Integrating Free-choice Marketplace, dieTitian coacHing, cultuRally Tailored messagIng to improVE Blood Pressure

NCT07075588 | Recruiting

• 2 other identifiers: IRB0045738025CDA1453103
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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

Keywords

Digital Farmacy; DASH Diet; Personalized dietitian coaching

Outcome Measures

Primary Outcomes (1)

• Systolic blood pressure (mmHg)

  Systolic blood pressure measured in millimeters of mercury (mmHg) by the home blood pressure device and in the electronic medical record (EMR)

  Baseline, 3, 6 and 12 months

Secondary Outcomes (6)

• Hemoglobin A1c (percent)

  Baseline, 3, and 6 months

• Weight in pounds

  Baseline, 3, 6, and 12 months

• Change in Dietary Patterns assessed by 24 hour dietary recall

  Baseline and 6 months

• Cost effectiveness

  Baseline and 12 weeks

• Cultural appropriateness and acceptability assessed by Cultural Sensitivity Assessment Tool

  Baseline, 6 and 12 months

Study Arms (2)

iTHRIVE intervention arm

EXPERIMENTAL

iTHRIVE intervention will include access to a digital produce prescription platform, virtual dietitian coaching, a Home blood pressure monitor with App integration, and produce

Behavioral: iTHRIVE intervention

Comparator Arm

ACTIVE COMPARATOR

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

Behavioral: Active comparator

Interventions

Active comparator BEHAVIORAL

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

Comparator Arm

iTHRIVE intervention BEHAVIORAL

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

iTHRIVE intervention arm

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• % 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American Heart Association: collaborator
• Johns Hopkins University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (3)

Johns Hopkins Community Physicians

Baltimore, Maryland, 21205, United States

RECRUITING

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

NOT YET RECRUITING

Holy Cross Hospital

Gaithersburg, Maryland, 20876, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Oluwabunmi Ogungbe, PhD, MPH, RN

  Johns Hopkins School of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oluwabunmi Ogungbe, PhD, MPH, RN

CONTACT

410-614-1519; oogungb3@jh.edu

Yvonne Commodore-Mensah, PhD, MHS, RN

CONTACT

410614159; ycommod1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 20, 2025
• Study Start: June 25, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): March 20, 2028
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)