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临床试验/NCT03150186
NCT03150186Unknown不适用

Environmental Assessment of Secondhand Smoke Exposure in Private Settings and Outdoor Settings in Europe

Institut Català d'Oncologia1 个研究点 分布在 1 个国家目标入组 1,080 人开始时间: 2017年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,080
试验地点
1
主要终点
SHS exposure in private and outdoor settings

研究概览

简要总结

This is a European study which is part of a larger research project (TackSHS project) funded by the European Union's Horizon 2020 Research and Innovation Programme (Grant Agreement 681040) and led by the Catalan Institute of Oncology. The main goal of the study is to assess the environmental levels of secondhand smoke (SHS) in non-regulated settings such as private and outdoor settings of 12 European countries (Bulgaria, France, Germany, Greece, Ireland, Italy, Latvia, Poland, Portugal, Romania, Spain and the United Kingdom) representing geographical, legislative (country-specific smoke-free policies) and cultural variations across Europe.

This is a multi-country cross-sectional study based on objective environmental measurements of SHS levels. Private settings studied are homes and cars and outdoors settings are terraces of hospitality venues, children playgrounds and entrances of primary school buildings. A total of 1,080 environmental measures of airborne nicotine will be collected. 20 environmental measures will be collected from homes and each of the outdoor settings for the 12 countries involved in the study (960 samples). Regarding cars, 60 environmental measurements will be collected in two countries (Spain and the UK) (120 samples), which have been selected taking into account differences in smoke-free legislation. Further information about SHS exposure will be collected for each setting through brief questionnaires or forms. Medians and interquartile ranges of nicotine concentrations will be calculated by country for each setting studied. Nicotine concentrations will be compared using non-parametric tests according to country, socioeconomic status and other determinants of exposure for each setting.

详细描述

OBJECTIVES

Main objective: to assess the levels of SHS in a range of private settings and outdoor settings in different European countries according to the type of setting, the smoke-free legislation and socioeconomic characteristics.

Specific objectives:

  • To assess levels of SHS in homes and cars according to socioeconomic status
  • To assess levels of SHS in outdoor settings (children playgrounds, terraces of hospitality venues and entrances of school buildings) according to socioeconomic status
  • To analyze associations between air nicotine concentrations and self-reported information related to tobacco smoking and exposure to SHS in homes and cars
  • To analyze associations between air nicotine concentrations and observational variables related to exposure to SHS in outdoor settings (children playgrounds, terraces of hospitality venues and entrances of school buildings)
  • To assess relationships between levels of SHS and type of smoking legislation and socio-demographic characteristics across Europe according to different types of settings measured
  • To develop evidence-based policy recommendations for policy makers and health authorities

METHODS

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • non-smoking volunteers living in different homes with at least one smoker
  • participants living in more deprived neighborhoods (lower than 20th percentile of the SES distribution) or participants living in wealthier neighborhoods (above than 80th percentile of the SES distribution)
  • volunteers who travel in a car for at least 30min/day
  • profiles of participants: 10 daily-smoking volunteers that usually smoke within their car; 10 daily-smoking volunteers that do not smoke within their car; and 10 non-smoking volunteers.
  • Outdoor settings:
  • there should be at least five adults present at the moment of the measurement start
  • the settings should be located in more deprived neighborhoods (lower than 20th percentile of the SES distribution) or in wealthier neighborhoods (above than 80th percentile of the SES distribution)
  • playgrounds with slides, swings or other similar playing equipment and located outdoors (for children playgrounds)
  • terraces with at least one wall or roof, placed in cafeterias, bars or night pubs (for terraces)

排除标准

  • volunteers with literacy level or language skills preventing them from understanding the study documents

结局指标

主要结局

SHS exposure in private and outdoor settings

时间窗: Passive sampling (homes and cars): 1 week in homes and 24 hours in cars; active sampling (outdoor settings): 30 minutes

Vapour-phase nicotine (μg/m3) measured via passive sampling in private homes and cars and via active sampling in three types of outdoor settings.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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