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 @ 5:14 PM
Ignite Modification Date:
2025-12-24 @ 5:14 PM
NCT ID:
NCT06257550
Eligibility Criteria:
Inclusion Criteria:
1. 18 years or older
2. Self-identify as Black/African American
3. Have diagnosed hypertension stages 1 (130-139/80-89 mm Hg) OR 2 (\>140/90 mm Hg), determined via self-report and/or Electronic Medical Records (EMR)
4. Live in census tracts identified by Montgomery County Department of Planning as HFPA:
1. Healthy Food Availability Index score is low (0-9.5),
2. Median household income ≤185% of Federal Poverty Level
3. \>30% households have no vehicle, Distance to supermarket \>1/4 mile.
5. Participants must have refrigeration, food appliances (microwave, stove),
6. Cell phone to receive messages
Exclusion Criteria:
1. Age \<18 years
2. Type 1 or Type 2 Diabetes defined as a hemoglobin A1c ≥6.5% or diabetes treatment
3. Diagnosis of end-stage renal disease (ESRD)
4. Condition which interferes with outcome measurement (e.g., dialysis)
5. Serious medical condition which either limits life expectancy or requires active management (e.g. cancer)
6. Significant food allergies, preferences, intolerances, or dietary requirements that would interfere with diet adherence
7. Patients with cognitive impairment or other condition preventing their participation in the intervention
8. Current participation in a care management program related to health conditions (e.g., weight reduction, smoking cessation)
9. Current participation in another clinical trial that could interfere with the study protocol
10. Those planning to move out of the geographic area in 12 months
11. Unwillingness to provide informed consent
12. Other conditions or situations at the discretion of the Investigative team
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT06257550
Study Brief:
Protocol Section:
NCT06257550