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Effects of Providing Tailored Information About e-Cigarettes in a Web-Based Smoking Cessation Intervention: Protocol for a Randomized Controlled Trial
BACKGROUND: There is an ongoing debate whether electronic cigarettes (e-cigarettes) should be advocated for smoking cessation. Because of this uncertainty, information about the use of e-cigarettes for smoking cessation is usually not provided in governmental smoking cessation communications. Howeve...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
JMIR Publications
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8164120/ https://www.ncbi.nlm.nih.gov/pubmed/33988520 http://dx.doi.org/10.2196/27088 |
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author | Elling, Jan Mathis Crutzen, Rik Talhout, Reinskje de Vries, Hein |
author_facet | Elling, Jan Mathis Crutzen, Rik Talhout, Reinskje de Vries, Hein |
author_sort | Elling, Jan Mathis |
collection | PubMed |
description | BACKGROUND: There is an ongoing debate whether electronic cigarettes (e-cigarettes) should be advocated for smoking cessation. Because of this uncertainty, information about the use of e-cigarettes for smoking cessation is usually not provided in governmental smoking cessation communications. However, there is an information need among smokers because despite this uncertainty, e-cigarettes are used by many smokers to reduce and quit tobacco smoking. OBJECTIVE: The aim of this study is to describe the protocol of a randomized controlled trial that assesses the effect of providing tailored information about e-cigarettes compared to not providing this information on determinants of decision making and smoking reduction and abstinence. This information is provided in the context of a digital smoking cessation intervention. METHODS: A randomized controlled trial with a 6-month follow-up period will be conducted among adult smokers motivated to quit smoking within 5 years. Participants will be 1:1 randomized into either the intervention condition or control condition. In this trial, which is grounded on the I-Change model, participants in both conditions will receive tailored feedback on attitude, social influence, preparatory plans, self-efficacy, and coping plans. Information on 6 clusters of smoking cessation methods (face-to-face counselling, eHealth interventions, telephone counselling, group-based programs, nicotine replacement therapy, and prescription medication) will be provided in both conditions. Smokers in the intervention condition will also receive detailed tailored information on e-cigarettes, while smokers in the control condition will not receive this information. The primary outcome measure will be the number of tobacco cigarettes smoked in the past 7 days. Secondary outcome measures will include 7-day point prevalence tobacco abstinence, 7-day point prevalence e-cigarette abstinence, and determinants of decision making (ie, knowledge and attitude regarding e-cigarettes). All outcomes will be self-assessed through web-based questionnaires. RESULTS: This project is supported by a research grant of the National Institute for Public Health and the Environment (Rijksinstituut voor Volksgezondheid en Milieu). Ethical approval was granted by the Ethics Review Committee Health, Medicine and Life Sciences at Maastricht University (FHML-REC/2019/072). Recruitment began in March 2020 and was completed by July 2020. We enrolled 492 smokers in this study. The results are expected to be published in June 2021. CONCLUSIONS: The experimental design of this study allows conclusions to be formed regarding the effects of tailored information about e-cigarettes on decision making and smoking behavior. Our findings can inform the development of future smoking cessation interventions. TRIAL REGISTRATION: Dutch Trial Register Trial NL8330; https://www.trialregister.nl/trial/8330 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27088 |
format | Online Article Text |
id | pubmed-8164120 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | JMIR Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-81641202021-06-03 Effects of Providing Tailored Information About e-Cigarettes in a Web-Based Smoking Cessation Intervention: Protocol for a Randomized Controlled Trial Elling, Jan Mathis Crutzen, Rik Talhout, Reinskje de Vries, Hein JMIR Res Protoc Protocol BACKGROUND: There is an ongoing debate whether electronic cigarettes (e-cigarettes) should be advocated for smoking cessation. Because of this uncertainty, information about the use of e-cigarettes for smoking cessation is usually not provided in governmental smoking cessation communications. However, there is an information need among smokers because despite this uncertainty, e-cigarettes are used by many smokers to reduce and quit tobacco smoking. OBJECTIVE: The aim of this study is to describe the protocol of a randomized controlled trial that assesses the effect of providing tailored information about e-cigarettes compared to not providing this information on determinants of decision making and smoking reduction and abstinence. This information is provided in the context of a digital smoking cessation intervention. METHODS: A randomized controlled trial with a 6-month follow-up period will be conducted among adult smokers motivated to quit smoking within 5 years. Participants will be 1:1 randomized into either the intervention condition or control condition. In this trial, which is grounded on the I-Change model, participants in both conditions will receive tailored feedback on attitude, social influence, preparatory plans, self-efficacy, and coping plans. Information on 6 clusters of smoking cessation methods (face-to-face counselling, eHealth interventions, telephone counselling, group-based programs, nicotine replacement therapy, and prescription medication) will be provided in both conditions. Smokers in the intervention condition will also receive detailed tailored information on e-cigarettes, while smokers in the control condition will not receive this information. The primary outcome measure will be the number of tobacco cigarettes smoked in the past 7 days. Secondary outcome measures will include 7-day point prevalence tobacco abstinence, 7-day point prevalence e-cigarette abstinence, and determinants of decision making (ie, knowledge and attitude regarding e-cigarettes). All outcomes will be self-assessed through web-based questionnaires. RESULTS: This project is supported by a research grant of the National Institute for Public Health and the Environment (Rijksinstituut voor Volksgezondheid en Milieu). Ethical approval was granted by the Ethics Review Committee Health, Medicine and Life Sciences at Maastricht University (FHML-REC/2019/072). Recruitment began in March 2020 and was completed by July 2020. We enrolled 492 smokers in this study. The results are expected to be published in June 2021. CONCLUSIONS: The experimental design of this study allows conclusions to be formed regarding the effects of tailored information about e-cigarettes on decision making and smoking behavior. Our findings can inform the development of future smoking cessation interventions. TRIAL REGISTRATION: Dutch Trial Register Trial NL8330; https://www.trialregister.nl/trial/8330 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27088 JMIR Publications 2021-05-14 /pmc/articles/PMC8164120/ /pubmed/33988520 http://dx.doi.org/10.2196/27088 Text en ©Jan Mathis Elling, Rik Crutzen, Reinskje Talhout, Hein de Vries. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 14.05.2021. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included. |
spellingShingle | Protocol Elling, Jan Mathis Crutzen, Rik Talhout, Reinskje de Vries, Hein Effects of Providing Tailored Information About e-Cigarettes in a Web-Based Smoking Cessation Intervention: Protocol for a Randomized Controlled Trial |
title | Effects of Providing Tailored Information About e-Cigarettes in a Web-Based Smoking Cessation Intervention: Protocol for a Randomized Controlled Trial |
title_full | Effects of Providing Tailored Information About e-Cigarettes in a Web-Based Smoking Cessation Intervention: Protocol for a Randomized Controlled Trial |
title_fullStr | Effects of Providing Tailored Information About e-Cigarettes in a Web-Based Smoking Cessation Intervention: Protocol for a Randomized Controlled Trial |
title_full_unstemmed | Effects of Providing Tailored Information About e-Cigarettes in a Web-Based Smoking Cessation Intervention: Protocol for a Randomized Controlled Trial |
title_short | Effects of Providing Tailored Information About e-Cigarettes in a Web-Based Smoking Cessation Intervention: Protocol for a Randomized Controlled Trial |
title_sort | effects of providing tailored information about e-cigarettes in a web-based smoking cessation intervention: protocol for a randomized controlled trial |
topic | Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8164120/ https://www.ncbi.nlm.nih.gov/pubmed/33988520 http://dx.doi.org/10.2196/27088 |
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