Evaluation of an innovative mHealth-based integrated modality for smoking cessation in Chinese smokers: protocol for a randomized controlled trial

(2023) 23:561 Chu et al. BMC Public Health https://doi.org/10.1186/s12889-023-15448-7 BMC Public Health Open Access STUDY PROTOCOL Evaluation of an innovative mHealth‑based integrated modality for smoking cessation in Chinese smokers: protocol for a randomized controlled trial Shuilian Chu1, Lin Feng1, Yingting Zuo1, Hang Jing1, Di Zhang1, Zhaohui Tong2, Ju Shi3, Haomiao Ma2, Zhijin Zhang2 and Lirong Liang1* Abstract 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. Keywords Mobile health, Smoking cessation, WeChat app, Integrated modality, Randomized controlled trial *Correspondence: Lirong Liang Full list of author information is available at the end of the article © The Author(s) 2023. 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://creativeco mmons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Chu et al. BMC Public Health (2023) 23:561 Background Tobacco use is the leading cause of preventable morbidity and mortality in the world, and quitting smoking is known as the best approach to reduce these hazards [1]. Due to nicotine dependence, it is necessary to offer help to quit tobacco use [1]. Although many evidence-based treatment approaches to smoking cessation have been developed, the financing of smoking cessation services, such as tobacco quitlines, is a significant challenge for many governments, particularly those in low- and middle-income countries [2]. Consequently, many smokers do not have access to cessation services, and their quit rates are low [2]. This situation also exists in China, where more than 300 million Chinese people continue to use tobacco [3]. Among these smokers, 36.4% had tried to quit in the past 12 months, whereas more than 90% of them had never received any professional help [3]. A nationwide survey showed that there are only 366 smoking cessation clinics in mainland China [4], which leaded to smokers in most parts of China did not access to face-to-face treatment from smoking cessation specialists. Evidence has shown that the tobacco quitline is effective and could remove barriers that may hinder face-to-face service delivery [5]. However, there are only three quitlines in mainland China, all of which are facing the challenges of low awareness and utilization due to a lack of financial and policy support [6–8]. In addition, more and more people prefer to communicate via chat applications on their smartphones rather than by telephone [9]. Therefore, it needs to develop novel accessible, affordable, and effective approaches to assist smokers in quitting. The rapid development of mobile health (mHealth) technology makes it possible to address the above concerns [10]. Moreover, during the COVID-19 pandemic, people preferred to obtain medical and health services through mHealth [11, 12], and this trend may continue in the post-epidemic era [13]. A variety of mHealth approaches, such as short message service (SMS) texting, web, social media, and mobile applications (apps), have existed to deliver smoking cessation behavioral interventions [10] and demonstrated the potential to assist smokers in quitting smoking [14, 15]. But at the same time, some limitations were also found that may reduce their availability and effectiveness, such as non-tailored contents, lack of interactivity, etc. Given the dynamic, quickly evolving nature of the technology, a possible strategy to overcome these limitations has been proposed that is to integrate interventions from multiple sources [10], but it still needs high-quality evidence to support it. China is regarded as the fastest growing smartphone market, and has the largest smartphone user group (n > 850 million people) in the world [16]. WeChat is the Page 2 of 13 most popular app in China, which has become a major tool for communication, entertainment, and payment for Chinese smartphone users [17]. (...truncated)