Urban and Rural Disparities in a WeChat-Based Smoking Cessation Intervention among Chinese Smokers

Introduction: Tobacco use, which is directly responsible for 10% of total deaths per year globally, remains consistently high, with approximately 20% of the population reporting regular consumption globally. Moreover, health disparities regarding tobacco consumption and smoking cessation are growing between rural and urban populations worldwide. Social media interventions for tobacco cessation may effectively reach both groups. The objective of this study was to evaluate the efficacy of a WeChat-delivered smoking cessation intervention among rural and urban Chinese smokers, and to assess moderating variables that may contribute to differential intervention efficacy. Methods: WeChat was used to recruit smokers into this intervention study between 1 July and 5 August 2019. Participants were randomized to one of three intervention schedules: participants in the Standard Group and the Enhanced Group received 20 smoking-related messages over 2 weeks, whereas participants in the Enhanced Group received an extra 6 oral health-related messages for one week. Participants in the control group received 20 smoking-related messages after the post-intervention assessment. Participants completed questionnaires at baseline and at 4 weeks follow-up. Our primary outcome was smoking cessation stage of change and secondary outcome was 24-h point prevalence abstinence (PPA). Urban and rural areas were based on self-reported living areas. Chi-squared test, Fisher’s exact test, ANOVA test, linear regression, and logistic regression were used for analysis. Results: Overall, 403 participants completed the intervention (233 rural, 107 suburban, 63 urban). Compared to urban participants, rural participants were more likely to have progressed to a later stage of change (β = 0.40, 95% CI: 0.13, 0.67) and to report higher 24-h PPA rates at follow-up (aOR = 3.23, 95% CI: 1.36, 7.68). After stratification by living area, the intervention effects in stage of change and 24-h PPA rate at follow-up were only found in the urban subgroup. Discussion: Smokers who lived in rural areas reported better smoking cessation outcomes compared with urban smokers; however, the efficacy of a WeChat-based smoking cessation intervention was only found for participants living in an urban area. WeChat based smoking cessation interventions should be used to promote smoking cessation in urban, suburban, and rural areas.

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Retraining automatic action tendencies for smoking using mobile phone-based approach-avoidance bias training: A study protocol for a randomized controlled study

Trials ◽

10.1186/s13063-019-3835-0 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Alla Machulska ◽

Kristian Kleinke ◽

Tanja Joan Eiler ◽

Armin Grünewald ◽

Rainer Brück ◽

...

Keyword(s):

Smoking Cessation ◽

Mobile Phone ◽

Outcome Measures ◽

Smoking Cessation Intervention ◽

Secondary Outcome ◽

Control Group ◽

Randomized Controlled ◽

Quit Smoking ◽

Cessation Intervention

Abstract Background Automatic tendencies to approach drug-related cues have been linked to the development and maintainance of harmful drug-taking behavior. Recent studies have demonstrated that these automatic approach tendencies can be targeted directly by means of cognitive bias modification (CBM). Moreover, changing those approach tendencies may enhance treatment outcomes. However, training and therapy effects tend to be rather small and adherence to the training might be impaired by time-consuming multiple laboratory training sessions. Here, we present a protocol for a randomized controlled design to improve CBM training efficiency and facilitate access to the training by providing mobile-phone-based training sessions at home to current smokers motivated to quit smoking. Methods Participants (n = 100) are current smokers who smoke at least six cigarettes per day for at least 6 months and are willing to quit smoking. All participants attend a brief behavioral smoking cessation intervention (TAU) and are randomly assigned either to an experimental (TAU + training) or a control group. Participants in the experimental condition are given access to a training application (app) aimed at retraining automatic approach biases for smoking cues. Participants are instructed to perform the app training outside the laboratory context on a daily basis for 14 consecutive days. Participants in the control group do not receive the training. Primary outcome measures are changes in smoking-related approach biases and reductions in daily nicotine consumption as assessed at baseline, post-training and at 6-week follow up. Secondary outcome measures include approach biases for alternative stimuli or smoking stimuli to which participants were not exposed during training, attentional and association biases, biochemical outcomes, and self-reported smoking behavior, also measured at three different time points (baseline, post-training, and follow up). After completion of the study, smokers in the control condition will receive access to the training app. Discussion This randomized controlled trial is the first to test the effectiveness of an app-based CBM intervention as an adjunct to a brief smoking cessation intervention in smokers motivated to quit smoking. The results of this study can inform future research in the optimization and advancement of CBM treatment for addiction. Trial registration Current Controlled Trials, ISRCTN15690771. Registered on 20 November 2018.

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The Impact of a Brief Intervention on Maternal Smoking Behavior

PEDIATRICS ◽

10.1542/peds.105.s2.267 ◽

2000 ◽

Vol 105 (Supplement_2) ◽

pp. 267-271

Author(s):

Judith A. Groner ◽

Karen Ahijevych ◽

Lindsey K. Grossman ◽

Leslie N. Rich

Keyword(s):

Smoking Cessation ◽

Controlled Trial ◽

Safety Information ◽

Stage Of Change ◽

Smoking Cessation Intervention ◽

Control Group ◽

Primary Care Center ◽

Cessation Intervention ◽

Quit Rate ◽

The Impact

Objective. To determine if mothers receiving a smoking cessation intervention emphasizing health risks of environmental tobacco smoke (ETS) for their children have a higher quit rate than 1) mothers receiving routine smoking cessation advice or 2) a control group. Design. Randomized, controlled trial. Setting. Primary care center in a large urban children's hospital. Intervention. Four hundred seventy-nine mothers were randomly assigned to a smoking cessation intervention either aimed at their child's health or their own health, or to a control group receiving safety information. Outcome Measures. Smoking status, stage of change, cigarettes/day, location smoking occurred, and knowledge of ETS effects. Results. Complete data (baseline and both follow-ups) were available for 166 subjects. There was no impact of group assignment on the quit rate, cigarettes/day, or stage of change. The Child Health Group intervention had a sustained effect on location where smoking reportedly occurred (usually outside) and on improved knowledge of ETS effects. Conclusions. Further research is needed to devise more effective methods of using the pediatric health care setting to influence adult smoking behaviors.

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Retraining automatic action tendencies for smoking using mobile phone-based approach-avoidance bias training: Study protocol for a randomized controlled study

10.21203/rs.2.376/v2 ◽

2019 ◽

Author(s):

Alla Machulska ◽

Kristian Kleinke ◽

Tanja Joan Eiler ◽

Armin Grünewald ◽

Rainer Brück ◽

...

Keyword(s):

Smoking Cessation ◽

Mobile Phone ◽

Outcome Measures ◽

Smoking Cessation Intervention ◽

Control Group ◽

Quit Smoking ◽

Cessation Intervention ◽

Randomized Control ◽

Bias Modification

Abstract Background: Automatic tendencies to approach drug-related cues have been linked to the development and maintainance of harmful drug taking behavior. Recent studies have demonstrated that these automatic approach tendencies can be targeted directly by means of Cognitive Bias Modification (CBM) approaches. Moreover, changing those approach tendencies may enhance treatment outcomes. However, training and therapy effects tend to be rather small and adherence to the training might be impaired by time-consuming multiple lab-training sessions. Here, we present a protocol for a randomized control design to improve CBM training efficiency and facilitate access to the training by providing mobile phone-based training sessions at home to current smokers motivated to quit smoking. Methods: Participants (n = 100) are current smokers who smoke at least 6 cigarettes per day for at least 6 months and are willing to quit smoking. All participants attend a brief behavioral smoking cessation intervention (TAU) and are randomly assigned either to an experimental (TAU + training) or a control group. Participants in the experimental condition are given access to a training app aimed at retraining automatic approach biases for smoking cues. Participants are instructed to perform the app-training outside the laboratory context on a daily basis for 14 consecutive days. Participants in the control group do not receive the training. Primary outcome measures are changes in smoking-related approach biases and reductions in daily nicotine consumption as assessed at baseline, post-training and at a six-week follow-up. Secondary outcome measures include approach biases for alternative stimuli or smoking stimuli to which participants were not exposed during training, attentional and association biases, biochemical outcomes, and self-reported smoking behavior, also measured at three different time points (baseline, post-training, follow-up). After completion of the study, smokers in the control condition will receive access to the training app. Discussion: This RCT is the first to test the effectiveness of an app-based CBM intervention as an adjunct to a brief smoking cessation intervention in smokers motivated to quit smoking. The results of this study can inform future research in the optimisation and advancement of CBM treatment for addiction. Trial registration: Registered with Current Controlled Trials: study ID ISRCTN15690771. Registered on 20 November 2018; http://www.isrctn.com/ISRCTN15690771 Key words: Approach Bias, Cogitive Bias Modification, cigarette smoking, nicotine addiction, Randomized Control Trial, smartphone apps

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A WeChat-Based Smoking Cessation Intervention for Chinese Smokers: A Randomized Controlled Trial (Preprint)

10.2196/preprints.25676 ◽

2020 ◽

Author(s):

Ting Luo ◽

Mirandy S. Li ◽

Donna Williams ◽

Jackson Fritz ◽

Kaylin Beiter ◽

...

Keyword(s):

Smoking Cessation ◽

Oral Health ◽

Health Education ◽

Nicotine Dependence ◽

Controlled Trial ◽

Smoking Cessation Intervention ◽

Standard Group ◽

Oral Health Education ◽

Cessation Intervention

BACKGROUND China is the largest tobacco producer and has the highest number of tobacco consumers in the world. Extensive research has demonstrated ways that social media can assist in quitting smoking. WeChat is the most commonly used social media platform in China; however, it has not yet been used for smoking cessation interventions. OBJECTIVE The objectives of this study are (1) to evaluate the effectiveness of a WeChat-based smoking cessation intervention; and (2) to examine a possible synergistic effect of integrating oral health and smoking-related information into a tailored, Transtheoretical Model (TTM) guided smoking cessation intervention. METHODS Eligible adults were recruited through WeChat from July 1 to August 6, 2019, to participate in a 3-arm, single-blinded, randomized controlled trial. 403 participants were enrolled and randomized into three groups: Standard Group (smoking cessation intervention only, n=136), Enhanced Group (smoking cessation + oral health education interventions, n=136), or Waitlist Group (delayed smoking cessation intervention, n=132). The intervention was delivered through WeChat with total of three weeks. Participants were asked to complete questionnaires at baseline and follow-up assessments as well as process evaluation at each intervention week. The primary outcome was Stage of Change, and the secondary outcomes were 7-day Point Prevalence Abstinence (PPA), 24-hour PPA, daily cigarette use, and nicotine dependence at 4 weeks follow-up after intervention comparing intervention groups and control group. The overall attrition rate was 46%. Paired t-tests, McNemar tests, and linear and logistic regression were used to examine differences in smoking cessation outcomes within and between groups. RESULTS Compared to baseline, at follow-up, all groups experienced smokers had significantly greater reduction in nicotine dependence scores (Standard: 1.8; Enhanced: 1.9, and Waitlist: 0.4). At 4-week follow-up, compared to the Waitlist Group, smokers from the Enhanced Group and the Standard Group had significantly lower nicotine dependence scores, lower daily cigarette use, and were more likely to have stage of change progression movement. Participants in Enhanced Group (β=-1.28, 95%CI: -2.13, -0.44) and the Standard Group (β=-1.13, 95%CI: -1.95, -0.30) also reported larger change in nicotine dependence score, compared to participants in the Waitlist Group. CONCLUSIONS This WeChat-based intervention was overall effective for smoking cessation, with enhanced cessation when additionally incorporating an oral health education intervention. Future smoking cessation programs should consider inclusion of oral health education. More broadly, in light of continued social distancing, WeChat could be considered as a platform for smoking cessation and other behavioral interventions.

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Retraining automatic action tendencies for smoking using mobile phone-based approach-avoidance bias training: Study protocol for a randomized controlled study

10.21203/rs.2.376/v3 ◽

2019 ◽

Author(s):

Alla Machulska ◽

Kristian Kleinke ◽

Tanja Joan Eiler ◽

Armin Grünewald ◽

Rainer Brück ◽

...

Keyword(s):

Smoking Cessation ◽

Mobile Phone ◽

Outcome Measures ◽

Smoking Cessation Intervention ◽

Control Group ◽

Quit Smoking ◽

Cessation Intervention ◽

Randomized Control ◽

Bias Modification

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A Mobile Social Network–Based Smoking Cessation Intervention for Chinese Male Smokers: Protocol for a Pilot Randomized Controlled Trial

JMIR Research Protocols ◽

10.2196/18071 ◽

2020 ◽

Vol 9 (9) ◽

pp. e18071 ◽

Cited By ~ 1

Author(s):

Jinsong Chen ◽

Elsie Ho ◽

Yannan Jiang ◽

Robyn Whittaker ◽

Tingzhong Yang ◽

...

Keyword(s):

Smoking Cessation ◽

Social Network ◽

Intervention Group ◽

Smoking Cessation Intervention ◽

Cigarette Consumption ◽

Control Group ◽

Smoking Abstinence ◽

Cessation Intervention ◽

Chinese Male

Background Approximately 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. Objective This 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. Methods A 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). Results Recruitment 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). Conclusions If 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 Registration Australian 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

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Evaluation of a (pilot) stage-tailored brief smoking cessation intervention among hospital patients

Australian Health Review ◽

10.1071/ah000083 ◽

2000 ◽

Vol 23 (3) ◽

pp. 83 ◽

Cited By ~ 15

Author(s):

Chris Rissel ◽

Allison Salmon ◽

Ann-Maree Hughes

Keyword(s):

Smoking Cessation ◽

Health Worker ◽

Smoking Prevalence ◽

Stage Of Change ◽

Smoking Cessation Intervention ◽

Control Group ◽

Cessation Intervention ◽

Hospital Patients ◽

Smoking Attitudes

Despite the significant benefits of advising all smokers to quit, hospital patients who smoke do not systematicallyreceive this advice. This study sought to determine the prevalence of smoking, attitudes of patients towards notsmoking while in hospital, and the feasibility and effectiveness of a brief smoking cessation intervention in a pre-admissionclinic context. Over 230 smokers received a brief smoking cessation intervention, while a control group(n=114) received only a free Quit Kit. The age-standardised smoking prevalence was 19%; a further 3% of patientswere recent quitters. Most smokers do not expect or experience problems with not smoking while in hospital. Briefsmoking cessation advice tailored to stage-of-change by a health worker in a hospital pre-admission clinic significantlyincreased the quit rates for females.

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A Mobile Social Network–Based Smoking Cessation Intervention for Chinese Male Smokers: Protocol for a Pilot Randomized Controlled Trial (Preprint)

10.2196/preprints.18071 ◽

2020 ◽

Author(s):

Jinsong Chen ◽

Elsie Ho ◽

Yannan Jiang ◽

Robyn Whittaker ◽

Tingzhong Yang ◽

...

Keyword(s):

Smoking Cessation ◽

Social Network ◽

Intervention Group ◽

Smoking Cessation Intervention ◽

Cigarette Consumption ◽

Control Group ◽

Smoking Abstinence ◽

Cessation Intervention ◽

Chinese Male

BACKGROUND Approximately 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 (<i>SCAMPI: Smoking Cessation App for Chinese Male: Pilot Intervention</i>) is designed to help Chinese male smokers to quit smoking. OBJECTIVE This 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. METHODS A 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 (<i>placebo app</i>). RESULTS Recruitment 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). CONCLUSIONS If 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. CLINICALTRIAL Australian New Zealand Clinical Trials Registry ACTRN12618001089224; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375381 INTERNATIONAL REGISTERED REPORT RR1-10.2196/18071

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Post creation strategies in a smoking cessation intervention based on motivational interviewing using Facebook: a mixed-methods content analysis (Preprint)

10.2196/preprints.15580 ◽

2019 ◽

Author(s):

David Pócs ◽

Tímea Óvári ◽

Csaba Hamvai ◽

Oguz Kelemen

Keyword(s):

Smoking Cessation ◽

Motivational Interviewing ◽

Tobacco Use ◽

Negative Feedback ◽

Smoking Cessation Intervention ◽

Control Group ◽

Tobacco Use Cessation ◽

Web Based ◽

Cessation Intervention ◽

Significant Difference

BACKGROUND Smoking cessation support on Facebook (FB) is a cost-effective and extensible way to reduce tobacco use among young people. Motivational interviewing (MI) is a practical counselling style in face-to-face smoking cessation support and can be useful in web-based interventions as well. OBJECTIVE This study aimed at identifying which post creation strategies based on MI could achieve positive changes in FB post characteristics and FB users’ comments. METHODS We included MI-adherent posts (N=701) which were not boosted and were targeted at tobacco users. These FB posts have been categorized into five different groups according to specific MI strategies. The control group comprised entertaining and informative posts. Primary outcomes seem to highlight how the content has stimulated interactions (engagement rate), inhibited interactions (negative feedback) or appealed to the audience of the FB page (fan-total reach ratio). The first comments received on the FB posts were evaluated and used as secondary outcomes. We applied the classification of MI approach: change talk (CT), sustain talk (ST), desire, ability, reason, need (DARN), and commitment, activation, taking steps (CAT). RESULTS FB posts which used MI strategies were associated with significantly higher engagement rate (p=.010), higher fan-total reach ratio (p<.001), and more CT (p<.001), DARN (p=.005), or CAT comments (p=.003) compared to the control group. ‘Elaborating CT’ strategies elicited considerably more CT (p<.001) and DARN comments (p=.020). ‘Affirming CT’ strategies obtained higher fan-total reach ratio (p=.011) and generated significantly more CT (p=.006) and CAT comments (p<.001). ‘Reflecting CT’ strategies received significantly higher fan-total reach ratio (p<.001). Finally, ‘relational MI’ strategies achieved significantly higher engagement rate (p<.001) compared to the control group. It should be noted that we did not find significant difference in negative feedback and the number of ST comments. CONCLUSIONS Post creation strategies based on MI stimulated interactions with FB users and generated conversation about tobacco use cessation without relevant negative feedback. Our findings suggest that MI strategies may play a remarkable role in post creation within a web-based smoking cessation intervention. In the future, these strategies could be applicable to other online platforms, such as public health websites, health blogs, mobile applications or social networking groups.

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Assessing the efficacy and impact of a personalised smoking cessation intervention among type 2 diabetic smokers: study protocol for an open-label randomised controlled trial (DISCGO-RCT)

BMJ Open ◽

10.1136/bmjopen-2020-040117 ◽

2020 ◽

Vol 10 (11) ◽

pp. e040117

Author(s):

Carole Clair ◽

Aurélie Augsburger ◽

Priska Birrer ◽

Isabella Locatelli ◽

Joelle Schwarz ◽

...

Keyword(s):

Type 2 Diabetes ◽

Smoking Cessation ◽

Smoking Cessation Intervention ◽

Randomised Control Trial ◽

Primary Study ◽

Smoking Abstinence ◽

Open Label ◽

Cessation Intervention

IntroductionFew studies have assessed the efficacy of smoking cessation interventions in individuals with type 2 diabetes, but interventions adapted to the specific needs of this population are warranted. The aim of this study is to assess the efficacy of a smoking cessation intervention in a population of smokers with type 2 diabetes and to measure the metabolic impact of smoking cessation.Methods and analysisThe study is an open-label, randomised control trial. Participants recruited from a sanitary region of Switzerland will be randomly allocated to either the intervention or the control arm. The intervention group will have four individual counselling sessions over 12 weeks. Trained research nurses will conduct the behavioural intervention, using motivational interviews and addressing diabetes and gender specificities. The control group will have one short counselling session at baseline and will be given written information on smoking cessation. Both groups will have a follow-up visit at 26 and 52 weeks. Demographic and medical data will be collected at baseline and follow-up, along with blood and urine samples. The primary study outcome is continuous smoking abstinence validated by expired-air carbon monoxide from week 12 to week 52. Secondary study outcomes are continuous and 7-day point prevalence smoking abstinence at 12 and 26 weeks; change in motivation to quit and cigarette consumption; and change in glycosylated haemoglobin levels, body weight, waist circumference and renal function after smoking cessation. In a subsample of 80 participants, change in stool microbiota from baseline will be measured at 3, 8 and 26 weeks after smoking cessation.Ethics and disseminationEthical approval has been obtained by the competent ethics committee (Commission cantonale d’éthique de la recherche sur l’être humain, CER-VD 2017–00812). The results of the study will be disseminated through publications in peer-reviewed journals and conference presentations.Trial registration numbersClinicalTrials.gov NCT03426423 and SNCTP000002762; Pre-results.

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