Recruiting
Integrating Free-choice Marketplace, dieTitian coacHing, cultuRally Tailored messagIng to improVE Blood Pressure
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.
ClinicalTrials.gov IDNCT07075588
PhaseNA
Enrollment100
SponsorJohns Hopkins University
Age21 Years
SexALL
Conditions studied
Hypertension, Hypertension Complicated With Type 2 Diabetes
About this study
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.
Interventions
- Behavioral: iTHRIVE intervention — Integration 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
- Behavioral: Active comparator — Active 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
Primary outcomes
- Systolic blood pressure (mmHg) (Baseline, 3, 6 and 12 months)
Eligibility information
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
Study locations
- Johns Hopkins Community Physicians, Baltimore, Maryland 21205 United States
- Johns Hopkins School of Nursing, Baltimore, Maryland 21205 United States
- Holy Cross Hospital, Gaithersburg, Maryland 20876 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.