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

November 4, 2025 updated by: Johns Hopkins University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Oluwabunmi Ogungbe, PhD, MPH, RN
  • Phone Number: 4106141519
  • Email: oogungb3@jh.edu

Study Contact Backup

  • Name: Yvonne Commodore-Mensah, PhD, MHS, RN
  • Phone Number: 4106141519
  • Email: ycommod1@jhmi.edu

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:

  1. Weekly Pulse Surveys
  2. Adaptive culturally tailored messages
  3. Personalized Dietitian Coaching
  4. Produce Prescription "FARMacy" Mobile Market
  5. 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
0, 12 weeks and 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: 0, 12 weeks, 24 weeks
Recruitment yield per time
0, 12 weeks, 24 weeks
Cost of the intervention
Time Frame: 0, 12 weeks, 24 weeks
Intervention cost/person will be estimated based on the cost of the intervention
0, 12 weeks, 24 weeks
Participant Accrual
Time Frame: 0, 12 weeks and 24 weeks
Referrals, participation rates, and recruitment yields.
0, 12 weeks and 24 weeks
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.
0, 12 weeks and 24 weeks
Hemoglobin A1c
Time Frame: 0, 12 and 24 weeks
Hemoglobin A1c (percent)
0, 12 and 24 weeks
Height in inches
Time Frame: 0, 12 and 24 weeks
Height will be measured
0, 12 and 24 weeks
Weight in pounds
Time Frame: 0, 12 weeks and 24 weeks
Weight will be measured
0, 12 weeks and 24 weeks
Systolic Blood pressure
Time Frame: 0, 12 and 24 weeks
Blood pressure measured in millimeters of mercury (mmHg)
0, 12 and 24 weeks
Diastolic Blood pressure
Time Frame: 0, 12 and 24 weeks
Blood pressure measured in millimeters of mercury (mmHg)
0, 12 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Heart Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Oluwabunmi Ogungbe, PhD, MPH, RN, JHU School Of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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