Abstract
BackgroundThere 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.ObjectiveThe 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.MethodsA 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.ResultsThis 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.ConclusionsThe 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 RegistrationDutch Trial Register Trial NL8330; https://www.trialregister.nl/trial/8330International Registered Report Identifier (IRRID)DERR1-10.2196/27088
Highlights
BackgroundTobacco smoking is a major public health threat, contributing to increased morbidity and mortality [1]
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
A recent Cochrane systematic review concluded that the current evidence provides moderate certainty that e-cigarettes with nicotine are superior to e-cigarettes without nicotine and nicotine replacement therapy concerning smoking cessation [7]
Summary
BackgroundTobacco smoking is a major public health threat, contributing to increased morbidity and mortality [1]. We will describe the study protocol for a randomized controlled trial assessing an intervention aimed at quitting combustible cigarette smoking and the potential added effects of providing tailored information on electronic cigarettes (e-cigarettes). 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. Trial Registration: Dutch Trial Register Trial NL8330; https://www.trialregister.nl/trial/8330 International Registered Report Identifier (IRRID): DERR1-10.2196/27088
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