SMS-based smoking cessation intervention among university students: study protocol for a randomised controlled trial (NEXit trial)

Trials, Apr 2015

Background Most smoking efforts targeting young people have so far been focused on prevention of initiation, whereas smoking cessation interventions have largely been targeted towards adult populations. Thus, there is limited evidence for effective smoking cessation interventions in young people, even though many young people want to quit smoking. Mobile communication technology has the potential to reach large numbers of young people and recent text-based smoking cessation interventions using phones have shown promising results. Methods/design The study aims to evaluate a newly developed text-based smoking cessation intervention for students in colleges and universities in Sweden. The design is a randomised controlled trial (RCT) with a delayed/waiting list intervention control condition. The trial will be performed simultaneously in all colleges and universities served by 25 student health care centres in Sweden. Outcomes will be evaluated after 4 months, with 2 cessation primary outcomes and 4 secondary outcomes. After outcome evaluation the control group will be given access to the intervention. Discussion The study will examine the effectiveness of a stand-alone SMS text-based intervention. The intervention starts with a motivational phase in which the participants are given an opportunity to set a quit date within 4 weeks of randomisation. This first phase and the subsequent core intervention phase of 12 weeks are totally automated in order to easily integrate the intervention into the daily routines of student and other health care settings. As well as providing data for the effectiveness of the intervention, the study will also provide data for methodological analyses addressing a number issues commonly challenging in Internet-based RCTs. For example, an extensive follow-up strategy will be used in order to evaluate the use of repeated attempts in the analysis, and in particular to explore the validity of a possible missing not at random assumption that the odds ratio between the primary outcome and response is the same at every attempt. Trial registration ISRCTN: ISRCTN75766527, dated assigned 4 November 2014. Protocol version: Version 1, and date 7 November 2014.

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SMS-based smoking cessation intervention among university students: study protocol for a randomised controlled trial (NEXit trial)

Mssener et al. Trials SMS-based smoking cessation intervention among university students: study protocol for a randomised controlled trial (NEXit trial) Ulrika Mssener 0 3 Marcus Bendtsen 2 Nadine Karlsson 0 3 Ian R White 1 Jim McCambridge 0 3 5 Preben Bendtsen 4 0 Department of Medicine and Health Sciences, Linkoping University , 581 83 Linkoping , Sweden 1 MRC Biostatistics Unit, Cambridge Institute of Public Health , Robinson Way, Cambridge CB2 0SR , UK 2 Department of Computer and Information Science, Linkoping University , 581 83 Linkoping , Sweden 3 Department of Medicine and Health Sciences, Linkoping University , 581 83 Linkoping , Sweden 4 Department of Medical Specialist and Department of Medicine and Health Sciences, Linkoping University , Motala, 581 83 Linkoping , Sweden 5 Department of Health Sciences, University of York , Heslington YO10 5DD , UK Background: Most smoking efforts targeting young people have so far been focused on prevention of initiation, whereas smoking cessation interventions have largely been targeted towards adult populations. Thus, there is limited evidence for effective smoking cessation interventions in young people, even though many young people want to quit smoking. Mobile communication technology has the potential to reach large numbers of young people and recent text-based smoking cessation interventions using phones have shown promising results. Methods/design: The study aims to evaluate a newly developed text-based smoking cessation intervention for students in colleges and universities in Sweden. The design is a randomised controlled trial (RCT) with a delayed/waiting list intervention control condition. The trial will be performed simultaneously in all colleges and universities served by 25 student health care centres in Sweden. Outcomes will be evaluated after 4 months, with 2 cessation primary outcomes and 4 secondary outcomes. After outcome evaluation the control group will be given access to the intervention. Discussion: The study will examine the effectiveness of a stand-alone SMS text-based intervention. The intervention starts with a motivational phase in which the participants are given an opportunity to set a quit date within 4 weeks of randomisation. This first phase and the subsequent core intervention phase of 12 weeks are totally automated in order to easily integrate the intervention into the daily routines of student and other health care settings. As well as providing data for the effectiveness of the intervention, the study will also provide data for methodological analyses addressing a number issues commonly challenging in Internet-based RCTs. For example, an extensive follow-up strategy will be used in order to evaluate the use of repeated attempts in the analysis, and in particular to explore the validity of a possible missing not at random assumption that the odds ratio between the primary outcome and response is the same at every attempt. Tobacco; Smoking cessation; Students; Text messages; Mobile phones; SMS - Background Worldwide, nearly 100.000 young people start smoking every day and in Sweden the annual number of new younger smokers is between 16,000 and 20,000 [1,2]. Longer-term reductions in the prevalence of smoking in the general population in Sweden have started to level off and in 2013 the proportions of daily smokers among both men and women were 11% [3]. In young people between 16 and 29 years of age the prevalence of daily smoking in 2013 was 12% among women and 7% among men, whereas occasional smoking was approximately twice as common in women and 3 times as common among men [3]. Smoking is responsible for more than 60 diseases and is globally the most important preventable cause of ill health and death. For every death related to smoking, more than 20 additional individuals will suffer from at least 1 serious smoking-related illness [4]. Tobacco is responsible for approximately 9.6% of the total disease burden in Sweden [5] and around 6,000 people die every year in Sweden due to smoking [1]. Many of the negative health effects of smoking develop after many years of smoking and there is a linear doseresponse relationship between smoking and tobacco-induced diseases, such that the longer a person smokes the more likely the person will develop a smoking-related illness [1]. Most smokers start in their teens and over the course of a year most young smokers want to quit or cut down [6]. Among all smokers, around 65% in some studies want to quit and around half of all smokers make at least 1 quit attempt each year, but only 10% seek or gain access to evidence- based helping resources [7]. The addictive nature of smoking makes cessation difficult and the cost, time commitments and logistics associated with treatment are additional barriers [8]. Identifying effective interventions to help young people to quit smoking would have a major impact on population health. However, there is a limited amount of evidence for effectiv (...truncated)


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Ulrika Müssener, Marcus Bendtsen, Nadine Karlsson, Ian R White, Jim McCambridge, Preben Bendtsen. SMS-based smoking cessation intervention among university students: study protocol for a randomised controlled trial (NEXit trial), Trials, 2015, pp. 140, 16, DOI: 10.1186/s13063-015-0640-2