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NCT06257550 | ENROLLING BY INVITATION | Hypertension

AdapTive Personalized Dietitian coacHing, Messaging and pRoduce prescrIption to improVE Healthy Dietary Behaviors
Sponsor:

Johns Hopkins University

Brief Summary:

THRIVE intervention is a 2-arm randomized pilot trial testing the feasibility and preliminary efficacy of producing prescriptions, tailored dietitian counseling with adaptive messages, and linkages to social resources among 60 Black adults with hypertension.

Condition or disease

Hypertension

Intervention/treatment

THRIVE Intervention

Active Comparator

Phase

NA

Detailed Description:

Nearly 55% of Black adults have hypertension and uncontrolled blood pressure. Dietary Approaches to Stop Hypertension (DASH) promotes a dietary pattern rich in fruits and vegetables (fruits and vegetables), low-fat dairy, lean meats with reduced saturated fat, and sweets, which is effective in lowering blood pressure. The proposed THRIVE intervention will enroll 60 Black adults with hypertension living in Healthy Food Priority Areas (HFPAs) in a 2-arm randomized pilot study. One group will receive Produce prescriptions, personalized dietitian coaching, and adaptive bi-directional messaging; the other group will receive standard produce bags. Both groups will be linked to needed social services. The investigators will assess changes in overall DASH adherence, acceptability, and feasibility at 3- and 6-months post-randomization. The investigators will: 1) Develop and beta test THRIVE among Black adults with hypertension living in HFPAs; 2) Test feasibility and preliminary efficacy of THRIVE at 6 \& 12 weeks; 3) Determine short-term sustainability of THRIVE at 6 months.

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : SINGLE
Masking Description : Outcomes assessors and data analysts will be masked to treatment allocation.
Primary Purpose : PREVENTION
Official Title : THRIVE: AdapTive Personalized Dietitian coacHing, Messaging and pRoduce prescrIption to improVE Healthy Dietary Behaviors
Actual Study Start Date : 2024-06-10
Estimated Primary Completion Date : 2025-05-31
Estimated Study Completion Date : 2025-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 79 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • 1. 18 years or older
  • 2. Self-identify as Black/African American
  • 3. Have diagnosed hypertension stages 1 (130-139/80-89 mm Hg) OR 2 (\>140/90 mm Hg), determined via self-report and/or Electronic Medical Records (EMR)
  • 4. Live in census tracts identified by Montgomery County Department of Planning52 as HFPA
    • 1. Healthy Food Availability Index score is low (0-9.5),
    • 2. Median household income ≤185% of Federal Poverty Level
    • 3. \>30% households have no vehicle, Distance to supermarket \>1/4 mile.
    • 5. Participants must have refrigeration, food appliances (microwave, stove),
    • 6. Cell phone to receive messages
    Exclusion Criteria
    • 1. Age \<18 years
    • 2. Type 1 or Type 2 Diabetes defined as a hemoglobin A1c ≥6.5% or diabetes treatment
    • 3. Diagnosis of end-stage renal disease (ESRD)
    • 4. Condition which interferes with outcome measurement (e.g., dialysis)
    • 5. Serious medical condition which either limits life expectancy or requires active management (e.g. cancer)
    • 6. Significant food allergies, preferences, intolerances, or dietary requirements that would interfere with diet adherence
    • 7. Patients with cognitive impairment or other condition preventing their participation in the intervention
    • 8. Current participation in a care management program related to health conditions (e.g., weight reduction, smoking cessation)
    • 9. Current participation in another clinical trial that could interfere with the study protocol
    • 10. Those planning to move out of the geographic area in 12 months
    • 11. Unwillingness to provide informed consent
    • 12. Other conditions or situations at the discretion of the Investigative team
AdapTive Personalized Dietitian coacHing, Messaging and pRoduce prescrIption to improVE Healthy Dietary Behaviors

Location Details

NCT06257550

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Locations

Not yet recruiting

United States, Maryland

Johns Hopkins University

Baltimore, Maryland, United States, 21205