Effectiveness of a motivational intervention based on spirometry results to achieve smoking cessation in primary healthcare patients: randomised, parallel, controlled multicentre study

ObjectiveThis 12-month study in a primary healthcare network aimed to assess the effectiveness of usual smoking cessation advice compared with personalised information about the spirometry results.DesignRandomised, parallel, controlled, multicentre clinical trial.SettingThis study involved 12 primary healthcare centres (Tarragona, Spain).ParticipantsActive smokers aged 35–70 years, without known respiratory disease. Each participant received brief smoking cessation advice along with a spirometry assessment. Participants with normal results were randomised to the intervention group (IG), including detailed spirometry information at baseline and 6-month follow-up or control group (CG), which was simply informed that their spirometry values were within normal parameters.Main outcomeProlonged abstinence (12 months) validated by expired-CO testing.ResultsSpirometry was normal in 571 patients in 571 patients (45.9% male), 286 allocated to IG and 285 to CG. Baseline characteristics were comparable between the groups. Mean age was 49.8 (SD ±7.78) years and mean cumulative smoking exposure was 29.2 (±18.7) pack-years. Prolonged abstinence was 5.6% (16/286) in the IG, compared with 2.1% (6/285) in the CG (p=0.03); the cumulative abstinence curve was favourable in the IG (HR 1.98; 95% CI 1.29 to 3.04).ConclusionsIn active smokers without known respiratory disease, brief advice plus detailed spirometry information doubled prolonged abstinence rates, compared with brief advice alone, in 12-month follow-up, suggesting a more effective intervention to achieve smoking cessation in primary healthcare.Trial registration numberNCT01194596.

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Boosting Chinese healthcare service providers’ utilization of behavioural and pharmacotherapy interventions for cigarette smoking cessation by ‘WeChat WeQuit’ program

10.1101/19012682 ◽

2019 ◽

Author(s):

Yanhui Liao ◽

Yunfei Wang ◽

Zhenzhen Wu ◽

Yuhang Liu ◽

Chudong Wang ◽

...

Keyword(s):

Health Care ◽

Smoking Cessation ◽

Cigarette Smoking ◽

Training Program ◽

Healthcare Service ◽

Service Providers ◽

Intervention Group ◽

Control Group ◽

Health Care Settings

AbstractIntroductionIn China, standard smoking cessation practices are rarely used by healthcare service providers (HSPs). WeChat, a popular social media app, has been widely used in China.MethodsIn this single-blind, randomized trial, undertaken in China with 8-week interventions and follow-up to 52 weeks, about 2,200 providers from different health care settings will be randomly selected to the intervention or control group. This trial will be conducted in China between June 2018 to October 2019. The intervention group will receive regular smoking cessation training program messages by the professional team to 8 weeks and follow to 52 weeks. A hard copy of the manual will be sent to each provider from the intervention group by mail after randomization. The Control group will only communicate by themselves and receive thanks messages for 8 weeks, and follow-up to 52 weeks. The trial will be carried out in two phases. The first phase is the pilot study (n=200, 8-week intervention and follow-up to 16 weeks) and the second is the main study (n=2000, 8-week intervention and follow-up to 52 weeks). The primary outcome measure will be the utilization rate of behavioural and pharmacotherapy interventions for smoking patients from 8 to 52 weeks. This trial is registered at ClinicalTrials.gov (number NCT03556774).ConclusionsThis program will be the first evidence-based educational program in smoking cessation designed specifically for the improvement of Chinese HSPs’ utilization of behavioural and pharmacotherapy interventions for cigarette smoking cessation in health care settings by the ‘WeChat WeQuit’ program.ImplicationsThis protocol may show that ‘WeChat WeQuit’ training program will be effective in increasing the provision of effective tobacco cessation interventions by Chinese-speaking HSPs, especially therapists, to patients with cigarette smoking, which will provide valuable insights into bridging the gap between need and services for smoking cessation in China. Overall, we believe this program will be likely to have very substantial public health benefits if it would provide a widely accessible and efficacious smoking cessation information for Chinese HSPs.

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The Effects of Smoking-Cessation Counseling Based on the Stages-of-Change Model in Dental Patients; Semi-Experimental Study

10.21203/rs.2.10418/v1 ◽

2019 ◽

Author(s):

Zahra Ghorbani ◽

Arezoo Ebn Ahmady ◽

Zahra Hosseini ◽

Somayyeh Azimi

Keyword(s):

Smoking Cessation ◽

Stages Of Change ◽

Intervention Group ◽

Dental Student ◽

Control Group ◽

Smoking Cessation Counseling ◽

Dental Patients ◽

Significant Difference ◽

And Control

Abstract Background Dentists may take part in smoking cessation counseling of dental patients by using the time they are engaged in dental procedures and by emphasizing on oral manifestations of smoking. The present study aimed to evaluate the effects of smoking cessation counseling by a dentist on preparation for change to quit smoking in smoker patients. Methods This study was performed on 150 smoking patients admitted to Dental School of Shahid Beheshti University of Medical sciences, Tehran, Iran. The patients were randomly divided into two groups of 75 patients. The intervention group received smoking cessation counseling by a single senior dental student. A self-administered questionnaire containing questions regarding the position of the individual in change cycle stages was completed by both intervention and control group at baseline and at one-month follow up. For statistical analysis, paired t-tests, Mann-Whitney U and multivariate linear regression models was used with a significance level of P<0.05. Results At baseline, there were no significant differences between the intervention and control groups in terms of change cycle stages of smoking cessation. Also, there was no significant difference between change cycle stages at baseline and one-month follow up in control group; but this difference in intervention group was significant (p=0.006). The proportion of patients in the pre-contemplation stage decreased by 43% while the proportion of patients in the contemplation and action stages increased by 20% and 16% respectively. Conclusions The smoking cessation counseling enhances forward movement through the stages-of-change of smoking cessation. Measurement of this movement may be an important intermediary in evaluating small clinical trials of counseling.

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Exploring Efficacy of a Serious Game (Tobbstop) for Smoking Cessation During Pregnancy: Randomized Controlled Trial (Preprint)

10.2196/preprints.12835 ◽

2018 ◽

Author(s):

Francesc X Marin-Gomez ◽

Rocio Garcia-Moreno Marchán ◽

Anabel Mayos-Fernandez ◽

Gemma Flores-Mateo ◽

Esther Granado-Font ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Tobacco Use ◽

Controlled Trial ◽

Intervention Group ◽

Serious Game ◽

Control Group ◽

Randomized Controlled ◽

Pregnant Smokers

BACKGROUND Tobacco use during pregnancy entails a serious risk to the mother and harmful effects on the development of the child. Europe has the highest tobacco smoking prevalence (19.3%) compared with the 6.8% global mean. Between 20% to 30% of pregnant women used tobacco during pregnancy worldwide. These data emphasize the urgent need for community education and implementation of prevention strategies focused on the risks associated with tobacco use during pregnancy. OBJECTIVE The aim of this study was to investigate the efficacy of an intervention that incorporates a serious game (Tobbstop) to help pregnant smokers quit smoking. METHODS A two-arm randomized controlled trial enrolled 42 women who visited 2 primary care centers in Catalonia, Spain, between March 2015 and November 2016. All participants were pregnant smokers, above 18 years old, attending consultation with a midwife during the first trimester of pregnancy, and had expressed their desire to stop smoking. Participants were randomized to the intervention (n=21) or control group (n=21). The intervention group was instructed to install the game on their mobile phone or tablet and use it for 3 months. Until delivery, all the participants were assessed on their stage of smoking cessation during their follow-up midwife consultations. The primary outcome was continuous tobacco abstinence until delivery confirmed by the amount of carbon monoxide at each visit, measured with a carboxymeter. RESULTS Continuous abstinence until delivery outcome was 57% (12/21) in the intervention group versus 14% (3/21) in the control group (hazard ratio=4.31; 95% CI 1.87-9.97; P=.001). The mean of total days without smoking until delivery was higher in the intervention group (mean 139.75, SD 21.76) compared with the control group (mean 33.28, SD 13.27; P<.001). In addition, a Kapplan-Meier survival analysis showed that intervention group has a higher abstinence rate compared with the control group (log-rank test, χ21=13.91; P<.001). CONCLUSIONS Serious game use is associated with an increased likelihood to maintain abstinence during the intervention period if compared with those not using the game. Pregnancy is an ideal opportunity to intervene and control tobacco use among future mothers. On the other hand, serious games are an emerging technology, growing in importance, which are shown to be a good tool to help quitting smoking during pregnancy and also to maintain this abstinent behavior. However, because of the study design limitations, these outcomes should be interpreted with caution. More research, using larger samples and longer follow-up periods, is needed to replicate the findings of this study. CLINICALTRIAL ClinicalTrials.gov NCT01734421; https://clinicaltrials.gov/ct2/show/NCT01734421 (Archived by WebCite at http://www.webcitation.org/75ISc59pB)

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Tailored Web-Based Smoking Interventions and Reduced Attrition: Systematic Review and Meta-Analysis

Journal of Medical Internet Research ◽

10.2196/16255 ◽

2020 ◽

Vol 22 (10) ◽

pp. e16255

Author(s):

Amika Shah ◽

Michael Chaiton ◽

Dolly Baliunas ◽

Robert Schwartz

Keyword(s):

Systematic Review ◽

Smoking Cessation ◽

Passive Control ◽

Controlled Trial ◽

Meta Analysis ◽

Intervention Group ◽

Control Group ◽

Web Based ◽

The Impact

Background The increasing number of internet users presents an opportunity to deliver health interventions to large populations. Despite their potential, many web-based interventions, including those for smoking cessation, face high rates of attrition. Further consideration of how intervention features impact attrition is needed. Objective The aim of this systematic review is to investigate whether tailored web-based smoking cessation interventions for smokers are associated with reduced rates of attrition compared with active or passive untailored web-based interventions. The outcomes of interest were dropout attrition at 1-, 3-, 6-, and 12-month follow-ups. Methods Literature searches were conducted in May 2018 and updated in May 2020 on MEDLINE (Medical Literature Analysis and Retrieval System Online), PsycINFO (Psychological Information), EMBASE (Excerpta Medica dataBASE), CINAHL (Cumulated Index to Nursing and Allied Health Literature), Scopus, and the Cochrane Tobacco Addiction Group Specialized Register with the following search terms: smoking cessation, tailored, or web- or internet-based. Included studies were published in English before or in May 2020 using a randomized controlled trial design. Studies were restricted to those with web-based delivery, a tailored intervention group, an untailored control group, and a reported outcome of smoking cessation. Studies were assessed for methodological quality using the Cochrane Risk of Bias tool. Two reviewers independently extracted the study characteristics and the number of participants lost to follow-up for each treatment group. Results A total of 13 studies were included in the systematic review, of which 11 (85%) were included in the meta-analysis. Tailoring had no statistically significant effect on dropout attrition at 1-month (risk ratio [RR]=1.02, 95% CI 0.95-1.09; P=.58; I2=78%), 3-month (RR=0.99, 95% CI 0.95-1.04; P=.80; I2=73%), 6-month (RR=1.00, 95% CI 0.95-1.05; P=.90; I2=43%), or 12-month (RR=0.97, 95% CI 0.92-1.02; P=.26; I2=28%) follow-ups. Subgroup analyses suggested that there was a statistically significant effect of tailoring between the active and passive subgroups at 1-month (P=.03), 3-month (P<.001), and 6-month (P=.02) follow-ups but not at 12-month follow-up (P=.25). Conclusions The results suggest that tailoring of web-based smoking cessation interventions may not be associated with reduced rates of dropout attrition at 1-, 3-, 6-, or 12-month follow-ups. Significant differences between studies that include untailored active and passive control groups suggest that the role of tailoring may be more prominent when studies include a passive control group. These findings may be because of variability in the presence of additional features, the definition of smokers used, and the duration of smoking abstinence measured. Future studies should incorporate active web-based controls, compare the impact of different tailoring strategies, and include populations outside of the Western countries.

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Mindfulness-Based Intervention for Children with Mental Health Problems: a 2-Year Follow-up Randomized Controlled Study

Mindfulness ◽

10.1007/s12671-021-01771-w ◽

2021 ◽

Author(s):

Katarina Laundy ◽

Peter Friberg ◽

Walter Osika ◽

Yun Chen

Keyword(s):

Mental Health ◽

Disruptive Behavior ◽

Mental Health Problems ◽

Intervention Group ◽

Health Problems ◽

Controlled Study ◽

Control Group ◽

Registration Number ◽

Group A

Abstract Objectives Moderate mental health problems are highly prevalent and increasing in Swedish schoolchildren, elevating risk for future mental and somatic disability. The aim of this study was to determine whether an 8-week mindfulness-based intervention, Training for Mindfulness and Resilience (TMR), mitigates mental health symptoms and increases resilience during a 2-year follow-up. Methods Schoolchildren (aged 9–14 years) reporting moderate mental health problems were randomized into either TMR intervention group (N = 22) or control group, receiving best current practice (N = 12). We used validated questionnaires to measure anxiety, depression, anger, disruptive behavior, self-concept, resilience, stress, and mindfulness before treatment with either TMR or control, as well as at 6 months, 1 year, and 2 years follow-up. Results We found a statistically significant effect of TMR intervention vs control, on resilience, anxiety, anger, and disruptive behavior. Compared to baseline, TMR increased the level of resilience at 6 months (p < .001); anxiety at 1 (p < = .033) and 2 years (p = .04); anger at 6 months (p = .004) and 2 years (p = .039); disruptive behavior at 6 months (p = .006). In the control group, a decrease in resilience between 6 months and 2 years (p = .05) was observed. No other significant effects were found in the control group. Conclusions This study suggested that TMR improved mental health in schoolchildren with effects on anxiety and anger lasting for 2 years, and on resilience and disruptive behavior lasting for 6 months. Trial Registration Number NCT04806542, date of registration 18th of March 2021, retrospectively registered.

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A Randomised Controlled Trial Evaluating the Effectiveness and Tolerability of Step-up and Step-down Varenicline Therapy for Smoking Cessation: A Study Protocol

The Journal of Smoking Cessation ◽

10.1017/jsc.2017.17 ◽

2017 ◽

Vol 13 (3) ◽

pp. 179-185

Author(s):

Aaron D. Drovandi ◽

Peta-Ann Teague ◽

Beverley D. Glass ◽

Bunmi Malau-Aduli

Keyword(s):

Smoking Cessation ◽

Adverse Events ◽

Outcome Measures ◽

Controlled Trial ◽

Intervention Group ◽

Withdrawal Symptoms ◽

Secondary Outcome ◽

Control Group ◽

Step Down

Background: Varenicline remains the most effective medication for smoking cessation; however, discontinuation as a result of adverse events negatively impacts medication adherence, and the likelihood of a quit attempt being successful. Post-treatment cravings and withdrawal symptoms may also occur, increasing the likelihood of treatment failure, due to lapse and relapse after achieving initial abstinence. This protocol details a trial investigating changes in the effectiveness and tolerability of varenicline, when an extended step-up and step-down regimen are used.Methods: A phase four, randomised, double-blinded, placebo-controlled single-centre study with a treatment period of 16 weeks, and follow-up period of 12 weeks will be conducted. Up to 201 participants will be enrolled and allocated in a 1:1:1 ratio to a placebo-matching control group, step-up, or step-down intervention group, all receiving behavioural counselling and quitting advice. Participants will be contacted weekly during treatment and fortnightly during follow-up. Eligible participants are smokers over 18 years old, willing to quit smoking, are able to attend clinic visits, and have no uncontrolled or serious medical issues. Primary outcome measures are comparisons of biochemically confirmed continuous abstinence rates, 7-day point prevalence abstinence rates, and the frequency, severity and duration of adverse events, cravings and withdrawal symptoms. Secondary outcome measures are participant adherence to the study medication throughout treatment, and comparisons of changes in smoking satisfaction and reward. Effects of each regimen on smoking cessation will be assessed by logistic regression, with survival analyses used for a more precise estimate of when cessation occurs. Primary endpoints will then be compared using a general linear model. Australian New Zealand Clinical Trials Registry: ACTRN12616000802404p

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Tailored Web-Based Smoking Interventions and Reduced Attrition: Systematic Review and Meta-Analysis (Preprint)

10.2196/preprints.16255 ◽

2019 ◽

Author(s):

Amika Shah ◽

Michael Chaiton ◽

Dolly Baliunas ◽

Robert Schwartz

Keyword(s):

Systematic Review ◽

Smoking Cessation ◽

Passive Control ◽

Controlled Trial ◽

Meta Analysis ◽

Intervention Group ◽

Control Group ◽

Web Based ◽

The Impact

BACKGROUND The increasing number of internet users presents an opportunity to deliver health interventions to large populations. Despite their potential, many web-based interventions, including those for smoking cessation, face high rates of attrition. Further consideration of how intervention features impact attrition is needed. OBJECTIVE The aim of this systematic review is to investigate whether tailored web-based smoking cessation interventions for smokers are associated with reduced rates of attrition compared with active or passive untailored web-based interventions. The outcomes of interest were dropout attrition at 1-, 3-, 6-, and 12-month follow-ups. METHODS Literature searches were conducted in May 2018 and updated in May 2020 on MEDLINE (Medical Literature Analysis and Retrieval System Online), PsycINFO (Psychological Information), EMBASE (Excerpta Medica dataBASE), CINAHL (Cumulated Index to Nursing and Allied Health Literature), Scopus, and the Cochrane Tobacco Addiction Group Specialized Register with the following search terms: smoking cessation, tailored, or web- or internet-based. Included studies were published in English before or in May 2020 using a randomized controlled trial design. Studies were restricted to those with web-based delivery, a tailored intervention group, an untailored control group, and a reported outcome of smoking cessation. Studies were assessed for methodological quality using the Cochrane Risk of Bias tool. Two reviewers independently extracted the study characteristics and the number of participants lost to follow-up for each treatment group. RESULTS A total of 13 studies were included in the systematic review, of which 11 (85%) were included in the meta-analysis. Tailoring had no statistically significant effect on dropout attrition at 1-month (risk ratio [RR]=1.02, 95% CI 0.95-1.09; P=.58; I2=78%), 3-month (RR=0.99, 95% CI 0.95-1.04; P=.80; I2=73%), 6-month (RR=1.00, 95% CI 0.95-1.05; P=.90; I2=43%), or 12-month (RR=0.97, 95% CI 0.92-1.02; P=.26; I2=28%) follow-ups. Subgroup analyses suggested that there was a statistically significant effect of tailoring between the active and passive subgroups at 1-month (P=.03), 3-month (P<.001), and 6-month (P=.02) follow-ups but not at 12-month follow-up (P=.25). CONCLUSIONS The results suggest that tailoring of web-based smoking cessation interventions may not be associated with reduced rates of dropout attrition at 1-, 3-, 6-, or 12-month follow-ups. Significant differences between studies that include untailored active and passive control groups suggest that the role of tailoring may be more prominent when studies include a passive control group. These findings may be because of variability in the presence of additional features, the definition of smokers used, and the duration of smoking abstinence measured. Future studies should incorporate active web-based controls, compare the impact of different tailoring strategies, and include populations outside of the Western countries.

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Smoking cessation using preference-based tools among socially disadvantaged smokers: study protocol for a pragmatic, multicentre randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2021-048859 ◽

2021 ◽

Vol 11 (6) ◽

pp. e048859

Author(s):

Fabienne El-Khoury ◽

Tarik El Aarbaoui ◽

Mégane Héron ◽

Gilles Hejblum ◽

Brigitte Métadieu ◽

...

Keyword(s):

Smoking Cessation ◽

Controlled Trial ◽

Intervention Group ◽

Point Prevalence ◽

Control Group ◽

Socially Disadvantaged ◽

Institutional Review ◽

Registration Number ◽

Sevrage Tabagique ◽

Randomised Controlled

IntroductionMany smoking cessation aids such as nicotine replacement treatments and e-cigarettes have been proven effective in aiding smoking cessation attempts. Encouraging smokers with low socioeconomic position (SEP) to choose their smoking aid tool based on their preferences, and giving that tool free of charge, might increase the odds of smoking cessation. This trial examines the effectiveness of the ‘STOP’ (Sevrage Tabagique à l’aide d’Outils dédiés selon la Préférence: Smoking cessation using preference-based tools), a preference-based smoking cessation intervention for smokers with low SEP.Methods and analysisThe STOP study is a randomised, multicentre, controlled trial (RCT). Smokers with low SEP and wishing to quit will be randomised to either the intervention or the control group (standard care). Participants in the intervention group will be asked to choose between different types of nicotine substitutes (patches, inhalers, gum, tablets, etc) and/or an electronic cigarette which will be delivered free of charge to aid their smoking cessation attempt.The primary outcome will be smoking abstinence at 6 months after inclusion, defined as self-reported 7-day point prevalence of tobacco abstinence. Secondary outcomes include the total number of days of abstinence at 6 months after inclusion, 7-day point prevalence tobacco abstinence at 1 and 3 months after inclusion and number of relapses.The study will also include an economic evaluation, and a process evaluation using a mixed methods approach.Ethics and disseminationThe study was approved by the ‘Île de France II’ Institutional Review Board on 8 September 2020 (CPP Île de France II; Ref No: 20.01.31.65528 RIPH2 HPS), and results will be published in a peer-reviewed journal.Trial registration numberNCT04654585.

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Effects of a participatory organisational, core work task focused workplace intervention on employees’ primary healthcare consultations: secondary analysis of a cluster RCT

Occupational and Environmental Medicine ◽

10.1136/oemed-2020-106558 ◽

2020 ◽

pp. oemed-2020-106558

Author(s):

Elisabeth Framke ◽

Ole Henning Sørensen ◽

Line R M Pedersen ◽

Jacob Pedersen ◽

Ida E H Madsen ◽

...

Keyword(s):

Primary Healthcare ◽

Controlled Trial ◽

Intervention Group ◽

Secondary Analysis ◽

Healthcare Utilisation ◽

Cluster Randomised Controlled Trial ◽

Workplace Intervention ◽

Control Group ◽

Rate Ratios

ObjectivesWe aimed to examine whether a participatory organisational workplace intervention focusing on core tasks at work resulted in lower primary healthcare utilisation of employees.MethodsThe cluster randomised controlled trial included 78 preschools, 44 allocated to the intervention group (1745 employees) and 34 allocated to the control group (1267 employees). The intervention aimed to involve employees in improving the psychosocial work environment while focusing on core tasks at work. Using Poisson regression, we tested the rate ratios (RRs) of consultations in the intervention compared with the control group in terms of all consultations in primary healthcare and general practitioner (GP) consultations, respectively, per person-year during 31 months of follow-up. The fully adjusted model included adjustment for sex, age, job group, workplace type and size, and previous primary healthcare utilisation.ResultsDuring the follow-up, intervention group employees had 11.0 consultations/person-year, while control group employees had 11.6 consultations/person-year (RR 0.97, 95% CI 0.92 to 1.01). Employees in the intervention group had 7.5 GP consultations/person-year, while control group employees had 8.2 GP consultations/person-year (RR 0.95, 95% CI 0.90 to 0.99). Post hoc analyses indicated that the effect of the intervention was particularly strong in employees in preschools with a moderate or high level of implementation.ConclusionsThe participatory organisational workplace intervention focusing on core tasks at work among preschool employees had a small, statistically non-significant effect on overall primary healthcare utilisation and a small, statistically significant effect on GP consultations. These results suggest a beneficial effect of the participatory organisational intervention on employees’ health.Trial registration numberISRCTN16271504

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