FRESHAIR4Life: Building the Case for Action

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:

• 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 Overview

• Status: Not yet recruiting
• Conditions: Tobacco Use; Pollution; Exposure; Non-communicable Disease

• Study Type: Observational
• Enrollment (Estimated): 1750

Contacts and Locations

• Study Contact: Name: Rianne MJJ van der Kleij, PhD; Phone Number: +31622642623; Email: m.j.j.van_der_kleij-van_der_sluis@lumc.nl
• Study Contact Backup: Name: Charlotte M Hoffman, MD; Phone Number: +31638955206; Email: c.m.hoffman@lumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Collaborators: University of Edinburgh; Makerere University; Maastricht University; University of York; University of Crete; University of Groningen; International Primary Care Respiratory Group; The Initiative; Lungs Europe; Ministry of Health, Kyrgyzstan; Romanian Center for Studies in Family Medicine
• Investigators: Principal Investigator: Rianne MJJ van der Kleij, PhD, Leiden University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Estimated): October 10, 2023

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Mixed-methods; Implementation studies; Participatory research
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Noncommunicable Diseases
• Other Study ID Numbers: 23-3075; 101095461 (Other Grant/Funding Number: Horizon Europe); 10063681; 10060974; 1006440 (Other Grant/Funding Number: UKRI)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No