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

Johns Hopkins University

Status: Begins enrollment in 2 months

Conditions: Hypertension; Hypertension Complicated With Type 2 Diabetes

Treatments: Behavioral: iTHRIVE intervention; Behavioral: Active comparator

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07075588

IRB00457380

25CDA1453103 (Other Grant/Funding Number)

Details and patient eligibility

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.

Full description

Cardiovascular-kidney-metabolic (CKM) syndrome is a devastating public health crisis that affects nearly 90% of US adults. CKM accounts for >30% of all US deaths and >5 million hospitalizations annually and imposes an annual economic burden of ≥$1 trillion, with a disproportionate impact on Black, Hispanic adults. Inequitable access to care, high-quality food, culturally tailored dietitian support, and living in "food deserts" (also known as Healthy Food Priority Areas (HFPAs) exacerbate CKM disparities. Innovative approaches are urgently needed to sustainably improve food access and CKM health of Black and Hispanic adults.

More than three times as many Black adults (31%) in Baltimore City live in HFPAs compared to White adults (9%). About 45% of households in Montgomery County earn less than the self-sufficiency standard, 64% of Supplemental Nutrition Assistance Program (SNAP)-eligible adults are unenrolled, the highest rate in MD. In 2022, 48% of Prince George's County residents lived in HFPAs. Reasons for these disparities are complex and comprise factors at the individual, provider, community, and systemic levels.

Evidence-based interventions that improve CKM health include personalized dietitian coaching, home blood pressure monitoring (HBPM), and culturally tailored messages. Digital interventions could improve access to dietitians and fruits/vegetables (f/v) through digital "FARMacy" (akin to a virtual farmers market). Implementation strategies for the delivery of these digital interventions are critical gaps, and clinic integration remains unclear. Digital FARMacy platforms offer potential for increased reach and engagement-relative effectiveness and implementation approach have not been explored.

The investigators propose to test the effects of iTHRIVE using a randomized controlled trial among 100 adult participants living in HFPAs in MD counties with uncontrolled BP defined as systolic blood pressure (SBP) ≥130 milimiters of mercury (mmHg) and diabetes or moderate risk chronic renal disease. Participants will be randomized to either iTHRIVE (digital FARMacy, personalized dietitian coaching with produce prescription [PRx], and HBPM) or enhanced usual care (EUC, general dietary advice, standard food bags). The investigators will assess the effectiveness of iTHRIVE in improving systolic blood pressure at 6 months and evaluate the reach, adoption, implementation, maintenance, and budget impact of iTHRIVE

Enrollment: 100 estimated patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 2 patient groups

iTHRIVE intervention arm

Experimental group

Description:

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

Treatment:

Behavioral: iTHRIVE intervention

Comparator Arm

Active Comparator group

Description:

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

Treatment:

Behavioral: Active comparator