Develop a personalised serious game applet for smoking cessation: protocol for enterprise-based cluster randomised controlled trial.

Abstract

Tobacco use causes approximately 8 million deaths worldwide each year. Against the backdrop of a rapidly expanding game market, there is growing potential to develop tailored gaming interventions for smoking cessation. This study protocol describes the development of a personalised Serious Game Applet based on an integrated TTM-PMT-HAPA framework (Transtheoretical Model, Protection Motivation Theory, Health Action Process Approach) and evaluates its effectiveness compared with conventionalShort Messaging Service (SMS) -based smoking cessation interventions. Design: The study comprises two phases. The first involves developing the Serious Game Applet using the TTM-PMT-HAPA theoretical framework. The second phase consists of a multicentre, two-arm, single-blind cluster randomised controlled trial, which will enrol 1320 eligible smokers from various enterprises. Enterprises will be randomised to either the Serious Game Applet group or the SMS push control group. Eligible participants include daily smokers aged 18-45 years, working in non-tobacco-related enterprises, with exhaled carbon monoxide levels ≥6 ppm. Primary outcomes are smoking abstinence rates at 3 and 6 months. Secondary outcomes include abstinence rates at 1, 2 and 9 months; point-prevalence cessation rates at 1, 2, 3, 6 and 9 months; changes in cigarette consumption; stage transitions in smoking cessation; nicotine dependence scores and withdrawal symptoms. The trial will be conducted as a field study targeting smartphone users across three cities in Fujian Province, China. This study has been approved by the Biomedical Research Ethics Committee of Fujian Medical University (Approval No. 127, 2024). Results will be disseminated through peer-reviewed journals and academic conferences. ChiCTR2400088105.