Clinical trial NCT06074939: FRESHAIR4Life: Building the Case for Action
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Tobacco Use
Pollution; Exposure
Non-communicable Disease
Keywords: Implementation studies
Mixed-methods
Participatory research
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Maastricht University
name: University of York
name: University of Edinburgh
name: The Initiative
name: Lungs Europe
name: International Primary Care Respiratory Group
name: University of Groningen
name: University of Crete
name: Ministry of Health, Kyrgyzstan
name: Romanian Center for Studies in Family Medicine
name: Makerere University
First posted: 2023-10-10
Enrollment: 1750
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Quantitative and qualitative evaluation of perceived clinical symptoms due to tobacco use and/or AP exposure
timeFrame: 1 day
measure: Quantitative and qualitative evaluation and exploration of perceived psychological impact due to tobacco use and/or AP exposure
timeFrame: 1 day
measure: Quantitative and qualitative evaluation and exploration of social factors relating to tobacco use and/or AP exposure
timeFrame: 1 day
measure: 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
timeFrame: 1 day
measure: 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.
timeFrame: 1 day
measure: 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.
timeFrame: 1 day
measure: 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.
timeFrame: 1 day
measure: Qualitative evaluation and exploration of the relationship, power dynamics and (medical) hierarchies between adolescents, providers and other stakeholders.
timeFrame: 1 day
measure: 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.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Leiden University Medical Center
name: Rianne MJJ van der Kleij, PhD
role: PRINCIPAL_INVESTIGATOR
References: