Chatbot-Led Support Combined With Counselor-Led Support on Smoking Cessation in China: Protocol for a Pilot Randomized Controlled Trial

Abstract

BackgroundChina has a large population of smokers, with half of them dependent on tobacco and in need of cessation assistance, indicating the need for mobile health (mHealth) to provide cessation support. ObjectiveThe study aims to assess the feasibility and preliminary effectiveness of combining chatbot-led support with counselor-led support for smoking cessation among community smokers in China. MethodsThis is a 2-arm, parallel, assessor-blinded, pilot randomized controlled trial nested in a smoke-free campus campaign in Zhuhai, China. 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 WeChat-based counseling from trained counselors. Follow-up will occur at 1, 3, and 6 months after treatment initiation. The primary smoking outcome is bioverified abstinence (exhaled carbon monoxide <4 parts per million or 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. Feasibility outcomes include eligibility rate, consent rate, intervention engagement, and retention rate. An intention-to-treat approach and regression models will be used for primary analyses. ResultsParticipant recruitment began in March 2023, and the intervention began in April 2023. The data collection was completed in June 2024. The results of the study will be published in peer-reviewed journals and presented at international conferences. ConclusionsThis study will provide novel insights into the feasibility and preliminary effectiveness 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. Trial RegistrationClinicalTrials.gov NCT05777005; https://clinicaltrials.gov/study/NCT05777005 International Registered Report Identifier (IRRID)DERR1-10.2196/58636