Produce Prescription for Healthy Blood Pressure (PRxBP)
12 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
104
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
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Texas
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Dallas, Texas, Estados Unidos, 75080
- 17360 Coit Road
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Sin intervención: Delayed control
Participants receive the Produce Prescription for Healthy Blood Pressure Program following end point data collection for the Experimental arm
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in mean blood pressure (systolic and diastolic) between baseline (pre-intervention) and endpoint (6 months)
Periodo de tiempo: 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.
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Change in mean blood pressure (systolic and diastolic) between baseline (pre-intervention) and endpoint (6 months)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in hypertension medication use across program period (baseline, month 1, 2, 3, 4, 5, and endpoint [6 months])
Periodo de tiempo: 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)
Periodo de tiempo: 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.
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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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: Changes in fruit and vegetable preparation behaviors between baseline (pre-intervention) and endpoint (6 months)
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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)
|
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Changes in healthcare utilization across program period (baseline, month 1, 2, 3, 4, 5, endpoint [6 months])
Periodo de tiempo: 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.
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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)
Periodo de tiempo: 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])
Periodo de tiempo: 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])
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
5 de mayo de 2023
Finalización primaria (Actual)
18 de diciembre de 2023
Finalización del estudio (Actual)
1 de julio de 2024
Fechas de registro del estudio
Enviado por primera vez
21 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
12 de junio de 2026
Publicado por primera vez (Actual)
15 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB2023-0100
- 2022-70424-38535 (Otro número de subvención/financiamiento: USDA Gus Schumacher Nutrition Incentive Program)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .