Recruiting

Digital FARMacy

Sponsor:

Johns Hopkins University

Code:

NCT07075588

Conditions

Hypertension

Hypertension Complicated With Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Accepted

Interventions

iTHRIVE intervention

Active comparator

Study Details

Brief summary:

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.

Conditions

Hypertension

Hypertension Complicated With Type 2 Diabetes

Study ID

NCT07075588

Start date

Jun 25, 2026

Status verified date

Jun, 2026

Completion date

Mar 20, 2028

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: iTHRIVE intervention arm

iTHRIVE 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 Arm

The active comparator arm will receive enhanced usual care, standard produce bags, general dietary advice, and a home blood pressure monitor

Interventions

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

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 outcome measure

  • Systolic blood pressure (mmHg) [ Time Frame: Baseline, 3, 6 and 12 months ]

Central Contacts and Locations

Central contacts

Oluwabunmi Ogungbe, PhD, MPH, RN

410-614-1519oogungb3@jh.edu

Yvonne Commodore-Mensah, PhD, MHS, RN

410614159ycommod1@jhmi.edu

Locations

Johns Hopkins Community Physicians

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Margaret Utibe

410-873-7993thrive-fim@jh.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Keywords

  • Digital Farmacy
  • DASH Diet
  • Personalized dietitian coaching

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-06-30.