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临床试验/NCT00995254
NCT00995254已完成不适用

Reducing Secondhand Smoke Exposure Among Young Children

Boston University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2008年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
1
主要终点
improvement of smoking hygiene practices within the household as reported by the subjects (i.e. reduction in the number of cigarettes smoked indoors at home while a child was present during the previous week)

研究概览

简要总结

Second hand smoking (SHS) is a health hazard to infants and children, in whom it is associated with lower respiratory tract infections, wheezing, cough, middle ear infections and sudden infant death syndrome. Evidence from developed nations suggests that measures to reduce exposure to SHS can improve children's health outcomes; this has not been systematically studied in a developing country setting. The investigators hypothesize that implementation of a package of smoking hygiene intervention measures delivered by community health workers (CHWs) will reduce Chinese children's exposure to SHS and improve their respiratory health.

To test this hypothesis, the investigators have identified three specific aims: (1) to obtain baseline data on second hand tobacco exposure among young children, health status of young children and smoking status of parents and other household members, (2) to generate preliminary effectiveness data for CHW-delivered SHI, and (3) to develop culturally appropriate biochemical measures to assess children's exposure to household SHS. The investigators propose to conduct this study in an urban district in Shanghai, China. After an initial assessment, the investigators will conduct a randomized controlled trial of households in a community, selected based on important study criteria, within the district. The investigators selected this design because it is most likely to produce a scientifically valid answer to our primary study question. All eligible smokers in the intervention group will receive behavioral counseling to address health hazards of SHS towards children, brief advice to quit or to adopt a no smoking policy around children, and educational pamphlets on the hazards of SHS, from a trained CHW in their community. A questionnaire will be used for data collection at the start and at 2 and 6 months. To assess the extent of total SHS exposure, children's urine cotinine (the indicator of nicotine) level will be measured at the first contact and at 2-and 6- months. To validate household members reported level of smoking the investigators will measure air nicotine levels of a sub-sample (10%) of households via passive monitors. The results of this study will provide clinical evidence for the development of CHW-delivered interventions designed to reduce exposure to SHS and improve the respiratory health of children in a resource-poor community. If successful, the program can serve as a model for implementation in other developing country settings. Furthermore, successful results could also be used to draft guidelines for health promotion interventions, which could be implemented as a policy for all primary health care settings. Finally, the study, which would be the first of its type in a developing country setting, will form the basis for future research and program development in the area of SHS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • household member has smoked one or more cigarettes daily for the past 30 days as self reported;
  • household smoker smokes a total of at least 10 cigarettes per week at home in the presence of the child, as self reported;
  • smoker household member and the child are living together in the same household and will live together during the entire period of the study;
  • residents of the study community;
  • able to communicate in Mandarin Chinese or local Shanghai dialect; AND
  • has signed an informed consent form or given verbal consent (for those who cannot read and write).

排除标准

  • reported residential coal burning and confirmed by the interviewer;
  • households with breast-feeding child;
  • household members do not smoke at home;
  • smoker member does not live in the same household as the under 5 child;
  • non-local community resident; OR
  • not able to communicate in Mandarin Chinese or Shanghai dialect.

研究组 & 干预措施

Control group

No Intervention

Control group will ONLY receive SHI after completion of the study

Intervention group

Experimental

Intervention group will receive smoking hygiene intervention (SHI) at three individualized contacts.

干预措施: SHI counseling (Behavioral)

结局指标

主要结局

improvement of smoking hygiene practices within the household as reported by the subjects (i.e. reduction in the number of cigarettes smoked indoors at home while a child was present during the previous week)

时间窗: at 6 month follow up

次要结局

  • reduction of reported health care utilization due to respiratory disease(at 6 months follow up)
  • reduction of respiratory illness incidence among young children as reported by key household members(at 6 month follow up)

研究者

申办方类型
Other

研究点 (1)

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