Integrating Free-choice Marketplace, dieTitian coacHing, cultuRally Tailored messagIng to improVE Blood Pressure
Launched by JOHNS HOPKINS UNIVERSITY · Jul 17, 2025
Trial Information
Current as of July 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial, called iTHRIVE, is studying a new way to help adults with high blood pressure, especially those who also have type 2 diabetes or kidney problems. The study will test a program that combines digital tools, coaching from dietitians who give personalized advice and produce prescriptions (meaning participants get help accessing fresh fruits and vegetables), and home blood pressure monitoring. The goal is to see if this approach can improve blood pressure control in people living in areas where healthy food is hard to find.
To take part, you need to be between 21 and 70 years old, identify as Black/African American or Hispanic/Latino, and have high blood pressure along with prediabetes, type 2 diabetes, or moderate kidney disease. Participants must live in specific communities in Maryland where access to healthy food is limited and meet certain income and living conditions. During the study, participants will receive personalized diet support, fresh produce, and tools to measure their blood pressure at home. The trial is not yet recruiting, and people with serious health issues, certain dietary restrictions, or other ongoing health programs may not be eligible. This study aims to find better ways to support people in managing their blood pressure through diet and technology in their own homes.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 21-70 years
- • Self-identify as Black/African American or Hispanic/Latino
- * Have Stage 2 CKM defined as:
- * Systolic BP ≥130mmHg (measured at screening) AND at least one of:
- • Hypertension (ICD-10: I10-I16)
- • Prediabetes (HbA1c 5.7-6.4%) or Type 2 Diabetes (HbA1c ≥6.5%)
- • Stage 3 chronic kidney disease (CKD) (eGFR 30-59 mL/min/1.73m²)
- * Live in census tracts identified by the Montgomery/ Prince George's/Baltimore City County Departments of Planning as HFPA:
- • Healthy Food Availability Index score is low (0-9.5),
- • Median household income ≤185% of Federal Poverty Level
- • 30% of households have no vehicle,
- • Distance to supermarket \>1/4 mile. 5. Have refrigeration, food preparation appliances (microwave, stove), and cell phones for the App
- Exclusion Criteria:
- • Age \<21 years
- • Diagnosis of end-stage renal disease (ESRD), dialysis
- • Serious medical condition that either limits life expectancy or requires active management (e.g., cancer)
- • Significant food allergies, preferences, intolerances, or dietary requirements that would interfere with diet adherence
- • Active alcohol or substance use disorder (i.e., not sober/abstinent for ≥ 30 days)
- • Patients with cognitive impairment or other condition preventing their participation in the intervention
- • Pregnant, breastfeeding, or planning pregnancy
- • Current participation in a care management program related to health conditions (e.g., weight reduction, smoking cessation) or another clinical trial that could interfere with the study protocol
- • Planning to move out of the geographic area in 12 months
About Johns Hopkins University
Johns Hopkins University, a prestigious research institution located in Baltimore, Maryland, is renowned for its commitment to advancing medical science and public health through innovative clinical trials. With a rich history of groundbreaking research and a multidisciplinary approach, the university's clinical trial initiatives focus on translating scientific discoveries into effective treatments and interventions. Leveraging state-of-the-art facilities and a collaborative network of experts, Johns Hopkins University conducts rigorous clinical studies that aim to improve patient outcomes and address critical health challenges. Its dedication to ethical standards and participant safety underscores its role as a leader in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Baltimore, Maryland, United States
Patients applied
Trial Officials
Oluwabunmi Ogungbe, PhD, MPH, RN
Principal Investigator
Johns Hopkins School of Nursing
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported