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Study protocol of the Our Futures Vaping Trial: a cluster randomised controlled trial of a school-based eHealth intervention to prevent e-cigarette use among adolescents

BACKGROUND: Effective and scalable prevention approaches are urgently needed to address the rapidly increasing rates of e-cigarette use among adolescents. School-based eHealth interventions can be an efficient, effective, and economical approach, yet there are none targeting e-cigarettes within Aust...

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Autores principales: Gardner, Lauren A., Rowe, Amy-Leigh, Stockings, Emily, Champion, Katrina E., Hides, Leanne, McBride, Nyanda, Allsop, Steve, O’Dean, Siobhan, Sunderland, Matthew, Lee, Yong Yi, Mihalopoulos, Cathy, Freeman, Becky, Leung, Janni, McRobbie, Hayden, Stapinski, Lexine, Lee, Nicole, Thornton, Louise, Debenham, Jennifer, Teesson, Maree, Newton, Nicola C.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10090743/
https://www.ncbi.nlm.nih.gov/pubmed/37046211
http://dx.doi.org/10.1186/s12889-023-15609-8
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author Gardner, Lauren A.
Rowe, Amy-Leigh
Stockings, Emily
Champion, Katrina E.
Hides, Leanne
McBride, Nyanda
Allsop, Steve
O’Dean, Siobhan
Sunderland, Matthew
Lee, Yong Yi
Mihalopoulos, Cathy
Freeman, Becky
Leung, Janni
McRobbie, Hayden
Stapinski, Lexine
Lee, Nicole
Thornton, Louise
Debenham, Jennifer
Teesson, Maree
Newton, Nicola C.
author_facet Gardner, Lauren A.
Rowe, Amy-Leigh
Stockings, Emily
Champion, Katrina E.
Hides, Leanne
McBride, Nyanda
Allsop, Steve
O’Dean, Siobhan
Sunderland, Matthew
Lee, Yong Yi
Mihalopoulos, Cathy
Freeman, Becky
Leung, Janni
McRobbie, Hayden
Stapinski, Lexine
Lee, Nicole
Thornton, Louise
Debenham, Jennifer
Teesson, Maree
Newton, Nicola C.
author_sort Gardner, Lauren A.
collection PubMed
description BACKGROUND: Effective and scalable prevention approaches are urgently needed to address the rapidly increasing rates of e-cigarette use among adolescents. School-based eHealth interventions can be an efficient, effective, and economical approach, yet there are none targeting e-cigarettes within Australia. This paper describes the protocol of the OurFutures Vaping Trial which aims to evaluate the efficacy and cost-effectiveness of the first school-based eHealth intervention targeting e-cigarettes in Australia. METHODS: A two-arm cluster randomised controlled trial will be conducted among Year 7 and 8 students (aged 12–14 years) in 42 secondary schools across New South Wales, Western Australia and Queensland, Australia. Using stratified block randomisation, schools will be assigned to either the OurFutures Vaping Program intervention group or an active control group (health education as usual). The intervention consists of four web-based cartoon lessons and accompanying activities delivered during health education over a four-week period. Whilst primarily focused on e-cigarette use, the program simultaneously addresses tobacco cigarette use. Students will complete online self-report surveys at baseline, post-intervention, 6-, 12-, 24-, and 36-months after baseline. The primary outcome is the uptake of e-cigarette use at 12-month follow-up. Secondary outcomes include the uptake of tobacco smoking, frequency/quantity of e-cigarettes use and tobacco smoking, intentions to use e-cigarettes/tobacco cigarettes, knowledge about e-cigarettes/tobacco cigarettes, motives and attitudes relating to e-cigarettes, self-efficacy to resist peer pressure and refuse e-cigarettes, mental health, quality of life, and resource utilisation. Generalized mixed effects regression will investigate whether receiving the intervention reduces the likelihood of primary and secondary outcomes. Cost-effectiveness and the effect on primary and secondary outcomes will also be examined over the longer-term. DISCUSSION: If effective, the intervention will be readily accessible to schools via the OurFutures platform and has the potential to make substantial health and economic impact. Without such intervention, young Australians will be the first generation to use nicotine at higher rates than previous generations, thereby undoing decades of effective tobacco control. TRIAL REGISTRATION: The trial has been prospectively registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12623000022662; date registered: 10/01/2023). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12889-023-15609-8.
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spelling pubmed-100907432023-04-13 Study protocol of the Our Futures Vaping Trial: a cluster randomised controlled trial of a school-based eHealth intervention to prevent e-cigarette use among adolescents Gardner, Lauren A. Rowe, Amy-Leigh Stockings, Emily Champion, Katrina E. Hides, Leanne McBride, Nyanda Allsop, Steve O’Dean, Siobhan Sunderland, Matthew Lee, Yong Yi Mihalopoulos, Cathy Freeman, Becky Leung, Janni McRobbie, Hayden Stapinski, Lexine Lee, Nicole Thornton, Louise Debenham, Jennifer Teesson, Maree Newton, Nicola C. BMC Public Health Study Protocol BACKGROUND: Effective and scalable prevention approaches are urgently needed to address the rapidly increasing rates of e-cigarette use among adolescents. School-based eHealth interventions can be an efficient, effective, and economical approach, yet there are none targeting e-cigarettes within Australia. This paper describes the protocol of the OurFutures Vaping Trial which aims to evaluate the efficacy and cost-effectiveness of the first school-based eHealth intervention targeting e-cigarettes in Australia. METHODS: A two-arm cluster randomised controlled trial will be conducted among Year 7 and 8 students (aged 12–14 years) in 42 secondary schools across New South Wales, Western Australia and Queensland, Australia. Using stratified block randomisation, schools will be assigned to either the OurFutures Vaping Program intervention group or an active control group (health education as usual). The intervention consists of four web-based cartoon lessons and accompanying activities delivered during health education over a four-week period. Whilst primarily focused on e-cigarette use, the program simultaneously addresses tobacco cigarette use. Students will complete online self-report surveys at baseline, post-intervention, 6-, 12-, 24-, and 36-months after baseline. The primary outcome is the uptake of e-cigarette use at 12-month follow-up. Secondary outcomes include the uptake of tobacco smoking, frequency/quantity of e-cigarettes use and tobacco smoking, intentions to use e-cigarettes/tobacco cigarettes, knowledge about e-cigarettes/tobacco cigarettes, motives and attitudes relating to e-cigarettes, self-efficacy to resist peer pressure and refuse e-cigarettes, mental health, quality of life, and resource utilisation. Generalized mixed effects regression will investigate whether receiving the intervention reduces the likelihood of primary and secondary outcomes. Cost-effectiveness and the effect on primary and secondary outcomes will also be examined over the longer-term. DISCUSSION: If effective, the intervention will be readily accessible to schools via the OurFutures platform and has the potential to make substantial health and economic impact. Without such intervention, young Australians will be the first generation to use nicotine at higher rates than previous generations, thereby undoing decades of effective tobacco control. TRIAL REGISTRATION: The trial has been prospectively registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12623000022662; date registered: 10/01/2023). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12889-023-15609-8. BioMed Central 2023-04-12 /pmc/articles/PMC10090743/ /pubmed/37046211 http://dx.doi.org/10.1186/s12889-023-15609-8 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Gardner, Lauren A.
Rowe, Amy-Leigh
Stockings, Emily
Champion, Katrina E.
Hides, Leanne
McBride, Nyanda
Allsop, Steve
O’Dean, Siobhan
Sunderland, Matthew
Lee, Yong Yi
Mihalopoulos, Cathy
Freeman, Becky
Leung, Janni
McRobbie, Hayden
Stapinski, Lexine
Lee, Nicole
Thornton, Louise
Debenham, Jennifer
Teesson, Maree
Newton, Nicola C.
Study protocol of the Our Futures Vaping Trial: a cluster randomised controlled trial of a school-based eHealth intervention to prevent e-cigarette use among adolescents
title Study protocol of the Our Futures Vaping Trial: a cluster randomised controlled trial of a school-based eHealth intervention to prevent e-cigarette use among adolescents
title_full Study protocol of the Our Futures Vaping Trial: a cluster randomised controlled trial of a school-based eHealth intervention to prevent e-cigarette use among adolescents
title_fullStr Study protocol of the Our Futures Vaping Trial: a cluster randomised controlled trial of a school-based eHealth intervention to prevent e-cigarette use among adolescents
title_full_unstemmed Study protocol of the Our Futures Vaping Trial: a cluster randomised controlled trial of a school-based eHealth intervention to prevent e-cigarette use among adolescents
title_short Study protocol of the Our Futures Vaping Trial: a cluster randomised controlled trial of a school-based eHealth intervention to prevent e-cigarette use among adolescents
title_sort study protocol of the our futures vaping trial: a cluster randomised controlled trial of a school-based ehealth intervention to prevent e-cigarette use among adolescents
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10090743/
https://www.ncbi.nlm.nih.gov/pubmed/37046211
http://dx.doi.org/10.1186/s12889-023-15609-8
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