Produce Prescription for Healthy Blood Pressure (PRxBP)

June 12, 2026 updated by: Alexandra Luisa MacMillan Uribe, Texas A&M University

The Produce Prescription for Healthy Blood Pressure Program to Manage Hypertension Among West Dallas, TX Residents

The investigators want to understand the effects of the Produce Prescription for Healthy Blood Pressure program on blood pressure control and people's health. The overall project goal is to improve blood pressure levels of West Dallas residents with high blood pressure through participation in this produce prescription program.

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

The Produce Prescription for Healthy Blood Pressure (PRx-BP) program pairs produce prescriptions with education on healthy eating and blood pressure management. The PRx-BP program includes weekly "prescribed" produce boxes; Do Well Be Well with Hypertension (a curriculum focused on adopting a healthy lifestyle and managing hypertension); a blood pressure monitoring kit; and the CareSignal program, in which participants monitor their blood pressure using text messages. The goal of this project is to understand whether PRx-BP can improve blood pressure levels among adults with hypertension living in West Dallas, TX, a largely underserved community. To achieve this goal, the investigators will complete the following objectives: 1) use feedback from focus groups with West Dallas residents who have hypertension to tailor the PRx-BP program; 2) test how effective PRx-BP is on lowering blood pressure, compared to a group who will not receive PRx-BP through a pilot randomized wait-list controlled trial; 3) understand how to improve ways the program is delivered through a process evaluation; and 4) determine how much the program costs relative to its ability to lower blood pressure through a cost-effectiveness analysis. By providing fresh produce and education, resources, and support for managing blood pressure, the investigators anticipate that blood pressure levels and the frequency and cost of using healthcare will decrease.

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.
104

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 Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75080
        • 17360 Coit Road

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

No

Description

Inclusion Criteria:

  1. >18 years old
  2. blood pressure reading of >130/80 mmHg
  3. member of a low-income household
  4. benefits under the Food and Nutrition Act of 2008 (e.g., is eligible for Supplemental Nutrition Assistance Program) or medical assistance under a Texas State plan or a waiver of such a plan under title XIX of the Social Security Act and enrolled under such plan or waiver.

Exclusion Criteria:

None

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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: PRx-BP Program
Participants receive the Produce Prescription for Healthy Blood Pressure Program
Behavioral: Produce Prescription for Healthy Blood Pressure (PRx-BP) program
Pairs produce prescription with healthy eating and blood pressure management education. The PRx-BP program includes weekly "prescribed" produce boxes; Do Well Be Well with Hypertension (a curriculum focused on adopting a healthy lifestyle and managing hypertension); a blood pressure monitoring kit; and CareSignal program, in which participants monitor their blood pressure using text messages.
No Intervention: Delayed control
Participants receive the Produce Prescription for Healthy Blood Pressure Program following end point data collection for the Experimental arm

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
Change in mean blood pressure (systolic and diastolic) between baseline (pre-intervention) and endpoint (6 months)
Time Frame: Change in mean blood pressure (systolic and diastolic) between baseline (pre-intervention) and endpoint (6 months)
Blood pressure will be measured at baseline (pre-intervention; prior to commencement of PRxBP program for intervention group) and endpoint (post-intervention; after PRx BP program ends for intervention group), measured in triplicate (both measured as mmHg) using best-practice research standards with the clinically validated Omron IntelliSense Professional Blood Pressure Monitor.
Change in mean blood pressure (systolic and diastolic) between baseline (pre-intervention) and endpoint (6 months)

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
Change in hypertension medication use across program period (baseline, month 1, 2, 3, 4, 5, and endpoint [6 months])
Time Frame: Changes in hypertension medication use across baseline, month 1, 2, 3, 4, 5, and endpoint (6 months)
Self-reported changes in hypertension medication use (dose, frequency, medication type) during baseline and endpoint data collection sessions and on monthly basis during program period
Changes in hypertension medication use across baseline, month 1, 2, 3, 4, 5, and endpoint (6 months)
Changes in servings of fruit and vegetables between baseline (pre-intervention) and endpoint (6 months)
Time Frame: Changes in servings of fruit and vegetables between baseline (pre-intervention) and endpoint (6 months)
Dietary Health Questionnaire (DHQ) III: Self-administered, web-based food frequency questionnaire with 135-food and beverage items. After questionnaire completion, through the DHQ III website, an output is generated for researchers containing several nutrients and food groups (including fruit and vegetable intake). DHQ III provides reasonable nutrient estimates. Three studies support its validity and reliability.
Changes in servings of fruit and vegetables between baseline (pre-intervention) and endpoint (6 months)
Changes in Healthy Eating Index score between baseline (pre-intervention) and endpoint (6 months)
Time Frame: Changes in Healthy Eating Index score between baseline (pre-intervention) and endpoint (6 months)
Healthy Eating Index (HEI): The DHQ III output file (via the DHQ III website) will contain HEI total and individual component scores. HEI measures adherence with the Dietary Guidelines for Americans and consists of 13 component scores and total score (0-100, with higher scores indicating closer adherence).
Changes in Healthy Eating Index score between baseline (pre-intervention) and endpoint (6 months)
Changes in household food security raw score between baseline (pre-intervention) and endpoint (6 months)
Time Frame: Changes in household food security raw score between baseline (pre-intervention) and endpoint (6 months)
USDA ERS US Household Food Security Survey Module, 6-item Short Form: Specific and sensitive self-administered measure of household food security. Total score ranges from 0-6 with scores between 0-1 indicating food security, 2-4 low food security, and 5-6 very low food security.
Changes in household food security raw score between baseline (pre-intervention) and endpoint (6 months)
Changes in fruit and vegetable preparation behaviors between baseline (pre-intervention) and endpoint (6 months)
Time Frame: Changes in fruit and vegetable preparation behaviors between baseline (pre-intervention) and endpoint (6 months)
Self-efficacy for preparing meals with fruits and vegetables will be measured using a previously validated and reliable self-administered questionnaire. Frequency of cooking meals at home will be measured using a previously established question that will be modified to reflect preparation of fruits and vegetables in meals and snacks.
Changes in fruit and vegetable preparation behaviors between baseline (pre-intervention) and endpoint (6 months)
Changes in healthcare utilization across program period (baseline, month 1, 2, 3, 4, 5, endpoint [6 months])
Time Frame: Changes in healthcare utilization across program period (baseline, month 1, 2, 3, 4, 5, endpoint [6 months])
Participants will receive a monthly survey to self-report hypertension-relevant healthcare utilization measures: any clinic visits, non-emergent emergency department (ED) visits, ED visits, well-visits, hospitalizations, and 30-day readmissions.
Changes in healthcare utilization across program period (baseline, month 1, 2, 3, 4, 5, endpoint [6 months])
Changes in dietary carotenoid score between baseline (pre-intervention) and endpoint (6 months)
Time Frame: Changes in dietary carotenoid score between baseline (pre-intervention) and endpoint (6 months)
We will measure dermal carotenoids using the Veggie Meter (VM) machine. The VM is a non-invasive, portable machine that measures subdermal carotenoid levels using resonance Raman spectroscopy. The VM produces a score linear to dietary carotenoids; a higher score indicates higher fruit and vegetable intake with 100 units corresponding to intake of 1 cup of fruits and/or vegetables per day. VM readings will be recorded in duplicate and averaged.
Changes in dietary carotenoid score between baseline (pre-intervention) and endpoint (6 months)
Changes in healthcare associated costs across program period (baseline, month 1, 2, 3, 4, 5, and endpoint [6 months])
Time Frame: Changes in healthcare associated costs across program period (baseline, month 1, 2, 3, 4, 5, and endpoint [6 months])
Participants will report associated costs within the study time period: medical and medication costs and charges to participant.
Changes in healthcare associated costs across program period (baseline, month 1, 2, 3, 4, 5, and endpoint [6 months])

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.
Texas A&M University

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.
May 5, 2023

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.
December 18, 2023

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.
July 1, 2024

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).
April 21, 2026

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.
June 12, 2026

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.
June 15, 2026

Study Record Updates

Last Update Posted (Actual)

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.
June 15, 2026

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.
June 12, 2026

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.
June 1, 2026

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.
  • IRB2023-0100
  • 2022-70424-38535 (Other Grant/Funding Number: USDA Gus Schumacher Nutrition Incentive Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Our sample size is not large enough to warrant sharing data without compromising anonymity. We are considering sharing a larger dataset collected as part of a pre-/post-study design.

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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