Dataset Information

Effects of a Text Messaging Smoking Cessation Intervention Among Online Help Seekers and Primary Health Care Visitors in Sweden: Protocol for a Randomized Controlled Trial Using a Bayesian Group Sequential Design.

ABSTRACT:

Background

A steady decline of the smoking prevalence in Sweden has been recorded over the past decade; however, people still start and continue to smoke. There is a need for effective smoking cessation interventions that can scale to a national level and that are designed to reach individuals requiring smoking cessation support in the general population.

Objective

Previous randomized controlled trials of smoking cessation interventions among high school and university students in Sweden have found consistent evidence that text messaging interventions are effective in helping students quit smoking. However, there are no studies that investigate the effects of text messaging interventions in a more general population. The objective of this study is to estimate the effects of a text messaging intervention on individuals seeking help to quit online and individuals visiting primary health care units.

Methods

A 2-arm, parallel-group (1:1), randomized controlled trial will be employed to address the study objectives. The trial will follow a Bayesian group sequential design. Recruitment will be conducted using online advertisement (Google, Bing, and Facebook) and through health care professionals at primary health care units. All participants will receive treatment as usual; however, participants who are allocated to the intervention arm will also be given access to a 12-week text message smoking cessation intervention. Primary outcomes are 8-week prolonged abstinence and 4-week point prevalence, measured 3 months and 6 months postrandomization. Mediator variables (self-efficacy, importance, and know-how) will be measured to estimate causal mediation models.

Results

Recruitment commenced in September 2020 and will not exceed 24 months. This means that a complete dataset will be available at the latest towards the end of 2022. We expect to publish the findings from this trial by June 2023.

Conclusions

This trial will further our understanding of the effects of text messaging interventions among a more general population than has previously been studied. We also aim to learn about differential effects between those who seek support online and those who are given facilitated support at primary health care units. Trial recruitment is limited to the Swedish population; however, a strength of this study is the pragmatic way in which participants are recruited. Through online advertisements, individuals are recruited in reaction to their own interest in seeking help to quit. At primary health care units, individuals who were not necessarily looking for smoking cessation support are given information about the trial. This closely mimics the way the intervention would be disseminated in a real-world setting and may therefore strengthen the argument of generalizability of findings.

Trial registration

ISRCTN 13455271; http://www.isrctn.com/ISRCTN13455271.

International registered report identifier (irrid)

PRR1-10.2196/23677.

SUBMITTER: Bendtsen M

PROVIDER: S-EPMC7746491 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effects of a Text Messaging Smoking Cessation Intervention Among Online Help Seekers and Primary Health Care Visitors in Sweden: Protocol for a Randomized Controlled Trial Using a Bayesian Group Sequential Design.

Bendtsen Marcus M Thomas Kristin K Linderoth Catharina C Bendtsen Preben P

JMIR research protocols 20201203 12

<h4>Background</h4>A steady decline of the smoking prevalence in Sweden has been recorded over the past decade; however, people still start and continue to smoke. There is a need for effective smoking cessation interventions that can scale to a national level and that are designed to reach individuals requiring smoking cessation support in the general population.<h4>Objective</h4>Previous randomized controlled trials of smoking cessation interventions among high school and university students in ...[more]

PMID: 33269703

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Project description:BackgroundSmoking continues to be a leading risk factor for several diseases globally. We hypothesised that an intervention delivered via text messages could help individuals who were looking to quit.MethodsA two-arm, parallel-groups, randomised controlled trial was employed. Both groups received treatment as usual, with the intervention group also receiving a 12-week text messaging intervention. Participants were adult, weekly or more frequent smokers, recruited online and in primary health care centres. Research personnel were blinded, while participants were not. Primary outcomes were prolonged abstinence and point prevalence of abstinence, 3 and 6 months post-randomisation. All randomised participants were included in analyses.ResultsBetween 18 September 2020 and 16 June 2022, we randomised 1012 participants (intervention: 505, control: 507). Outcome data was available for 67% (n = 682) of participants at 3 months and 64% (n = 643) at 6 months. At 3 months, the odds ratio (OR) of prolonged abstinence was 2.15 (95% compatibility interval [CoI] = 1.51; 3.06, probability of effect [POE] > 99.9%, p < 0.0001), and for point prevalence of abstinence, it was 1.70 (95% CoI = 1.18; 2.44, POE = 99.8%, p = 0.0034) in favour of the text messaging intervention. At 6 months, the OR of prolonged abstinence was 2.38 (95% CoI = 1.62; 3.57, POE > 99.9%, p = < 0.0001), and for point prevalence, it was 1.49 (95% CoI = 1.03; 2.14, POE = 98.3%, p = 0.0349) in favour of the text messaging intervention. Analyses with imputed data were not markedly different.ConclusionsAmongst general population help-seekers-who on average had smoked for 25 years-access to a 12-week text messaging intervention produced higher rates of self-reported smoking abstinence in comparison to treatment as usual only. The intervention could be part of the societal response to the burden which smoking causes; however, findings are limited by risk of bias due to attrition, self-reported outcomes, and lack of blinding.Trial registrationThe trial was preregistered in the ISRCTN registry on 27/07/2020 (ISRCTN13455271).

Project description:BackgroundThe ubiquity of Internet connectivity, and widespread unmet needs, requires investigations of digital interventions for people seeking help with their drinking. The objective of this study was to test the effectiveness of a digital alcohol intervention compared to existing online resources for help seekers.MethodsThis parallel randomised controlled trial included 2129 risky drinkers with access to a mobile phone and aged 18 years or older. Randomised sub-studies investigated consent procedures and control group design. Simple computerised randomisation was used. Participants were aware of allocation after randomisation; research personnel were not. The digital intervention was designed around weekly monitoring of alcohol consumption followed by feedback and tools for behaviour change. Primary outcomes were total weekly consumption (TWC) and frequency of heavy episodic drinking (HED), measured 2 and 4 months post-randomisation.ResultsBetween 25/04/2019 and 26/11/2020, 2129 participants were randomised (intervention: 1063, control: 1066). Negative binomial regression was used to contrast groups, with both Bayesian and maximum likelihood inference. The posterior median incidence rate ratio (IRR) of TWC was 0.89 (95% CI = 0.81;0.99, 98.2% probability of effect, P-value = 0.033) at 2 months among 1557 participants and 0.77 (95% CI = 0.69;0.86, > 99.9% probability of effect, P-value < 0.001) at 4 months among 1429 participants. For HED, the IRR was 0.83 (95% CI = 0.75;0.93, > 99.9% probability of effect, P-value = 0.0009) at 2 months among 1548 participants and 0.71 (95% CI = 0.63;0.79, probability of effect > 99.9%, P-value < 0.0001) at 4 months among 1424 participants. Analyses with imputed data were not markedly different.ConclusionsA digital alcohol intervention produced self-reported behaviour change among online help seekers in the general population. The internal and external validity of this trial is strong, subject to carefully considered study limitations arguably inherent to trials of this nature. Limitations include higher than anticipated attrition to follow-up and lack of blinding.Trial registrationThe trial was prospectively registered ( ISRCTN48317451 ).

Project description:BackgroundDespite promising data in Western countries, there is a dearth of research into the efficacy of text messaging-based smoking cessation programs in other settings, including the Middle East, where smoking prevalence rates are higher.ObjectiveThis paper reports cessation rates observed in SMS Turkey, a text messaging-based smoking cessation program for adult smokers in Ankara, Turkey.MethodsThis study was a small-scale, parallel-group randomized controlled trial (RCT) conducted in Ankara, Turkey. Participants were adult daily smokers who were seriously thinking about quitting in the next 15 days and living in Ankara, Turkey. The text messaging intervention, SMS Turkey, provided 6 weeks of daily messages aimed at giving participants skills to help them quit smoking. Messages were sent in an automated fashion, except 2 days and 7 days after the initial quit day. On days 2 and 7, the research assistant manually assigned participants to content "paths" based on whether they were still not smoking or had relapsed. The control arm received a brochure that provided similar information about smoking cessation. The main outcome measure was self-reported 3-month sustained abstinence, verified by carbon monoxide (CO) readings. Neither participants nor researchers were blinded to arm assignment.ResultsThe 151 participants were randomly assigned to 1 of 2 groups: 76 to the SMS Turkey intervention group and 75 to the brochure control group. Using intention to treat, all 151 participants were included in analyses. Three-month cessation trends were not significantly higher in the intervention group: 11% intervention vs 5% control had quit (χ(2)(1)=1.4, P=.24; R(2)=2.0, 95% CI 0.62-6.3). When the sample was stratified by sex, female intervention participants (14%, n=5) were significantly more likely to have quit at 3 months than female control participants (0%, n=0; χ(2)(1)=3.7, P=.05). Among light smokers (ie, those smoking less than 20 cigarettes per day), intervention participants (17%, n=5) also were significantly more likely to have quit compared to control participants (0%, n=0; χ(2)(1)=5.3, P=.02). We noted no difference in cessation rates for males or heavy smokers. Participants experienced significant technology problems during the study. Some participants received duplicate text messages at least once during the trial; others failed to receive some program messages. Neither receiving duplicate messages (χ(2)(1)=0.12, P=.73), or missing 5 or more program messages (χ(2)(1)=0.75, P=.39) negatively affected quitting rates.ConclusionsAlthough the study was not powered to detect statistically significant differences, as the primary aim was to provide estimates of effect size that could be used to better inform a power analysis for a larger trial, findings provide optimism that SMS Turkey may be able to affect quitting rates in environments with high smoking prevalence, such as Ankara, Turkey. The SMS Turkey software program did not work as well as it did 2 years previous. The system will need to be updated to maintain software compatibility with ongoing technology evolution.Trial registrationClinicaltrials.gov NCT00912795 http://clinicaltrials.gov/ct2/show/NCT00912795 (Archived by WebCite® at http://www.webcitation.org/6Ch1cIA8l).

Project description:BackgroundMobile health strategies for smoking cessation (eg, SMS text messaging-based interventions) have been shown to be effective in helping smokers quit. However, further research is needed to better understand user experiences with these platforms.ObjectiveThis qualitative study aims to explore the experiences of real-world users of a publicly available smoking cessation program (SmokefreeTXT).MethodsSemistructured phone interviews were conducted with 36 SmokefreeTXT users between March and July 2014. Of these 36 participants, 50% (18/36) of participants completed the SmokefreeTXT program (ie, did not opt out of the program before the 6- to 8-week completion period), and 50% (18/36) did not complete the program (ie, requested to opt out of the program before the completion period). Interview questions focused on smoking behaviors, quitting history, opinions on the program's content and structure, answering assessment questions, using keywords, reasons for opting out, and perceived usefulness of the program for quitting smoking. A thematic content analysis was conducted, with a focus on themes to increase program engagement and optimization.ResultsThe findings highlighted features of the program that participants found beneficial, as well as some elements that showed opportunities for improvement to boost program retention and successful cessation. Specifically, most participants found the SmokefreeTXT program to be convenient and supportive of cessation; however, some found the messages to be repetitive and reported a desire for more flexibility based on their readiness to quit and cessation progress. We also found that program completion did not necessarily indicate successful smoking cessation and that program opt out, which might be interpreted as a less positive outcome, may occur because of successful cessation. Finally, several participants reported using SmokefreeTXT together with other evidence-based cessation methods or non-evidence-based strategies.ConclusionsQualitative interviews with real-world SmokefreeTXT users showed high program acceptability, engagement with program features, and perceived utility for smoking cessation. Our findings directly informed several program updates, such as adding an adaptive quit date feature and offering supplemental information on live support services for users who prefer human interaction during the cessation process. The study has implications for other digital tobacco cessation interventions and highlights important topics that warrant future research, such as the relationship between program engagement (eg, opt out and retention) and successful cessation.

Project description:BackgroundMobile health tools such as text messaging programs can support smoking cessation. However, high rates of disengagement from these tools decrease their effectiveness.ObjectiveThe purpose of this study was to identify user characteristics associated with retention in an adult text messaging smoking cessation intervention.MethodsAdults initiating a quit attempt using the publicly available program SmokefreeTXT between March 6 and June 21, 2016 (n=6215), were included. Data were collected to assess nicotine dependence, frequency of being around other smokers, time of the day for cigarette cravings, extrinsic and intrinsic motivation to quit smoking, confidence in quitting, and long-term intention to be smoke free. Multivariable survival analysis modeling for time to opt out was conducted to identify characteristics associated with opting out over the course of the intervention, adjusting for age, sex, and smoking frequency, reset of the quit date by the user, and the number of days enrolled before initiating the quit attempt. Among those who opted out, multivariable multinomial logistic regression analysis was used to identify predictors of opting out early (within 3 days and between 4 and 7 days into the quit attempt) compared to opting out late (more than 7 days into the quit attempt), adjusting for the same confounders.ResultsSurvival analyses indicated that younger age, female sex, higher levels of nicotine dependence, lower intention to be smoke free, and enrolling in SmokefreeTXT ≤1 week before initiating the quit attempt were associated with an increased risk of opting out. For example, users who smoked within 5 minutes of waking up were 1.17 times more likely to opt out than those who smoked more than 5 minutes after waking up (95% CI 1.01-1.35). Among users who opted out from SmokefreeTXT, logistic regression modeling indicated that compared to users who were never or rarely around other smokers, those who were sometimes around other smokers had 1.96 times more likely to opt out within the first 3 days of the quit attempt (95% CI 1.18-3.25). In addition, compared to users with high levels of long-term quit intention, users with lower levels of intention had 1.80 times the odds of opting out between 4 and 7 days into the quit attempt (95% CI 1.02-3.18). Users who reset their quit date after initiating a quit attempt were less likely to opt out at either time point compared with those who did not reset their quit date.ConclusionsSeveral user characteristics are associated with retention in an adult text messaging smoking cessation program. These results provide guidance on potential characteristics that should be addressed in future text messaging smoking cessation programs. Providing additional support to users with these characteristics may increase retention in text messaging programs and ultimately lead to smoking cessation.

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:AIMS:To determine the degree to which the observed benefit of Text2Quit was accounted for by psychosocial mechanisms derived from its quit smoking messaging versus from the use of extra-programmatic smoking cessation treatments and services. DESIGN:Prospective, multiple mediation model of a randomized controlled trial (RCT). SETTING:United States nation-wide. PARTICIPANTS:A total of 409 adult daily smokers participated. Participants were, on average, 35 years of age, predominantly female (68%), white (79%), lacked a college degree (70%), had medium nicotine dependence (average Fagerström Nicotine Dependence Score score of 5.2) and more than half (62%) had made a previous quit attempt. INTERVENTION:Adult daily smokers browsing the web for smoking cessation support (n = 409; recruited 19 May2011-10 July 2012) were randomized to receive smoking cessation support via Text2Quit versus a smoking cessation material. MEASUREMENTS:Mediators (i.e. changes in psychosocial constructs of health behavior change, use of extra-programmatic treatment) were assessed at 1 month using single-item measures and outcome (i.e. self-reported 7-day point prevalence abstinence) at 6-month follow-up. FINDINGS:Mediators accounted for 35% of the effect of Text2Quit on smoking cessation. Only psychosocial mechanisms had complete mediational paths, with increases in self-efficacy [b = 0.10 (0.06-0.15)], quitting know-how [b = 0.07 (0.03-0.11)] and the sense that someone cared [b = 0.06 (0.01-0.11)], partially explaining the conferred benefit of Text2Quit. Use of outside resources, including treatments promoted explicitly by Text2Quit, i.e. medication [b = 0.001 (-0.01 to 0.01), quitline [b = -0.002 (-0.01 to 0.04)], treatments and resources not promoted by Text2Quit, i.e. online forums [b = 0.01 (-0.01 to 0.04)] and self-help materials [b = -0.01 (-0.04 to 0.02)], did not have complete mediational paths. An interaction effect existed for medication use that suggested that for participants not using medication, Text2Quit conferred substantial benefit, but not for participants using medication. CONCLUSIONS:Text-messaging programs for smoking cessation appear primarily to confer benefit by promoting improvements in the psychosocial processes related to quitting rather than through the use of extra-programmatic smoking cessation treatments and services.

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:Millions of smokers use the Internet for smoking cessation assistance each year; however, most smokers engage minimally with even the best designed websites. The ubiquity of mobile devices and their effectiveness in promoting adherence in other areas of health behaviour change make them a promising tool to address adherence in Internet smoking cessation interventions. Text messaging is used by most adults, and messages can proactively encourage use of a web-based intervention. Text messaging can also be integrated with an Internet intervention to facilitate the use of core Internet intervention components.We identified four aspects of a text message intervention that may enhance its effectiveness in promoting adherence to a web-based smoking cessation programme: personalisation, integration, dynamic tailoring and message intensity. Phase I will use a two-level full factorial design to test the impact of these four experimental features on adherence to a web-based intervention. The primary outcome is a composite metric of adherence that incorporates general utilisation metrics (eg, logins, page views) and specific feature utilisation shown to predict abstinence. Participants will be N=860 adult smokers who register on an established Internet cessation programme and enrol in its text message programme. Phase II will be a two-arm randomised trial to compare the efficacy of the web-based cessation programme alone and in conjunction with the optimised text messaging intervention on 30-day point prevalence abstinence at 9 months. Phase II participants will be N=600 adult smokers who register to use an established Internet cessation programme and enrol in text messaging. Secondary analyses will explore whether adherence mediates the effect of treatment condition on outcome.This protocol was approved by Chesapeake IRB. We will disseminate study results through peer-reviewed manuscripts and conference presentations related to the methods and design, outcomes and exploratory analyses.NCT02585206.

Dataset Information

Effects of a Text Messaging Smoking Cessation Intervention Among Online Help Seekers and Primary Health Care Visitors in Sweden: Protocol for a Randomized Controlled Trial Using a Bayesian Group Sequential Design.

Background

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

Effects of a Text Messaging Smoking Cessation Intervention Among Online Help Seekers and Primary Health Care Visitors in Sweden: Protocol for a Randomized Controlled Trial Using a Bayesian Group Sequential Design.

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