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

NCT06257550 | Completed DMC

• 2 other identifiers: IRB0042749224FIM1264121
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 80 Black adults with hypertension.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Recruitment rate

  0, 12 weeks, 24 weeks

• Cost of the intervention

  0, 12 weeks, 24 weeks

• Participant Accrual

  0, 12 weeks and 24 weeks

• Number of referrals to health and social need resources

  0, 12 weeks and 24 weeks

• Systolic Blood pressure

  0, 12 and 24 weeks

Study Arms (2)

THRIVE Intervention Arm

EXPERIMENTAL

The THRIVE intervention arm will receive produce prescription, personalized dietitian coaching, adaptive bi-directional messaging; and linkages to social services.

Behavioral: THRIVE Intervention

Comparator Arm

ACTIVE COMPARATOR

The comparator arm will receive standard produce bags; and linkages to social services.

Behavioral: Active Comparator

Interventions

THRIVE Intervention BEHAVIORAL

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

THRIVE Intervention Arm

Active Comparator BEHAVIORAL

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.

Comparator Arm

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Self-identify as Black/African American
• 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)
• Live in census tracts identified by Montgomery County Department of Planning as HFPA:
• Healthy Food Availability Index score is low (0-9.5),
• Median household income ≤185% of Federal Poverty Level
• \>30% households have no vehicle, Distance to supermarket \>1/4 mile.
• Participants must have refrigeration, food appliances (microwave, stove),
• Cell phone to receive messages

You may not qualify if:

• Age \<18 years
• Type 1 or Type 2 Diabetes defined as a hemoglobin A1c ≥6.5% or diabetes treatment
• Diagnosis of end-stage renal disease (ESRD)
• Condition which interferes with outcome measurement (e.g., dialysis)
• Serious medical condition which 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
• Patients with cognitive impairment or other condition preventing their participation in the intervention
• Current participation in a care management program related to health conditions (e.g., weight reduction, smoking cessation)
• Current participation in another clinical trial that could interfere with the study protocol
• Those planning to move out of the geographic area in 12 months
• Unwillingness to provide informed consent
• Other conditions or situations at the discretion of the Investigative team

Sponsors & Collaborators

• Johns Hopkins University: lead
• American Heart Association: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Oluwabunmi Ogungbe, PhD, MPH, RN

  JHU School Of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors and data analysts will be masked to treatment allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 14, 2024
• Study Start: June 10, 2024
• Primary Completion: October 20, 2025
• Study Completion: October 31, 2025
• Last Updated: November 5, 2025

Record last verified: 2025-11

Locations

US (1)