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: |
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English Acronym: |
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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: |
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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: |
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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): |
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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 |
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Applicant's institution: |
School of Public Health, Sun Yat-sen University |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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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 |
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Name of the ethic committee: |
Ethics Committees of School of Public Health, Sun Yat-sen University, Guangzhou, China |
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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: |
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Contact Name of the ethic committee: |
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伦理委员会联系地址: |
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Contact Address of the ethic committee: |
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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 |
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Primary sponsor: |
Sun Yat-sen University |
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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 |
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Primary sponsor's address: |
74 Second Zhongshan Road, Guangzhou, Guangdong, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
英国医学研究理事会 |
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Source(s) of funding: |
Medical Research Council |
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研究疾病: |
吸烟 |
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Target disease: |
tobacco use |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
观察性研究 |
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Study type: |
Observational study |
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研究所处阶段: |
探索性研究/预试验 | ||||||||||||||||||||||
Study phase: |
0 |
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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. |
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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. |
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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. |
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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. |
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研究设计: |
队列研究 |
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Study design: |
Cohort study |
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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. |
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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. |
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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. |
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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: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
结束 Completed |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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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. |
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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: |
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Blinding: |
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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 |