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

NCT03150186 | Unknown DMC

• 1 other identifier: TackSHS WP2
• Study Type: observational
• Target: 1,080
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Second Hand Tobacco Smoke

Keywords

second hand smoke; passive smoking; airborne nicotine; private settings; outdoors

Outcome Measures

Primary Outcomes (1)

• SHS exposure in private and outdoor settings

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

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

Study Arms (3)

SHS exposure in homes

Measurement of nicotine level in private homes

Other: SHS exposure in homes

SHS exposure in private cars

Measurement of nicotine level in private cars

Other: SHS exposure in private cars

SHS exposure in outdoor settings

Measurement of nicotine level in outdoor settings (children playgrounds, terraces of hospitality venues, and entrances of primary school buildings)

Other: SHS exposure in outdoor settings

Interventions

SHS exposure in homes OTHER

The investigators will recruit 20 non-smoking volunteers living in different homes with at least one smoker: 10 participants living in more deprived neighborhoods and 10 participants living in wealthier neighborhoods. Nicotine vapor phase will be measured using passive SHS samplers. The investigators will contact with participants and make an arrangement for measuring levels of nicotine at homes. First, the investigators will hang up a passive sampler in the main room of the house in accordance with the written protocol of sample collection. One week later, the investigators will come back to the house in a second visit to remove the sample. During the second visit the investigators will administer a specific questionnaire about environmental tobacco exposure to the participant.

SHS exposure in homes

SHS exposure in private cars OTHER

The investigators will measure levels of nicotine in 30 cars (two samples per car) in 2 European countries with different smoke-free legislation (Spain and UK). A convenience sampling will be performed considering feasibility. The investigators will recruit 30 drivers: 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. To be eligible, participants have to spend a minimum of 30 minutes per day within the car. Nicotine vapor phase will be measured using passive SHS samplers. Two samplers will be hung up in each car during a period of 24 hours. One sampler will be open during the 24-hour sampling period. The other sampler will be only open during travelling time.

SHS exposure in private cars

SHS exposure in outdoor settings OTHER

In three types of outdoor settings (children playgrounds, terraces of hospitality venues, and entrances of primary school buildings), nicotine vapor phase will be measured using active SHS samplers. For each country, a convenience sampling of 60 outdoor settings (20 of each of the above mentioned settings) will be performed. Data collection will be conducted from March to October. The measurements will be able to be taken at any time of day providing that there are at least five adults. The investigators will collect nicotine samples using samplers attached to an air pump. Measurements will last 30 minutes. While measurements are being taken, data collectors will also conduct observations in accordance with the protocol of active sampling collection.

SHS exposure in outdoor settings

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Private homes, private cars, three types of outdoor settings (terraces of hospitality venues (1), children playgrounds (2) and entrances of primary school buildings (3) in 12 European countries

You may qualify if:

• Homes:
• 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)
• Cars:
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Institut Català d'Oncologia: lead
• Public Health Agency of Barcelona: collaborator
• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: collaborator
• University of Aberdeen: collaborator
• Istituto per lo Studio, la Prevenzione e la Rete Oncologica: collaborator
• Universidad Politécnica de Cartagena: collaborator

Study Sites (1)

Agència de Salut Pública de Barcelona

Barcelona, Catalonia, 08023, Spain

Location

Related Links

• TackSHS Project

Study Officials

• Maria J López, PhD

  Public Health Agency of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: May 12, 2017
• Study Start: February 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: October 31, 2019
• Last Updated: May 12, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)