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OpenTrials
Completed

NCT Number: NCT06257550

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.

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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

Exclusion criteria

  • 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

Treatment and study plan

Thrive Intervention

Behavioral

THRIVE Intervention includes:

  • Weekly Pulse Surveys
  • Adaptive culturally tailored messages
  • Personalized Dietitian Coaching
  • Produce Prescription "FARMacy" Mobile Market
  • Linkages to Social Services

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.

Primary outcomes

  1. DASH Adherence as assessed by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)

    Time frame: 0, 12 weeks and 24 weeks

    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.

Secondary outcomes

  1. Recruitment rate

    Time frame: 0, 12 weeks, 24 weeks

    Recruitment yield per time

  2. Cost of the intervention

    Time frame: 0, 12 weeks, 24 weeks

    Intervention cost/person will be estimated based on the cost of the intervention

  3. Participant Accrual

    Time frame: 0, 12 weeks and 24 weeks

    Referrals, participation rates, and recruitment yields.

  4. Number of referrals to health and social need resources

    Time frame: 0, 12 weeks and 24 weeks

    Social needs as assessed by the number of participants connected to health services and services for social needs.

  5. Systolic Blood pressure

    Time frame: 0, 12 and 24 weeks

    Blood pressure measured in millimeters of mercury (mmHg)

  6. Diastolic Blood pressure

    Time frame: 0, 12 and 24 weeks

    Blood pressure measured in millimeters of mercury (mmHg)

  7. Hemoglobin A1c

    Time frame: 0, 12 and 24 weeks

    Hemoglobin A1c (percent)

  8. Height in inches

    Time frame: 0, 12 and 24 weeks

    Height will be measured

  9. Weight in pounds

    Time frame: 0, 12 weeks and 24 weeks

    Weight will be measured

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • American Heart Association

Registry information

Official study title

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

Acronym: THRIVE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 14, 2024
Registry last updated
Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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