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Completed

NCT Number: NCT07648758

Produce Prescription for Healthy Blood Pressure

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.

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Key information

Conditions

High Blood Pressure Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

17360 Coit Road

Dallas, Texas, 75080, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • >18 years old
  • blood pressure reading of >130/80 mmHg
  • member of a low-income household
  • 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

Treatment and study plan

Produce Prescription for Healthy Blood Pressure (PRx-BP) program

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Registry information

Official study title

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

Acronym: PRxBP

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jun 15, 2026
Registry last updated
Jun 15, 2026

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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