Integrating Free-choice Marketplace, dieTitian coacHing, cultuRally Tailored messagIng to improVE Blood Pressure
About this study
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.
- Condition
- Hypertension, Hypertension Complicated With Type 2 Diabetes
- Tested
- iTHRIVE intervention, Active comparator
- Sponsor
- Johns Hopkins University
Who can join
- Age
- 21 to 70 years
- Sex
- All sexes
- Healthy volunteers
- Accepted
Inclusion 15
- Minimum age: 21 years
- Maximum age: 70 years
- Study condition: Hypertension, Hypertension Complicated With Type 2 Diabetes
- 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 9
- 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
3 sites, 3 recruiting
Johns Hopkins Community Physicians
Baltimore, Maryland, United States
Johns Hopkins School of Nursing
Baltimore, Maryland, United States
Holy Cross Hospital
Gaithersburg, Maryland, United States
Contact
-
Oluwabunmi Ogungbe, PhD, MPH, RN
410-614-1519 oogungb3@jh.edu
-
Yvonne Commodore-Mensah, PhD, MHS, RN
410614159 ycommod1@jhmi.edu
Potential match only. Final eligibility is determined by the study team.