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 80 Black adults with hypertension.
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 80 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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
80
THRIVE Intervention includes: 1. Weekly Pulse Surveys 2. Adaptive culturally tailored messages 3. Personalized Dietitian Coaching 4. Produce Prescription "FARMacy" Mobile Market 5. Linkages to Social Services
The Active Comparator arm will receive standard produce bags through our food is medicine partner, and will receive the linkages to needed social and health resources intervention components.
Johns Hopkins University
Baltimore, Maryland, United States
DASH Adherence as assessed by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)
Adherence will be assessed by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24). The scores range from 0 to 100, with higher scores reflecting greater adherence.
Time frame: 0, 12 weeks and 24 weeks
Recruitment rate
Recruitment yield per time
Time frame: 0, 12 weeks, 24 weeks
Cost of the intervention
Intervention cost/person will be estimated based on the cost of the intervention
Time frame: 0, 12 weeks, 24 weeks
Participant Accrual
Referrals, participation rates, and recruitment yields.
Time frame: 0, 12 weeks and 24 weeks
Number of referrals to health and social need resources
Social needs as assessed by the number of participants connected to health services and services for social needs.
Time frame: 0, 12 weeks and 24 weeks
Systolic Blood pressure
Blood pressure measured in millimeters of mercury (mmHg)
Time frame: 0, 12 and 24 weeks
Diastolic Blood pressure
Blood pressure measured in millimeters of mercury (mmHg)
Time frame: 0, 12 and 24 weeks
Hemoglobin A1c
Hemoglobin A1c (percent)
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Time frame: 0, 12 and 24 weeks
Height in inches
Height will be measured
Time frame: 0, 12 and 24 weeks
Weight in pounds
Weight will be measured
Time frame: 0, 12 weeks and 24 weeks