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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
104
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Texas
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Dallas、Texas、アメリカ、75080
- 17360 Coit Road
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：PRx-BP Program
Participants receive the Produce Prescription for Healthy Blood Pressure Program
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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.
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介入なし：Delayed control
Participants receive the Produce Prescription for Healthy Blood Pressure Program following end point data collection for the Experimental arm
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in mean blood pressure (systolic and diastolic) between baseline (pre-intervention) and endpoint (6 months)
時間枠：Change in mean blood pressure (systolic and diastolic) between baseline (pre-intervention) and endpoint (6 months)
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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)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in hypertension medication use across program period (baseline, month 1, 2, 3, 4, 5, and endpoint [6 months])
時間枠：Changes in hypertension medication use across baseline, month 1, 2, 3, 4, 5, and endpoint (6 months)
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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)
時間枠：Changes in servings of fruit and vegetables between baseline (pre-intervention) and endpoint (6 months)
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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)
時間枠：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)
時間枠：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)
時間枠：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])
時間枠：Changes in healthcare utilization across program period (baseline, month 1, 2, 3, 4, 5, endpoint [6 months])
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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)
時間枠：Changes in dietary carotenoid score between baseline (pre-intervention) and endpoint (6 months)
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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])
時間枠：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])
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2023年5月5日
一次修了 (実際)
2023年12月18日
研究の完了 (実際)
2024年7月1日
試験登録日
最初に提出
2026年4月21日
QC基準を満たした最初の提出物
2026年6月12日
最初の投稿 (実際)
2026年6月15日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月15日
QC基準を満たした最後の更新が送信されました
2026年6月12日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- IRB2023-0100
- 2022-70424-38535 (その他の助成金/資金番号：USDA Gus Schumacher Nutrition Incentive Program)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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