中国人群减盐适宜技术在社区的应用研究

注册号:

Registration number:

ChiCTR-IOR-16010278 

最近更新日期:

Date of Last Refreshed on:

2016-12-28 11:16:52 

注册时间:

Date of Registration:

2016-12-28 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

中国人群减盐适宜技术在社区的应用研究

Public title:

Appropriate Technology of Salt Reduction in Chinese Population: A Community-Based Study

注册题目简写:

English Acronym:

研究课题的正式科学名称:

中国人群减盐适宜技术在社区的应用研究

Scientific title:

Appropriate Technology of Salt Reduction in Chinese Population: A Community-Based Study

研究课题代号(代码):

Study subject ID:

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

申请注册联系人:

杨正雄 

研究负责人:

陈春明 

Applicant:

Zhengxiong Yang 

Study leader:

Chunming Chen 

申请注册联系人电话:

Applicant telephone:

+86 10 63170892

研究负责人电话:

Study leader's
telephone:

+86 10 63170892

申请注册联系人传真 :

Applicant Fax:

研究负责人传真:

Study leader's fax:

申请注册联系人电子邮件:

Applicant E-mail:

zxyang@ilsichina.org

研究负责人电子邮件:

Study leader's E-mail:

chencm@ilsichina.org

申请单位网址(自愿提供):

Applicant website(voluntary supply):

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

申请注册联系人通讯地址:

北京市南纬路27号,中国疾病预防控制中心903室

研究负责人通讯地址:

北京市南纬路27号,中国疾病预防控制中心903室

Applicant address:

Room 903, Chinese Center for Disease Control and Prevention, 27 Nanwei Road, Beijing, China

Study leader's address:

Room 903, Chinese Center for Disease Control and Prevention, 27 Nanwei Road, Beijing, China

申请注册联系人邮政编码:

Applicant postcode:

100050

研究负责人邮政编码:

Study leader's postcode:

100050

申请人所在单位:

中国疾病预防控制中心

Applicant's institution:

Chinese Center for Disease Control and Prevention

研究负责人所在单位:

中国疾病预防控制中心

Affiliation of the Leader:

Chinese Center for Disease Control and Prevention

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

201113

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

中国疾病预防控制中心伦理审查委员会

Name of the ethic committee:

Chinese center for disease control and prevention ethical review committee

伦理委员会批准日期:

Date of approved by ethic committee:

2011-08-22 00:00:00

伦理委员会联系人:

Contact Name of the ethic committee:

伦理委员会联系地址:

Contact Address of the ethic committee:

伦理委员会联系人电话:

Contact phone of the ethic committee:

伦理委员会联系人邮箱:

Contact email of the ethic committee:

研究实施负责(组长)单位:

中国疾病预防控制中心

Primary sponsor:

Chinese Center for Disease Control and Prevention

研究实施负责(组长)单位地址:

北京市南纬路27号,中国疾病预防控制中心903室

Primary sponsor's address:

Room 903, Chinese Center for Disease Control and Prevention, 27 Nanwei Road, Beijing, China

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国疾病预防控制中心

具体地址:

北京市南纬路27号,中国疾病预防控制中心903室

Institution
hospital:

Chinese Center for Disease Control and Prevention

Address:

Room 903, Chinese Center for Disease Control and Prevention, 27 Nanwei Road, Beijing, China

经费或物资来源:

中澳卫生与艾滋病项目 (CAHHF)

Source(s) of funding:

China-Australia Health and HIV/AIDS Program (CAHHF)

研究疾病:

高盐摄入  

Target disease:

High salt intake

研究疾病代码:

Target disease code:

研究类型:

干预性研究

Study type:

Interventional study

研究所处阶段:

其它 

Study phase:

N/A

研究设计:

随机平行对照 

Study design:

Parallel 

研究目的:

1.摸索出行之有效的以社区为基础的人群减盐方法; 2.探索一套以社区为基础的国家、社会、个人共同出资,共同受益减盐模式。  

Objectives of Study:

1. Develop an effective community based salt reduction strategy; 2. Discover a collaborative salt reduction model with government,society, and individuals.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

1.肾病患者;2.每周在家吃饭次数少于10次的居民

Exclusion criteria:

1. participants with nephropathy;
2. participants who ate less than 10 meals a week at home.

研究实施时间:

Study execute time:

From 2011-09-17 00:00:00 To 2011-12-27 00:00:00  

征募观察对象时间:

Recruiting time:

From 2011-08-22 00:00:00 To 2011-09-16 00:00:00

干预措施:

Interventions:

组别:

强化干预组

样本量:

51

Group:

Intensive intervention group

Sample size:

干预措施:

限盐勺使用和健康教育课程

干预措施代码:

Intervention:

the promotion of quantitative salt spoon and health education courses

Intervention code:

组别:

一般干预组

样本量:

50

Group:

Routine intervention group

Sample size:

干预措施:

限盐勺使用和发放健康教育宣传材料

干预措施代码:

Intervention:

the promotion of quantitative salt spoon and distribute health education publicity materials

Intervention code:

组别:

对照组

样本量:

52

Group:

Control group

Sample size:

干预措施:

不采取任何干预措施

干预措施代码:

Intervention:

No any intervention measures

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

江西省 

市(区县):

 

Country:

China

Province:

Jiangxi

City:

单位(医院):

德兴市疾控中心 

单位级别:

市级 

Institution
hospital:

Dexing Center for Disease Control and Prevention

Level of the institution:

Municipal

测量指标:

Outcomes:

指标中文名:

尿钠

指标类型:

主要指标

Outcome:

Urine sodium

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿钾

指标类型:

主要指标

Outcome:

Urine potassium

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿肌酐

指标类型:

主要指标

Outcome:

Urine creatinine

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血压

指标类型:

主要指标

Outcome:

Blood pressure

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

身高

指标类型:

次要指标

Outcome:

Height

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体重

指标类型:

次要指标

Outcome:

Weight

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

尿液

组织:

Sample Name:

Urine

Tissue:

人体标本去向

使用后销毁  

说明

Fate of sample:

Destruction after use  

Note:

征募研究对象情况:

Recruiting status:

结束

/Completed

年龄范围:

Participant age:

最小 Min age 27 years
最大 Max age 64 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

由一个研究人员利用sas软件产生随机序列

Randomization Procedure (please state who generates the random number sequence and by what method):

Randomized Block design; study staff; SAS software

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否No

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

通过ResMan提供原始数据查询

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

IPD will be public accessable via ResMan

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

spss数据库

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

spss database

数据与安全监察委员会:

Data and Safety Monitoring Committee:

注册人:

Name of Registration:

 2016-12-28 11:16:52