Integrating Free-choice Marketplace, dieTitian coacHing, cultuRally Tailored messagIng to improVE Blood Pressure
Part of paid clinical trials in Baltimore, Maryland.
- Sponsor
- Johns Hopkins University
- Study ID
- NCT07075588
- Status
- Recruiting
Conditions
- Hypertension
- Hypertension Complicated With Type 2 Diabetes
Eligibility Criteria
- Sex
- ALL
- Age
- 21 Years - 70 Years
- Healthy Volunteers
- Accepted
Interventions
- iTHRIVE intervention — BEHAVIORALIntegration of three traditionally siloed components: 1. Digitally enabled food access 2. Personalized nutrition support 3. Clinical care-rision of home blood pressure device with app
- Active comparator — BEHAVIORALActive comparator arm will receive enhanced usual care that consists of: 1. Standard produce bag 2. Home blood pressure Device without app 3. General dietary advice
Study Details
iTHRIVE intervention is a 2-arm randomized controlled trial testing the effects of digital FARMacy, personalized dietitian coaching with produce prescriptions, and home blood pressure measurement in 100 hypertensive adults living in high food priority areas in counties in Maryland.
Key Dates
- First listed
- Jul 20, 2025
- Start date
- Jun 25, 2026
- Status verified
- Jun 2026
- Primary completion
- Apr 30, 2027
- Completion
- Mar 20, 2028
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: iTHRIVE intervention armiTHRIVE intervention will include access to a digital produce prescription platform, virtual dietitian coaching, a Home blood pressure monitor with App integration, and produce
- Active Comparator: Comparator ArmThe active comparator arm will receive enhanced usual care, standard produce bags, general dietary advice, and a home blood pressure monitor
Primary Outcome Measure
Systolic blood pressure (mmHg) [ Time Frame: Baseline, 3, 6 and 12 months ]
Central Contacts
- Oluwabunmi Ogungbe, PhD, MPH, RN410-614-1519
- Yvonne Commodore-Mensah, PhD, MHS, RN410614159
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Johns Hopkins Community Physicians | Baltimore | Maryland | 21205 | |
| Johns Hopkins School of Nursing | Baltimore | Maryland | 21205 | |
| Holy Cross Hospital | Gaithersburg | Maryland | 20876 | Erix Rivera (PRINCIPAL_INVESTIGATOR) |
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