Produce Prescription for Healthy Blood Pressure

NCT07648758 | Completed

• 2 other identifiers: IRB2023-01002022-70424-38535
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

High Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in hypertension medication use across program period (baseline, month 1, 2, 3, 4, 5, and endpoint [6 months])

  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)

  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)

  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)

  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)

  Changes in fruit and vegetable preparation behaviors between baseline (pre-intervention) and endpoint (6 months)

Study Arms (2)

PRx-BP Program

EXPERIMENTAL

Participants receive the Produce Prescription for Healthy Blood Pressure Program

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

Delayed control

NO INTERVENTION

Participants receive the Produce Prescription for Healthy Blood Pressure Program following end point data collection for the Experimental arm

Interventions

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.

PRx-BP Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

• None

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

17360 Coit Road

Dallas, Texas, 75080, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: June 15, 2026
• Study Start: May 5, 2023
• Primary Completion: December 18, 2023
• Study Completion: July 1, 2024
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)