Elling Jan Mathis, Crutzen Rik, Talhout Reinskje, de Vries Hein
Department of Health Promotion, Maastricht University/CAPHRI, Maastricht, Netherlands.
Centre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven, Netherlands.
JMIR Res Protoc. 2021 May 14;10(5):e27088. doi: 10.2196/27088.
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.
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.
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.
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.
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.
Dutch Trial Register Trial NL8330; https://www.trialregister.nl/trial/8330.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27088.
关于是否应提倡使用电子烟来戒烟,目前仍存在争议。由于这种不确定性,政府戒烟宣传中通常不会提供有关使用电子烟戒烟的信息。然而,吸烟者有了解这方面信息的需求,因为尽管存在不确定性,但许多吸烟者仍使用电子烟来减少吸烟量并戒烟。
本研究旨在描述一项随机对照试验的方案,该试验评估提供关于电子烟的定制信息与不提供此信息相比,对决策因素以及减少吸烟和戒烟的影响。此信息是在数字戒烟干预的背景下提供的。
将对有动力在5年内戒烟的成年吸烟者进行一项为期6个月随访期的随机对照试验。参与者将按1:1随机分为干预组或对照组。在这项基于行为改变模型的试验中,两组参与者都将收到关于态度、社会影响、准备计划、自我效能和应对计划的定制反馈。在两种情况下都会提供关于6类戒烟方法(面对面咨询、电子健康干预、电话咨询、基于小组的项目、尼古丁替代疗法和处方药)的信息。干预组的吸烟者还将收到关于电子烟的详细定制信息,而对照组的吸烟者不会收到此信息。主要结局指标将是过去7天内吸食的烟草香烟数量。次要结局指标将包括7天的烟草戒断率、7天的电子烟戒断率以及决策因素(即关于电子烟的知识和态度)。所有结局都将通过基于网络的问卷进行自我评估。
该项目得到了国家公共卫生与环境研究所(荷兰国家公共卫生与环境研究所)的研究资助。马斯特里赫特大学健康、医学与生命科学伦理审查委员会(FHML-REC/2019/072)已批准伦理许可。招募工作于2020年3月开始,并于2020年7月完成。我们在本研究中招募了492名吸烟者。结果预计于2021年6月发表。
本研究的实验设计能够就关于电子烟的定制信息对决策和吸烟行为的影响得出结论。我们的研究结果可为未来戒烟干预措施的制定提供参考。
荷兰试验注册库试验编号NL8330;https://www.trialregister.nl/trial/8330。
国际注册报告识别码(IRRID):DERR1-10.2196/27088。