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Produce Prescription for Healthy Blood Pressure (PRxBP)

12 de junho de 2026 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Real)

104

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Texas
      • Dallas, Texas, Estados Unidos, 75080
        • 17360 Coit Road

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  1. >18 years old
  2. blood pressure reading of >130/80 mmHg
  3. member of a low-income household
  4. 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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: PRx-BP Program
Participants receive the Produce Prescription for Healthy Blood Pressure Program
Comportamental: Produce Prescription for Healthy Blood Pressure (PRx-BP) 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.
Sem intervenção: Delayed control
Participants receive the Produce Prescription for Healthy Blood Pressure Program following end point data collection for the Experimental arm

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in mean blood pressure (systolic and diastolic) between baseline (pre-intervention) and endpoint (6 months)
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in hypertension medication use across program period (baseline, month 1, 2, 3, 4, 5, and endpoint [6 months])
Prazo: 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
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)
Prazo: 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)
Changes in Healthy Eating Index score between baseline (pre-intervention) and endpoint (6 months)
Prazo: 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).
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)
Prazo: 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.
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)
Prazo: 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.
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])
Prazo: 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])
Changes in dietary carotenoid score between baseline (pre-intervention) and endpoint (6 months)
Prazo: 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.
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])
Prazo: 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.
Changes in healthcare associated costs across program period (baseline, month 1, 2, 3, 4, 5, and endpoint [6 months])

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Texas A&M University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

5 de maio de 2023

Conclusão Primária (Real)

18 de dezembro de 2023

Conclusão do estudo (Real)

1 de julho de 2024

Datas de inscrição no estudo

Enviado pela primeira vez

21 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de junho de 2026

Primeira postagem (Real)

15 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

15 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

12 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • IRB2023-0100
  • 2022-70424-38535 (Número de outro subsídio/financiamento: USDA Gus Schumacher Nutrition Incentive Program)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano 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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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