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设计与实现基于真实世界研究的中国家庭添加盐消费智能监测系统:一项随机对照试验
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注册号:

Registration number:

ChiCTR1800018586 

最近更新日期:

Date of Last Refreshed on:

2019-10-20 

注册时间:

Date of Registration:

2018-09-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

设计与实现基于真实世界研究的中国家庭添加盐消费智能监测系统:一项随机对照试验 

Public title:

Design and implementation of intelligent monitoring system for household added salt consumption in China based on real-world study: a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

设计与实现基于真实世界研究的中国家庭添加盐消费智能监测系统:一项随机对照试验 

Scientific title:

Design and implementation of intelligent monitoring system for household added salt consumption in China based on real-world study: a 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:

曾茂 

研究负责人:

赵勇 

Applicant:

Mao Zeng 

Study leader:

Yong Zhao 

申请注册联系人电话:

Applicant telephone:

+86 13399823141 

研究负责人电话:

Study leader's telephone:

+86 13883460842 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

+86 023—68485031 

申请注册联系人电子邮件:

Applicant E-mail:

1273431021@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

zhaoyong@cqmu.edu.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:

重庆市渝中区医学院路1号228# 

研究负责人通讯地址:

重庆市渝中区医学院路1号228# 

Applicant address:

1 Yixueyuan Road, Yuzhong District, Chongqing, China  

Study leader's address:

1 Yixueyuan Road, Yuzhong District, Chongqing, China 

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:

400016 

申请人所在单位:

重庆医科大学 

Applicant's institution:

Chongqing Medical University 

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:

2017020 

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:

重庆医科大学医学研究伦理委员会 

Name of the ethic committee:

The Ethics Committee of Chongqing Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-11-20 

伦理委员会联系人:

洪玥铃 

Contact Name of the ethic committee:

Hong Yueling 

伦理委员会联系地址:

重庆市渝中区医学院路1号重庆医科大学科研处 

Contact Address of the ethic committee:

Research Office, Chongqing Medical University, 1 Yixueyuan Road, Yuzhong District, Chongqing, China  

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 023-68485114 

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:

重庆医科大学 

Primary sponsor:

Chongqing Medical University 

研究实施负责(组长)单位地址:

重庆市渝中区医学院路1号228号 

Primary sponsor's address:

1 Yixueyuan Road, Yuzhong District, Chongqing, 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):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆医科大学

具体地址:

重庆市渝中区医学院路1号228号

Institution
hospital:

Chongqing Medical University

Address:

1 Yixueyuan Road, Yuzhong District, Chongqing, China

经费或物资来源:

自筹经费 

Source(s) of funding:

Self-financing 

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:

其它 

Study phase:

N/A 

研究目的:

1)基于真实世界研究开发中国家庭添加盐消费智能监测系统 2)评估该系统在减少家庭平均每个标准人的每日添加盐消费量以及改善家庭主厨食盐消费相关的KAP方面的有效性。 

Objectives of Study:

1) develop an intelligent added salt monitoring system based on real-world study and 2) evaluate the effectiveness of the system in reducing daily added salt consumption of each standard person of the household and improving salt consumption-related KAP of household main cooks. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机抽样 

Study design:

Randomly Sampling 

纳入标准:

(1)愿意签署知情同意的家庭主厨; (2)居住在重庆,且未来六个月不会搬迁; (3)拥有可上网的手机(iOS或Android); (4)同意在手机上安装微信小程序。 

Inclusion criteria

(1) consenting household main cooks; (2) who plan to be living in Chongqing, China for six months of the study; (3) own a mobile phone (iOS or Android) with Internet access; (4) agree to have the WeChat mini programme on their mobile phones.  

排除标准:

(1)当前家庭成员中有使用自我监控系统或设备来跟踪或记录生活行为; (2)家庭中有参与其他盐相关试验的成员 (3)家庭成员中有认知或言语障碍或其他可能影响研究参与的疾病的既往史。 

Exclusion criteria:

(1) currently using a self-monitoring system or device to track or log living behaviour in household members; (2) having been involved in other salt experiments in household members; (3) prior history of cognitive or verbal impairments or other diseases that may impact on study participation. 

研究实施时间:

Study execute time:

From2019-01-01To 2020-12-31 

征募观察对象时间:

Recruiting time:

From2020-01-01To 2020-03-31 

干预措施:

Interventions:

组别:

干预组

样本量:

300

Group:

Case series

Sample size:

干预措施:

家庭智能添加盐监测系统

干预措施代码:

Intervention:

the intelligent added salt monitoring system

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆医科大学 

单位级别:

学校 

Institution
hospital:

Chongqing Medical University  

Level of the institution:

University 

测量指标:

Outcomes:

指标中文名:

添加盐

指标类型:

主要指标 

Outcome:

the added salt

Type:

Primary indicator 

测量时间点:

每天

测量方法:

家庭智能添加盐监测系统

Measure time point of outcome:

every day

Measure method:

the intelligent added salt monitoring system

指标中文名:

盐消费相关的KAP

指标类型:

主要指标 

Outcome:

salt consumption-related KAP

Type:

Primary indicator 

测量时间点:

基线时,3个月和6个月时

测量方法:

电子问卷

Measure time point of outcome:

at baseline, 3 and 6 months

Measure method:

online questionnaire

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

重庆医科大学公共卫生与管理学院一研究小组和重庆小善健康科技有限公司将组建宣传小组。该小组将根据研究内容和家庭智能添加盐监测系统的功能特点,制作电子版和纸质版的项目宣传单。在获得有良好合作关系的社区或学校的知情同意后,我们将在社区或学校分发印刷版的传单;与此同时,招聘信息的电子版也将在微信和微博平台上发布。另外我们将在现场展示智能盐监测系统的用途,功能和优势,以鼓励更多的家庭积极参与和合作研究。最后,根据计算机生成随机列表(SPSS),我们将随机选择300个自愿参与项目并符合纳入标准的家庭主厨,并与家庭主厨签订知情同意书。

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

The participated household main cooks will be recruited from Chongqing, China. A publicity group will be set by the research group in Chongqing Medical University and Chongqing Xiaoshan Health Technology Co., Ltd. According to the contents of the research and the functional characteristics of the intelligent added&

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/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):

https://journals.plos.org/plosone/s/data-availability

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

https://journals.plos.org/plosone/s/data-availability

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:

使用微信小程序和EpiData进行数据采集,使用Excel、MAXqda和SPSS20.0进行数据管理和分析

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

Data collection using WeChat applet and EpiData, data management and analysis using Excel, MAXqda and SPSS20.0

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-09-25
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