NCT07075588 · Johns Hopkins University
Integrating Free-choice Marketplace, dieTitian coacHing, cultuRally Tailored messagIng to improVE Blood Pressure
(iTHRIVE)
What this study is about
iTHRIVE intervention is a 2-treatment group$1 randomly assigned 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.
View original scientific description
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 outcome measures
Systolic blood pressure (mmHg)
Time frame: Baseline, 3, 6 and 12 months
Systolic blood pressure measured in millimeters of mercury (mmHg) by the home blood pressure device and in the electronic medical record (EMR)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Baltimore, Maryland
- Gaithersburg, Maryland
Collaborators
American Heart Association, National Institute on Minority Health and Health Disparities (NIMHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 30, 2026 · Source of record for eligibility and locations