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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06074939
Other study ID # 23-3075
Secondary ID 1010954611006368
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2023
Est. completion date June 2024

Study information

Verified date October 2023
Source Leiden University Medical Center
Contact Rianne MJJ van der Kleij, PhD
Phone +31622642623
Email m.j.j.van_der_kleij-van_der_sluis@lumc.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1750
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - People living outside the target area or not in direct contact with the target population.

Study Design


Locations

Country Name City State
n/a

Sponsors (12)

Lead Sponsor Collaborator
Leiden University Medical Center International Primary Care Respiratory Group, Lungs Europe, Maastricht University, Makerere University, Ministry of Health, Kyrgyzstan, Romanian Center for Studies in Family Medicine, The Initiative, University of Crete, University of Edinburgh, University of Groningen, University of York

Outcome

Type Measure Description Time frame Safety issue
Primary Quantitative and qualitative evaluation of perceived clinical symptoms due to tobacco use and/or AP exposure 1 day
Primary Quantitative and qualitative evaluation and exploration of perceived psychological impact due to tobacco use and/or AP exposure 1 day
Primary Quantitative and qualitative evaluation and exploration of social factors relating to tobacco use and/or AP exposure 1 day
Primary 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 1 day
Primary 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. 1 day
Primary 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. 1 day
Primary 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. 1 day
Primary Qualitative evaluation and exploration of the relationship, power dynamics and (medical) hierarchies between adolescents, providers and other stakeholders. 1 day
Primary 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. 1 day
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