measure: Change in Hypertension knowledge
timeFrame: Measured at baseline and 6 months and 15 months after start of the intervention
measure: Change in Nutrition knowledge
timeFrame: Measured at baseline and 6 months and 15 months after start of the intervention
measure: Change in Barriers to medication use
timeFrame: Measured at baseline and 6 months and 15 months after start of the intervention
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References: