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| ID | Type | Description | Link |
|---|---|---|---|
| 25CDA1453103 | Other Grant/Funding Number | American Heart Association |
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iTHRIVE intervention arm | Experimental | iTHRIVE intervention will include access to a digital produce prescription platform, virtual dietitian coaching, a Home blood pressure monitor with App integration, and produce |
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| Comparator Arm | Active Comparator | The active comparator arm will receive enhanced usual care, standard produce bags, general dietary advice, and a home blood pressure monitor |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iTHRIVE intervention | Behavioral | Integration of three traditionally siloed components:
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline, 3, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c (percent) | Hemoglobin A1c | Baseline, 3, and 6 months |
| Weight in pounds | Weight will be measured in pounds | Baseline, 3, 6, and 12 months |
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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
Distance to supermarket >1/4 mile. 5. Have refrigeration, food preparation appliances (microwave, stove), and cell phones for the App
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oluwabunmi Ogungbe, PhD, MPH, RN | Contact | 410-614-1519 | oogungb3@jh.edu | |
| Yvonne Commodore-Mensah, PhD, MHS, RN | Contact | 410614159 | ycommod1@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Oluwabunmi Ogungbe, PhD, MPH, RN | Johns Hopkins School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Community Physicians | Recruiting | Baltimore | Maryland | 21205 | United States |
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| Active comparator | Behavioral | Active comparator arm will receive enhanced usual care that consists of:
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| 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. | 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 | 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 | Baseline, 6 and 12 months |
| Height in inches | Height will be measured in inches | Baseline, 3,6 and 12months |
| Johns Hopkins School of Nursing | Not yet recruiting | Baltimore | Maryland | 21205 | United States |
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| Holy Cross Hospital | Not yet recruiting | Gaithersburg | Maryland | 20876 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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