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Dietary Approach to Stop Hypertension With Sodium (Na) Reduction for Chinese Canadians (DASHNa-CC)

2015年10月19日 更新者:Ping Zou、University of Toronto
The study examined the feasibility of the Dietary Approach to Stop Hypertension with Sodium (Na) Reduction for Chinese Canadian (DASHNa-CC) intervention and its potential effects on blood pressure, health-related quality of life, and health service utilization. Half of participants received usual care while the other half received the DASHNa-CC intervention.

研究概览

地位

完全的

条件

详细说明

Hypertension has been identified as the most important risk factor for cardiovascular diseases and accounts for a large proportion of stroke, myocardial infarction and heart failure in the Chinese population. While unhealthy diet has been identified as a modifiable risk factor for hypertension, there is a lack of culturally sensitive dietary intervention targeting Chinese Canadians. The 8-week DASHNa-CC intervention incorporated Dietary Approach to Stop Hypertension (DASH) diet, sodium reduction with the food therapy of Traditional Chinese Medicine, and included an intervention manual, two sessions of classroom instruction delivered in Mandarin, and a 20-minute telephone follow-up.

研究类型

介入性

注册 (实际的)

60

阶段

  • 不适用

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

45年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • were at least 45 years old;
  • had a systolic blood pressure 140 to 159 mmHg, or a diastolic blood pressure 90 to 99 mmHg, based on pre-intervention baseline assessment;
  • were able to understand (listen) and speak in Mandarin, read and write in Chinese; and
  • had access to a telephone.

Exclusion Criteria:

  • used antihypertensive medications or other medications that raise or lower blood pressure during the previous three months;
  • used TCM or professional TCM counselling to decrease blood pressure during the previous three months;
  • used insulin or oral hypoglycemic agents during the previous three months;
  • had a history of a cardiovascular event (stroke, myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass surgery, or other arteriosclerotic cardiovascular disease related therapeutic procedure) during the previous three months;
  • had a history of congestive heart failure;
  • had a cancer diagnosis or treatment during the past two years;
  • had special dietary requirements;
  • were pregnant, breast feeding, or planned for pregnancy prior to the anticipated end of study;
  • were a household member of another DASHNa-CC participant; or
  • planned to leave the area prior to the anticipated end of study.

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:支持治疗
  • 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:intervention
The intervention group received usual care plus the DASHNa-CC intervention.
The 8-week DASHNa-CC intervention incorporated Dietary Approach to Stop Hypertension (DASH) diet, sodium reduction with the food therapy of Traditional Chinese Medicine, and included an intervention manual, two sessions of classroom instruction delivered in Mandarin, and a 20-minute telephone follow-up.
education booklet, encouragement of physician visit, use of public health resources if needed
有源比较器:control
The control group received usual care.
education booklet, encouragement of physician visit, use of public health resources if needed

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
blood pressure
大体时间:8 weeks post randomization
systolic and diastolic blood pressure
8 weeks post randomization

次要结果测量

结果测量
措施说明
大体时间
health related quality of life
大体时间:8 weeks post randomization
used SF-36v2
8 weeks post randomization

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

2014年8月1日

初级完成 (实际的)

2014年12月1日

研究完成 (实际的)

2015年8月1日

研究注册日期

首次提交

2015年10月16日

首先提交符合 QC 标准的

2015年10月19日

首次发布 (估计)

2015年10月20日

研究记录更新

最后更新发布 (估计)

2015年10月20日

上次提交的符合 QC 标准的更新

2015年10月19日

最后验证

2015年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • UofT30496

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.

DASHNa-CC的临床试验

3
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