scholarly journals 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 (Preprint)

2021 ◽  
Author(s):  
Marcus Bendtsen ◽  
Preben Bendtsen ◽  
Ulrika Müssener
Keyword(s):  
High School ◽  
Smoking Cessation ◽  
High School Students ◽  
Text Messaging ◽  
Controlled Trial ◽  
School Students ◽  
Bayesian Analyses ◽  
Randomized Controlled ◽  
Prolonged Abstinence

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; <i>P</i>=.39) or 4-week smoking cessation (OR 1.42; 95% CI 0.83-2.46; <i>P</i>=.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. CLINICALTRIAL IRCTN Registry ISRCTN15396225; https://www.isrctn.com/ISRCTN15396225 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s13063-018-3028-2

scholarly journals 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

10.2196/29913 ◽  
2021 ◽  
Vol 9 (10) ◽  
pp. e29913
Author(s):  
Marcus Bendtsen ◽  
Preben Bendtsen ◽  
Ulrika Müssener
Keyword(s):  
High School ◽  
Smoking Cessation ◽  
High School Students ◽  
Text Messaging ◽  
Controlled Trial ◽  
School Students ◽  
Bayesian Analyses ◽  
Randomized Controlled ◽  
Prolonged Abstinence

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

scholarly journals Comparing the Efficacy of an Identical, Tailored Smoking Cessation Intervention Delivered by Mobile Text Messaging Versus Email: Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Inger Torhild Gram ◽  
Dillys Larbi ◽  
Silje Camilla Wangberg
Keyword(s):  
Smoking Cessation ◽  
Text Messaging ◽  
Controlled Trial ◽  
Text Message ◽  
Population Level ◽  
Randomized Controlled ◽  
Cessation Intervention ◽  
Double Blinded ◽  
Time Point

BACKGROUND There is a need to deliver smoking cessation support at a population level, both in developed and developing countries. Studies on internet-based and mobile phone–based smoking cessation interventions have shown that these methods can be as effective as other methods of support, and they can have a wider reach at a lower cost. OBJECTIVE This randomized controlled trial (RCT) aimed to compare, on a population level, the efficacy of an identical, tailored smoking cessation intervention delivered by mobile text messaging versus email. METHODS We conducted a nationwide 2-arm, double-blinded, fully automated RCT, close to a real-world setting, in Norway. We did not offer incentives to increase participation and adherence or to decrease loss to follow-up. We recruited users of the website, slutta.no, an open, free, multi-component Norwegian internet-based smoking cessation program, from May 2010 until October 2012. Enrolled smokers were considered as having completed a time point regardless of their response status if it was 1, 3, 6, or 12 months post cessation. We assessed 7315 participants using the following inclusion criteria: knowledge of the Norwegian language, age 16 years or older, ownership of a Norwegian cell phone, having an email account, current cigarette smoker, willingness to set a cessation date within 14 days (mandatory), and completion of a baseline questionnaire for tailoring algorithms. Altogether, 6137 participants were eligible for the study and 4378 participants (71.33%) provided informed consent to participate in the smoking cessation trial. We calculated the response rates for participants at the completed 1, 3, 6, and 12 months post cessation. For each arm, we conducted an intention-to-treat (ITT) analysis for each completed time point. The main outcome was 7-day self-reported point prevalence abstinence (PPA) at the completed 6 months post cessation. We calculated effect size of the 7-day self-reported PPA in the text message arm compared with the email arm as odds ratios (ORs) with 95% CIs for the 4 time points post cessation. RESULTS At 6 months follow-up, 21.06% (384/1823) of participants in the text message arm and 18.62% (333/1788) in the email arm responded (<italic>P</italic>=.07) to the surveys. In the ITT analysis, 11.46% (209/1823) of participants in the text message arm compared with 10.96% (196/1788) in the email arm (OR 1.05, 95% CI 0.86-1.30) reported to have achieved 7 days PPA. CONCLUSIONS This nationwide, double-blinded, large, fully automated RCT found that 1 in 9 enrolled smokers reported 7-day PPA in both arms, 6 months post cessation. Our study found that identical smoking cessation interventions delivered by mobile text messaging and email may be equally successful at a population level. CLINICALTRIAL ClinicalTrials.gov NCT01103427; https://clinicaltrials.gov/ct2/show/NCT01103427

scholarly journals Comparing the Efficacy of an Identical, Tailored Smoking Cessation Intervention Delivered by Mobile Text Messaging Versus Email: Randomized Controlled Trial

10.2196/12137 ◽  
2019 ◽  
Vol 7 (9) ◽  
pp. e12137 ◽  
Author(s):  
Inger Torhild Gram ◽  
Dillys Larbi ◽  
Silje Camilla Wangberg
Keyword(s):  
Smoking Cessation ◽  
Text Messaging ◽  
Controlled Trial ◽  
Text Message ◽  
Population Level ◽  
Randomized Controlled ◽  
Cessation Intervention ◽  
Double Blinded ◽  
Time Point

Background There is a need to deliver smoking cessation support at a population level, both in developed and developing countries. Studies on internet-based and mobile phone–based smoking cessation interventions have shown that these methods can be as effective as other methods of support, and they can have a wider reach at a lower cost. Objective This randomized controlled trial (RCT) aimed to compare, on a population level, the efficacy of an identical, tailored smoking cessation intervention delivered by mobile text messaging versus email. Methods We conducted a nationwide 2-arm, double-blinded, fully automated RCT, close to a real-world setting, in Norway. We did not offer incentives to increase participation and adherence or to decrease loss to follow-up. We recruited users of the website, slutta.no, an open, free, multi-component Norwegian internet-based smoking cessation program, from May 2010 until October 2012. Enrolled smokers were considered as having completed a time point regardless of their response status if it was 1, 3, 6, or 12 months post cessation. We assessed 7315 participants using the following inclusion criteria: knowledge of the Norwegian language, age 16 years or older, ownership of a Norwegian cell phone, having an email account, current cigarette smoker, willingness to set a cessation date within 14 days (mandatory), and completion of a baseline questionnaire for tailoring algorithms. Altogether, 6137 participants were eligible for the study and 4378 participants (71.33%) provided informed consent to participate in the smoking cessation trial. We calculated the response rates for participants at the completed 1, 3, 6, and 12 months post cessation. For each arm, we conducted an intention-to-treat (ITT) analysis for each completed time point. The main outcome was 7-day self-reported point prevalence abstinence (PPA) at the completed 6 months post cessation. We calculated effect size of the 7-day self-reported PPA in the text message arm compared with the email arm as odds ratios (ORs) with 95% CIs for the 4 time points post cessation. Results At 6 months follow-up, 21.06% (384/1823) of participants in the text message arm and 18.62% (333/1788) in the email arm responded (P=.07) to the surveys. In the ITT analysis, 11.46% (209/1823) of participants in the text message arm compared with 10.96% (196/1788) in the email arm (OR 1.05, 95% CI 0.86-1.30) reported to have achieved 7 days PPA. Conclusions This nationwide, double-blinded, large, fully automated RCT found that 1 in 9 enrolled smokers reported 7-day PPA in both arms, 6 months post cessation. Our study found that identical smoking cessation interventions delivered by mobile text messaging and email may be equally successful at a population level. Trial Registration ClinicalTrials.gov NCT01103427; https://clinicaltrials.gov/ct2/show/NCT01103427

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