FRESHAIR4Life: Building the Case for Action

Tobacco Use Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06074939
• Other study ID #: 23-3075
• Secondary ID: 1010954611006368
• Status: Not yet recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Non-communicable Disease
• Noncommunicable Diseases
• Pollution; Exposure
• Tobacco Use

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