Integrating Free-choice Marketplace, dieTitian coacHing, cultuRally Tailored messagIng to improVE Blood Pressure
NCT ID: NCT07075588
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2026-01-01
2027-03-20
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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iTHRIVE intervention arm
iTHRIVE intervention will include access to a digital produce prescription platform, virtual dietitian coaching, a Home blood pressure monitor with App integration, and produce
iTHRIVE intervention
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
Comparator Arm
The active comparator arm will receive enhanced usual care, standard produce bags, general dietary advice, and a home blood pressure monitor
Active comparator
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
Interventions
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iTHRIVE intervention
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 comparator
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 Criteria
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Inclusion Criteria
* 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
* 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
21 Years
70 Years
ALL
Yes
Sponsors
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American Heart Association
OTHER
National Institute on Minority Health and Health Disparities (NIMHD)
NIH
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Oluwabunmi Ogungbe, PhD, MPH, RN
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins School of Nursing
Locations
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Johns Hopkins School of Nursing
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Mojisola Olusola-Bello, MD, MPH
Role: primary
Other Identifiers
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25CDA1453103
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IRB00457380
Identifier Type: -
Identifier Source: org_study_id