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

N/ANot Yet RecruitingNCT07075588

Johns Hopkins University100 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

100

Conditions

Hypertension Hypertension Complicated With Type 2 Diabetes

Interventions

iTHRIVE interventionBEHAVIORAL

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

Active comparatorBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Johns Hopkins School of Nursing

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Systolic blood pressure (mmHg)

Systolic blood pressure measured in millimeters of mercury (mmHg) by the home blood pressure device and in the electronic medical record (EMR)

Time frame: Baseline, 3, 6 and 12 months

Secondary Outcomes

Hemoglobin A1c (percent)

Hemoglobin A1c

Time frame: Baseline, 3, and 6 months

Weight in pounds

Weight will be measured in pounds

Time frame: Baseline, 3, 6, and 12 months

Change in Dietary Patterns assessed by 24 hour dietary recall

Change in Dietary Approaches to Stop Hypertension (DASH) adherence scores are summarized from 24-hour dietary recall administered by the investigator. Score range 0-9, higher scores indicate better adherence.

Time frame: Baseline and 6 months

Cost effectiveness

Intervention cost/person will be estimated based on the total cost of the intervention and the estimated cost of treatment

Time frame: Baseline and 12 weeks

Cultural appropriateness and acceptability assessed by Cultural Sensitivity Assessment Tool

Self-reported acceptance of Data Apps using Cultural Sensitivity Assessment Tool ( CSAT) with a score range of 1 to 4. A score of 2.5 is the cut-off score for acceptability

Time frame: Baseline, 6 and 12 months

Height in inches

Height will be measured in inches

Time frame: Baseline, 3,6 and 12months

Central Contacts

Oluwabunmi Ogungbe, PhD, MPH, RN

CONTACT

410-614-1519 oogungb3@jh.edu

Yvonne Commodore-Mensah, PhD, MHS, RN

CONTACT

410614159 ycommod1@jhmi.edu

Data from ClinicalTrials.gov

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