Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Thomas K

PROVIDER: S-EPMC6249762 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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

Thomas Kristin K Bendtsen Marcus M Linderoth Catharina C Müssener Ulrika U

Trials 20181122 1

<h4>Background</h4>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.<h4>Methods</h4>The study is a two-arm, randomized controlled trial with an intervention group (mHealt ...[more]

PMID: 30466484

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Project description: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.

Project description:BackgroundThe 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.ObjectiveThe 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.MethodsA 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.ResultsComplete 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.ConclusionsHigher 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 registrationIRCTN Registry ISRCTN15396225; https://www.isrctn.com/ISRCTN15396225.International registered report identifier (irrid)RR2-10.1186/s13063-018-3028-2.

Project description:BackgroundBlack smokers have greater difficulty in quitting and higher rates of smoking-related diseases and disabilities than the general population. The smoking disparities experienced by this group are, in part, a consequence of multiple chronic life stressors (eg, racial discrimination) that engender increased exposure to interoceptive stress symptoms (eg, anxiety), which can ultimately lead to smoking as a means of immediate emotion regulation.ObjectiveThis study aimed to culturally adapt and initially test a novel mobile intervention (ie, Mobile Anxiety Sensitivity Program for Smoking [MASP]) that targets anxiety sensitivity (AS; a proxy for difficulty and responsivity to interoceptive stress) among Black smokers. The MASP intervention is culturally informed to address interoceptive stress management difficulties among Black smokers and is thus hypothesized to facilitate smoking cessation.MethodsIn phase 1, a total of 25 Black smokers with elevated AS will be administered MASP for 6 weeks. Following the completion of phase 1, we will further refine the MASP based on qualitative and quantitative data from participants to produce the final MASP iteration. In phase 2, a total of 200 Black smokers with elevated AS will be enrolled and randomly assigned to receive nicotine replacement therapy and either the smartphone-based National Cancer Institute QuitGuide app for standard mobile smoking cessation treatment or the MASP intervention. All participants in phases 1 and 2 will be enrolled remotely and will complete a web-based study screener; smartphone-based baseline assessment; daily smartphone-based ecological momentary assessments for 6 weeks; phone-based end-of-treatment qualitative interviews; and smartphone-based follow-up assessments at postbaseline weeks 1, 2 (quit date), 3, 4, 5, 6, 28, and 54 (weeks 28 and 54 follow-ups will be completed by phase 2 participants only). The MASP intervention is intended to offset barriers to treatment and encourage treatment engagement via smartphones.ResultsThis project was funded in September 2020. Phase 1 data collection began in January 2022. Phase 2 data collection is scheduled to begin in July 2022.ConclusionsIf successful, data from this study will support culturally informed treatment approaches for Black smokers and, pending findings of efficacy, provide an evidence-based mobile intervention for smoking cessation that is ready for dissemination and implementation.Trial registrationClinicalTrials.gov NCT04838236; https://clinicaltrials.gov/ct2/show/NCT04838236.International registered report identifier (irrid)DERR1-10.2196/38905.

Project description:BACKGROUND:Several large studies have shown that the risk of cardiovascular, respiratory, and wound-healing complications (including death) within 30 days of surgery is greater for smokers than for nonsmokers. However, there is evidence that even short-term perioperative smoking cessation may reduce postoperative morbidity. Over the past few years, it has become more evident that short message service (SMS)-based interventions can help individuals quit smoking. OBJECTIVE:The overall aim of this project is to fill the knowledge gap on whether an SMS-based smoking-cessation intervention can be effective in helping patients stop smoking perioperatively. The aim of this trial is to evaluate the effectiveness of an SMS-based intervention on smoking behavior of patients undergoing elective surgery. METHODS:A two-arm parallel-group randomized controlled trial will be conducted at 20 surgical departments in southeast Sweden. Smokers undergoing elective surgery who own a mobile phone will be included. Power calculations indicate that it will be necessary to randomize 434 participants. One group will be given access to a novel 12-week SMS program, which includes daily SMS messages with behavior change-enforcing text content and hyperlinks to interactive modules, while the other group will not be given access to the intervention. Both groups will have access to the surgical departments' current routine for smoking cessation prior to surgery. Primary outcome measures, prolonged abstinence, and point prevalence of smoking cessation will be measured through questionnaires at 3, 6, and 12 months after randomization. Logistic regression models adjusted using baseline characteristics will be explored to identify potential effects of the intervention. RESULTS:Recruitment started in late October 2018 and is expected to last for a maximum of 30 months. The first results are expected to be available approximately 3 months after the final date of recruitment. CONCLUSIONS:Owing to the structural problems and scarcity of time and resources, patients at most Swedish surgical departments are simply instructed to quit smoking, and perhaps, referred to a primary health care clinic. An SMS-based smoking-cessation aid can be effective in helping individuals quit smoking and is a very simple and time-efficient tool for surgical departments to use. TRIAL REGISTRATION:ISRCTN Registry ISRCTN33869008; http://www.isrctn.com/ISRCTN33869008. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/12511.

Project description:E-health tools are a new mechanism to expand patient care, allowing supplemental resources to usual care, including enhanced patient-provider communication. These applications to smoking cessation have yet to be tested in a hospitalized patient sample. This project aims to evaluate the effectiveness and cost-effectiveness of a tailored web-based and e-message smoking cessation program for current smokers that, upon hospital discharge, transitions the patient to continue a quit attempt when home (Decide2Quit).A randomized two-arm follow-up design will test the effectiveness of an evidence- and theoretically-based smoking cessation program designed for post-hospitalization.A total of 1,488 patients aged 19 or older, who smoked cigarettes in the previous 30 days, are being recruited from 27 patient care areas of a large urban university hospital. Study-eligible hospitalized patients receiving usual tobacco cessation usual care are offered study referral. Trained hospital staff assist the 744 patients who are being randomized to the intervention arm with registration and orientation to the intervention website. This e-mail and web-based program offers tailored messages as well as education, self-assessment and planning aids, and social support to promote tobacco use cessation. Condition-blind study staff assess participants for tobacco use history and behaviors, tobacco use cost-related information, co-morbidities and psychosocial factors at 0, 3, 6, and 12 months. The primary outcome is self-reported 30-day tobacco abstinence at 6 months follow-up. Secondary outcomes include 7-day point prevalence quit rates at 3-, 6-, and 12-month follow-up, 30-day point prevalence quit rates at 3 and 12 months, biologically confirmed tobacco abstinence at 6-month follow-up, and multiple point-prevalence quit rates based on self-reported tobacco abstinence rates at each follow-up time period. Healthcare utilization and quality of life are assessed at baseline, and 6- and 12-month follow-up to measure program cost-effectiveness from the hospital, healthcare payer, patient, and societal perspectives.Given the impact of tobacco use on medical resources, establishing feasible, cost-effective methods for reducing tobacco use is imperative. Given the minimal hospital staff burden and the automated transition to a post-hospitalization tailored intervention, this program could be an easily disseminated approach.Current Intervention Trial NCT01277250.

Project description:The use of nicotine replacement therapy before quitting smoking is called nicotine preloading. Standard smoking cessation protocols suggest commencing nicotine replacement therapy only on the first day of quitting smoking (quit day) aiming to reduce withdrawal symptoms and craving. However, other, more successful smoking cessation pharmacotherapies are used prior to the quit day as well as after. Nicotine preloading could improve quit rates by reducing satisfaction from smoking prior to quitting and breaking the association between smoking and reward. A systematic literature review suggests that evidence for the effectiveness of preloading is inconclusive and further trials are needed.This is a study protocol for a multicenter, non-blinded, randomized controlled trial based in the United Kingdom, enrolling 1786 smokers who want to quit, funded by the National Institute for Health Research, Health Technology Assessment program, and sponsored by the University of Oxford. Participants will primarily be recruited through general practices and smoking cessation clinics, and randomized (1:1) either to use 21 mg nicotine patches, or not, for four weeks before quitting, whilst smoking as normal. All participants will be referred to receive standard smoking cessation service support. Follow-ups will take place at one week, four weeks, six months and 12 months after quit day. The primary outcome will be prolonged, biochemically verified six-month abstinence. Additional outcomes will include point prevalence abstinence and abstinence of four-week and 12-month duration, side effects, costs of treatment, and markers of potential mediators and moderators of the preloading effect.This large trial will add substantially to evidence on the effectiveness of nicotine preloading, but also on its cost effectiveness and potential mediators, which have not been investigated in detail previously. A range of recruitment strategies have been considered to try and compensate for any challenges encountered in recruiting the large sample, and the multicentre design means that knowledge can be shared between recruitment teams. The pragmatic study design means that results will give a realistic estimate of the success of the intervention if it were to be rolled out as part of standard smoking cessation service practice.Current Controlled Trials ISRCTN33031001. Registered 27 April 2012.

Project description:BACKGROUND:China has the highest global prevalence of cigarette smokers, accounting for more than 40% of the total cigarette consumption in the world. Considering the shortage of smoking cessation services in China, and the acceptability, feasibility, and efficacy of mobile-phone-based text messaging interventions for quitting smoking in other countries, we conducted a mobile-phone-based smoking cessation study in China. METHODS AND FINDINGS:We conducted a randomized controlled trial in China across 30 cities and provinces from August 17, 2016, to May 27, 2017. Adult smokers aged 18 years and older with the intention to quit smoking were recruited and randomized to a 12-week high-frequency messaging (HFM) or low-frequency messaging (LFM) intervention ("Happy Quit") or to a control group in a 5:2:3 ratio. The control group received only text messages unrelated to quitting. The primary outcome was biochemically verified continuous smoking abstinence at 24 weeks. Secondary outcomes included (1) self-reported 7-day point prevalence of abstinence (i.e., not even a puff of smoke, for the last 7 days) at 1, 4, 8, 12, 16, 20, and 24 weeks; (2) self-reported continuous abstinence at 4, 12, and 24 weeks; and (3) self-reported average number of cigarettes smoked per day. A total of 1,369 participants received 12 weeks of intervention or control text messages with continued follow-up for 12 weeks. The baseline characteristics of participants among the HFM (n = 674), LFM (n = 284), and control (n = 411) groups were similar. The study sample included 1,295 (94.6%) men; participants had a mean age of 38.1 (SD 9.79) years and smoked an average of 20.1 (SD 9.19) cigarettes per day. We included the participants in an intention-to-treat analysis. Biochemically verified continuous smoking abstinence at 24 weeks occurred in 44/674 participants in the HFM group (6.5%), 17/284 participants in the LFM group (6.0%), and 8/411 participants (1.9%) in the control group; participants in both the HFM (odds ratio [OR] = 3.51, 95% CI 1.64-7.55, p < 0.001) and the LFM (OR = 3.21, 95% CI 1.36-7.54], p = 0.002) intervention groups were more likely to quit smoking than those in the control group. However, there was no difference in quit rate between the HFM and LFM interventions. We also found that the 7-day point quit rate from week 1 to week 24 ranged from approximately 10% to more than 26% with the intervention and from less than 4% to nearly 12% without the intervention. Those who continued as smokers in the HFM group smoked 1 to 3 fewer cigarettes per day than those in the LFM group over the 24 weeks of trial. Among study limitations, the participants were able to use other smoking cessation services (although very few participants reported using them), cotinine tests can only detect smoking status for a few days, and the proportion of quitters was small. CONCLUSIONS:Our findings demonstrate that a mobile-phone-based text messaging intervention (Happy Quit), with either high- or low-frequency messaging, led to smoking cessation in the present study, albeit in a low proportion of smokers, and can therefore be considered for use in large-scale intervention efforts in China. Mobile-phone-based interventions could be paired with other smoking cessation services for treatment-seeking smokers in China. TRIAL REGISTRATION:ClinicalTrials.gov NCT02693626.

Project description:BackgroundData suggest that Ghana has made significant improvements in the educational system, resulting in some accomplishments. Nonetheless, pupils' academic performance at the junior high school level and in the Basic Education Certificate Examination (BECE) remains poor nationally. Some factors have been identified to influence poor academic performance in some parts of Ghana, but none in the Krachi West district. Thus, it has become imperative to determine the local factors accountable for this trend and identify the most appropriate localised solutions.Materials and methodsAn embedded research design was employed to ascertain the influence of pupils' characteristics and school environment factors on academic performance. In all, 361 participants (325 BECE candidates, 12 teachers, 12 head teachers and 12 PTA/SMC Chairpersons) were selected using cluster sampling, simple random and purposive sampling across 12 schools in the district. The academic performance of pupils was assessed using scores from six (6) subjects in the standardised district-level mock examination.ResultsBased on the examination scores, half of the pupils performed poorly in the six subjects. Even though from the quantitative study, pupils' characteristics had no significant influence on academic performance, school location (β = -3.29, p < 0.01), school type (β = 1.15, p < 0.01), and school environmental factors (β = 0.807, p = 0.024) were significant predictors of academic performance in the district. Pupils in private schools were thrice more likely to achieve average academic performance than pupils from public schools (OR = 3.2, CI = 1.06-9.47). Also, schools with good environmental factors were twice as likely to have average academic performance than schools with poor environmental factors (OR = 2.2 CI = 1.11-4.52).ConclusionWhile school environment factors and pupil characteristics have a relationship with academic performance as suggested by the ecological theory, it was established in this study that only school location, school type and school environment factors were the significant predictors of academic performance in the Krachi West District. Therefore, education stakeholders need to consider these predictors when coming up with integrated but local strategies to improve pupils' academic performance in that district.

Project description:BackgroundApproximately 2 million Chinese people die annually from tobacco-related diseases, mostly men; yet, fewer than 8% of Chinese smokers ever receive any smoking cessation advice or support. A social network-based gamified smoking cessation intervention (SCAMPI: Smoking Cessation App for Chinese Male: Pilot Intervention) is designed to help Chinese male smokers to quit smoking.ObjectiveThis paper aims to present the protocol of a study examining the preliminary effectiveness of SCAMPI by comparing the prolonged abstinence rate of a group of users with a comparator group during a 6-week follow-up period.MethodsA two-arm pilot randomized controlled trial was conducted to assess the preliminary effectiveness and acceptability of the SCAMPI program as a smoking cessation intervention. After initial web-based screening, the first 80 eligible individuals who had gone through the required registration process were registered as participants of the trial. Participants were randomly allocated to the intervention group (n=40) and the control group (n=40). Participants in the intervention group used the full version of the SCAMPI program, which is a Chinese smoking cessation program developed based on the Behavior Change Wheel framework and relevant smoking cessation and design guidelines with involvement of target users. The program delivers a range of smoking cessation approaches, including helping users to make quitting plans, calculator to record quitting benefits, calendar to record progress, gamification to facilitate quitting, providing information about smoking harms, motivational messages to help users overcome urges, providing standardized tests to users for assessing their levels of nicotine dependence and lung health, and providing a platform to encourage social support between users. Participants in the control group used the restricted version of the SCAMPI program (placebo app).ResultsRecruitment for this project commenced in January 2019 and proceeded until March 2019. Follow-up data collection was commenced and completed by June 2019. The primary outcome measure of the study was the 30-day bio-verified smoking abstinence at the 6-week follow-up (self-reported data verified by the Nicotine Cotinine Saliva Test). The secondary outcome measures of the study included participants' cigarette consumption reduction (compared baseline daily cigarette consumption with end-of-trial daily cigarette consumption), participants' 7-day smoking abstinence at 4-week and 6-week follow-up (self-reported), participants' 30-day smoking abstinence at 6-week follow-up (self-reported data only), and participants' acceptability and satisfaction levels of using the SCAMPI program (measured by the Mobile App Rating Scale questionnaire).ConclusionsIf the SCAMPI program is shown to be preliminary effective, the study will be rolled out to be a future trial with a larger sample size and longer follow-up (6 months) to identify if it is an effective social network-based tool to support Chinese male smokers to quit smoking.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12618001089224; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375381.International registered report identifier (irrid)RR1-10.2196/18071.