Generation Pep - study protocol for an intersectoral community-wide physical activity and healthy eating habits initiative for children and young people in Sweden.

Background: There is overwhelming evidence for the preventive effects of regular physical activity and healthy eating habits on the risk for developing a non-communicable disease (NCD). Increasing attention has been paid to community-wide approaches in the battle against NCDs. Communities can create supportive policies, modify physical environments, and foster local stakeholder engagement through intersectoral collaboration to encourage communities to support healthy lifestyles. The Pep initiative is based on intersectoral community-wide collaboration among Sweden's municipalities. Primary targets are municipality professionals who work with children and young people as well as parents of children <18 years. The goal is to spread knowledge and create commitment to children's and young people's health with a special focus on physical activity and healthy eating habits to facilitate and support a healthy lifestyle. The overarching aim of the research project described in this study protocol is to investigate factors that influence the implementation of the Pep initiative in Sweden, to inform tailored implementation strategies addressing the needs and local prerequisites of the different municipalities. Methods: The project includes a qualitative and a quantitative study and is framed by a theoretical model involving four complementary forms of knowledge, explicitly recognized in the Pep initiative: knowledge about the issue; knowledge about interventions; knowledge about the context; and knowledge about implementation. Study 1 is a focus group study exploring barriers and facilitators for implementing the Pep initiative. The study will be carried out in six municipalities, selected purposively to provide wide variation in municipality characteristics, including population size and geographical location. Data will be analyzed using thematic analysis. Study 2 is a cross-sectional web-based survey investigating the implementability of the Pep initiative in Sweden's 290 municipalities. Conditions for implementing different areas of the Pep initiative will be examined in terms of the acceptability, appropriateness, and feasibility, three predictors of implementation success. Data will be analyzed using non-parametric statistics. Discussion: The findings of the two studies will increase understanding of the prerequisites for implementing the Pep initiative in Swedish municipalities, which will provide valuable input into how implementation of the Pep initiative can best be facilitated in the different municipality settings.

Adolescents' and professionals' experiences of metabolic and bariatric surgery and requirements for preoperative and postoperative support through mHealth: a qualitative study.

OBJECTIVES: This study aimed to explore adolescents' and professionals' incentives and experiences of metabolic and bariatric surgery (MBS) and to explore perceived needs and requirements for preoperative and postoperative support through an mHealth intervention to improve long-term healthy lifestyle behaviour and health outcomes. DESIGN: An inductive qualitative study using in-depth semistructured interviews. SETTING: Three hospital-based specialist paediatric obesity treatment units in Sweden. PARTICIPANTS: A total of 18 participants (14 women and 4 men). Nine adolescents aged between 17 and 22 years who had undergone or were about to undergo surgery, and nine professionals, including researchers and clinicians working in various professional roles such as physiotherapist, dietician, nurse, psychologist, physician and pedagogue. RESULTS: Both informant groups of participants highlighted that undergoing MBS is a complex process, and hence actions are required on several levels to optimise the positive, long-term effects of surgery. Efficient communication between the healthcare professionals and adolescents was considered crucial and a key success factor. Informants acknowledged the need for additional support that relates to psychosocial well-being and mental health in order to understand, form and accept new behaviours and identity. An mHealth intervention should be seen as complementary to physical appointments, and informants acknowledged that an app could be a way of improving access to healthcare, and a useful tool to allow for individually tailored and easily available support. CONCLUSIONS: The findings address the importance of a personal encounter and a need for additional support that relates to psychosocial well-being, mental health and healthy lifestyle behaviour. These findings should be incorporated into future research concerning mHealth interventions in MBS during adolescence.

Six-Month Outcomes from the NEXit Junior Trial of a Text Messaging Smoking Cessation Intervention for High School Students: Randomized Controlled Trial With Bayesian Analysis.

BACKGROUND: The prevalence of daily or occasional smoking among high school students in Sweden was approximately 20% in 2019, which is problematic since lifestyle behaviors are established in adolescence and track into adulthood. The Nicotine Exit (NEXit) Junior trial was conducted in response to a lack of evidence for the effects of text message smoking cessation interventions among high school students in Sweden. OBJECTIVE: The aim of this study was to estimate the 3- and 6-month effects of a text messaging intervention among high school students in Sweden on smoking cessation outcomes. METHODS: A 2-arm, single-blind randomized controlled trial was employed to estimate the effects of the intervention on smoking cessation in comparison to treatment as usual. Participants were recruited from high schools in Sweden using advertising and promotion by school staff from January 10, 2018, to January 10, 2019. Weekly or daily smokers who were willing to make a quit attempt were eligible for inclusion. Prolonged abstinence and point prevalence of smoking cessation were measured at 3 and 6 months after randomization. RESULTS: Complete case analysis was possible on 57.9% (310/535) of the participants at 6 months, with no observed statistically significant effect on 5-month prolonged abstinence (odds ratio [OR] 1.27, 95% CI 0.73-2.20; P=.39) or 4-week smoking cessation (OR 1.42; 95% CI 0.83-2.46; P=.20). Sensitivity analyses using imputation yielded similar findings. Unplanned Bayesian analyses showed that the effects of the intervention were in the anticipated direction. The findings were limited by the risk of bias induced by high attrition (42.1%). The trial recruited high school students in a pragmatic setting and included both weekly and daily smokers; thus, generalization to the target population is more direct compared with findings obtained under more strict study procedures. CONCLUSIONS: Higher than expected attrition rates to follow-up 6 months after randomization led to null hypothesis tests being underpowered; however, unplanned Bayesian analyses found that the effects of the intervention were in the anticipated direction. Future trials of smoking cessation interventions targeting high school students should aim to prepare strategies for increasing retention to mid- and long-term follow-up. TRIAL REGISTRATION: IRCTN Registry ISRCTN15396225; https://www.isrctn.com/ISRCTN15396225. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-018-3028-2.

Adapting a Parental Support App to Promote Healthy Diet and Physical Activity Behaviors (MINISTOP) for a Multi-Ethnic Setting: A Qualitative Study on the Needs and Preferences of Parents and Nurses within Swedish Child Health Care.

Early efforts for prevention of childhood overweight and obesity are needed. In order to adapt an app promoting healthy diet and physical activity behaviors in children (MINISTOP 1.0) for multi-ethnic communities, we explored: (1) needs and concerns among Somali-, Arabic-, and Swedish-speaking parents in terms of supporting healthy diet and activity behaviors in their children; (2) nurses' perceptions of parental needs and concerns in relation to diet and physical activity behaviors; and (3) how the features and content of the MINISTOP 1.0 app could be refined to better support health behaviors in children, among both parents and nurses. Focus groups with Somali-, Arabic-, and Swedish-speaking parents (n = 15), and individual interviews with nurses (n = 15) were conducted. Parents expressed several challenges in supporting children's health behaviors, the need for a tailored app, and alternative ways of accessing the content (audio/video). Nurses emphasized the need of supporting parents early, and the value of a shared platform in different languages, to facilitate communication. This study contributes valuable insights about parental needs and relevant adaptations to a parental support app, such as addition of audio/video files for increased accessibility. This adapted app version-MINISTOP 2.0, can be useful for childhood obesity prevention in multi-ethnic communities.

mHealth intervention for multiple lifestyle behaviour change among high school students in Sweden (LIFE4YOUth): protocol for a randomised controlled trial.

BACKGROUND: National surveys in Sweden demonstrate that the majority of young people do not engage in health promoting behaviours at levels recommended by the Public Health Agency of Sweden. The objective of this study is to estimate the effectiveness of a novel mHealth intervention named LIFE4YOUth, which targets multiple lifestyle behaviours (alcohol, diet, physical activity, and smoking) among high school students in Sweden. METHODS: A 2-arm parallel groups single blind randomised controlled trial (1:1) will be employed to estimate the effectiveness of the novel mHealth intervention. Students will be recruited at high schools throughout Sweden, and will be included if they fulfil one of six criteria relating to unhealthy behaviours with respect to alcohol, diet, physical activity and smoking. Eligible participants will be randomised to either receive the novel intervention immediately, or to be placed on a waiting list for 4 months. The intervention consists of a combination of recurring screening, text messages, and an interactive platform which is adaptable to individual preferences. Outcome measures with respect to alcohol, diet, physical activity and smoking will be assessed through questionnaires at 2 and 4 months post randomisation. DISCUSSION: The findings of this trial could be generalised to a diverse high-school student population as our recruitment encompass a large proportion of schools throughout Sweden with various educational profiles. Furthermore, if effective, the mHealth intervention has good potential to be able to be scaled up and disseminated at high schools nationally. TRIAL REGISTRATION: Registered prospectively on 2020-05-20 in ISRCTN ( ISRCTN34468623 ).

MINISTOP 2.0: a smartphone app integrated in primary child health care to promote healthy diet and physical activity behaviours and prevent obesity in preschool-aged children: protocol for a hybrid design effectiveness-implementation study.

BACKGROUND: Childhood obesity is still a major health problem in many countries, including Sweden. Childhood obesity and obesity-related behaviours in childhood, such as low physical activity and unhealthy eating habits, tend to track into adulthood, which highlights the need for early prevention. Our aims are to evaluate whether a parent-oriented mobile health app (the MINISTOP 2.0 app) integrated into primary child health care can improve diet and physical activity behaviours and reduce the prevalence of overweight and obesity in preschool-aged children as well as to evaluate the implementation among child health care nurses and parents. METHODS: This trial uses a hybrid type 1 effectiveness-implementation design. Families (n = 500) who attend a routine visit to one of 15-20 primary child health care centres throughout Sweden, when their child is 2.5 years, are offered participation in a randomised controlled trial (effectiveness evaluation). After acceptance, families will be randomised (1:1) to control or intervention groups. The intervention group receives a 6-month parent-oriented smartphone intervention aimed at improving the dietary and activity behaviours of their child (the MINISTOP 2.0 app) and the control group receives routine child health care. Dietary habits, physical activity and screen time (primary outcomes), body weight and height in children, and parental self-efficacy (secondary outcomes) are measured at baseline and at 6 months post randomisation. Implementation outcomes (i.e. perceived acceptability, appropriateness, and feasibility) of the intervention will be assessed among primary child health care nurses and parents in the trial through questionnaires and qualitative interviews. DISCUSSION: This trial will evaluate whether the MINISTOP 2.0 app can be used in primary child health care to improve diet and physical activity behaviours, and prevent overweight and obesity, in preschool-aged children. If effectiveness is proven, and the MINISTOP 2.0 app is considered acceptable, appropriate and feasible, it can be implemented nationally as part of the preventive strategies to combat childhood obesity provided by routine child health care. TRIAL REGISTRATION: The trial was registered at the Clinicaltrials.gov register platform (ID NCT04147039 ) on 31 October 2019.

Development of an Intervention Targeting Multiple Health Behaviors Among High School Students: Participatory Design Study Using Heuristic Evaluation and Usability Testing.

BACKGROUND: Mobile electronic platforms provide exciting possibilities for health behavior promotion. For instance, they can promote smoking cessation, moderate alcohol consumption, healthy eating, and physical activity. Young adults in Sweden are proficient in the use of technology, having been exposed to computers, smartphones, and the internet from an early age. However, with the high availability of mobile health (mHealth) interventions of varying quality, it is critical to optimize the usability of mHealth interventions to ensure long-term use of these health promotion interventions. OBJECTIVE: This study aims to investigate the usability of an mHealth intervention (LIFE4YOUth) targeting health behaviors among high school students through heuristic evaluation and usability testing. METHODS: A preliminary version of the LIFE4YOUth mHealth intervention, which was aimed at promoting healthy eating, physical activity, smoking cessation, and nonrisky drinking among high school students, was developed in early 2019. We completed a total of 15 heuristic evaluations and 5 usability tests to evaluate the usability of the mHealth intervention prototype to improve its functioning, content, and design. RESULTS: Heuristic evaluation from a total of 15 experts (10 employees and 5 university students, both women and men, aged 18-25 years) revealed that the major usability problems and the worst ratings, a total of 17 problems termed usability catastrophes, concerned shortcomings in displaying easy-to-understand information to the users or technical errors. The results of the usability testing including 5 high school students (both girls and boys, aged 15-18 years) showed that the design, quality, and quantity of content in the intervention may impact the users' level of engagement. Poor functionality was considered a major barrier to usability. Of the 5 participants, one rated the LIFE4YOUth intervention as poor, 2 rated as average, and 2 assessed it as good, according to the System Usability Scale. CONCLUSIONS: High school students have high expectations of digital products. If an mHealth intervention does not offer optimal functions, they may cease to use it. Optimizing the usability of mHealth interventions is a critical step in the development process. Heuristic evaluation and usability testing in this study provided valuable knowledge about the prototype from a user's perspective. The findings may lead to the development of similar interventions targeting the high school population.

The Mobile Health Multiple Lifestyle Behavior Interventions Across the Lifespan (MoBILE) Research Program: Protocol for Development, Evaluation, and Implementation.

BACKGROUND: Clustering of multiple lifestyle risk behaviors has been associated with a greater risk of noncommunicable diseases and mortality than one lifestyle risk behavior or no lifestyle risk behaviors. The National Board of Health and Welfare in Sweden reported in 2018 that it is important to provide additional support to individuals with multiple lifestyle risk behaviors, as risks from these behaviors are multiplicative rather than additive. However, the same report emphasized that there is a lack of knowledge regarding interventions that support changes to unhealthy lifestyle behaviors. OBJECTIVE: The MoBILE (Mobile health Multiple lifestyle Behavior Interventions across the LifEspan) research program has brought together two Swedish research groups supported by international collaborators. Through this collaboration, we aim to design and evaluate a number of novel and tailored mobile health (mHealth) multiple lifestyle behavior interventions across the life span of different health care populations. In addition, the MoBILE research program will extend ongoing research to include mHealth interventions for migrant pregnant women and children. METHODS: Each project within the MoBILE program will focus on a specific group: pregnant women, preschool children, high school and university students, and adults in primary and clinical care. All the projects will follow the same 4 phases: requirements, development, evaluation, and implementation. During the requirements phase, implementers and end users will aid the design of content and functionality of the interventions. In the development phase, findings from the first phase will be synthesized with expert domain knowledge and theoretical constructs to create interventions tailored to the target groups. The third phase, evaluation, will comprise randomized controlled trials conducted to estimate the effects of the interventions on multiple lifestyle risk behaviors (eg, alcohol, nutrition, physical activity, and smoking). The final phase will investigate how the interventions, if found effective, can be disseminated into different health care contexts. RESULTS: The research program commenced in 2019, and the first results will be available in 2020. Projects involving pregnant women, preschool children, and high school and university students will be completed in the first 3 years, with the remaining projects being planned for the program's final 3 years. CONCLUSIONS: The development of evidence-based digital tools is complex, as they should be guided by theoretical frameworks, and requires large interdisciplinary teams with competence in technology, behavioral science, and lifestyle-specific areas. Individual researchers or smaller research groups developing their own tools is not the way forward, as it means reinventing the wheel over and over again. The MoBILE research program therefore aims to join forces and learn from the past 10 years of mHealth research to maximize scientific outcomes, as well as the use of financial resources to expand the growing body of evidence for mHealth lifestyle behavior interventions. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/14894.

mHealth smoking cessation intervention among high school students: 3-month primary outcome findings from a randomized controlled trial.

BACKGROUND: Smoking among adolescents remains a global public health issue as youth continue to maintain high prevalence rates. The evidence for the efficacy of text messaging interventions to reduce smoking behavior is well established, yet there is still a need for studies targeting high school students. The aim of the study was to determine the effectiveness of a text-based smoking cessation intervention among high school students in Sweden. METHODS: The study was a two-arm randomized trial conducted from January 10 2018 to January 11 2019, data were analysed from April 12 2019 to May 21 2019. Inclusion criteria were high school students who were daily or weekly smokers willing to attempt to quit smoking and owned a mobile phone. The study invited all students at 630 high schools units throughout Sweden. The intervention group received text messages based on components of effective smoking cessation interventions for 12 weeks. The control group were offered treatment as usual. The primary outcomes were self-reported prolonged abstinence (not having smoked more than 5 cigarettes over the last 8 weeks) and 4-week point prevalence of smoking abstinence. FINDINGS: A total of 535 participants, with a median age of 17 (IQR 16-18), were randomized into the study; 276 (164 [59.4%] women) were allocated to the intervention and 259 (162 [62.5%] women) to the control group. The outcomes of the trial were analyzed on a total of 212 (76.8%) participants in the intervention group and 201 (77.6%) participants in the control group. Prolonged abstinence at the 3-month follow-up was reported by 49 (23.1%) individuals in the intervention group and 39 (19.4%) individuals in the control group (adjusted OR, 1.21; 95% CI, 0.73-2.01; P value, .46). Four-week point prevalence of complete smoking cessation was reported by 53 (25.0%) individuals in the intervention group and 31 (15.4%) individuals in the control group (adjusted OR, 1.87; 95% CI, 1.12-3.17; P value, .018). CONCLUSIONS: Estimates of 4-week point prevalence of complete cessation was 10 percentage points higher in the group that were given access to the intervention compared to the control. Findings provide confirmation that text messaging-based smoking cessation programs can affect quit rates among adolescents. TRIAL REGISTRATION: ISRCTN15396225; registration date October 13, 2017, https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-3028-2.

Using Mobile Devices to Deliver Lifestyle Interventions Targeting At-Risk High School Students: Protocol for a Participatory Design Study.

BACKGROUND: Unhealthy lifestyle behaviors such as insufficient physical activity, unhealthy diet, smoking, and harmful use of alcohol tend to cluster (ie, individuals may be at risk from more than one lifestyle behavior that can be established in early childhood and adolescence and track into adulthood). Previous research has underlined the potential of lifestyle interventions delivered via mobile phones. However, there is a need for deepened knowledge on how to design mobile health (mHealth) interventions taking end user views into consideration in order to optimize the overall usability of such interventions. Adolescents are early adopters of technology and frequent users of mobile phones, yet research on interventions that use mobile devices to deliver multiple lifestyle behavior changes targeting at-risk high school students is lacking. OBJECTIVE: This protocol describes a participatory design study with the aim of developing an mHealth lifestyle behavior intervention to promote healthy lifestyles among high school students. METHODS: Through an iterative process using participatory design, user requirements are investigated in terms of technical features and content. The procedures around the design and development of the intervention, including heuristic evaluations, focus group interviews, and usability tests, are described. RESULTS: Recruitment started in May 2019. Data collection, analysis, and scientific reporting from heuristic evaluations and usability tests are expected to be completed in November 2019. Focus group interviews were being undertaken with high school students from October through December, and full results are expected to be published in Spring 2020. A planned clinical trial will commence in Summer 2020. The study was funded by a grant from the Swedish Research Council for Health, Working Life, and Welfare. CONCLUSIONS: The study is expected to add knowledge on how to design an mHealth intervention taking end users' views into consideration in order to develop a novel, evidence-based, low-cost, and scalable intervention that high school students want to use in order to achieve a healthier lifestyle. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14588.

Exploring the Experiences of Individuals Allocated to a Control Setting: Findings From a Mobile Health Smoking Cessation Trial.

BACKGROUND: Tobacco smoking is the primary cause of preventable premature disease and death worldwide. Evidence of the efficacy of text messaging interventions to reduce smoking behavior is well established, but there is still a need for studies targeting young people, especially because young adult smokers are less likely to seek treatment than older adults. A mobile health intervention, Nicotine Exit (NEXit), targeting smoking among university students was developed to support university students to quit smoking. Short-term effectiveness was measured through a randomized controlled trial, which found that immediately after the 12-week intervention, 26% of smokers in the intervention group had prolonged abstinence compared with 15% in the control group. OBJECTIVE: The objective of this study was to explore the experience of being allocated to the control group in the NEXit smoking cessation intervention. METHODS: We asked students who were allocated to the control group in the main NEXit randomized controlled trial to report their experiences. An email was sent to the participants with an electronic link to a short questionnaire. We assessed the distribution of the responses to the questionnaire by descriptive analysis. We analyzed free-text comments to 4 questions. RESULTS: The response rate for the questionnaire was 33.8% (258/763), and we collected 143 free-text comments. Of the responders, 60.9% (157/258) experienced frustration, disappointment, and irritation about being allocated to the control group; they felt they were being denied support by having to wait for the intervention. Monthly text messages during the waiting period thanking them for taking part in the trial were perceived as negative by 72.3% (189/258), but for some the messages served as a reminder about the decision to quit smoking. Of the responders, 61.2% (158/258) chose to wait to quit smoking until they had access to the intervention, and 29.8% (77/258) decided to try to quit smoking without support. Of the respondents, 77.5% (200/258) claimed they were still smoking and had signed up or were thinking about signing up for the smoking cessation program at the time of the questionnaire. CONCLUSIONS: Most of the respondents reported negative feelings about having to wait for the support of the intervention and that they had decided to continue smoking. A similar number decided to wait to quit smoking until they had access to the intervention, and these respondents reported a high interest in the intervention. Free-text comments indicated that some control group participants believed that they had been excluded from the trial, while others were confused when asked to sign up for the intervention again. TRIAL REGISTRATION: ISRCTN Registry ISRCTN75766527; http://www.isrctn.com/ISRCTN75766527 (Archived by WebCite at http://www.webcitation.org/7678sUKbR).

mHealth smoking cessation intervention among high-school pupils (NEXit Junior): study protocol for a randomized controlled trial.

BACKGROUND: Mobile health (mHealth) interventions, using text messages to support high-school pupils to quit smoking, could be a novel and cost-effective approach. However, more research is needed, specifically to investigate long-term effectiveness. The study aims to evaluate the effectiveness of a newly developed mHealth intervention targeting smoking cessation among high-school pupils. METHODS: The study is a two-arm, randomized controlled trial with an intervention group (mHealth intervention) and a control group (treatment as usual: national smoking cessation help line). Outcome measures will be investigated at baseline and at 3, 6, and 12 months' follow-up. Primary outcome measures will be: prolonged abstinence and 4-week point prevalence of smoking abstinence. Secondary outcome measures will be: 7-day point prevalence of smoking abstinence; mean number of quit attempts since taking part in the study; number of uses of other smoking cessation services since first invitation to the study and number of cigarettes smoked weekly if still smoking. DISCUSSION: High schools in Sweden are bound by law to offer a smoke-free environment. However, little effort has been made to offer support to pupils who wish to quit smoking; rather the emphasis is on prevention of uptake. The study will examine the effectiveness of a stand-alone mHealth intervention targeting smokers among high-school pupils. TRIAL REGISTRATION: The trial was not retrospectively registered and has been registered at ISRCTN with the unique identification number ISRCTN15396225 . The trial was registered on 13 October 2017.

User satisfaction with the structure and content of the NEXit intervention, a text messaging-based smoking cessation programme.

BACKGROUND: Smoking is still the leading cause of preventable ill health and death. There is a limited amount of evidence for effective smoking cessation interventions among young people. To address this, a text messaging-based smoking cessation programme, the NEXit intervention, was developed. Short-term effectiveness, measured immediately after the 12-week intervention revealed that 26% of smokers in the intervention group had prolonged abstinence compared with 15% in the control group. The present study was performed to explore the users' experiences of the structure and content of the intervention in order to further develop the intervention. METHODS: Students participating in the main NEXit randomized controlled trial were invited to grade their experiences of the structure and content of the intervention after having completed follow-up. The participants received an e-mail with an electronic link to a short questionnaire. Descriptive analysis of the distribution of the responses to the questionnaire was performed. Free-text comments to 14 questions were analysed. RESULTS: The response rate for the user feedback questionnaire was 35% (n = 289/827) and 428 free-text comments were collected. The first motivational phase of the intervention was appreciated by 55% (158/289) of the participants. Most participants wanted to quit smoking immediately and only 124/289 (43%) agreed to have to decide a quit-date in the future. Most participants 199/289 (69%) found the content of the messages in the core programme to be very good or good, and the variability between content types was appreciated by 78% (224/289). Only 34% (97/289) of the participants thought that all or nearly all messages were valuable, and some mentioned that it was not really the content that mattered, but that the messages served as a reminder about the decision to quit smoking. CONCLUSIONS: The programme was largely perceived satisfactory in most aspects concerning structure and content by young people and most participants stated that they would recommend it to a friend who wants to quit smoking. The motivational phase might be worth shortening and the number of messages around the quit date itself reduced. Shorter messages seemed to be more acceptable. TRIAL REGISTRATION: ISRCTN75766527 .

Effectiveness of Short Message Service Text-Based Smoking Cessation Intervention Among University Students: A Randomized Clinical Trial.

IMPORTANCE: Smoking is globally the most important preventable cause of ill health and death. Mobile telephone interventions and, in particular, short message service (SMS) text messaging, have the potential to overcome access barriers to traditional health services, not least among young people. OBJECTIVE: To determine the effectiveness of a text-based smoking cessation intervention among young people. DESIGN, SETTING, AND PARTICIPANTS: A single-blind, 2-arm, randomized clinical trial (Nicotine Exit [NEXit]) was conducted from October 23, 2014, to April 17, 2015; data analysis was performed from April 23, 2014, to May 22, 2015. Participants included daily or weekly smokers willing to set a quit date within 1 month of enrollment. The study used email to invite all college and university students throughout Sweden to participate. INTERVENTIONS: The NEXit core program is initiated with a 1- to 4-week motivational phase during which participants can choose to set a stop date. The intervention group then received 157 text messages based on components of effective smoking cessation interventions for 12 weeks. The control group received 1 text every 2 weeks thanking them for participating in the study, with delayed access to the intervention. MAIN OUTCOMES AND MEASURES: The primary outcomes were self-reported prolonged abstinence (not having smoked >5 cigarettes over the past 8 weeks) and 4-week point prevalence of complete smoking cessation shortly after the completion of the intervention (approximately 4 months after the quit date). RESULTS: A total of 1590 participants, mainly between 21 and 30 years of age, were randomized into the study; 827 (573 [69.3%] women) were allocated to the intervention group and 763 (522 [68.4%] women) were included in the control group. Primary outcome data were available for 783 (94.7%) of the intervention group and 719 (94.2%) of the control group. At baseline, participants were smoking a median (range) of 63 (1-238) and 70 (2-280) cigarettes per week, respectively. Eight-week prolonged abstinence was reported by 203 participants (25.9%) in the intervention group and 105 (14.6%) in the control group; 4-week point prevalence of complete cessation was reported by 161 (20.6%) and 102 (14.2%) participants, respectively, a mean (SD) of 3.9 (0.37) months after the quit date. The adjusted odds ratios (95% CIs) for these findings were 2.05 (1.57-2.67) and 1.56 (1.19-2.05), respectively. CONCLUSIONS AND RELEVANCE: With the limitation of assessing only the short-term effect of the intervention, the effects observed in this trial are comparable with those for traditional smoking cessation interventions. The simple NEXit intervention has the potential to improve the uptake of effective smoking cessation interventions. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN75766527.

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

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. ISRCTN: ISRCTN75766527, dated assigned 4 November 2014. Protocol version: Version 1, and date 7 November 2014.