Tobacco UseNCT06074939
FRESHAIR4Life: Building the Case for Action
An observational study of Tobacco Use and Pollution; Exposure, run by Leiden University Medical Center.
Trial summary
The goal of this observational study is to understand the burden and determinants of tobacco use and air pollution (AP) exposure among mid- to late adolescents in Greece, the Kyrgyz Republic, Pakistan, Romania, and Uganda. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use, Pollution; Exposure, Non-communicable Disease
- How many people
- 1,750 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This study will be performed in Greece, Romania, the Kyrgyz Republic, Pakistan and Uganda. These countries all have a high NCD burden but differ largely in contextual factors like population size (from 6.7 million in the Kyrgyz Republic to 231 million in Pakistan), population age (median age of 15.9 years in Uganda, up to 44.7 years in Greece), income classification (low in Uganda, low-middle in Pakistan and the Kyrgyz Republic, and high in Greece and Romania) and life expectancy (62.9 years in Uganda to 81.1 years in Greece). All countries will have an urban area as starting point (for logistical reasons and due to high prevalence of the vast majority of risk factors in urban areas), with either a peri-urban or rural community as second investigation site. Genders will equally be included in the situational analysis.
Who may be able to join
- Adolescents: mid- to late-adolescents (14 to 21 years) within the target population;
- Family members: relatives in the first or second degree of (not necessarily participating) adolescents;
- Providers: any relevant stakeholder that is connected to adolescents through profession (e.g. school teacher, youth worker) and/or providers of (public) healthcare;
- Stakeholders: any relevant stakeholder with either a specific expertise, in-depth knowledge or overall overview on the subject, and in direct contact with the community (e.g. community member/leader, policy maker). Due to the community- and individual-level focus of this research, individuals associated with the tobacco industry are deliberately not included as stakeholders.
Who cannot join
- People living outside the target area or not in direct contact with the target population.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Building the Case for Action: A Situational Analysis to Guide the Implementation of Preventive Interventions in Adolescent Tobacco Use and Air Pollution Exposure
The goal of this observational study is to understand the burden and determinants of tobacco use and air pollution (AP) exposure among mid- to late adolescents in Greece, the Kyrgyz Republic, Pakistan, Romania, and Uganda. This context-specific knowledge will be crucial for selecting, adapting, and implementing preventive interventions in the next phase of the project.
The main questions the investigators aim to answer are:
Read more
- What is the perceived burden of tobacco use and AP exposure among adolescents?
- What are the contextual drivers and behavioral determinants contributing to (prevention of) these risk factors?
- How do the dynamics between stakeholders influence prevention efforts?
In this study, data will be collected through interviews, focus group discussions, photovoice, document analysis, observations, personal exposure monitoring, and questionnaires.
- Conditions
- Tobacco Use, Pollution; Exposure, Non-communicable Disease
- Keywords
- Implementation studies, Mixed-methods, Participatory research
- Medical subject headings
- Tobacco Use, Noncommunicable Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative and qualitative evaluation of perceived clinical symptoms due to tobacco use and/or AP exposure
Measured: 1 day
Quantitative and qualitative evaluation and exploration of perceived psychological impact due to tobacco use and/or AP exposure
Measured: 1 day
Quantitative and qualitative evaluation and exploration of social factors relating to tobacco use and/or AP exposure
Measured: 1 day
Quantitative evaluation of the burden due to tobacco use and/or AP exposure by monitoring personal exposure to air borne particulates (PM 10, PM 2.5 and PM 1), temperature and relative humidity, using personal exposure (PE) monitors
Measured: 1 day
Qualitative evaluation and exploration of contextual drivers relevant to intervention implementation for prevention of tobacco and/or AP exposure, e.g. current strategies, local infrastructure and accessibility of resources.
Measured: 1 day
Qualitative evaluation and exploration of contextual drivers relevant to intervention implementation for prevention of tobacco and/or AP exposure, e.g. the influence of social media.
Measured: 1 day
Qualitative evaluation and exploration of contextual drivers relevant to intervention implementation for prevention of tobacco and/or AP exposure, e.g. the local socio-political climate, policy regulations and industry tactics.
Measured: 1 day
Qualitative evaluation and exploration of the relationship, power dynamics and (medical) hierarchies between adolescents, providers and other stakeholders.
Measured: 1 day
Quantitative and qualitative evaluation and exploration of determinants of behavior change in adolescents and providers relating to intervention implementation for prevention of tobacco and/or AP exposure.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University, University of York, University of Edinburgh, The Initiative, Lungs Europe, International Primary Care Respiratory Group, University of Groningen, University of Crete, Ministry of Health, Kyrgyzstan, Romanian Center for Studies in Family Medicine, Makerere University
- Responsible party
- Principal investigator, Rianne MJJ van der Kleij, PhD, Leiden University Medical Center
- Investigators
- Rianne MJJ van der Kleij, PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074939
- Sponsor's protocol ID
- 23-3075
- Other IDs
- 101095461, 10063681; 10060974; 1006440
- Status last verified
- Oct 2023
- First submitted
- 26 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building the Case for Action: A Situational Analysis to Guide the Implementation of Preventive Interventions in Adolescent Tobacco Use and Air Pollution Exposure
- ClinicalTrials.gov ID
- NCT06074939
- Acronym / sponsor ID
- 23-3075
- Conditions
- Tobacco Use, Pollution; Exposure, Non-communicable Disease
- Keywords
- Implementation studies, Mixed-methods, Participatory research
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,750 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Maastricht University, University of York, University of Edinburgh, The Initiative, Lungs Europe, International Primary Care Respiratory Group, University of Groningen, University of Crete, Ministry of Health, Kyrgyzstan, Romanian Center for Studies in Family Medicine, Makerere University
- Study start
- Oct 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to understand the burden and determinants of tobacco use and air pollution (AP) exposure among mid- to late adolescents in Greece, the Kyrgyz Republic, Pakistan, Romania, and Uganda. This context-specific knowledge will be crucial for selecting, adapting, and implementing preventive interventions in the next phase of the project.
The main questions the investigators aim to answer are:
- What is the perceived burden of tobacco use and AP exposure among adolescents?
- What are the contextual drivers and behavioral determinants contributing to (prevention of) these risk factors?
- How do the dynamics between stakeholders influence prevention efforts?
In this study, data will be collected through interviews, focus group discussions, photovoice, document analysis, observations, personal exposure monitoring, and questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will be performed in Greece, Romania, the Kyrgyz Republic, Pakistan and Uganda. These countries all have a high NCD burden but differ largely in contextual factors like population size (from 6.7 million in the Kyrgyz Republic to 231 million in Pakistan), population age (median age of 15.9 years in Uganda, up to 44.7 years in Greece), income classification (low in Uganda, low-middle in Pakistan and the Kyrgyz Republic, and high in Greece and Romania) and life expectancy (62.9 years in Uganda to 81.1 years in Greece). All countries will have an urban area as starting point (for logistical reasons and due to high prevalence of the vast majority of risk factors in urban areas), with either a peri-urban or rural community as second investigation site. Genders will equally be included in the situational analysis.
Key inclusion criteria (4 listed)
- Adolescents: mid- to late-adolescents (14 to 21 years) within the target population;
- Family members: relatives in the first or second degree of (not necessarily participating) adolescents;
- Providers: any relevant stakeholder that is connected to adolescents through profession (e.g. school teacher, youth worker) and/or providers of (public) healthcare;
- Stakeholders: any relevant stakeholder with either a specific expertise, in-depth knowledge or overall overview on the subject, and in direct contact with the community (e.g. community member/leader, policy maker). Due to the community- and individual-level focus of this research, individuals associated with the tobacco industry are deliberately not included as stakeholders.
Key exclusion criteria (1 listed)
- People living outside the target area or not in direct contact with the target population.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantitative and qualitative evaluation of perceived clinical symptoms due to tobacco use and/or AP exposure
Time frame: 1 day
Quantitative and qualitative evaluation and exploration of perceived psychological impact due to tobacco use and/or AP exposure
Time frame: 1 day
Quantitative and qualitative evaluation and exploration of social factors relating to tobacco use and/or AP exposure
Time frame: 1 day
Quantitative evaluation of the burden due to tobacco use and/or AP exposure by monitoring personal exposure to air borne particulates (PM 10, PM 2.5 and PM 1), temperature and relative humidity, using personal exposure (PE) monitors
Time frame: 1 day
Qualitative evaluation and exploration of contextual drivers relevant to intervention implementation for prevention of tobacco and/or AP exposure, e.g. current strategies, local infrastructure and accessibility of resources.
Time frame: 1 day
Qualitative evaluation and exploration of contextual drivers relevant to intervention implementation for prevention of tobacco and/or AP exposure, e.g. the influence of social media.
Time frame: 1 day
Qualitative evaluation and exploration of contextual drivers relevant to intervention implementation for prevention of tobacco and/or AP exposure, e.g. the local socio-political climate, policy regulations and industry tactics.
Time frame: 1 day
Qualitative evaluation and exploration of the relationship, power dynamics and (medical) hierarchies between adolescents, providers and other stakeholders.
Time frame: 1 day
Quantitative and qualitative evaluation and exploration of determinants of behavior change in adolescents and providers relating to intervention implementation for prevention of tobacco and/or AP exposure.
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rianne MJJ van der Kleij, PhD principal investigator
Leiden University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Tobacco Use and Pollution; Exposure, run by Leiden University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rianne MJJ van der Kleij, PhD (+31622642623, m.j.j.van_der_kleij-van_der_sluis@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative and qualitative evaluation of perceived clinical symptoms due to tobacco use and/or AP exposure (time frame: 1 day). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.