Chatbot-led support combined with counselor-led support on smoking cessation in China: A study protocol of an effectiveness-implementation hybrid type 1 randomized controlled trial (Preprint)

BACKGROUND China has a large population of smokers, but smoking cessation treatment is not equally accessible or utilized, indicating the need for mobile health (mHealth) approaches to expand cessation support. OBJECTIVE We aim to assess the feasibility, preliminary effectiveness, and implementation of chatbot-led support combined with counselor-led support for smoking cessation among community smokers in China. METHODS This is a two-arm, parallel, assessor-blinded, hybrid type 1 effectiveness-implementation randomized controlled trial. All participants will receive brief face-to-face cessation advice and group cessation support led by a chatbot embedded in WeChat. In addition, participants in the intervention group will receive personalized online counseling from trained counselors. The participants will be followed up at 1, 3 and 6 months after treatment initiation. The primary outcome is feasibility, defined by the percentage of eligible smokers who agree to participate. The implementation process and outcomes are guided by the RE-AIM framework (reach, effectiveness, adoption, implementation, maintenance). The primary effectiveness outcome is bioverified abstinence (exhaled carbon monoxide < 4 parts per million and salivary cotinine < 30 ng/mL) at 6 months. Secondary outcomes include self-reported 7-day point prevalence of abstinence, smoking reduction rate, and quit attempts. We will use an intention-to-treat approach and regression models for primary analyses. RESULTS not applicable CONCLUSIONS This study will provide novel insights into the feasibility, effectiveness, and implementation of a chatbot-led intervention for smoking cessation in China. The findings of this study will inform the development and optimization of mHealth interventions for smoking cessation in China and other low- and middle-income countries. CLINICALTRIAL ClinicalTrials.gov, NCT05777005