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Produce Prescription for Healthy Blood Pressure (PRxBP)

2026년 6월 12일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

104

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Texas
      • Dallas, Texas, 미국, 75080
        • 17360 Coit Road

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: PRx-BP Program
Participants receive the Produce Prescription for Healthy Blood Pressure Program
행동: 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.
간섭 없음: Delayed control
Participants receive the Produce Prescription for Healthy Blood Pressure Program following end point data collection for the Experimental arm

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in mean blood pressure (systolic and diastolic) between baseline (pre-intervention) and endpoint (6 months)
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Change in hypertension medication use across program period (baseline, month 1, 2, 3, 4, 5, and endpoint [6 months])
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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])
기간: 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)
기간: 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])
기간: 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])

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Texas A&M University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 5월 5일

기본 완료 (실제)

2023년 12월 18일

연구 완료 (실제)

2024년 7월 1일

연구 등록 날짜

최초 제출

2026년 4월 21일

QC 기준을 충족하는 최초 제출

2026년 6월 12일

처음 게시됨 (실제)

2026년 6월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 12일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • IRB2023-0100
  • 2022-70424-38535 (기타 보조금/기금 번호: USDA Gus Schumacher Nutrition Incentive Program)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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