High Blood PressurePRxBPNCT07648758
Produce Prescription for Healthy Blood Pressure
A study testing Produce Prescription for Healthy Blood Pressure (PRx-BP) program in people with High Blood Pressure, run by Texas A&M University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Blood Pressure
- What is being tested?
- Produce Prescription for Healthy Blood Pressure (PRx-BP) program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2023to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- High Blood Pressure
- Being tested
- Produce Prescription for Healthy Blood Pressure (PRx-BP) program
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Produce Prescription for Healthy Blood Pressure (PRx-BP) programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PRx-BP Program | Experimental | Participants receive the Produce Prescription for Healthy Blood Pressure Program Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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])
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
Measured: 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)
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.
Measured: 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)
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).
Measured: 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)
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.
Measured: 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)
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.
Measured: 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])
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.
Measured: 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)
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.
Measured: 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])
Participants will report associated costs within the study time period: medical and medication costs and charges to participant.
Measured: Changes in healthcare associated costs across program period (baseline, month 1, 2, 3, 4, 5, and endpoint [6 months])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start5 May 2023
- Primary completion18 Dec 2023
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Luisa MacMillan Uribe, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648758
- Sponsor's protocol ID
- IRB2023-0100
- Other IDs
- 2022-70424-38535
- Acronym
- PRxBP
- Status last verified
- Jun 2026
- First submitted
- 21 Apr 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Produce Prescription for Healthy Blood Pressure Program to Manage Hypertension Among West Dallas, TX Residents
- ClinicalTrials.gov ID
- NCT07648758
- Acronym / sponsor ID
- PRxBP / IRB2023-0100
- Conditions
- High Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRx-BP Program | Experimental | Behavioral: Produce Prescription for Healthy Blood Pressure (PRx-BP) programParticipants receive the Produce Prescription for Healthy Blood Pressure Program |
| Delayed control | No intervention | –Participants receive the Produce Prescription for Healthy Blood Pressure Program following end point data collection for the Experimental arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Produce Prescription for Healthy Blood Pressure (PRx-BP) programPairs 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. | Behavioural | PRx-BP Program |
Primary outcome
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.
8 secondary outcomes
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)
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)
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)
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)
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)
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])
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)
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])
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Produce Prescription for Healthy Blood Pressure (PRx-BP) program in people with High Blood Pressure, run by Texas A&M University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.