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珠三角流动工人控烟干预研究试验
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注册号：

Registration number：

 ChiCTR-OPC-17011637 

最近更新日期：

Date of Last Refreshed on：

 2017-06-12 

注册时间：

Date of Registration：

2017-06-12 

注册号状态：

补注册  

Registration Status：

Retrospective registration  

注册题目：

珠三角流动工人控烟干预研究试验 

Public title：

Development of a Tobacco Control Trial among Migrant Workers in Guangzhou, China 

注册题目简写：

 

English Acronym：

 

研究课题的正式科学名称：

珠三角流动工人控烟干预研究试验 

Scientific title：

Development of a Tobacco Control Trial among Migrant Workers in Guangzhou, 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：

凌莉 

研究负责人：

凌莉 

Applicant：

Li Ling 

Study leader：

Li Ling 

申请注册联系人电话：

Applicant telephone：

+86 13600097711 

研究负责人电话：

Study leader's telephone：

+86 13600097711 

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：

lingli@mail.sysu.edu.cn 

研究负责人电子邮件：

Study leader's E-mail：

lingli@mail.sysu.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：

广东省广州市越秀区中山二路74号 

研究负责人通讯地址：

广东省广州市越秀区中山二路74号 

Applicant address：

74 Second Zhongshan Road, Guangzhou, Guangdong, China 

Study leader's address：

74 Second Zhongshan Road, Guangzhou, Guangdong, China 

申请注册联系人邮政编码：

Applicant postcode：

510080 

研究负责人邮政编码：

Study leader's postcode：

510080 

申请人所在单位：

中山大学公共卫生学院 

Applicant's institution：

School of Public Health, Sun Yat-sen 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：

2015-044 

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：

中山大学公共卫生学院生物医学研究伦理审查委员会 

Name of the ethic committee：

Ethics Committees of School of Public Health, Sun Yat-sen University, Guangzhou, China 

伦理委员会批准日期：

Date of approved by ethic committee：

2015-10-13 

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：

中山大学 

Primary sponsor：

Sun Yat-sen University 

研究实施负责（组长）单位地址：

广东省广州市越秀区中山二路74号 

Primary sponsor's address：

74 Second Zhongshan Road, Guangzhou, Guangdong, 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)：

广东

市(区县)：

广州

Country：

China

Province：

Guangdong

City：

Guangzhou

单位(医院)：

中山大学

具体地址：

广东省广州市越秀区中山二路74号

Institution
hospital：

Sun Yat-sen University

Address：

74 Second Zhongshan Road, Guangzhou, Guangdong, China

经费或物资来源：

英国医学研究理事会 

Source(s) of funding：

Medical Research Council 

研究疾病：

吸烟 

Target disease：

tobacco use 

研究疾病代码：

 

Target disease code：

 

研究类型：

观察性研究 

Study type：

Observational study 

研究所处阶段：

探索性研究/预试验 

Study phase：

0 

研究目的：

We aim to design a 5A's group consulting package, which will be adapted from WHO 5A's model and has potentials to be implemented in the workplaces settings in China. in the years to come, we will conduct a randomized controlled trial(RCT) to test its effectiveness in reducing non-smokers' exposure to SHS as measured by salivary cotinine levels in workplaces in China, with secondary aims of determining its effectiveness in reducing the uptake of smoking and reducing smoking rates in migrant workers. In this study, we will test the feasibility and acceptability of conducting a workplace-based migrant-workers intervention program of the 5A's and provide information to inform the future design of RCT. Research questions 1. How can the WHO 5A's model be adapted into 5A's group consulting intervention package that fits migrant workers in China? 2. To what extent it is feasible and acceptable of delivering the intervention in the workplaces setting, and how the evidence generated from this study will inform the design of the main trial. Objectives 1. To tailor the WHO 5A's model into 5A's group consulting intervention package that fits migrant workers. 2. To test the feasibility and acceptability of delivering the intervention , and provide information to the design of the main trial such as outcome suitability, number of clusters (factories) and size of each cluster (participants), effect size, intra-cluster correlation coefficient (ICC) , recruitment and attrition rates. 

Objectives of Study：

We aim to design a 5A's group consulting package, which will be adapted from WHO 5A's model and has potentials to be implemented in the workplaces settings in China. in the years to come, we will conduct a randomized controlled trial(RCT) to test its effectiveness in reducing non-smokers' exposure to SHS as measured by salivary cotinine levels in workplaces in China, with secondary aims of determining its effectiveness in reducing the uptake of smoking and reducing smoking rates in migrant workers. In this study, we will test the feasibility and acceptability of conducting a workplace-based migrant-workers intervention program of the 5A's and provide information to inform the future design of RCT. Research questions 1. How can the WHO 5A's model be adapted into 5A's group consulting intervention package that fits migrant workers in China? 2. To what extent it is feasible and acceptable of delivering the intervention in the workplaces setting, and how the evidence generated from this study will inform the design of the main trial. Objectives 1. To tailor the WHO 5A's model into 5A's group consulting intervention package that fits migrant workers. 2. To test the feasibility and acceptability of delivering the intervention , and provide information to the design of the main trial such as outcome suitability, number of clusters (factories) and size of each cluster (participants), effect size, intra-cluster correlation coefficient (ICC) , recruitment and attrition rates. 

药物成份或治疗方案详述：

First, the package would be designed by tailoring the WHO 5A's model into 5A's group consulting intervention package through literature review, in-depth interview and focus group discussion. The 5A's group consulting package intervention includes: 1. Factsheets detailing key information on smoking, SHS. 2. Guidelines for group guiders on how to deliver the 5A's group consulting (activities for different audiences: smokers, non-smokers exposed to SHS). 3. A leaflet that contains the key facts about smoking and SHS that can be disseminated to migrant workers after consulting. Second, we aim to recruit 8 factories (clusters) and all the migrant workers working in these factories from industrial zone of Guangzhou, China. The clusters will be randomized to the intervention and control group in a 1:1 ratio. Clusters allocated to the intervention arm will be offered the 5A's group consulting package. Factories will complete a factory survey of basic factory information, all participants will complete a questionnaire (about the status of tobacco exposure, knowledge and attitude of tobacco, and demographic information), and a non-smoking individual will provide a salvia sample which will be tested for cotinine. All these participant outcomes (questionnaire and salvia cotinine) will be measured before and after the 3-month intervention in both arms of the trial. In addition, a purposive sample of participants will be invited for interviews to investigate the facilitators and barriers for integrating 5A's group consulting package into workplace settings and how these can be enhanced or addressed at the end of this trial. 

Description for medicine or protocol of treatment in detail：

First, the package would be designed by tailoring the WHO 5A's model into 5A's group consulting intervention package through literature review, in-depth interview and focus group discussion. The 5A's group consulting package intervention includes: 1. Factsheets detailing key information on smoking, SHS. 2. Guidelines for group guiders on how to deliver the 5A's group consulting (activities for different audiences: smokers, non-smokers exposed to SHS). 3. A leaflet that contains the key facts about smoking and SHS that can be disseminated to migrant workers after consulting. Second, we aim to recruit 8 factories (clusters) and all the migrant workers working in these factories from industrial zone of Guangzhou, China. The clusters will be randomized to the intervention and control group in a 1:1 ratio. Clusters allocated to the intervention arm will be offered the 5A's group consulting package. Factories will complete a factory survey of basic factory information, all participants will complete a questionnaire (about the status of tobacco exposure, knowledge and attitude of tobacco, and demographic information), and a non-smoking individual will provide a salvia sample which will be tested for cotinine. All these participant outcomes (questionnaire and salvia cotinine) will be measured before and after the 3-month intervention in both arms of the trial. In addition, a purposive sample of participants will be invited for interviews to investigate the facilitators and barriers for integrating 5A's group consulting package into workplace settings and how these can be enhanced or addressed at the end of this trial. 

研究设计：

队列研究 

Study design：

Cohort study 

纳入标准：

Inclusion criteria for cluster recruitment: 1. Factory should be labor intensive in manufacture industry. 2. Have at least 80 migrant workers that can participate in the trial. 3. The manager should be willing to adhere to the planed intervention. Inclusion criteria for individual recruitment:we will include rural to urban migrants, no matter whether they smoke or not, who are willing to participate in the trial. 

Inclusion criteria

Inclusion criteria for cluster recruitment: 1. Factory should be labor intensive in manufacture industry. 2. Have at least 80 migrant workers that can participate in the trial. 3. The manager should be willing to adhere to the planed intervention. Inclusion criteria for individual recruitment:we will include rural to urban migrants, no matter whether they smoke or not, who are willing to participate in the trial. 

排除标准：

Exclusion criteria for cluster recruitment:have taken part in a similar tobacco control activity before. Exclusion criteria for individual recruitment:we will exclude workers who do not smoke and have no SHS exposure at all. 

Exclusion criteria：

Exclusion criteria for cluster recruitment:have taken part in a similar tobacco control activity before. Exclusion criteria for individual recruitment:we will exclude workers who do not smoke and have no SHS exposure at all. 

研究实施时间：

Study execute time：

从From2015-09-01至To 2016-01-22 

征募观察对象时间：

Recruiting time：

从From2015-08-24至To 2015-08-28 

干预措施：

Interventions：

组别：

干预组

样本量：

 149

Group：

intervention group

Sample size：

干预措施：

5A小组咨询干预包

干预措施代码：

Intervention：

5A's group consulting package intervention

Intervention code：

组别：

对照组

样本量：

 166

Group：

control group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

no

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国 

省(直辖市)：

 广东 

市(区县)：

  

Country：

 China 

Province：

 Guangdong 

City：

  

单位(医院)：

 高天（中山）金属制造有限公司 

单位级别：

 N/A 

Institution
hospital：

 Go Tin (Zhongshan) Hardware manufacturing limited  

Level of the institution：

 N/A 

国家：

 中国 

省(直辖市)：

 广东 

市(区县)：

  

Country：

 China 

Province：

 Guangdong 

City：

  

单位(医院)：

 万里（中山）脚轮制造有限公司 

单位级别：

 N/A 

Institution
hospital：

 Wan Li (Zhongshan) castor manufacturing limited  

Level of the institution：

 N/A 

国家：

 中国 

省(直辖市)：

 广东 

市(区县)：

  

Country：

 China 

Province：

 Guangdong 

City：

  

单位(医院)：

 世通（中山）脚轮制造有限公司 

单位级别：

 N/A 

Institution
hospital：

 Shi Tong (Zhongshan) castor manufacturing limited  

Level of the institution：

 N/A 

国家：

 中国 

省(直辖市)：

 广东 

市(区县)：

  

Country：

 China 

Province：

 Guangdong 

City：

  

单位(医院)：

 光阳电器有限公司 

单位级别：

 N/A 

Institution
hospital：

 Guang Yang electrical appliance co., LTD  

Level of the institution：

 N/A 

测量指标：

Outcomes：

指标中文名：

可行性

指标类型：

主要指标 

Outcome：

Feasibility score

Type：

Primary indicator 

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

可接受性

指标类型：

主要指标 

Outcome：

Acceptability

Type：

Primary indicator 

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

唾液可替宁含量

指标类型：

次要指标 

Outcome：

Salivary cotinine concentration

Type：

Secondary indicator 

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

戒烟率

指标类型：

次要指标 

Outcome：

Smoking quit rate

Type：

Secondary indicator 

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

知识态度的变化

指标类型：

次要指标 

Outcome：

Knowledge and attitude change

Type：

Secondary indicator 

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

损耗率

指标类型：

次要指标 

Outcome：

Attrition rate

Type：

Secondary indicator 

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

组内相关系数

指标类型：

次要指标 

Outcome：

interclass correlation coefficient

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：

唾液

组织：

Sample Name：

Saliva

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 17 岁 years
最大 Max age 64 岁 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）：

Four manufacturing factories were purposively selected from the list of factories provided by the government, and were randomized to into intervention and control group according to the cooperation desire of these factories.

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

Four manufacturing factories were purposively selected from the list of factories provided by the government, and were randomized to into intervention and control group according to the cooperation desire of these factories.

盲法：

Blinding：

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）：

临床试验公共管理平台

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

http://www.medresman.org

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：

Epidata 3.1 和 IBM SPSS 20.0

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

Epidata 3.1 and IBM SPSS 20.0

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

 2017-06-12
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