Skip to main content
Download PDF
  • Study Protocol
  • Open access
  • Published:

Efficacy of an individual-tailored smoking cessation intervention APP among Chinese smokers: study protocol for a randomized controlled trial

BMC Public Health volumeĀ 24, ArticleĀ number:Ā 65 (2024) Cite this article

Abstract

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 (nā€‰=ā€‰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 provesĀ 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.

Peer Review reports

Introduction

Smoking is the single largest preventable cause of disease, disability, and death facing the world. In 2019, tobacco use accounted for 7.69 million deaths and 200 million disability-adjusted life-years lossĀ worldwide [1]. China has approximately 308 million smokers [2], and 2.4 million people in China are dying of tobacco-induced diseases annually [1]. To curb the epidemic of tobacco in China, the Chinese government signed the World Health Organization Framework Convention on Tobacco Control (WHO FCTC), which suggests offering help to quit tobacco use. Besides, in 2019, the State Council issued the ā€˜Healthy China Action (2019ā€“2030)ā€™, in which the ā€˜Tobacco Control Actionā€™ clearly stipulated the goal of ā€œreducing the smoking rate of people over 15 years old to 20% by 2030ā€ [3].

Numerous efforts have commenced for tobacco control purposes, one of which is the offering of professional smoking cessation aids. In China, smoking cessation services consist of brief smoking cessation interventions, smoking cessation clinics, and smoking cessation hotlines. Health professionals are suggested to perform brief smoking cessation interventions when smokers visit the hospital [4]. From 2010 to 2018, the proportion of smokers receiving advice from clinicians to quit smoking rose from 33.9Ā toĀ 46.4% [5]. Besides,Ā since 2014, the Chinese government has started to support the establishment of three Smoking cessation clinics (SCCs) in each province per year [6], as of 2021, China had more than 600 smoking cessation clinics providing professional cessation services for smokers [7]. SCCs generally are located within hospitals, and smokers could visit SCCs for intensive smoking cessation behavior intervention and drug treatment [8]. Smokers in China could also seek cessation services through smoking cessation hotlines, which provide theory-based telephone counseling and behavioral intervention. There areĀ numerous regional and national quitlines offering voice consultation service and manual consultationĀ for smokers in China.

However, these smoking cessation services are underused, withĀ nearly 90% of smokers who have tried quitting over the past 12 months did not seek professional help [5]. Quitting smoking without professional help is hard to achieve as nicotine dependence is a stubborn addictive disease. Previous study indicates only 2-5% of untreated smokers can maintain long-term abstinence [9]. Fortunately, much can be done now. With the advent of internet technology, mobile health (mHealth) has been gradually deployed in the medical field. mHealth is a general term for the use of mobile phones and other wireless technology in medical care. The most common application of mHealth is the use of mobile devices to educate consumers about preventive healthcare services [10, 11]. Many research groups have dedicated themselves to exploiting this to facilitate smoking cessation [12,13,14,15], among which smartphone smoking cessation application (hereafter refers to ā€˜SSC APPā€™) is one hotspot as SSC APP has the potential to be an accessible, cost-effective, and efficient approach to facilitating smoking cessation and is in line with the development trend of time [16, 17].

Smartphones are rather popular in China, with 986Ā million people accessing the Internet through their mobile phones [18]. In addition, several studies suggest that Chinese smokers are open to SSC APPs and find it promising [19,20,21,22]. Compared with the existing smoking cessation services in China, SSC APP can be accessed at any time, is available anywhere through a smartphone, can reach smokers who want to quit smoking but do not want to seek professional support in person, and can increase the accessibility to evidence-based smoking cessation help. Additionally, we believe the existing smoking cessation services and SSC APP could complement and reinforce each other. Equipping automatic SSC APP with reliable professional health service providers could address smokersā€™ more specific questions while the deployment of SSC APP may diminish the workload of health professionals in clinics and on quit lines. Overall, there is an opening through which we could simultaneously help more people to quit smoking and optimize the existing smoking cessation services in China.

Due to cultural differences, SSC APPs proved effective in foreign countries may not perform well in China, hence the need to develop SSC APPs based on Chinese culture and relevant context. Several exploratory SSC APPs have been developed in recent years, including two WeChat Mini Programs (a lightweight application that can be accessed and used within the WeChat platform without requiring users to download or install any additional software a portable) developed by Chaoyang Hospital [23] and China-Japan Friendship Hospital [24] and one CBT-based SSC APP developed by Sir Run Run Shaw Hospital [25]. To further advance the development and utilization of SSC APPs, especially personalized ones, the Tobacco Control Office of the Chinese Center for Disease Control and Prevention, which oversees the existing smoking cessation services and is committed to controlling the epidemic of tobacco in China, plans to develop a theory-based, individual-tailored SSC APP and integrate it with the existing smoking cessation services such as smoking cessation clinics to better help smokersĀ quitting smoking. To begin, a randomized controlled trial (RCT) will be conducted to evaluate the efficacy of this SSC APP. The gestation and development of the APP will be detailed in a future paper. This article intends to elaborate on the procedures of the RCT.

Methods

Design

This study will be a two-arm, single-blind, parallel-group RCT. It has been registered in the Chinese Clinical Trial Registry (trial registration number: ChiCTR2200062097).

Study setting

This study will be completely conducted online with no restrictions on setting or location. A WeChat Official Account designed specifically for this study will be deployed to collect the baseline and follow-up data. The recruitment will be conducted from July 2023 to September 2023 or will be terminated when the target sample size is reached. The final 30-week follow-up period is projected to be completed by February 2024.

Study population

To better understand the efficacy of this SSC APP, our study targets the largest potential user group. Thus, current Chinese smokers who are motivated to make a quit attempt within 1 month will be enrolled in this study.

Inclusion criteria

  • Aged 18 or above

  • Current smoker, including daily smoker and occasional smoker

  • Intend to quit smoking within 1 month

  • Proficiency in smartphone

  • Agree to take part in this study and is prepared to be assigned randomly to one of two treatment conditions

  • Provide electronic informed consent

Exclusion criteria

  • Currently following other smoking cessation programs

  • Has no access to an Android smartphone

  • Inability to finish the study follow-up

Sample size and power calculation

The proposed sample size is based on the primary outcome of self-reported 6-month continuous abstinence. Based on a meta-analysis conducted by Ybarra [26], the 6-month continuous abstinence for mobile phone-based smoking cessation intervention is 13.1%, compared with 6.4% in the control group. To detect a 2-sided significant difference between groups with a power of 80% and significance level of 5%, 309 participants in each arm are estimated to be required. Considering a 35.8% loss to follow-up in one study concerning SSC APP conducted in China [27], the final minimum sample size is 481 per group. Eventually, we set a target sample size at 1,000 people to cover the minimum sample size.

Recruitment and informed consent

Recruitment will take place both online and offline. For online recruitment, Weibo, WeChat Official Accounts, web forums, and so onĀ will be used to post the recruitment advertisements. With respect to offline recruitment, staff in local CDCs will assist in the distribution of recruitment posters and publicity. All recruitment channels will be attached with a Quick Response (QR) code of the WeChat Official Account of this research. After following the Official Account and completing the prescreening assessment, participantsā€™ eligibility will be assessed automatically by computer algorithms. Baseline data, including sociodemographic characteristics and smoking history, will be collected in the prescreening assessment.

Eligible participants will receive a consent form with a summary of this study, including the study procedures, the risks and benefits, the intervention content of both the intervention group and control group, the potential of being allocated to either group, the compensation for participating this study and retaining in follow-up, how confidentiality is maintained, and explaining the data collection and data sharing procedures. Then participants will be asked to provide informed consent electronically by checking the box ā€œIā€™ve read and understand the content of this study, and I agree to participate in this study.ā€ To prevent unintended checks, a verification code will be required when participants decide to sign the informed consent. Besides, participants will be asked to provide a mobile phone number for short messaging system (SMS) reminders of research progress, follow-up questionnaires, as well as potential follow-up calls if they fail to complete the questionnaires on time.

Randomization, allocation concealment and blinding

After enrollment, eligible participants will be assigned to either the control group or intervention group in a ratio of 1:1 (500 in each). Two stratification factors, each at two levels, will be used: age (ā‰¤ā€‰40 years, >ā€‰40) and daily cigarette consumption (ā‰¤ā€‰20 pack-years, >ā€‰20). A random permuted block sizes of 2, 4, or 6 will be used to achieve similar numbers of participants in both the intervention group and the control group.

Allocation concealment can be guaranteed as the random number sequence will be generated by a biostatistician who is not a member of the research team, and the random number sequence will be kept secret from researchers who are responsible for the recruitment.

As the interventions in two groups cannot be completely blinded in this study, this RCT will be single-blind in which all outcome assessors and data analysts will be blind to group allocation.

Detailed description of intervention procedure and control group

This study aims to evaluate the efficacy of the individual-tailored smoking cessation intervention APP developed by the Tobacco Control Office. Thus, participants assigned to the intervention group will receive the APP and use it to guide their smoking cessation attempts, while participants in the control group will receive a self-help smoking cessation manual. To balance the effect of the self-help material, participants in the intervention group will receive them as well. In this way, this study could clearly determine the efficacy of this SSC APP.

Control group: self-help smoking cessation manual

ā€œTo help you stop smokingā€, a 24 pages self-help smoking cessation manual developed by the Tobacco Control Office, is comprised of 12 sections, including the harms of smoking, the benefit of quitting smoking, the instruction on quitting smoking and medication usage, how to deal with setbacks, etc.

Participants in the control group will receive the self-help material alone to facilitate their smoking cessation attempts after randomization.

Intervention group: individual-tailored smoking cessation intervention APP group

This individual-tailored smoking cessation intervention APP was developed by the Tobacco Control Office. The Behavior Change Wheel (BCW) theory [28, 29] and Transtheoretical Model [30, 31] informed the function development of this APP as the Capability, Opportunity, and Motivation needed to quit smoking at each stage were analyzed thoroughly to justify the functions setting. This APP also embraces the key elements and concepts of cognitive behavioral therapy (CBT), including changing underlying beliefs about smoking and learning and practicing a variety of coping skills [32,33,34]. Also, during the development of this APP, suggestions and feedbacks from volunteer smokers were seriously considered. When the fundamental framework was formed, the Delphi method was exploited to solicit opinions and effective techniques from experienced smoking cessation experts and refine the APP iteratively. To recapitulate, this APP is theory-based and user-centered.

At the first login, users will receive a thorough assessment questionnaire to evaluate their current stage, quit motivation, past quit attempts, current smoking usage, and conceptions about smoking. This functional analysis could set the stage for later individual-tailored interventions. Then, an assessment report will be generated accordingly, including usersā€™ addiction level, current stage of behavior change, barriers to and facilitators of smoking cessation, personalized advice, and so on. Those in the preparation stage will be suggested to set a quit date and will receive stepwise guidance about the wherewithal to quit smoking. Considering the withdrawal symptoms and other challenges facing current smokers, users will receive tips and aids for coping with withdrawal symptoms, urges to smoke, and other problems during the first month. As for those in the contemplation stage, they may not yet be ready to make a quit attempt, hence they will be prompted to use this APP to record their smokingĀ behavior, which provides an opening through which the APP could further intervene by sending specific motivational messages and presenting other smoking cessation-related material to them. These interventions may catalyze the transition from contemplation to preparation to quit. Along with these interventions and instructions, other functions will also be exploited to facilitate smoking cessation, such as an emergency help when smoking cravings occur. The gamification principle will be deployed to optimize the user experience as well. The functional framework of this SSC APP is shown in Fig.Ā 1.

Fig. 1
figure 1

Functional framework of the SSC APP

Full size image

Participants in the intervention group will receive this APP and the self-help material to facilitate their smoking cessation attempts after randomization.

Follow-up and data collection

Participants in both groups will be followed up for 6 months and receive electric follow-up questionnaires sent by the WeChat Official Account 1 month, 3 months, and 6 months after enrollment. SMS will be used to remind them to complete the questionnaires on time. Non-responders will receive up to 3 additional reminder messages or calls within 1 week following the initial invitation. Compensation will be paid to improve their willingness to respond and remain in this study. When the follow-up finishes, participants in both groups will be acknowledged for their participation and participants in the control group will be referred to our SSC APP if they have not quit smoking.

Compensation

Participants in both groups will receive compensation through phone bill recharge after completing each follow-up questionnaire to stimulate their motivation to remain in the study. Considering participants are more likely to drop off at later follow-ups, the compensation will increase successively but the total financial value of the compensation will stand at 50 RMB (approximately US $7.86). Participants from both intervention and control groups will receive the same amount of compensation, and the answers to the questionnaires will not have any impact on the value of compensation received.

Withdrawal from the program

It will be emphasized in the recruitment advertisement and the informed consent form that participation in this study is voluntary, and that participants will be free to withdraw at any stage of the study.

Outcomes and measures

Primary outcome and measures

As we explained before, our SSC APP includes motivational protocols for those not ready to decide on a target quit date. In this study, we intend to explore the efficacy of the SSC APP as a whole, so the follow-up in this study will be tied to the date of intervention initiation. 6-month continued abstinence is selected as the primary outcomes. Considering there is no close contact or interaction between participants and the study team, biochemical verification may be infeasible as the SRNT guidelines have suggested [35], it will be self-reported. 6-month continued abstinence will be defined using the Russell 6 Standard [36] but without biochemical verification (i.e., tolerate fewer than five incidents of smoking from the quit date) and will be measured through the question ā€œHave you smoked at all since (date of the start of the continuous abstinence period) ? A: No, not a puff; B: 1ā€“5 cigarettes; C: More than 5 cigarettes.ā€

Secondary outcomes and measures

The following secondary outcome measures will be assessed in all participants at 1-month, 3-months, and 6-months after enrollment: 7-day point-prevalence abstinences, 3-month continuous abstinence, reduction in the number of cigarettes smoked per day, the number of quitting attempts, and attendance to other smoking cessation services.

The 7-day point-prevalence abstinence will be measured through the question ā€œHave you ever smoked over the past 7 days?ā€ The measurement of 3-month continuous abstinence is identical to that of 6-month continued abstinence as explained before. The number of cigarettes smoked per day and the number of quitting attempts will be asked at each follow-up. Attendance to other smoking cessation services will be measured through the question ā€œHave you ever used any other professional smoking cessation services? If yes, please describe them briefly.ā€

As the participants in this study will be smokers willing to quit within 1 month, we presume this study will mainly reveal if our APP could help smokers in the preparation stage to quit successfully. However, since not every smoker proclaiming interest in quitting will make a quit attempt by their due date [37], this study could also explore whether our APP can increase the motivation of smokers to quit smoking. Therefore, we will specifically measure how many participants in each group have made attempts to quit 1 month after enrollment to explore the efficacy of our APP in increasing the motivation to make a serious quit attempt.

For those who relapse at the follow-up points, the reduction in the number of cigarettes smoked per day, the number of quit attempts, and attendance to other smoking cessation services will be considered as secondary outcomes and will be used to compare against the baseline data.

Furthermore, APP acceptability and engagement will be measured in the intervention group 1 month after enrollment by an adopted TAM (Technology Acceptance Model) questionnaire, which involves perceived usefulnessĀ and perceived ease of use [38]. Also, the frequency and duration of each login, the utilization of each specific function, and the compliance with guidance will be recorded automatically for further analysis. The full list of measurements is presented in TableĀ 1.

Table 1 Schedule of enrollment and follow-up assessments
Full size table

Procedures

FigureĀ 2 shows the trial flow chart. Eligibility will be assessed at baseline and eligible participants will be allocated to either the intervention or control group in a ratio of 1:1 after stratification. Participants in both groups will receive self-help materials and the participants in the intervention group will receive the SSC APP in addition. Then participants in both groups will be followed up Ā forĀ 6 months after enrollment.

Fig. 2
figure 2

Trial flow diagram

Full size image

Statistical analysis

Upon completion of data collection, data will be cleaned and prepared for data analysis. Primary and secondary outcome variables will be checked for distribution, outliers, and missing patterns, and appropriate steps will be taken where necessary. All analysis will be conducted through SAS 9.4. Baseline demographics and smoking-related characteristics will be summarized and presented. Continuous variables (e.g. age) will be presented as numbers observed, means, and standard deviations. Categorical variables (e.g. marital status) will be presented as frequencies and percentages.

The main analysis will be focused on the comparison of smoking cessation rates in the intervention and control groups. This involves a comparison of the primary outcome variables and some secondary outcome variables including 7-day point-prevalence abstinence and self-reported continuous abstinence at each follow-up point. Independent t-tests and Ļ‡2 tests will be used to detect differences between the two groups depending on the type of variables. Logistic regression will be explored to assess group differences after adjusting for any baseline demographic or clinical characteristics that showed significant differences and variables that have been reported to be associated with smoking cessation [39].

Our analysis will be conducted based on intention-to-treat (ITT) principle and participants who are lost to follow-ups will be considered as continuing smokers with no reduction in cigarette consumption compared with baseline. The results from the analysis using the Multiple Imputation and Last Observation Carried Forward approaches to process missing data and per-protocol analysis will be conducted as sensitivity analyses. Subgroup analysis by baseline characteristics on quitting outcomes will be conducted by interaction terms.

Ethics approvals and dissemination

Ethics approval (reference number: 202204) was obtained from the Ethical Review Committee of the Chinese Center for Disease Control and Prevention. Informed consent will be obtained from all the participants electronically. Results are expected to be published in peer-reviewed journals and presented at conferences.

Safety

As most nicotine withdrawal symptoms are moderate and will subside within several weeks, we believe that this intervention is barely harmful to any participants. In case some participants experience any severe physical or mental withdrawal symptoms, professionals from the Chaoyang smoking cessation clinic will be available at any stage. Serious symptoms occurred will be recorded and reported.

Confidentiality

The company responsible for software operations will sign a confidentiality agreement and complete the cyber security evaluation to avoid any data breach. All study-related data will be exported and stored securely on the research teamā€™s encrypted computer under a coded identification number to maintain participant confidentiality. All data that contain personal identifiers, such as screening data for eligibility and informed consent forms, will be stored separately from study records identified by a code number. Only the principal investigator and research assistants will have access to the study data.

Discussion

In recent years, SSC APPs have been booming worldwide. Hundreds of SSC APPs are circulating in the APP market on platforms like Google play and the Apple store, and they have attracted tremendous downloads [40, 41]. However, most APPs are not based on relevant scientific theories and there is little scientific evidence from randomized controlled trials on the impact of these APPs, especially in China, where no validated smoking cessation APP isĀ publicly available now [40, 42]. Furthermore, due to the different cultural contexts, effective SSC APPs in foreign countries may not be well-worked in China [22].

This study will help us to evaluate the efficacy of an individual-tailored smoking cessation intervention APP developed by the Tobacco Control Office based on the BCW theory and the Transtheoretical Model. Ideally, it will help us understand how smartphones can be used to promote smoking cessation. If this APP provesĀ to be effective, it could be integrated with the existing smoking cessation services and further facilitate smoking cessation at the population level. As a country with more than 300Ā million smokers, any amount of improvement could be amplified by the huge smoking population and yield considerable benefits.

As this study will be conducted online, several limitations lay ahead. First, it is unlikely to collect biochemical samples as participants are scattered remotely in various places. Thus, self-reported 6-month continued abstinence will be considered as an alternative to biochemically verified abstinence. Besides, without close contact or interaction, participants may be less likely to take this study seriously and thus more likely to be lost to follow-up. Hence, participants will be reminded through different approaches at the follow-up points and receive monetary incentives after completing follow-up questionnaires.

Overall, this study could shed some light on the efficacy of an individual-tailored smoking cessation intervention APP in China with the potential to address the existing and unmet demands of Chinese smokers. We predict this innovative study to be a promising attempt and may have major implications for smoking prevention policy and mobile health in general.

Availability of data and materials

Data generated and/or analyzed during the current study will be available from the corresponding author on reasonable request after the main results of the study have been published.

References

  1. Collaborators G. 2019 T. Spatial, temporal, and demographic patterns in prevalence of smoking tobacco use and attributable disease burden in 204 countries and territories, 1990ā€“2019: a systematic analysis from the Global Burden of Disease Study 2019. Lancet Lond Engl. 2021;397(10292):2337ā€“2360. https://doi.org/10.1016/S0140-6736(21)01169-7.

  2. Xiao L, Nan Y, Di XB, Meng ZD. [Study on smoking behavior and its changes among chinese people aged 15 years and above in 2018]. Zhonghua Liu Xing Bing Xue Za Zhi Zhonghua Liuxingbingxue Zazhi. 2022;43(6):811ā€“7. https://doi.org/10.3760/cma.j.cn112338-20211130-00934.

    ArticleĀ  CASĀ  PubMedĀ  Google ScholarĀ 

  3. Tobacco control----Chinese center for disease control and prevention. https://en.chinacdc.cn/health_topics/tobacco_control/. Accessed 21 Feb 2023.

  4. Chu S, Wang S, Shi J. Current situation and countermeasures of smoking cessation service system construction in China. Prev Med. 2022;34(12):1235ā€“9. https://doi.org/10.19485/j.cnki.issn2096-5087.2022.12.009

  5. Nan Y, Di XB, Zeng XY, et al. [Quit intention and smoking cessation behavior of current smokers aged 15 years and above in China, 2018]. Zhonghua Liu Xing Bing Xue Za Zhi Zhonghua Liuxingbingxue Zazhi. 2022;43(6):818ā€“23. https://doi.org/10.3760/cma.j.cn112338-20211130-00932.

    ArticleĀ  CASĀ  PubMedĀ  Google ScholarĀ 

  6. Notice from the National Health and Family Planning Commission of the People's Republic of China on Issuing the National Health Literacy Promotion Plan (2014-2020). Bulletin of the National Health and Family Planning Commission of the People's Republic of China. 2014(04):30ā€“4. https://www.cnki.net/KCMS/detail/detail.aspx?dbcode=CJFD&dbname=CJFDLASN2016&filename=WSGB201404007&uniplatform=OVERSEA&v=cZXDFo1efsqkzEJa3cD97wn2RcLuUNY7GPYZ12QVx6nnqD6wdjuPSN3WCvGHm9W_. Accessed 21 Feb 2023.

  7. Xinhuanet. [ Healthy China Action Tobacco Control Action: Tobacco Control Work Achieves. ā€œFour Improvements and One Reductionā€ ]. Published December 31, 2021. http://www.xinhuanet.com/health/20211231/fc6aedf018dd448cb7c78b188d4da1e6/c.html. Accessed 21 Feb 2023.

  8. Lin B, Xie L, Xie X, Yan Y, Zhang L, Xiao L. Predictors for quitting smoking in smoking cessation clinicsamong female smokers in China. Tob Induc Dis. 2023;21(February):1ā€“13. https://doi.org/10.18332/tid/159132.

    ArticleĀ  Google ScholarĀ 

  9. Hughes JR, Keely J, Naud S. Shape of the relapse curve and long-term abstinence among untreated smokers. Addict Abingdon Engl. 2004;99(1):29ā€“38. https://doi.org/10.1111/j.1360-0443.2004.00540.x.

    ArticleĀ  Google ScholarĀ 

  10. Harvey EJ. mHealth and the change it represents. Can J Surg. 2019;62(3):148. https://doi.org/10.1503/cjs.007919.

    ArticleĀ  PubMedĀ  PubMed CentralĀ  Google ScholarĀ 

  11. Oā€™Connor M, Bowles KH. Telehealth and mHealth. Res Nurs Health. 2021;44(1):3ā€“4. https://doi.org/10.1002/nur.22101.

    ArticleĀ  PubMedĀ  Google ScholarĀ 

  12. Kefaliakos A, Pliakos I, Chardalias K, Charalampidou M, Diomidous M. Smoking Cessation: Services and Applications for Mobile Devices. Stud Health Technol Inform. 2016;226:217ā€“9. PMID: 27350508.

  13. Chahar P, Mohanty VR, Aswini YB. Designing and validation of text messages for m-Health intervention for tobacco cessation and management. Indian J Cancer. 2018;55(4):390ā€“3. https://doi.org/10.4103/ijc.IJC_569_17.

    ArticleĀ  PubMedĀ  Google ScholarĀ 

  14. Borland R, Balmford J, Benda P. Population-level effects of automated smoking cessation help programs: a randomized controlled trial: Effect of automated quit smoking programs. Addiction. 2013;108(3):618ā€“28. https://doi.org/10.1111/j.1360-0443.2012.04091.x.

    ArticleĀ  PubMedĀ  Google ScholarĀ 

  15. Obermayer JL, Riley WT, Asif O, Jean-Mary J. College smoking-cessation using cell phone text messaging. J Am Coll Health J ACH. 2004;53(2):71ā€“8. https://doi.org/10.3200/JACH.53.2.71-78.

    ArticleĀ  Google ScholarĀ 

  16. Heron KE, Smyth JM. Ecological momentary interventions: incorporating mobile technology into psychosocial and health behaviour treatments. Br J Health Psychol. 2010;15(Pt 1):1ā€“39. https://doi.org/10.1348/135910709X466063.

    ArticleĀ  PubMedĀ  Google ScholarĀ 

  17. Barroso-Hurtado M, SuĆ”rez-Castro D, MartĆ­nez-Vispo C, BecoƱa E, LĆ³pez-DurĆ”n A. Smoking Cessation apps: a systematic review of Format, Outcomes, and features. Int J Environ Res Public Health. 2021;18(21): 11664. https://doi.org/10.3390/ijerph182111664.

    ArticleĀ  PubMedĀ  PubMed CentralĀ  Google ScholarĀ 

  18. CHINA INTERNET NETWORK INFORMATION CENTER. [The 48th Statistical Report on the Development of Chinaā€™s Internet Network]. https://cit.buct.edu.cn/2021/0925/c7951a157922/page.htm.

  19. Xie J, Hu Y, Chen O, Zhou Y. A survey of the willingness of smokers using smartphones to use smoking cessation apps. Chin J Prev Control Chronic Dis. 2021;23:11843ā€“6. https://doi.org/10.16386/j.cjpccd.issn.1004-6194.2021.11.010.

    ArticleĀ  Google ScholarĀ 

  20. Zhang YY, Tang WT, Zhang H, et al. Barriers and facilitators for Smoking Cessation in chinese smokers with chronic obstructive Pulmonary Disease: a qualitative study. Int J Chron Obstruct Pulmon Dis. 2022;17:1107ā€“20. https://doi.org/10.2147/COPD.S356935.

    ArticleĀ  PubMedĀ  PubMed CentralĀ  Google ScholarĀ 

  21. Luk TT, Wong SW, Lee JJ, Chan SSC, Lam TH, Wang MP. Exploring community smokersā€™ perspectives for developing a chat-based Smoking Cessation intervention delivered through Mobile Instant Messaging: qualitative study. JMIR MHealth UHealth. 2019;7(1): e11954. https://doi.org/10.2196/11954.

    ArticleĀ  PubMedĀ  PubMed CentralĀ  Google ScholarĀ 

  22. Xu J, Bricker J, Fu X, et al. Design and development of Smoking Cessation apps based on smokersā€™ and Providersā€™ perspectives in China: Survey Study. JMIR MHealth UHealth. 2019;7(10): e12200. https://doi.org/10.2196/12200.

    ArticleĀ  PubMedĀ  PubMed CentralĀ  Google ScholarĀ 

  23. [ Professional Smoking Cessation Help Mini programs. ā€œThe Way of Quitting Smokingā€ Officially Launched ].https://www.chinanews.com.cn/life/2021/04-21/9459706.shtml. Accessed 19 Apr 2023.

  24. [onlinequit]. https://www.chinatca.cn/. Accessed 19 Ap 2023.

  25. Liao Y, Tang J. Efficacy of cognitive behavioural therapy-based smartphone app for smoking cessation in China: a study protocol of a randomised controlled trial. BMJ Open. 2021;11(1): e041985. https://doi.org/10.1136/bmjopen-2020-041985.

    ArticleĀ  PubMedĀ  PubMed CentralĀ  Google ScholarĀ 

  26. Ybarra ML, Jiang Y, Free C, Abroms LC, Whittaker R. Participant-level meta-analysis of mobile phone-based interventions for smoking cessation across different countries. Prev Med. 2016;89:90ā€“7. https://doi.org/10.1016/j.ypmed.2016.05.002.

    ArticleĀ  PubMedĀ  PubMed CentralĀ  Google ScholarĀ 

  27. Liu L. [Evaluation of Effectiveness on A Smart-phone App for Smoking Cessation in China]. Chinese Center for Disease Control and Prevention. 2018. https://kns.cnki.net/KCMS/detail/detail.aspx?dbname=CMFD201901&filename=1018308933.nh.

  28. Michie S, Atkins L, West R. The Behaviour Change Wheel: A Guide To Designing Interventions. Silverback Publishing. 2014. p. 281.

  29. Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci IS. 2011;6:42. https://doi.org/10.1186/1748-5908-6-42.

    ArticleĀ  PubMedĀ  Google ScholarĀ 

  30. Prochaska JO, Velicer WF. The transtheoretical model of health behavior change. Am J Health Promot AJHP. 1997;12(1):38ā€“48. https://doi.org/10.4278/0890-1171-12.1.38.

    ArticleĀ  CASĀ  PubMedĀ  Google ScholarĀ 

  31. Siewchaisakul P, Luh DL, Chiu SYH, Yen AMF, Chen CD, Chen HH. Smoking cessation advice from healthcare professionals helps those in the contemplation and preparation stage: an application with transtheoretical model underpinning in a community-based program. Tob Induc Dis. 2020;18:57. https://doi.org/10.18332/tid/123427.

    ArticleĀ  PubMedĀ  PubMed CentralĀ  Google ScholarĀ 

  32. Turner R, Swearer Napolitano SM. Cognitive behavioral therapy (CBT). 2010. https://digitalcommons.unl.edu/edpsychpapers/147/.

  33. Center for Substance Abuse Treatment. Brief Interventions and Brief Therapies for Substance Abuse. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 1999. (Treatment Improvement Protocol (TIP) Series, No. 34.) Available from: https://www.ncbi.nlm.nih.gov/books/NBK64947/. Accessed 30 June 2022.

  34. The Efficacy of Cognitive Behavioral Therapy: A Review of Meta-analyses | SpringerLink. https://link.springer.com/article/10.1007/s10608-012-9476-1. Accessed 30 June 2022.

  35. Benowitz NL, Bernert JT, Foulds J, et al. Biochemical Verification of Tobacco Use and abstinence: 2019 update. Nicotine Tob Res Off J Soc Res Nicotine Tob. 2020;22(7):1086ā€“97. https://doi.org/10.1093/ntr/ntz132.

    ArticleĀ  Google ScholarĀ 

  36. West R, Hajek P, Stead L, Stapleton J. Outcome criteria in smoking cessation trials: proposal for a common standard. Addict Abingdon Engl. 2005;100(3):299ā€“303. https://doi.org/10.1111/j.1360-0443.2004.00995.x.

    ArticleĀ  Google ScholarĀ 

  37. Kotz D, Brown J, West R. Predictive validity of the motivation to stop scale (MTSS): a single-item measure of motivation to stop smoking. Drug Alcohol Depend. 2013;128(1ā€“2):15ā€“9. https://doi.org/10.1016/j.drugalcdep.2012.07.012.

    ArticleĀ  CASĀ  PubMedĀ  Google ScholarĀ 

  38. Holden RJ, Karsh BT. The technology acceptance model: its past and its future in health care. J Biomed Inform. 2010;43(1):159ā€“72. https://doi.org/10.1016/j.jbi.2009.07.002.

    ArticleĀ  PubMedĀ  Google ScholarĀ 

  39. Vangeli E, Stapleton J, Smit ES, Borland R, West R. Predictors of attempts to stop smoking and their success in adult general population samples: a systematic review. Addict Abingdon Engl. 2011;106(12):2110ā€“21. https://doi.org/10.1111/j.1360-0443.2011.03565.x.

    ArticleĀ  Google ScholarĀ 

  40. Rajani NB, Weth D, Mastellos N, Filippidis FT. Adherence of popular smoking cessation mobile applications to evidence-based guidelines. BMC Public Health. 2019;19(1):743. https://doi.org/10.1186/s12889-019-7084-7.

    ArticleĀ  PubMedĀ  PubMed CentralĀ  Google ScholarĀ 

  41. Robinson CD, Seaman EL, Grenen E, et al. A content analysis of smartphone apps for adolescent smoking cessation. Transl Behav Med. 2020;10(1):302ā€“9. https://doi.org/10.1093/tbm/iby113.

    ArticleĀ  PubMedĀ  Google ScholarĀ 

  42. Cheng F, Xu J, Su C, Fu X, Bricker J. Content analysis of smartphone apps for Smoking Cessation in China: empirical study. JMIR MHealth UHealth. 2017;5(7):e93. https://doi.org/10.2196/mhealth.7462.

    ArticleĀ  PubMedĀ  PubMed CentralĀ  Google ScholarĀ 

Download references

Acknowledgements

Not applicable.

Funding

This research is supported by Beijing Municipal Health Commission (the Capitalā€™s Funds for Health Improvement and Research (CFH), Grant no. 2022-1G-4221) and the Tobacco epidemic surveillance and integrated tobacco control intervention project. The trial sponsors and contact information: Beijing Municipal Health Commission, Block B, Central Office Building 70, Zaolinqian Street, Xicheng District, Beijing, China, 100053, tel: + 8610- 83970601; the Tobacco epidemic surveillance and integrated tobacco control intervention project was financed by State financial allocations. Both funding bodies are government agencies. These funding agencies have no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results. The authors are solely responsible for the design of the research and for the preparation of the manuscript.

Author information

Author notes

  1. Lirong Liang and Lin Xiao are equally contributed to this work.

Authors and Affiliations

  1. Tobacco Control Office, Chinese Center for Disease Control and Prevention, 155 Changbai Road Changping District, Beijing, 102206, China

    Xiaoyun Xie,Ā Yi Nan,Ā Luge ZhangĀ &Ā Lin Xiao

  2. Department of Research on Tobacco Dependence Therapies, Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University, No.8 Gong-Ti-Nan-Lu, Chaoyang District, Beijing, 100020, China

    Lirong Liang

Authors
  1. Xiaoyun Xie
    View author publications

    You can also search for this author in PubMedĀ Google Scholar

  2. Lirong Liang
    View author publications

    You can also search for this author in PubMedĀ Google Scholar

  3. Yi Nan
    View author publications

    You can also search for this author in PubMedĀ Google Scholar

  4. Luge Zhang
    View author publications

    You can also search for this author in PubMedĀ Google Scholar

  5. Lin Xiao
    View author publications

    You can also search for this author in PubMedĀ Google Scholar

Contributions

XYX, LGZ, YN, LRL, and LX conceived and designed the study. XYX and LGZ wrote the main manuscript text with input from all authors, and all authors reviewed and contributed to the manuscript. This manuscript was supervised by NY, LRL and XL.

Corresponding author

Correspondence to Lin Xiao.

Ethics declarations

Ethics approval and consent to participate

This study protocol has been reviewed by expert panel from Beijing Municipal Health Commission and Chinese Center for Disease Control and Prevention respectively for funding applying and Ethical review, respectively. Ethics approval was granted by the Ethical Review Committee of the Chinese Center for Disease Control and Prevention (reference number: 202204) on March 30, 2022 (Protocol Version 1.0). Informed consent will be obtained from all the participants electronically (no e-signature). If there are any major protocol modifications in the protocol, we will communicate the modifications to investigators, Ethical Review Committee, trial participants, trial registries and journals. All methods will be performed in accordance with the Declaration of Helsinki.

Consent for publication

Not applicable as we will not collect any images or videos of participants and no individual details will be reported in this manuscript.

Competing interests

The authors declare no competing interests.

Additional information

Publisherā€™s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Lirong Liang is the co-first author.

Rights and permissions

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Xie, X., Liang, L., Nan, Y. et al. Efficacy of an individual-tailored smoking cessation intervention APP among Chinese smokers: study protocol for a randomized controlled trial. BMC Public Health 24, 65 (2024). https://doi.org/10.1186/s12889-023-16496-9

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: https://doi.org/10.1186/s12889-023-16496-9

Keywords

BMC Public Health

ISSN: 1471-2458

Contact us