Produce Prescription for Healthy Blood Pressure (PRxBP)
12 juni 2026 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
104
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Texas
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Dallas, Texas, Förenta staterna, 75080
- 17360 Coit Road
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: PRx-BP Program
Participants receive the Produce Prescription for Healthy Blood Pressure 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.
|
|
Inget ingripande: Delayed control
Participants receive the Produce Prescription for Healthy Blood Pressure Program following end point data collection for the Experimental arm
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in mean blood pressure (systolic and diastolic) between baseline (pre-intervention) and endpoint (6 months)
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in hypertension medication use across program period (baseline, month 1, 2, 3, 4, 5, and endpoint [6 months])
Tidsram: 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
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Changes in hypertension medication use across baseline, month 1, 2, 3, 4, 5, and endpoint (6 months)
|
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Changes in servings of fruit and vegetables between baseline (pre-intervention) and endpoint (6 months)
Tidsram: 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)
|
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Changes in Healthy Eating Index score between baseline (pre-intervention) and endpoint (6 months)
Tidsram: Changes in Healthy Eating Index score between baseline (pre-intervention) and endpoint (6 months)
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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).
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Changes in Healthy Eating Index score between baseline (pre-intervention) and endpoint (6 months)
|
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Changes in household food security raw score between baseline (pre-intervention) and endpoint (6 months)
Tidsram: 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.
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Changes in household food security raw score between baseline (pre-intervention) and endpoint (6 months)
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Changes in fruit and vegetable preparation behaviors between baseline (pre-intervention) and endpoint (6 months)
Tidsram: 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.
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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])
Tidsram: 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])
|
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Changes in dietary carotenoid score between baseline (pre-intervention) and endpoint (6 months)
Tidsram: 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.
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Changes in dietary carotenoid score between baseline (pre-intervention) and endpoint (6 months)
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Changes in healthcare associated costs across program period (baseline, month 1, 2, 3, 4, 5, and endpoint [6 months])
Tidsram: Changes in healthcare associated costs across program period (baseline, month 1, 2, 3, 4, 5, and endpoint [6 months])
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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])
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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
5 maj 2023
Primärt slutförande (Faktisk)
18 december 2023
Avslutad studie (Faktisk)
1 juli 2024
Studieregistreringsdatum
Först inskickad
21 april 2026
Först inskickad som uppfyllde QC-kriterierna
12 juni 2026
Första postat (Faktisk)
15 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB2023-0100
- 2022-70424-38535 (Annat bidrag/finansieringsnummer: USDA Gus Schumacher Nutrition Incentive Program)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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