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Rural China Electric Kettle Promotion Program
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注册号:

Registration number:

ChiCTR-IOR-17013373 

最近更新日期:

Date of Last Refreshed on:

2017-11-14 

注册时间:

Date of Registration:

2017-11-14 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中国农村地区电水壶使用推广项目 

Public title:

Rural China Electric Kettle Promotion Program 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中国农村地区电水壶使用推广试点:在中国贫困家庭采用分层随机抽样试验的方法研究电水壶使用率,以及对水质、室内空气污染、健康影响的效果 

Scientific title:

Rural China Electric Kettle Promotion Program Pilot: A Cluster-Randomized Controlled Trial of the Program Impacts on Electric Kettle Adoption, Drinking Water Quality, Indoor Air Pollution, and Reported Health Outcomes in Poverty Households in the People’s Republic of China 

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:

张琦 

研究负责人:

陶勇 

Applicant:

Zhang Qi 

Study leader:

Tao Yong 

申请注册联系人电话:

Applicant telephone:

+86 13718259779 

研究负责人电话:

Study leader's telephone:

+86 13901077917 

申请注册联系人传真 :

Applicant Fax:

+86 010-89706594 

研究负责人传真:

Study leader's fax:

+86 010-89706594 

申请注册联系人电子邮件:

Applicant E-mail:

zhangqi@ncrwstg.chinacdc.cn 

研究负责人电子邮件:

Study leader's E-mail:

taoyong@ncrwstg.chinacdc.cn 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

www.crwstc.org 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

www.crwstc.org 

申请注册联系人通讯地址:

北京市昌平区政府街13号 

研究负责人通讯地址:

北京市昌平区政府街13号 

Applicant address:

13 Zhengfu Street, Changping, Beijing, China 

Study leader's address:

13 Zhengfu Street, Changping, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

102200 

研究负责人邮政编码:

Study leader's postcode:

102200 

申请人所在单位:

中国疾病预防控制中心农村改水技术指导中心 

Applicant's institution:

National Center for Rural Water Supply Technical Guidance,Chinese 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:

2017002 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

中国疾病预防控制中心农村改水技术指导中心伦理委员会 

Name of the ethic committee:

National Center for Rural Water Supply Technical Guidance?Ethical Review Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-10-25 

伦理委员会联系人:

Zhang Rong 

Contact Name of the ethic committee:

张荣 

伦理委员会联系地址:

北京市昌平区政府街13号 

Contact Address of the ethic committee:

13 Zhengfu Street, Changping, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 010-69712564 

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农村改水技术指导中心 

Primary sponsor:

National Center for Rural Water Supply Technical Guidance, Chinese Center for Disease Control and Prevention 

研究实施负责(组长)单位地址:

北京市昌平区政府街13号 

Primary sponsor's address:

13 Zhengfu Street, Changping, Beijing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

自筹 

Source(s) of funding:

Self-funded 

研究疾病:

经水传播的传染病(和空气污染暴露) 

Target disease:

Waterborne pathogens (and air pollution exposure) 

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:

以往的研究显示,中国农村家庭大多使用生物质燃料烧水,而提高电水壶使用是在中国农村家庭提升饮水安全、降低家庭空气污染、改善环境健康效应的一个简单有效的途径。本研究将在中国安徽省开展农村贫困家庭电水壶推广使用项目,以评估这一措施的潜在效益。 研究中的干预组家庭将获得健康知识宣传材料(以台历和挂图的形式),包括使用电水壶的益处、个人卫生和环境卫生常识等,并将获赠一个免费的、材质符合食品安全规定的电水壶。 本研究的主要目的是确定农村贫困家庭是否愿意改变饮用水或烧水的方式,即从使用生物质燃料改为使用电水壶烧水,或者是从饮用生水或桶装水改为饮用电水壶烧的开水。同时,本研究将对烧水和饮水行为的转变对饮水安全和减少室内空气污染的影响进行研究。 

Objectives of Study:

Previous research suggests that increasing electric kettle use could provide a relatively simple means for expanding access to safe drinking water, reducing household air pollution, and improving environmental health outcomes in rural Chinese households currently boiling water with solid-fuels. This study will evaluate the potential benefits of a Rural Electric Kettle Promotion Program for poverty households in rural Anhui Province. Households in the treatment group will be provided promotional materials (a calendar and poster) and information about the benefits of electric kettle use and improve hygiene and sanitation, and will also be provided a free, food-grade quality, electric kettle. The primary objective of this study is to determine whether this promotion program causes poverty households currently boiling their drinking water with solid-fuels (or drinking untreated water or bottled water) to switch to boiling their drinking water with electric kettles and how such a switch might improve safe drinking water access and reduce household air pollution.  

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:

被当地政府确定为贫困家庭中的18岁以上的成年人将会代表其家庭参与本研究的调查,无论其性别、民族、语言的文化水平。 

Inclusion criteria

Adults aged 18 or older who live in government classified poverty households (based on 2016 data/records) will be eligible to provide consent for their household to participate. We will not have any inclusion or exclusion criterion based on gender, race, ethnicity, language, or literacy. 

排除标准:

17岁及以下的未成年人将不会参与本研究的调查 

Exclusion criteria:

Respondents aged 17 or younger who do not consent to participate in the study.  

研究实施时间:

Study execute time:

From2017-11-04To 2019-09-30 

征募观察对象时间:

Recruiting time:

From2017-11-04To 2017-11-19 

干预措施:

Interventions:

组别:

干预组

样本量:

450

Group:

Treatment

Sample size:

干预措施:

受邀参加电水壶推广使用的健康教育活动、获得健康教育材料和一个免费的电水壶

干预措施代码:

Intervention:

Invited to electric kettle promotion event (and offered free kettles and promotional materials)

Intervention code:

组别:

对照组

样本量:

450

Group:

Control

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

安徽 

市(区县):

 

Country:

China 

Province:

Anhui 

City:

 

单位(医院):

中国疾病预防控制中心 

单位级别:

国家疾病预防控制中心 

Institution
hospital:

China CDC  

Level of the institution:

state CDC 

测量指标:

Outcomes:

指标中文名:

采用电水壶烧水的家庭比例

指标类型:

主要指标 

Outcome:

Adoption of electric kettle for boiling drinking water

Type:

Primary indicator 

测量时间点:

2017-11, 2018-02, 2018-05, 2018-08, 2018-11

测量方法:

问卷调查和用电量监测

Measure time point of outcome:

2017-11, 2018-02, 2018-05, 2018-08, 2018-11

Measure method:

Self-report, electricity use meters (Tepsung model 10/16A), enumerator observations

指标中文名:

饮用水耐热大肠菌群检出率

指标类型:

次要指标 

Outcome:

Thermotolerant coliforms in drinking water

Type:

Secondary indicator 

测量时间点:

2017-11/12, 2018-05

测量方法:

饮水水样采集和检测,采用中国国标方法

Measure time point of outcome:

2017-11/12, 2018-05

Measure method:

Point-of-consumption drinking water sample collection and laboratory analysis using multiple tube fermentation (using China CDC national standards and protocol)

指标中文名:

PM2.5浓度

指标类型:

次要指标 

Outcome:

Particulate matter 2.5 mg/m3 (PM2.5) concentrations

Type:

Secondary indicator 

测量时间点:

2017-11/12, 2018-05/6

测量方法:

采用由北京大学研制的空气污染监测仪

Measure time point of outcome:

2017-11/12, 2018-05/6

Measure method:

Proprietary air pollution sensors developed by PKU (PM2.5 and other)

指标中文名:

腹泻发病率

指标类型:

次要指标 

Outcome:

Diarrhea prevalence

Type:

Secondary indicator 

测量时间点:

2017-11, 2018-05

测量方法:

被调查人报告(调查时、7天内、2周内)

Measure time point of outcome:

Measure method:

Self-report (current, 7-day recall, 14-day recall)

指标中文名:

用肥皂洗手的比例

指标类型:

次要指标 

Outcome:

Prevalence of hand washing with soap

Type:

Secondary indicator 

测量时间点:

2017-11, 2018-05

测量方法:

被调查人报告、调查员观察

Measure time point of outcome:

2017-11, 2018-05

Measure method:

Self-report, enumerator observations

指标中文名:

咳嗽发病率

指标类型:

附加指标 

Outcome:

Cough prevalence

Type:

Additional indicator 

测量时间点:

2017-11, 2018-05

测量方法:

被调查人报告(调查时、7天内)

Measure time point of outcome:

2017-11, 2018-05

Measure method:

Self-report (current, 7-day recall)

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

正在进行

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):

本研究将采用整群抽样的方式,随机抽取30个贫困村,然后根据基线调查得到的每个村使用电水壶的比例配对,随机分成干预组和对照组。随机序列的产生由A. Cohen使用Stata v.13.1 (StataCorp, College Station, Texas, USA)软件的随机数产生功能确定。

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

The study will randomize 30 clusters in equal proportions to treatment or control using stratified randomization by geography (two levels) and cluster proportions of reported electric kettle use at baseline. Randomization sequence generation will be conducted by A. Cohen using a random number generator (with a

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

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):

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

None

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:

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

N/A

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2017-11-14
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