Efficacy of smoking prevention program 'Smoke-free Kids': study protocol of a randomized controlled trial

Background  

A strong increase in smoking is noted especially among adolescents. In the Netherlands, about 5% of all 10-year olds, 25% of all 13-year olds and 62% of all 17-year olds report ever smoking. In the U.S., an intervention program called 'Smoke-free Kids' was developed to prevent children from smoking. The present study aims to assess the effects of this home-based smoking prevention program in the Netherlands.     

A randomized controlled trial of hypnotherapy for smoking cessation

A randomized controlled study in a family practice setting was conducted on the use of hypnosis in helping people quit smoking. In the hypnosis group 21 percent of patients quit smoking by the three month follow-up compared with 6 percent in the control group. By six months there were no significant differences between the two groups, and at one year 22 percent in the hypnosis group and 20 percent in the control group had quit. The only significant predictor of success with quitting was having a college education.     

Efficacy of a smoking cessation intervention using the AHCPR guideline tailored for Koreans: a randomized controlled trial

This study was undertaken to evaluate a tailored smoking cessation intervention, which is applicable to Korean culture, using the Agency for Health Care Policy and Research (AHCPR) guideline. On-site counselors provided brief nurse-assisted smoking cessation counseling, including follow-up telephone support, to prevent a relapse in 200 randomly assigned smoking patients. These patients were referred by their physicians regardless of their willingness in smoking cessation in the outpatient department at a university hospital. Nicotine replacement therapy was not provided. Another 201 patients served as a control. After 5 months, current smoking cessation was self-reported on the phone and validated later by a portable carbon monoxide analyzer. After 5 months, the participants in the intervention group were no more likely to quit smoking than the control group. A subgroup analysis by age showed that the intervention among 166 younger smokers (aged 49 or less) was significantly more likely to be effective {risk ratio = 5.76 [95% confidence interval (CI) 1.34-24.74]} than it was among 235 older smokers (aged 50 or more) [risk ratio = 1.03 (95% CI 0.53-1.99)]. This study suggests a smoking cessation intervention using the AHCPR guideline tailored for Koreans, is effective for assisting outpatients aged 49 or younger to quit smoking.     

Increasing smoking cessation care in a preoperative clinic: a randomized controlled trial

BACKGROUND: Evidence suggests that preoperative clinics, like other hospital outpatient clinics and inpatient wards, fail to systematically provide smoking cessation care to patients having planned surgery. METHODS: The aim of the study was to assess the efficacy, acceptability, and cost of a multifaceted intervention to facilitate the provision of comprehensive smoking cessation care to patients attending a preoperative clinic. Two hundred ten smoking patients attending a preoperative clinic at a major teaching hospital in Australia took part in the study. One hundred twenty-four patients were randomly assigned to an experimental group and 86 patients to a usual cessation care group. A multifaceted intervention was developed that included the use of opinion leaders, consensus processes, computer-delivered cessation care, computer-generated prompts for care provision by clinic staff, staff training, and performance feedback. RESULTS: Ninety-six percent of experimental group patients received behavioral counseling and tailored self-help material. Experimental group patients were significantly more likely than usual care patients to report receiving brief advice by nursing (79% vs. 47%; P < 0.01) and anaesthetic (60% vs. 39%; P < 0.01) staff. Experimental group patients who were nicotine dependent were also more likely to be offered preoperative nicotine replacement therapy (NRT) (82% vs. 8%; P < 0.01) and be prescribed postoperative NRT (86% vs. 0%; P < 0.01). The multifaceted intervention was found to be acceptable by staff. CONCLUSION: A multifaceted clinical practice change intervention may be effective in improving the delivery of smoking cessation care to preoperative surgical patients.     

A multicentre randomized trial of combined individual and telephone counselling for smoking cessation

Objective

The present study assessed the effectiveness of smoking cessation programs combining individual and telephone counselling, compared to individual or telephone counselling alone.

Method

A randomized, multicentre, open-label trial was performed between January 2009 and July 2011 at six smoking cessation clinics in Spain. Of 772 smokers assessed for eligibility, 600 (77%) met inclusion criteria and were randomized. Smokers were randomized to receive individual counselling, combined telephone and individual counselling, or telephone counselling. The primary outcome was biochemically validated continuous abstinence at 52 weeks.

Results

The 52-week abstinence rate was significantly lower in the telephone group compared to the combined group (20.1% vs. 29.0%; OR, 1.32; 95% CI, 1.1–2.7) and to the individual counselling group (20.1% vs. 27.9%; OR, 1.37; 95% CI, 1.0–2.8). The 52-week abstinence rates were not significantly higher in the combined group than the individual group (OR, 0.97; 95% CI, 0.7–1.4).

Conclusion

Individual counselling and combined individual and telephone counselling were associated with higher 52-week abstinence rates than telephone counselling alone. A combined approach may be highly useful in the clinical treatment of smokers, as it involves less clinic visits than individual counselling alone, thus reducing the program cost, and it increases patient compliance compared to telephone counselling alone.     

A school nurse-delivered adolescent smoking cessation intervention: a randomized controlled trial

BACKGROUND: The aim of the present study was to evaluate the efficacy of a school nurse-delivered smoking cessation intervention to improve abstinence rates among adolescents interested in quitting. METHODS: Seventy-one high schools in Massachusetts were randomized to either a four-session one-on-one school nurse-delivered smoking cessation intervention (37 schools, n = 571) or usual smoking cessation care control condition (34 schools, n = 577). Adolescents in grades 9-12 who smoked in the past 30 days completed surveys at baseline, 6 weeks and 3 months. The study was conducted during the 2002-2003 school year. RESULTS: Thirty-day self-reported abstinence rates were significantly greater in students in the intervention compared to control condition at 6 weeks (18% vs. 2%, respectively) and 3 months (24% vs. 5%, respectively). After adjusting for school and potential confounders, students in the intervention schools had odds of quitting 8 times greater than students in the control schools at 6 weeks (OR = 8.4; 95% CI 3.7, 20.6) and 6 times greater at 3 months (OR = 6.4; 95% CI 3.4, 11.4). School nurses delivered intervention with a high degree of fidelity. CONCLUSIONS: A four-session smoking cessation intervention can feasibly be delivered by school nurses and increase self-reported short-term abstinence rates among students interested in quitting smoking.     

Effectiveness of a web-based self-help smoking cessation intervention: protocol of a randomised controlled trial

Background  

Cigarette smoking is a major risk factor for many chronic and fatal illnesses. Stopping smoking directly reduces those risks. The aim of this study is to investigate the effectiveness of a web-based interactive self-help programme for smoking cessation, known as the StopSite, by comparing it to an online self-help guide. Both interventions were based on cognitive-behavioural and self-control principles, but the former provided exercises, feedback and interactive features such as one-to-one chatrooms and a user forum, which facilitated mutual support and experience sharing.     

The effectiveness of smoking cessation methods for smokers in public health maternity clinics: a randomized trial.

Little insight is available in the literature on how best to assist the pregnant smoker in public health maternity clinics to quit during pregnancy. A randomized pretest/posttest experiment was used to evaluate the effectiveness of two different self-help cessation methods. Three hundred and nine pregnant women from three public health maternity clinics were assigned randomly to one of three groups with one-third assigned to each: a control group; a group receiving the American Lung Association's Freedom From Smoking Manual; and those receiving A Pregnant Woman's Self-Help Guide to Quit Smoking. Using a saliva thiocyanate (SCN) and behavioral report at mid-pregnancy and end of pregnancy to confirm cessation or reduction, 2 per cent in the control group quit and 7 per cent reduced their SCN levels substantially. Of the women assigned to the ALA method, 6 per cent quit and 14 per cent reduced their SCN levels substantially. Of the women who used the Guide, 14 per cent quit and 17 per cent reduced their SCN levels substantially. Results of this trial indicate that health education methods tailored to the pregnant smoker are more effective in changing smoking behavior than the standard clinic information and advice to quit and/or the use of smoking cessation methods not tailored to the needs of the pregnant smoker.     

Effect of a smoking cessation intervention for women in subsidized neighborhoods: A randomized controlled trial

ObjectiveTo evaluate the effectiveness of a community based participatory research (CBPR) developed, multi-level smoking cessation intervention among women in subsidized housing neighborhoods in the Southeastern US.MethodsA total of n = 409 women in 14 subsidized housing neighborhoods in Georgia and South Carolina participated in this group randomized controlled trial conducted from 2009 to 2013. Intervention neighborhoods received a 24-week intervention with 1:1 community health worker contact, behavioral peer group sessions, and nicotine replacement. Control neighborhoods received written cessation materials at weeks 1, 6, 12, 18. Random coefficient models were used to compare smoking abstinence outcomes at 6 and 12 months. Significance was set a p < 0.05.ResultsThe majority of participants (91.2%) were retained during the 12-month intervention period. Smoking abstinence rates at 12 months for intervention vs. control were 9% vs. 4.3%, p = 0.05. Additional analyses accounting for passive smoke exposure in these multi-unit housing settings demonstrated 12 month abstinence rates of 12% vs. 5.3%, p = 0.016. However, in the multivariate regression analyses, there was no significant effect of the intervention on the odds of being a non-smoker (OR = 0.44, 95% CI: 0.18–1.07). Intervention participants who kept coach visits, attended group sessions, and used patches were more likely to remain abstinent.ConclusionsThis CBPR developed intervention showed potential to engage smokers and reduce smoking among women in these high-poverty neighborhoods. Effectiveness in promoting cessation in communities burdened with fiscal, environmental and social inequities remains a public health priority.     

The Pap smear screening as an occasion for smoking cessation and physical activity counselling: effectiveness of the SPRINT randomized controlled trial

ABSTRACT: BACKGROUND: The organized Cervical Cancer Screening Programme (CCSP) in Italy might represent an occasion to deliver smoking cessation (SC) counselling to women attending the Pap test examination. Evidence of effectiveness of physical activity (PA) promotion and intervention in adjunct to SC counselling is not strong.Objective of the SPRINT trial was to evaluate the effectiveness of a standard SC counselling intervention delivered by trained midwives in the CCSP, and whether the adjunct of a PA counselling to the SC counselling might increase quit rates. METHODS: We undertook a randomized controlled trial of 1,100 women undergoing the Pap examination in the three study centres (Florence, Turin, Mantua): 363 were randomly assigned to the SC counselling arm, 366 to the SC + PA counselling arm, and 371 to the control group. The intervention was a standard brief SC counselling combined with a brief counselling on increasing PA, and was tailored according to the Di Clemente-Prochaska motivational stages of change for SC and/or PA. Primary outcomes were quit rates, improvement in the motivational stages of change for SC, and reduced daily cigarette consumption. Analysis was by intention to treat; RESULTS: Participants randomized in both intervention arms and in the preparation stage of change for SC doubled their likelihood of quitting at 6-month follow-up in comparison to controls (odds ratio [OR]=2.1, 95% confidence interval [95%CI]:1.0-4.6). Moreover, participants in the intervention arms and in the contemplation stage were more likely to reduce their daily cigarette consumption after the intervention (OR=1.8, 95%CI:1.1-3.0). Our study did not show any effect of PA counselling on various outcomes; CONCLUSIONS: Smoking cessation counselling delivered by midwives to smokers in preparation and contemplation stages of change during the Pap-smear screening was effective and should be recommended, given the high number of women attending the cervical cancer screening programme in Italy. Moreover, the daily number of women invited for the Pap-smear examination should be slightly lowered, in order to let midwives deliver SC counselling to smokers.Trial registrationCurrent Controlled Trials ISRCTN52660565.     

Effectiveness of a minimal contact smoking cessation program for Dutch general practitioners: a randomized controlled trial

BACKGROUND. Until recently, Dutch general practitioners contributed little to tobacco control. This is due to several factors, among which is the lack of a feasible intervention program for adult smokers. Such a minimal contact behavioral intervention, using the Stage-of-Change concept, is now available. Effectiveness was tested in a randomized trial. METHOD. Twenty-two general practitioners and their practice assistants were trained in applying the program. In all, 530 smoking patients were enrolled, randomly assigned to either the intervention or the usual treatment condition. Analysis of treatment effects was performed with logistic regression analysis. In a backward stepwise procedure confounding effects of baseline differences were eliminated. RESULTS. At 12-month follow-up, self-reported abstinence rates (including nonrespondents as smokers) differed significantly between intervention subjects and controls: 13.4 vs 7.3% point prevalence (odds ratio 1.51, P < 0.05). An analysis of consecutive abstinence, defined as being abstinent at both 6- and 12-month follow-up, showed that 8.2% of the intervention group compared to 3.1% of the controls had sustained abstinence for more than 6 months (odds ratio 3.04, P < 0.001). CONCLUSIONS. Results indicate that an effective smoking cessation program for use in Dutch general practice, already shown to be feasible, is now available. Outcomes are generally consistent with recent international literature.     

Predictors of smoking cessation among African-Americans enrolled in a randomized controlled trial of bupropion

OBJECTIVES: Identification of individual characteristics that predict successful smoking cessation treatment has been limited to studies with mostly white participants. This study identifies factors that predict successful quitting among African-Americans participating in a smoking cessation trial. METHODS: Twenty-one baseline variables were analyzed as potential predictors from a double-blind placebo-controlled, randomized trial that used bupropion SR for smoking cessation among 600 African-American smokers. Chi-square tests, two sample t tests, and multiple logistic regression procedures were employed to identify predictors of 7-day abstinence among the 535 participants who completed the 7-week medication phase. RESULTS: Univariate predictors of cessation were receiving bupropion (P < 0.0001), not smoking menthol cigarettes (P = 0.0062), smoking after 30 min of waking (P < 0.0001), older age (P = 0.0085), smoking fewer cigarettes per day (P = 0.0038), and lower cotinine levels (P = 0.0002). Logistic regression identified three significant independent predictors. Participants who received bupropion treatment were more than twice as likely to quit smoking at the end of treatment compared to participants who received placebo (OR = 2.62; 95% CI = 1.77-3.88, P < 0.0001), while smoking within 30 min of waking (OR = 0.40; 95% CI = 0.25-0.62, P < 0.0001) and higher salivary cotinine levels at baseline (OR = 0.799; 95% CI = 0.629-0.922, P < 0.0001) reduced the likelihood of quitting. CONCLUSIONS: This is the first report identifying predictors of smoking cessation among African-Americans participating in a clinical trial. Results indicate that, aside from bupropion treatment, various indicators of addiction were the strongest predictors. While this is similar to findings among white smokers, thresholds of addiction may need to be adjusted for African-American smoking patterns. Additional studies focused on diverse populations are needed to improve treatment approaches and to identify population-specific factors that are important for treatment-matching approaches.     

Efficacy of a text messaging (SMS) based smoking cessation intervention for adolescents and young adults: Study protocol of a cluster randomised controlled trial

Background  

Particularly in groups of adolescents with lower educational level the smoking prevalence is still high and constitutes a serious public health problem. There is limited evidence of effective smoking cessation interventions in this group. Individualised text messaging (SMS) based interventions are promising to support smoking cessation and could be provided to adolescents irrespective of their motivation to quit. The aim of the current paper is to outline the study protocol of a trial testing the efficacy of an SMS based intervention for smoking cessation in apprentices.     

Reach and uptake of Internet- and phone-based smoking cessation interventions: Results from a randomized controlled trial

ObjectiveTo study whether demographic and smoking-related characteristics are associated with participation (reach) in a smoking cessation trial and subsequent use (uptake) of two specific smoking interventions (Internet-based program and proactive telephone counseling).MethodsWe used data from a four-arm randomized smoking cessation trial (2011). Participants (n = 1,809) were recruited among 9,924 smokers who previously participated in two health surveys in Denmark (2007–2008 and 2010). Interventions were as follows: (1) an Internet-based smoking cessation program, (2) proactive telephone counseling, (3) reactive telephone counseling and (4) a self-help booklet.ResultsReach (defined as the proportion accepting to participate in the trial of those invited) was highest among persons aged 40–59 years, women, heavy smokers and persons with long education. Among trial participants, uptake (defined as any use of the specific intervention at 1-month follow-up) was 69% for the Internet-based program, 74% and 9% for proactive and reactive telephone counseling, respectively, and 84% for the self-help booklet. Young age was associated with the uptake of the Internet-based program, and short education was associated with using proactive telephone counseling.ConclusionsInternet-based interventions and proactive telephone counseling appeal to different age and educational groups. Further, offering similar intervention content by a proactive and a reactive approach can be associated with different intervention uptake.     

Dissemination of an efficacious antenatal smoking cessation program in public hospitals in Australia: a randomized controlled trial.

This study investigated the impact of a behaviorally based intervention designed to increase the number of hospitals that routinely provide effective smoking cessation programs for pregnant women. In Queensland, Australia, 70 publicly funded hospitals were matched on numbers of births and maternal socioeconomic status and randomly allocated to an awareness-only intervention group or a behaviorally based intervention group. Success was defined as the routine offer of an evidence-based smoking cessation program to at least 80% of the pregnant clients who smoke. At 1 month, 65% of the behaviorally based intervention hospitals agreed to provide materials about smoking cessation programs for their antenatal patients, compared with 3% of the awareness-only hospitals. After 1 year, 43% of the intervention hospitals still provided the material, compared with 9% of the awareness-only hospitals. These findings show that a brief intervention to hospitals can encourage antenatal staff to provide smoking cessation materials to pregnant women.     

A randomized controlled trial of multiple tailored messages for smoking cessation among callers to the cancer information service

Self-help materials computer-tailored to the specific needs of smokers have shown promise as a high-reach, low-cost intervention for smoking cessation. Adding tailored cessation materials to telephone-based cessation counseling may be a way of generating greater efficacy in promoting and maintaining cessation. The objective of this study is to assess the efficacy of adding different types of behavioral smoking cessation materials to brief telephone-based cessation counseling.A total of 1,978 smokers calling the National Cancer Institute's (NCI's) Cancer Information Service (CIS) for help in quitting smoking initially received brief cognitive-behavioral cessation counseling from a CIS information specialist. Following a baseline interview administered by the information specialist, subjects were randomly assigned to one of four conditions, each delivered by U.S. mail: a single, untailored smoking cessation guide (SU); a single, tailored smoking cessation guide (ST); a series of four (multiple) printed materials tailored only to baseline data (MT); and a series of four (multiple) printed materials tailored to baseline as well as retailored using 5-month interim progress data (MRT). The primary outcome measure was 7-day point prevalence abstinence rates assessed using a computer-assisted telephone interview (CATI) at 12-month follow-up.At 12-month follow-up, using intent-to-treat, imputed, and per-protocol analyses, no differences were found among the four experimental conditions (linear trend), or when the ST, MT, and MRT groups were compared with the control (SU) group. Participants in the two multiple message group conditions combined (MT + MRT), however, had significantly higher abstinence rates than participants in the two single message group conditions combined (SU + ST). Moreover, among subjects who reported quitting at the 5-month follow-up, participants receiving the MRT materials reported higher abstinence rates at 12 months than the other three groups combined (SU + ST + MT). The results of this study support the effectiveness, over and above a single telecounseling interaction, of multiple tailored print material contacts on cessation. These effects, however may be due to tailoring, or the longitudinal nature of the two multiple tailored conditions, or both. The strongest evidence for tailoring occurred in the MRT condition for relapse prevention, suggesting that print materials tailored to interim progress may be especially effective in this context. The qualities of specific psychosocial and communication elements in tailored materials should receive attention in future research.     

Predictors of smoking reduction and cessation in a cohort of danish moderate and heavy smokers

BACKGROUND: The aim of this study was to examine the extent and gender distribution of unassisted tobacco reduction and cessation in a cohort of moderate and heavy smokers and to identify possible predictor variables associated with these changes in smoking behavior. METHODS: This was a prospective population study of 3,791 moderate and heavy smokers, 15 g tobacco/day or more, who were enrolled in the Copenhagen City Heart Study in 1976-1978 and attended a reexamination 5 years later. Data on smoking behavior were collected at baseline and follow-up. Smoking reduction was defined as a decrease in mean daily tobacco consumption of 10 g or more. Using multivariate logistic regression, subjects who reported reduced smoking or who reported smoking cessation were compared with subjects who continued the habit unchanged. RESULTS: After 5 years 13% of the men and 9% of the women had reduced their tobacco consumption, and 9 and 7%, respectively, had quit altogether. Smoking reduction was strongly associated with high tobacco consumption (25+ g/day) at baseline and also with severely impaired lung function (FEV(1) <50% predicted) and overweight (BMI >25). Predictors of smoking cessation included impaired lung function and a tobacco consumption of 15-24 g/day. Additional determinants of smoking reduction and cessation such as inhalation habits and sociodemographic variables differed by gender. CONCLUSIONS: Several predictors of smoking reduction and cessation were identified, indicating that these subgroups of smokers differ substantially from continuing smokers. This should be taken into account when assessing potential health benefits from these changes in smoking behavior.     

Motivational Interviewing for encouraging quit attempts among unmotivated smokers: Study protocol of a randomized, controlled, efficacy trial

ABSTRACT: BACKGROUND: Although current clinical practice guidelines recommend Motivational Interviewing for use with smokers not ready to quit, the strength of evidence for its use is rated as not optimal. The purpose of the present study is to address key methodological limitations of previous studies by ensuring fidelity in the delivery of the Motivational Interviewing intervention, using an attention-matched control condition, and focusing on unmotivated smokers whom meta-analyses have indicated may benefit most from Motivational Interviewing. It is hypothesized that MI will be more effective at inducing quit attempts and smoking cessation at 6-month follow-up than brief advice to quit and an intensity-matched health education condition. METHODS: A sample of adult community resident smokers (N= 255) who report low motivation and readiness to quit are being randomized using a 2:2:1 treatment allocation to Motivational Interviewing, Health Education, or Brief Advice. Over 6 months, participants in Motivational Interviewing and Health Education receive 4 individual counseling sessions and participants in Brief Advice receive one brief in-person individual session at baseline. Rigorous monitoring and independent verification of fidelity will assure the counseling approaches are distinct and delivered as planned. Participants complete surveys at baseline, week 12 and 6-month follow-up to assess demographics, smoking characteristics, and smoking outcomes. Participants who decide to quit are provided with a self-help guide to quitting, help with a quit plan, and free pharmacotherapy. The primary outcome is self-report of one or more quit attempts lasting at least 24 hours between randomization and 6-month follow-up. The secondary outcome is biochemically confirmed 7-day point prevalence cessation at 6-month follow-up. Hypothesized mediators of the presumed treatment effect on quit attempts are greater perceived autonomy support and autonomous motivation. Use of pharmacotherapy is a hypothesized mediator of Motivational Interviewing's effect on cessation. DISCUSSION: This trial will provide the most rigorous evaluation to date of Motivational Interviewing's efficacy for encouraging unmotivated smokers to make a quit attempt. It will provide also provide effect-size estimates of MI's impact on smoking cessation to inform future clinical trials and inform the clinical practice guidelines. Trial registration ClinicalTrials.gov NCT01188018.