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Trial record 4 of 5 for:    TackSHS

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03150186
First Posted: May 12, 2017
Last Update Posted: May 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Agència de Salut Pública de Barcelona
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
University of Aberdeen
Istituto per lo Studio e la Prevenzione Oncologica
Universidad Politécnica de Cartagena
Information provided by (Responsible Party):
Institut Català d'Oncologia
  Purpose

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.


Condition Intervention
Second Hand Tobacco Smoke Other: SHS exposure in homes Other: SHS exposure in private cars Other: SHS exposure in outdoor settings

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Environmental Assessment of Secondhand Smoke Exposure in Private Settings and Outdoor Settings in Europe

Resource links provided by NLM:


Further study details as provided by Institut Català d'Oncologia:

Primary Outcome Measures:
  • SHS exposure in private and outdoor settings [ Time Frame: 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.


Estimated Enrollment: 1080
Actual Study Start Date: February 1, 2017
Estimated Study Completion Date: October 31, 2019
Estimated Primary Completion Date: March 1, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
SHS exposure in homes
Measurement of nicotine level in private homes
Other: SHS exposure in homes
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 private cars
Measurement of nicotine level in private cars
Other: SHS exposure in private cars
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 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
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

  • volunteers with literacy level or language skills preventing them from understanding the study documents
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03150186


Locations
Spain
Agència de Salut Pública de Barcelona
Barcelona, Catalonia, Spain, 08023
Sponsors and Collaborators
Institut Català d'Oncologia
Agència de Salut Pública de Barcelona
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
University of Aberdeen
Istituto per lo Studio e la Prevenzione Oncologica
Universidad Politécnica de Cartagena
Investigators
Principal Investigator: Maria J López, PhD Agència de Salut Pública de Barcelona
  More Information

Additional Information:
Responsible Party: Institut Català d'Oncologia
ClinicalTrials.gov Identifier: NCT03150186     History of Changes
Other Study ID Numbers: TackSHS WP2
First Submitted: May 10, 2017
First Posted: May 12, 2017
Last Update Posted: May 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut Català d'Oncologia:
second hand smoke
passive smoking
airborne nicotine
private settings
outdoors

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action