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Background: The objective of the present study was to examine the short-term effectiveness of the national German quitline for smoking cessation. Methods: A parallel-group, two-arm, superiority, randomized controlled trial with data collection at baseline and post-intervention (three months from baseline) was conducted. Individuals were randomized to either the intervention group, receiving up to six telephone counselling calls, or the control group, receiving an active control intervention (self-help brochure). The primary outcome was the seven-day point prevalence abstinence at post-assessment. Secondary outcomes included changes in smoking-related cognitions and coping strategies from pre- to post-assessment, the perceived effectiveness of intervention components, and the satisfaction with the intervention. Results: A total of n = 905 adult daily smokers were assigned to either the intervention group (n = 477) or the control group (n = 428). Intention-to-treat analyses demonstrated that individuals allocated to the telephone counselling condition were more likely to achieve seven-day point prevalence abstinence at post-assessment compared to those allocated to the self-help brochure condition (41.1% vs. 23.1%; OR = 2.3, 95% CI [1.7, 3.1]). Participants who received the allocated intervention in both study groups displayed significant improvements in smoking-related cognitions and coping strategies with the intervention group showing greater enhancements than the control group. This pattern was also found regarding the perceived effectiveness of intervention components and the satisfaction with the intervention. Conclusion: The present study provides first empirical evidence on the short-term effectiveness of the national German quitline for smoking cessation, highlighting its potential as an effective public health intervention to reduce the burden of disease associated with smoking. Trial registration: This study is registered in the German Clinical Trials Register (DRKS00025343). Date of registration: 2021/06/07. [ABSTRACT FROM AUTHOR]

Background and aims: Tobacco use has posed a tremendous public health problem for China. The Chinese government has taken great efforts to curb the tobacco epidemic. However, the existing smoking cessation services available in China are underused and have some limitations. Our research team intends to develop a smartphone smoking cessation application (SSC APP) and integrate it with the existing smoking cessation services. This study aims to assess the efficacy of the SSC APP developed by our research team through a randomized controlled trial (RCT). Methods: Current smokers who are motivated to quit within 1 month (n = 1000) will be recruited both online and offline, and all potential participants will register and complete the prescreening assessment online. Participants will be randomly assigned to either the intervention group (receiving the SSC APP and a self-help smoking cessation manual) or the control group (receiving a self-help smoking cessation manual only) using a block randomization method. This study will be a two-arm, single-blind, parallel-group RCT. Participants will be followed up after enrollment through online questionnaires or by phone call. The primary outcome is self-reported 6-month continuous abstinence. The main secondary outcomes include self-reported 7-day point-prevalence abstinence at each follow-up; self-reported 3-month continuous abstinence; reduction in the number of cigarettes smoked per day; and the number of recent quit attempts. Discussion: If this SSC APP proves to be effective, it could be integrated with the existing smoking cessation services and further facilitate smoking cessation at the population level in China. Trial registration: Chinese Clinical Trial Registry: ChiCTR2200062097, Registered July 22, 2022. [ABSTRACT FROM AUTHOR]

Background and aims: Developing accessible, affordable, and effective approaches to smoking cessation is crucial for tobacco control. Mobile health (mHealth) based interventions have the potential to aid smokers in quitting, and integrating treatments from multiple sources may further enhance their accessibility and effectiveness. As part of our efforts in smoking cessation, we developed a novel behavioral intervention delivery modality for smoking cessation that integrated three interventions using the WeChat app, called the "Way to Quit" modality (WQ modality). It is presented here the protocol for a randomized controlled trial evaluating the effectiveness, feasibility, and cost-effectiveness of the WQ modality in Chinese smokers. Methods: Eligible participants (n = 460) will be recruited via online advertisement in Beijing, China. They will be randomly assigned to receive either quitline-based treatment (QT, n = 230) or WQ modality-based treatment (WQ, n = 230) using a block randomization method. Participants in the QT group will receive telephone-assisted treatment over a four-week period (multi-call quitline protocol), while those in the WQ group will receive integrated interventions based on the WQ modality for four weeks. A four-week supply of nicotine replacement therapy (gums) will be provided to all participants. Participants will be asked to complete phone or online follow-up at 1, 3, 6, and 12-months. At 1-month follow-up, individuals with self-reported smoking abstinence for more than 7 days will be invited to receive an exhaled carbon monoxide (CO) test for biochemical validation. The primary aim is to determine whether the WQ modality is effective in assisting smokers in quitting smoking. The secondary aims are to evaluate the acceptability, satisfaction, and cost-effectiveness of the WQ modality. Discussion: If the WQ modality is determined to be effective, acceptable, and affordable, it will be relatively easy to reach and provide professional cessation treatments to the communities, thus helping to reduce the disparities in smoking cessation services between different regions and socioeconomic groups. Trial registration: Chinese Clinical Trial Registry: ChiCTR2200066427, Registered December 5, 2022. [ABSTRACT FROM AUTHOR]

Background: Addressing children's tobacco smoke exposure (TSE) remains a public health priority. However, there is low uptake and ineffectiveness of treatment, particularly in low-income populations that face numerous challenges to smoking behavior change. A multilevel intervention combining system-level health messaging and advice about TSE delivered at community clinics that disseminate the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), combined with nicotine replacement and intensive multimodal, individual-level behavioral intervention may improve TSE control efforts in such high-risk populations.Methods/design: This trial uses a randomized two-group design with three measurement points: baseline, 3-month and 12-month follow-up. The primary outcome is bioverified child TSE; the secondary outcome is bioverified maternal quit status. Smoking mothers of children less than 6 years old are recruited from WIC clinics. All participants receive WIC system-level intervention based on the "Ask, Advise, Refer (AAR)" best practices guidelines for pediatrics clinics. It includes training all WIC staff about the importance of maternal tobacco control; and detailing clinics with AAR intervention prompts in routine work flow to remind WIC nutrition counselors to ask all mothers about child TSE, advise about TSE harms and benefits of protection, and refer smokers to cessation services. After receiving the system intervention, mothers are randomized to receive 3 months of additional treatment or an attention control intervention: (1) The multimodal behavioral intervention (MBI) treatment includes telephone counseling sessions about child TSE reduction and smoking cessation, provision of nicotine replacement therapy, a mobile app to support cessation efforts, and multimedia text messages about TSE and smoking cessation; (2) The attention control intervention offers equivalent contact as the MBI and includes nutrition-focused telephone counseling, mobile app, and multimedia text messages about improving nutrition. The control condition also receives a referral to the state smoking cessation quitline.Discussion: This study tests an innovative community-based, multilevel and integrated multimodal approach to reducing child TSE in a vulnerable, low-income population. The approach is sustainable and has potential for wide reach because WIC can integrate the tobacco intervention prompts into routine workflow and refer smokers to free evidence-based behavioral counseling interventions, such as state quitlines.Trial Registration: Clinicaltrials.gov NCT02602288 . Registered 9 November 2015. [ABSTRACT FROM AUTHOR]

Background: Cigarette smoking is one of the major preventable causes of death and diseases in Qatar. The study objective was to test the effect of a structured smoking cessation program delivered by trained pharmacists on smoking cessation rates in Qatar.Methods: A prospective randomized controlled trial was conducted in eight ambulatory pharmacies in Qatar. Eligible participants were smokers 18 years and older who smoked one or more cigarettes daily for 7 days, were motivated to quit, able to communicate in Arabic or English, and attend the program sessions. Intervention group participants met with the pharmacists four times at 2 to 4 week intervals. Participants in the control group received unstructured brief smoking cessation counseling. The primary study outcome was self-reported continuous abstinence at 12 months. Analysis was made utilizing data from only those who responded and also using intent-to-treat principle. A multinomial logistic regression model was fitted to assess the predictors of smoking at 12 months. Analysis was conducted using IBM-SPSS® version 23 and STATA® version 12.Results: A total of 314 smokers were randomized into two groups: intervention (n = 167) and control (n = 147). Smoking cessation rates were higher in the intervention group at 12 months; however this difference was not statistically significant (23.9% vs. 16.9% p = 0.257). Similar results were observed but with smaller differences in the intent to treat analysis (12.6% vs. 9.5%, p = 0.391). Nevertheless, the daily number of cigarettes smoked for those who relapsed was significantly lower (by 4.7 and 5.6 cigarettes at 3 and 6 months respectively) in the intervention group as compared to the control group (p = 0.041 and p = 0.018 respectively). At 12 months, the difference was 3.2 cigarettes in favor of the intervention group but was not statistically significant (p = 0.246). Years of smoking and daily number of cigarettes were the only predictors of smoking as opposed to quitting at 12 months (p = 0.005; p = 0.027 respectively).Conclusions: There was no statistically significant difference in the smoking cessation rate at 12 months between the groups. However, the smoking cessation program led to higher (albeit non-significant) smoking cessation rates compared with usual care. More research should be conducted to identify factors that might improve abstinence.Trial Registration: Clinical Trials NCT02123329 . Registration date 20 April 2014. [ABSTRACT FROM AUTHOR]

Background: Most smokers do not use smoking cessation (SC) services although it increases successful quits. Passive referral providing SC information to smokers is commonly used in SC studies. Little was known about active referral in the community setting. This study aims to motivate community smokers to quit by brief SC advice using a validated AWARD model (Ask, Warn, Advise, Refer and Do-it-again) that adjunct with active referral of smokers to various SC services in Hong Kong.Methods/design: This is a single-blinded, parallel three-armed cluster randomized controlled trial (RCT) with two treatment groups of (1) brief SC advice using the AWARD model, active referral to SC services plus a referral card and a health warning leaflet (active referral group) and (2) brief SC advice using AWARD model and health warning leaflet (brief advice group) and a control group receives general very brief advice with a self-help booklet. A total of 1291 smokers will be recruited from 66 clusters (recruitment sessions) with 22 will be allocated to each of the two intervention and one control groups. SC ambassadors will be trained for delivering the interventions and conducting telephone follow-up. The primary outcomes are self-reported 7-days point prevalence (PP) abstinence at 3 and 6 months follow-up. Intention-to-treat principle and multi-level regressions will be used for data analysis.Discussion: This is the first RCT on assessing a model combining brief advice and active referral to SC services among community smokers. The results will inform the practices of SC services and intervention studies.Trial Registration: NCT02539875 (ClinicalTrials.gov registry; registered retrospectively on 22 July 2015). [ABSTRACT FROM AUTHOR]

Background: Smoking is Australia's leading preventable cause of premature mortality and a major contributor to the national disease burden. If quit rates do not dramatically improve, then smoking will continue to be a major public health issue for decades to come. Harm-reduction approaches using novel nicotine products like e-cigarettes as long term replacements for smoking have the potential to improve quit rates. However, little research has assessed such approaches.Methods/design: Design: Three-arm parallel-group pragmatic randomised controlled trial.Participants: People living in Australia who are at least 18 years old, smoke five or more cigarettes per day and are willing to try a sample of nicotine products.Intervention: Participants are randomised to receive standard quit advice and medicinal nicotine (Condition A); quit or substitute advice and medicinal nicotine (Condition B); or quit or substitute advice and medicinal nicotine and e-cigarettes (Condition C). Participants choose which (if any) nicotine products to receive to try in a free sample pack followed by a two to three week free supply of their favourite product(s) and the option to purchase more at a discounted price. Follow-up surveys will assess nicotine product use and smoking.Primary Outcome: Continuous abstinence for at least 6 months. Target sample size: 1600 people (Condition A: 340; Condition B: 630; Condition C: 630) provides at least 80 % power at p = 0.05 to detect a 5 % difference in abstinence rates between each condition.Discussion: This trial will provide data on tobacco harm-reduction approaches and in particular the use of e-cigarettes as a replacement for smoking.Trial Registration: Australian and New Zealand Clinical Trials Registry: ACTRN12612001210864. Date of registration: 15/11/2012. [ABSTRACT FROM AUTHOR]

Background: Smoking cessation interventions for hospitalized smokers are effective in promoting smoking cessation, but only if the tobacco dependence treatment continues after the patient leaves the hospital. Sustaining tobacco dependence treatment after hospital discharge is a challenge for health care systems. Our previous single-site randomized controlled trial demonstrated the effectiveness of an intervention that facilitated the delivery of comprehensive tobacco cessation treatment, including both medication and counseling, after hospital discharge. We subsequently streamlined the intervention model to increase its potential for dissemination. This new model is being tested in a larger multi-site trial with broader eligibility criteria in order to enroll a more representative sample of hospitalized smokers. This paper describes the trial design and contrasts it with the earlier study. Methods/Design: A 2-arm, 3-site randomized controlled trial is testing the hypothesis that a multi-component Sustained Care intervention is more effective than Standard Care in helping hospitalized cigarette smokers stop smoking after hospital discharge. The trial enrolls adult daily cigarette smokers who are admitted to 1 of 3 participating hospitals in Massachusetts or Pennsylvania. Participants receive the same smoking cessation intervention in the hospital. They are randomly assigned to receive either Standard Care or Sustained Care after hospital discharge. Participants in the Sustained Care arm receive a free 3-month supply of FDA-approved smoking cessation medication and 5 interactive voice response calls that provide tailored motivational messages, medication refills, and access to a live tobacco treatment counselor. Participants in the Standard Care arm receive a smoking cessation medication recommendation and information about community resources. Outcomes are assessed at 1, 3, and 6 months after discharge. The primary outcome is biochemically-validated tobacco abstinence for the past 7 days at 6-month follow-up. Other outcome measures include self-reported tobacco abstinence measures, use of medication and counseling after discharge, hospital readmissions, and program cost-effectiveness. Discussion: We adapted a proven intervention for hospitalized smokers to enhance its potential for dissemination and are testing it in a multi-site trial. Study enrollment data suggests that the trial achieved the goal of recruiting a broader sample of hospitalized smokers. [ABSTRACT FROM AUTHOR]

Background The likelihood of an adolescent taking up smoking may be influenced by his or her society, school and family. Thus, changes in the immediate environment may alter a young person's perception of smoking. Methods/design The proposed multi-center, cluster-randomized controlled trial will be stratified by the baseline prevalence of smoking in schools. Municipalities with fewer than 100,000 inhabitants will be randomly assigned to a control or intervention group. One secondary school will be randomly selected from each municipality. These schools will be randomized to two groups: the students of one will receive any existing educational course regarding smoking, while those of the other school will receive a four-year, class-based curriculum intervention (22 classroom lessons) aimed at reinforcing a smoke-free school policy and encouraging smoking cessation in parents, pupils, and teachers. The intervention will also include annual meetings with parents and efforts to empower adolescents to change the smoking-related attitudes and behaviors in their homes, classrooms and communities. We will enroll children aged 12-13 years as they enter secondary school during two consecutive school years (to obtain sufficient enrolled subjects). We will follow them for five years, until two years after they leave secondary school. All external evaluators and analysts will be blinded to school allocation. The aim of this study is to analyze the effectiveness of a complex intervention in reducing the prevalence of smoking in the third year of compulsory secondary education (ESO) and two years after secondary school, when the participants are 14-15 and 17-18 years old, respectively. Discussion Most interventions aimed at preventing smoking among adolescents yield little to no positive long-term effects. This clinical trial will analyze the effectiveness of a complex intervention aimed at reducing the incidence and prevalence of smoking in this vulnerable age group. [ABSTRACT FROM AUTHOR]

Background: Secondhand smoke exposure (SHSe) harms children's health, yet effective interventions to reduce child SHSe in the home and car have proven difficult to operationalize in pediatric practice. A multilevel intervention combining pediatric healthcare providers' advice with behavioral counseling and navigation to pharmacological cessation aids may improve SHSe control in pediatric populations. Methods/design: This trial uses a randomized, two-group design with three measurement periods: pre-intervention, end of treatment and 12-month follow-up. Smoking parents of children < 11-years-old are recruited from pediatric clinics. The clinic-level intervention includes integrating tobacco intervention guideline prompts into electronic health record screens. The prompts guide providers to ask all parents about child SHSe, advise about SHSe harms, and refer smokers to cessation resources. After receiving clinic intervention, eligible parents are randomized to receive: (a) a 3-month telephone-based behavioral counseling intervention designed to promote reduction in child SHSe, parent smoking cessation, and navigation to access nicotine replacement therapy or cessation medication or (b) an attention control nutrition education intervention. Healthcare providers and assessors are blind to group assignment. Cotinine is used to bioverify child SHSe (primary outcome) and parent quit status. Discussion: This study tests an innovative multilevel approach to reducing child SHSe. The approach is sustainable, because clinics can easily integrate the tobacco intervention prompts related to "ask, advise, and refer" guidelines into electronic health records and refer smokers to free evidence-based behavioral counseling interventions, such as state quitlines. [ABSTRACT FROM AUTHOR]

Background: Tobacco consumption is the most preventable cause of morbidity-mortality in the world. One aspect of smoking cessation that merits in-depth study is the use of an application designed for smartphones (app), as a supportive element that could assist younger smokers in their efforts to quit. To assess the efficacy of an intervention that includes the assistance of a smoking cessation smartphone application targeted to young people aged 18 to 30 years who are motivated to stop smoking. Methods/design: Cluster randomised clinical trial. Setting: Primary Health Care centres (PHCCs) in Catalonia. Analyses based on intention to treat. Participants: motivated smokers of 10 or more cigarettes per day, aged 18 to 30 years, consulting PHCCs for any reason and who provide written informed consent to participate in the trial. Intervention group will receive a 6-month smoking cessation programme that implements recommendations of a Clinical Practice Guideline, complemented with a smartphone app designed specifically for this programme. Control group will receive the usual care. The outcome measure will be abstinence at 12 months confirmed by exhaled-air carbon monoxide concentration of at least 10 parts per million at each control test. Discussion: To our knowledge this is the first randomised controlled trial of a programme comparing the efficacy of usual care with a smoking cessation intervention involving a mobile app. If effective, the modality could offer a universal public health management approach to this common health concern. [ABSTRACT FROM AUTHOR]

Background: Tobacco smoking remains one of the biggest public health threats. Smartphone apps offer new promising opportunities for supporting smoking cessation in real-time. The social context of smokers has, however, been neglected in smartphone apps promoting smoking cessation. This randomized controlled trial investigates the effectiveness of a smartphone app in which smokers quit smoking with the help of a social network member.Methods: This protocol describes the design of a single-blind, two-arm, parallel-group, intensive longitudinal randomized controlled trial. Participants of this study are adult smokers who smoke at least one cigarette per day and intend to quit smoking at a self-set quit date. Blocking as means of group-balanced randomization is used to allocate participants to intervention or control conditions. Both intervention and control group use a smartphone-compatible device for measuring their daily smoking behavior objectively via exhaled carbon monoxide. In addition, the intervention group is instructed to use the SmokeFree Buddy app, a multicomponent app that also facilitates smoking-cessation specific social support from a buddy over a smartphone application. All participants fill out a baseline diary for three consecutive days and are invited to the lab for a background assessment. They subsequently participate in an end-of-day diary phase from 7 days before and until 20 days after a self-set quit date. Six months after the self-set quit date a follow-up diary for three consecutive days takes place. The primary outcome measures are daily self-reported and objectively-assessed smoking abstinence and secondary outcome measures are daily self-reported number of cigarettes smoked.Discussion: This is the first study examining the effectiveness of a smoking cessation mobile intervention using the SmokeFree Buddy app compared to a control group in a real-life setting around a self-set quit date using a portable objective measure to assess smoking abstinence. Opportunities and challenges with running studies with smoking participants and certain design-related decisions are discussed.Trial Registration: This trial was prospectively registered on 04/04/2018 at ISRCTNregistry: ISRCTN11154315 . [ABSTRACT FROM AUTHOR]

Background: Actively referring smokers to smoking cessation (SC) services could increase quitting and is scalable for the population. The objective of this study is to compare 2 different intensities of SC active referral for smokers in the community of Hong Kong.Methods/design: This is a single-blind, parallel 3-armed cluster randomized controlled trial (cRCT) consisting of high-intensity SC active referral (HAR Group), low-intensity SC referral by text messaging on promoting SC services use (Text Group) and a control group receives general very brief advice. Biochemically validated daily smokers will be proactively recruited in the community from 68 clusters (recruitment sessions). The primary outcome is self-reported 7-days point prevalence abstinence (PPA) at the 3- and 6- month follow-ups. Secondary outcomes are SC service use, smoking reduction rate (SRR, daily cigarette consumption reduced by ≥50%; excluding quitters) and biochemically validated quit rate (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml). Outcome assessors and data analysts will be blinded to group allocation. Intention-to-treat principle and Generalized Estimating Equation (GEE) regressions will be used for data analysis.Discussion: This will be the first trial on evaluating the efficacy of the 2 different intensities of SC active referral on smoking cessation in community smokers. It is anticipated that the results from this trial can provide evidence to the effectiveness of high-intensity active referral to SC services and low intensity SC referral by using text messaging in achieving smoking abstinence.Trial Registration: ClinicalTrials.gov Identifier: NCT02804880 , June 17, 2016. [ABSTRACT FROM AUTHOR]