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临床试验/NCT05926193
NCT05926193已完成不适用

Arraigados Juntos - Rooted Together, Food as Medicine Project

Duke University2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2023年3月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
2
主要终点
Change in blood pressure

研究概览

简要总结

Causes' Fresh Produce Program (FPP) in Durham County has addressed barriers to food security related to transportation with an innovative delivery model, but lacks evidence regarding the impact of food supplementation on chronic diseases like hypertension, which is prevalent in historically excluded populations in Durham County. The goal of this research study is to determine the efficacy of the modified Dietary Approach to Stop Hypertension (DASH) diet in Black/African American and Hispanic/Latinx participants with chronic hypertension who identify as food insecure using a randomized controlled trial. This research will leverage FPP's innovative distribution system to deliver medically-tailored produce bags and provide education workshops to the experimental participants relative to their experimental group. The study population group intends to include members of the Durham community and surrounding areas that identify as members of either the Black/African American or Hispanic/Latinx populations. Success will be measured in pre- and post-intervention biomarkers and qualitative participant experience data. Recognizing the risk of using Protected Health Information of Durham community members, many of whom are members of historically excluded populations that have been subjugated to harmful and extractive research practices, steps will be taken to ensure that collected information about research participants' personal and health information is protected and used only for the purposes of research. Ultimately, this research aims to work directly with the community to address hypertension outside of the clinic using food and education delivered directly to participants. The success of such an intervention could lead to expansion of delivering medically and culturally tailored foods to the larger FPP population and beyond.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult parent/legal guardian (age 18 or older)
  • Documented essential hypertension (systolic BP >140 and/or diastolic BP >90, at least two documented clinical measurements)
  • Self-reported African American or Latino

排除标准

  • Hypertension due to secondary cause (e.g. renovascular hypertension, hyperthyroidism, Cushing's disease etc.)
  • Homelessness or insecure/transitional housing
  • Inability to prepare or cook food for themselves
  • Participants not living in Durham County, N.C.
  • Pregnant women

结局指标

主要结局

Change in blood pressure

时间窗: Baseline, 6 weeks, 12 weeks

Systolic and diastolic BP will be documented at end of visit

次要结局

  • Patient satisfaction with culturally relevant foods(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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