Produce Prescription for Healthy Blood Pressure (PRxBP)
2026年6月12日 更新者: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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
104
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Texas
-
Dallas、Texas、美国、75080
- 17360 Coit Road
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的: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.
|
|
无干预:Delayed control
Participants receive the Produce Prescription for Healthy Blood Pressure Program following end point data collection for the Experimental arm
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in mean blood pressure (systolic and diastolic) between baseline (pre-intervention) and endpoint (6 months)
大体时间: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)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in hypertension medication use across program period (baseline, month 1, 2, 3, 4, 5, and endpoint [6 months])
大体时间: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)
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Changes in servings of fruit and vegetables between baseline (pre-intervention) and endpoint (6 months)
大体时间: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)
大体时间: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)
大体时间:Changes in household food security raw score between baseline (pre-intervention) and endpoint (6 months)
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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)
大体时间: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)
|
|
Changes in healthcare utilization across program period (baseline, month 1, 2, 3, 4, 5, endpoint [6 months])
大体时间: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)
大体时间: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])
大体时间: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])
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2023年5月5日
初级完成 (实际的)
2023年12月18日
研究完成 (实际的)
2024年7月1日
研究注册日期
首次提交
2026年4月21日
首先提交符合 QC 标准的
2026年6月12日
首次发布 (实际的)
2026年6月15日
研究记录更新
最后更新发布 (实际的)
2026年6月15日
上次提交的符合 QC 标准的更新
2026年6月12日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- IRB2023-0100
- 2022-70424-38535 (其他赠款/资助编号:USDA Gus Schumacher Nutrition Incentive Program)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.