Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03150186 |
| Other study ID # |
TackSHS WP2 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
May 10, 2017 |
| Last updated |
May 10, 2017 |
| Start date |
February 1, 2017 |
| Est. completion date |
October 31, 2019 |
Study information
| Verified date |
May 2017 |
| Source |
Institut Català d'Oncologia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
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
STUDY DESIGN
This is a multi-country cross-sectional study based on objective environmental measurements
of SHS levels.
STUDY SETTINGS
The study will be carried out in private and outdoor settings in the following 12 European
countries: Bulgaria, France, Germany, Greece, Ireland, Italy, Latvia, Poland, Portugal,
Romania, Spain and the United Kingdom. Private settings studied will be homes and cars and
outdoor settings will be terraces of hospitality venues, children playgrounds and entrances
of primary school buildings.
SAMPLING
A total of 1,080 environmental measures 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 (20 samples × 4 settings × 12countries = 960 samples). Regarding cars, 60
environmental measurements will be collected in two countries (Spain and UK) (120 samples),
which have been selected taking into account differences in smoking legislation.
A convenience sampling will be performed considering feasibility and trying to include
participants from different socioeconomic status (SES). Neighborhood SES will be measured
using ecological synthetic SES indexes available in each country. Measures will be taken in
private and outdoor settings located in the most deprived neighborhoods (those below the
20th percentile of the SES distribution) and the least deprived neighborhoods (those above
the 80th percentile of the SES distribution).
FIELDWORK
Private settings: homes and cars
For each country, the investigators will measure levels of nicotine in 20 homes. We 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 during one week using passive SHS
samplers. At the end of the week, the investigators will administer a specific questionnaire
about SHS exposure to the participant.
The investigators will measure levels of nicotine in 30 cars (two samples per car) in two
European countries with different smoke-free legislation (Spain and UK). A convenience
sampling will be performed considering feasibility and trying to include participants with
different smoking habits. 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. Outdoor settings: nicotine vapor phase will be measured
using active SHS samplers. For each country, a convenience sampling of 60 outdoor settings
(20 children playgrounds, 20 terraces of hospitality venues, and 20 entrances of primary
school buildings) will be performed considering feasibility and trying to include the
outdoor settings from different SES neighborhoods. 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 measures are
being taken, data collectors will also conduct observations in accordance with the protocol
of active sampling collection. In each country, the investigators will measure levels of
nicotine in 30 outdoor settings (10 playgrounds, 10 terraces of hospitality venues, and 10
entrances of primary school buildings) located in more deprived neighborhoods and 30 outdoor
settings (as above) located in wealthier neighborhoods.
MAIN OUTCOMES
Vapour-phase nicotine (μg/m3) is the main objective outcome. The investigators will also
register sample's code, location sampled, date and time when the monitor was installed and
removed, time of tobacco exposure, volume of the area, smoke-free rules of the setting, and
further relevant information related to the SHS exposure according to the different settings
studied (e.g., for private settings: socio-demographic variables, intensity of tobacco
exposure (number of smokers), minutes of exposure per day, number of cigarettes smoked per
day, ventilation, use of air-conditioning or heating (only in cars), etc.; for outdoor
settings: no smoking signs, presence of ashtrays and butts, smoke smell, number of people
smoking, total number of adults and children, kind of venue, age group allowed to play (only
in playgrounds), number of walls or roof (only in terraces), etc.).
DATA SOURCES
Environmental samples: Nicotine vapor phase will be measured using SHS samplers, which
consist of a 37-mm diameter plastic cassette containing a filter treated with sodium
bisulphate.
Passive samplers will be placed in private homes and cars. The samplers will be placed for a
period of seven days in homes and of 24 hours in cars. In homes, samplers will be hung
freely in the air approximately 2 meters high. They will not be placed where air does not
circulate such as a corner, under a shelf or buried in curtains.
Active samplers will be used in outdoors settings. The samplers will be attached to an air
pump with a flow rate ranging from 2 to 3 L/min, and 30-min measurements will be taken.
Questionnaire/Form: Questionnaires or forms will be fulfilled by trained personnel at the
same time the samples are taken. There is a specific questionnaire or form to be filled for
each setting. All questionnaires/forms gather some common questions and other specific
questions according to the setting studied. Questionnaires/forms gather information on
sampling area, date and time the samplers are placed and removed, the presence of tobacco
smoking, specific characteristics of the setting studied, attitudes and behaviors towards
tobacco, etc.
DATA MANAGEMENT
The study data will be kept in different databases according to the setting studied.
Information obtained through forms and questionnaires will be entered on a computer by
collaborators from each country. Then, all data bases will be encrypted and later on sent by
e-mail to the ASPB. Individual forms and questionnaires will be scanned and sent
electronically to the ASPB. Original versions will also be sent by post. All forms and
questionnaires will be stored by the ASPB in agreement with the current law. Nicotine
samples will be sent properly stored and identified to the ASPB during the fieldwork.
LAB ANALYSIS
All the nicotine samples will be analyzed by the laboratory of the Public Health Agency of
Barcelona (Spain) using the gas chromatography/mass spectrometry method. Nicotine analysis
will be conducted by the gas chromatography/mass spectrometry method, which has been
officially accredited by the Spanish National Accreditation Entity (ENAC) according to ISO
17025 guidelines. This method allows quantifying the total amount of nicotine in the sample,
with a lower limit of detection of 5 ng. Subsequently, the time weighted average nicotine
concentration (μg/m3) can be estimated by dividing the amount of extracted nicotine by the
volume of air sampled multiplied by the total number of minutes the filter has been exposed.
Blank samples will be analyzed for quality assurance and to assess potential contamination
of the filters during manipulation of monitors, storage, shipment or shipment. A blank
sample for each 20 samples will be analyzed.
STATISTICAL ANALYSIS
A first descriptive analysis will be conducted for all outcomes included in the study.
Categorical variables will be described by raw frequencies and percentages and continuous
variables will be described by means and standard deviations or medians and interquartile
range (IQR). Medians and IQR of nicotine concentrations will be calculated by country for
each setting studied. Box-plots will be used to visualize the distribution of nicotine
concentrations. Nicotine concentrations obtained will be compared according to country, SES
and other determinants of exposure for each setting, using non-parametric tests (the Mann
Whitney U test or Kruskal-Wallis test as appropriate). Finally, correlations between
nicotine concentration and variables related to the SHS recorded in the questionnaires or
forms will be also assessed.
ETHICS
All participants taking part in environmental measurements collected in private settings
(homes and cars) will be properly informed verbally and in writing, providing all pertinent
information about the aims, methods, procedures, ethical issues and measures taken.
Enrolling in the study will be voluntary and signing a written informed consent will be
mandatory to take part in the study as agreement to participate. Informed consent will not
be obtained to collect environmental measurements in outdoor settings. All written informed
consents will be firstly stored in locked filing cabinets and principal investigators will
be responsible for the informed consent of participants of their country. Later, written
informed consent will be scanned, copied and sent electronically to the ASPB. All original
informed consent will be post to the ASPB using a traceable mail courier. All original
informed consent will be stored in accordance with Spanish legislation. All personal
information will be treated as confidential and will be stored in agreement with the current
laws. The study will be conducted in accordance with the Good Clinical Practice Guidelines
of the Declaration of Helsinki and the current legal regulation about confidentiality of
data.
INFORMED CONSENT
All informed consent will be written in English and in official language, according to the
country involved in the project, to ensure potential participant's comprehension. The
informed consent gathers information about the aims, methods and procedures of the study and
properly informs about involvement of the participants and their rights as participants of
the study. Two different specific informed consents have been designed according to the
private setting (homes or cars) where the measurements are taken.
