HypertensionHypertension Complicated With Type 2 Diabetes
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
21 – 70
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
100 (estimated)
Sponsor
Johns Hopkins University · Other
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
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 …
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
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