Integrating Free-choice Marketplace, dieTitian coacHing, cultuRally Tailored messagIng to improVE Blood Pressure
Recruiting · NCT07075588 · Interventional (participants receive a specific treatment) · Lead sponsor: Johns Hopkins University
View the official record on ClinicalTrials.gov →Interventions studied
Active comparatoriTHRIVE intervention
What this trial is about
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.
Who can take part
Age range
21 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
6 locations listed across 1 US state.
- Johns Hopkins Community Physicians - Baltimore, Maryland, United States
- Johns Hopkins School of Nursing - Baltimore, Maryland, United States
- Johns Hopkins Community Physicians - Baltimore, Maryland, United States
- Johns Hopkins School of Nursing - Baltimore, Maryland, United States
- Holy Cross Hospital - Gaithersburg, Maryland, United States
- Holy Cross Hospital - Gaithersburg, Maryland, United States