Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT05220332
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05220332
Study Brief:
Protocol Section:
NCT05220332