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

ConditionsHypertensionHypertension Complicated With Type 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-70
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

21-70 years

Self-identify as Black/African American or Hispanic/Latino

Hypertension (ICD-10: I10-I16)

Prediabetes (HbA1c 5.7-6.4%) or Type 2 Diabetes (HbA1c ≥6.5%)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • iTHRIVE intervention

    Behavioral

    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

    Behavioral

    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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: iTHRIVE intervention armExperimental treatment 1 intervention
Group B: Comparator ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

Hemoglobin A1c (percent)

Hemoglobin A1c

Time frame
Baseline, 3, and 6 months
2

Weight in pounds

Weight will be measured in pounds

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

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

American Heart Association

Collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Source ClinicalTrials.gov
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