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Zhejiang Province Pilot of Intervention Evaluation Project of Salt Reduction and Prevention and Control of Hypertension: a Cluster Randomized Controlled Trial
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注册号:

Registration number:

ChiCTR2000033349 

最近更新日期:

Date of Last Refreshed on:

2020-06-03 

注册时间:

Date of Registration:

2020-05-29 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

减盐防控高血压干预评价项目浙江省试点整群随机对照研究  

Public title:

Zhejiang Province Pilot of Intervention Evaluation Project of Salt Reduction and Prevention and Control of Hypertension: a Cluster Randomized Controlled Trial  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

减盐防控高血压干预评价项目浙江省试点整群随机对照研究  

Scientific title:

Zhejiang Province Pilot of Intervention Evaluation Project of Salt Reduction and Prevention and Control of Hypertension: a Cluster Randomized Controlled Trial  

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:

杜晓甫 

研究负责人:

钟节鸣 

Applicant:

Du Xiaofu 

Study leader:

Zhong Jieming 

申请注册联系人电话:

Applicant telephone:

+86 0571-87115161 

研究负责人电话:

Study leader's telephone:

+86 0571-87115159 

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:

xfdu@cdc.zj.cn 

研究负责人电子邮件:

Study leader's E-mail:

jmzhong@cdc.zj.cn 

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:

浙江省杭州市滨江区滨盛路3399号 

研究负责人通讯地址:

浙江省杭州市滨江区滨盛路3399号 

Applicant address:

3399 Binsheng Road, Binjiang District, Hangzhou 

Study leader's address:

3399 Binsheng Road, Binjiang District, Hangzhou 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

浙江省疾病预防控制中心 

Applicant's institution:

Zhejiang Provincial Center for Disease Control and Prevention 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2019056 

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:

浙江省疾病预防控制中心伦理审查委员会 

Name of the ethic committee:

Zhejiang Provincial Center for Disease Control and Prevention Ethical Review Committee  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-12-30 

伦理委员会联系人:

蒋征刚 

Contact Name of the ethic committee:

Jiang Zhenggang 

伦理委员会联系地址:

浙江省杭州市滨江区滨盛路3399号 

Contact Address of the ethic committee:

3399 Binsheng Road, Binjiang District, Hangzhou 

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:

浙江省疾病预防控制中心 

Primary sponsor:

Zhejiang Provincial Center for Disease Control and Prevention 

研究实施负责(组长)单位地址:

浙江省杭州市滨江区滨盛路3399号 

Primary sponsor's address:

3399 Binsheng Road, Binjiang District, Hangzhou 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江省疾病预防控制中心

具体地址:

滨江区滨盛路3399号

Institution
hospital:

Zhejiang Provincial Center for Disease Control and Prevention

Address:

3399 Binsheng Road, Binjiang District

经费或物资来源:

中国疾病预防控制中心慢性非传染性疾病预防控制中心 

Source(s) of funding:

National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention 

研究疾病:

高血压 

Target disease:

Hypertension 

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:

探索性研究/预试验 

Study phase:

研究目的:

(1)了解项目地区居民盐与高血压相关知识水平、居民食盐摄入水平与来源和高血压及其相关疾病患病及危险因素流行状况。 (2)根据基线调查制定减盐综合防控措施。 (3)干预后进行效果评估,评价减盐综合干预措施效果。 

Objectives of Study:

(1) To understand the knowledge level of salt and hypertension, the level and source of salt intake of residents in the project area, and the prevalence of hypertension and related diseases. (2) Formulate comprehensive salt reduction prevention and control measures based on the baseline survey. (3) After the intervention, conduct an effect evaluation to evaluate the effect of comprehensive salt reduction intervention measures. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)年龄:18-69岁; (2)当地居民6个月以上,12月内不得有社区搬迁计划; (3)签署知情同意书的协议。 

Inclusion criteria

1. Aged 18-75 years; 2. Living in the community at least 6 months, there will be no move plan of community relocation plan within 12 months in the future; 3. An agreement to sign informed consent.  

排除标准:

(1)孕妇或哺乳期妇女; (2)目前正在参加任何其他的临床试验; (3)任何可能影响干预和后续行动的严重精神或身体疾病; (4)符合下列条件之一的24小时尿液采样将被剔除: a)因小便失禁导致不能收集尿液; b)候选人难以收集尿液,找不到助手; c)急性/慢性尿路感染,阴道感染和肛周感染的患者; d)泌尿道、阴道和消化道急性出血性疾病患者; e)严重呕吐和腹泻症状的患者。 

Exclusion criteria:

1. Women in pregnant or lactation period; 2. Currently participate in any other clinical trial; 3. Any severe psychiatric or physical diseases which might impact intervention and follow up; 4. Samples for 24-hour urine collection will be rejected if anyone satisfying any of the following conditions: 1) Urine cant be collected due to aconuresis; 2) The candidate has difficulty to collect urine and cant find an assistant; 3) Patients with acute/chronic urinary tract infection, vaginal infection and perianal infection; 4) Patients with acute hemorrhagic diseases in urinary tract, vagina and digestive tract; 5) Patients with severe vomiting and diarrheic symptoms.  

研究实施时间:

Study execute time:

From2017-01-01To 2021-12-31 

干预措施:

Interventions:

组别:

干预组

样本量:

6000

Group:

Intervention group

Sample size:

干预措施:

综合减盐干预

干预措施代码:

Intervention:

Comprehensive strategy

Intervention code:

组别:

对照组

样本量:

1500

Group:

Control group

Sample size:

干预措施:

不接受综合减盐干预措施

干预措施代码:

Intervention:

The control group did not accept comprehensive salt reduction interventions during the intervention

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

海宁 

Country:

China 

Province:

Zhejiang 

City:

Haining 

单位(医院):

海宁市疾病预防控制中心 

单位级别:

N/A 

Institution
hospital:

Haining Center for Disease Control and Prevention  

Level of the institution:

N/A 

国家:

中国 

省(直辖市):

浙江 

市(区县):

鄞州区 

Country:

China 

Province:

Zhejiang 

City:

Yinzhou Distict 

单位(医院):

鄞州区疾病预防控制中心 

单位级别:

N/A 

Institution
hospital:

Yinzhou Center for Disease Control and Prevention  

Level of the institution:

N/A 

国家:

中国 

省(直辖市):

浙江 

市(区县):

义乌 

Country:

China 

Province:

Zhejiang 

City:

Yiwu 

单位(医院):

义乌市疾病预防控制中心 

单位级别:

N/A 

Institution
hospital:

Yiwu Center for Disease Control and Prevention  

Level of the institution:

N/A 

国家:

中国 

省(直辖市):

浙江 

市(区县):

泰顺县 

Country:

China 

Province:

Zhejiang 

City:

Taishun County 

单位(医院):

泰顺县疾病预防控制中心 

单位级别:

N/A 

Institution
hospital:

Taishun Center for Disease Control and Prevention  

Level of the institution:

N/A 

国家:

中国 

省(直辖市):

浙江 

市(区县):

莲都区 

Country:

China 

Province:

Zhejiang 

City:

Liandu District 

单位(医院):

莲都区疾病预防控制中心 

单位级别:

N/A 

Institution
hospital:

Liandu Center for Disease Control and Prevention  

Level of the institution:

N/A 

测量指标:

Outcomes:

指标中文名:

二十四小时尿钠排泄量

指标类型:

主要指标 

Outcome:

24-hour urinary sodium excretion

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:

减盐有关知识、信念、行为

指标类型:

次要指标 

Outcome:

Knowledge, beliefs and behaviors related to salt

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:

标本中文名:

血液

组织:

Sample Name:

blood

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 18 years
最大 Max age 69 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):

为了避免混杂和沾染,项目整体设计为整群随机平行对照,设置4个干预组和1个对照组,采用抽签法决定干预组和对照组。最终,义乌市、海宁市、泰顺县和鄞州区为干预地区,实施减盐综合干预措施;莲都区为对照地区,即空白对照,不进行任何减盐措施。随机序列由项目组人员实施产生。

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

In order to avoid confusion and contamination, the overall the project was designed as random parallel controls. There were 4 intervention groups and 1 control group. In the end, determined by the lottery method, Yiwu City, Haining City, Taishun County and Yinzhou District were the intervention areas.

盲法:

开放

Blinding:

open-label

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

发表文章

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

Articles Publication

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:

电子采集和管理系统

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

Electronic Data Capture, EDC

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-05-29
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