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Reducing Chronic Kidney Disease Burden in an Underserved Population

2020年11月25日 更新者：Baylor Research Institute

A Prospective, Randomized Two Group Study to Evaluate the Feasibility and Initial Efficacy of a Community-engaged Screening, Identification, and F&V Intervention to Improve F&V Intake and CKD Outcomes in 140 AA Adults

To evaluate a scalable population health strategy to 1) screen, 2) identify, and 3) intervene with individuals at high risk of CKD progression to ESRD that could be implemented in other high risk communities and health care systems. This novel study will evaluate the feasibility and preliminary efficacy of providing F&V to individuals identified at high risk study for CKD and ESRD through community health screenings. Further, it will evaluate whether providing education as to how to prepare F&V for consumption, the latter being done for all F&V recipients in PI's preliminary published studies but its efficacy was not specifically tested, increases F&V intake and thereby reduces CKD progression risk as well as related clinical outcomes.

研究概览

地位

完全的

条件

干预/治疗

详细说明

"Fruits and Veggies for Health" is a prospective, randomized two group study to evaluate a community-engaged screening, identification, and F&V intervention to improve CKD outcomes in 140 AA adults (greater than 18 years). Participants will be randomized to a 1) F&V only (F&V Only), or 2) F&V plus a nutrition/cooking program (F&V + Cook).

研究类型

介入性

注册 (实际的)

142

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

  • 美国
    • Texas
      • Dallas、Texas、美国、75210
        • Baylor Research Institute

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

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Willingness to participate in 6 month F&V study
  • Positive urine dipstick.
  • African American (self declared) race
  • Access to internet via personal computer or mobile device
  • Ability to read and write in English

Exclusion Criteria:

  • Negative urine dipstick
  • Currently receiving dialysis or needing dialysis (stage 5 Kidney disease)
  • Have received or need kidney transplant
  • Pregnant or plan to become pregnant in the next 6 months
  • Baseline urine potassium > 60 mEq/g creatinine
  • Nephrotic proteinuria demonstrated on urine ACR measurement
  • Lacking access to the internet via personal computer or mobile device
  • Unable to read or write in English

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：卫生服务研究
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Fruits and Vegetables Only
This group will receive a prescribed amount of free fruits and vegetables (F & V) for 6 weeks through pick-up at a farm stand, or direct delivery. After 6 weekly pick-up/deliveries, participants will be provided vouchers and reminders to obtain F&V at farm stands for an additional 18 weeks with minimal contact
其他：Fruits and Vegetables
Fruits and vegetables delivery, once/week for 24 weeks
实验性的：Fruits and Vegetables and Cook
In addition to the prescribed amount of free F&V, participants will receive 6 weekly, group nutrition and cooking education classes based on "The Happy Kitchen" curriculum. Participants will also receive free ingredients to complete the recipe from each weekly session at home.
其他：Fruits and Vegetables
Fruits and vegetables delivery, once/week for 24 weeks
其他：Cooking
Nutrition education and cooking instruction class, one class/week for 6 weeks
其他名称：
  • The Happy Kitchen

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 from baseline concentration of Urine angiotensinogen (AGT) at 6 weeks and 6 months
大体时间：Baseline; 6 weeks; 6 months
Primary surrogate marker of eGFR
Baseline; 6 weeks; 6 months
Change from baseline of Urine albumin-to-creatinine ratio (ACR) at 6 weeks and 6 months
大体时间：Baseline; 6 weeks; 6 months
Measure of renal damage
Baseline; 6 weeks; 6 months
Changes from baseline in fruit and vegetable intake at 6 weeks and 6 months
大体时间：Baseline; 6 weeks; 6 months
Track changes in fruit and vegetable intake via ASA24 food diary
Baseline; 6 weeks; 6 months
Changes from baseline in dietary fat intake at 6 weeks and 6 months
大体时间：Baseline; 6 weeks; 6 months
Track changes in fat (g) intake via ASA24 food diary
Baseline; 6 weeks; 6 months
Changes from baseline in caloric intake at 6 weeks and 6 months
大体时间：Baseline; 6 weeks; 6 months
Track changes in total caloric(kcal) intake via ASA24 food diary
Baseline; 6 weeks; 6 months

次要结果测量

结果测量
措施说明
大体时间
Changes from baseline in systolic and diastolic Blood pressure at 6 weeks and 6 months
大体时间：Baseline; 6 weeks; 6 months
Measure changes in systolic/diastolic blood pressure (mm Hg) to assess cardiovascular disease risk (CVD)
Baseline; 6 weeks; 6 months
Changes from baseline in serum Lipoprotein levels at 6 weeks and 6 months
大体时间：Baseline; 6 weeks; 6 months
Measure changes in total cholesterol, HDL, and LDL (mg/dL) by fingerstick to assess CVD risk
Baseline; 6 weeks; 6 months
Changes from baseline in serum Glycosolated hemoglobin A1C (HgA1C) levels at 6 weeks and 6 months
大体时间：Baseline; 6 weeks; 6 months
Measure changes in HgA1C (mg/dL) by fingerstick as a marker of diabetes and to assess CVD risk
Baseline; 6 weeks; 6 months
Changes from baseline in Blood glucose at 6 weeks and 6 months
大体时间：Baseline; 6 weeks; 6 months
Measure fasting glucose(mg/dL) as a marker of diabetes and to assess CVD risk
Baseline; 6 weeks; 6 months
Changes from baseline in Body mass index (BMI) at 6 weeks and 6 months
大体时间：Baseline; 6 weeks; 6 months
Measure body mass index(lb/inches squared) to assess CVD risk
Baseline; 6 weeks; 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。

赞助

Baylor Research Institute

调查人员

  • 首席研究员：Donald Wesson, MD, MBA、Baylor RI

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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)

2019年1月24日

初级完成 (实际的)

2020年6月13日

研究完成 (实际的)

2020年7月14日

研究注册日期

首次提交

2019年2月1日

首先提交符合 QC 标准的

2019年2月4日

首次发布 (实际的)

2019年2月6日

研究记录更新

最后更新发布 (实际的)

2020年11月27日

上次提交的符合 QC 标准的更新

2020年11月25日

最后验证

2020年7月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 1R21DK113440-01A1 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

All IPD that underlie results in a publication

IPD 共享时间框架

Data will be available within 6 mths of outcome publication

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 分析代码

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.

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