FRESHAIR4Life: Building the Case for Action

Sponsor

Leiden University Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06074939

Collaborator

Maastricht University (Other), University of York (Other), University of Edinburgh (Other), The Initiative (Other), Lungs Europe (Other), International Primary Care Respiratory Group (Other), University of Groningen (Other), University of Crete (Other), Ministry of Health, Kyrgyzstan (Other), Romanian Center for Studies in Family Medicine (Other), Makerere University (Other)

1,750

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Use Pollution; Exposure Non-communicable Disease

Study Design

Study Type:

Observational

Anticipated Enrollment :

1750 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Investigators

Principal Investigator: Rianne MJJ van der Kleij, PhD, Leiden University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rianne MJJ van der Kleij, PhD, Principal Investigator, Leiden University Medical Center

ClinicalTrials.gov Identifier:

NCT06074939

Other Study ID Numbers:

23-3075
101095461
10063681; 10060974; 1006440

First Posted:

Oct 10, 2023

Last Update Posted:

Oct 10, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Rianne MJJ van der Kleij, PhD, Principal Investigator, Leiden University Medical Center

Implementation studies

Mixed-methods

Participatory research

Additional relevant MeSH terms:

Noncommunicable Diseases

Study Results

No Results Posted as of Oct 10, 2023