AdapTive Personalized Dietitian coacHing, Messaging and pRoduce prescrIption to improVE Healthy Dietary Behaviors (THRIVE)

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: THRIVE Intervention; Behavioral: Active Comparator

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 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
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Planning 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: THRIVE Intervention Arm; The THRIVE intervention arm will receive produce prescription, personalized dietitian coaching, adaptive bi-directional messaging; and linkages to social services.	Behavioral: THRIVE Intervention; THRIVE Intervention includes: Weekly Pulse Surveys; Adaptive culturally tailored messages; Personalized Dietitian Coaching; Produce Prescription "FARMacy" Mobile Market; Linkages to Social Services
Active Comparator: Comparator Arm; The comparator arm will receive standard produce bags; and linkages to social services.	Behavioral: Active Comparator; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0, 12 weeks and 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Recruitment yield per time	0, 12 weeks, 24 weeks
Cost of the intervention	Intervention cost/person will be estimated based on the cost of the intervention	0, 12 weeks, 24 weeks
Participant Accrual	Referrals, participation rates, and recruitment yields.	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.	0, 12 weeks and 24 weeks
Hemoglobin A1c	Hemoglobin A1c (percent)	0, 12 and 24 weeks
Height in inches	Height will be measured	0, 12 and 24 weeks
Weight in pounds	Weight will be measured	0, 12 weeks and 24 weeks
Systolic Blood pressure	Blood pressure measured in millimeters of mercury (mmHg)	0, 12 and 24 weeks
Diastolic Blood pressure	Blood pressure measured in millimeters of mercury (mmHg)	0, 12 and 24 weeks

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Oluwabunmi Ogungbe, PhD, MPH, RN, JHU School Of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2024
• Primary Completion (Actual): October 20, 2025
• Study Completion (Actual): October 31, 2025

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2025
• Last Update Submitted That Met QC Criteria: November 4, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: IRB00427492; 24FIM1264121 (Other Grant/Funding Number: American Heart Association)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No