VAPGAMO trial protocol: a cluster-randomised controlled evaluation of a digital game-based learning intervention to reduce adolescent vaping intention in Malaysian public secondary schools

VAPGAMO试验方案:一项针对马来西亚公立中学青少年电子烟使用意愿降低的基于数字游戏的学习干预措施的整群随机对照评估

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Abstract

INTRODUCTION: Youth vaping remains a global public health challenge. We will evaluate a pragmatic, theory-driven digital game-based learning intervention (VAPGAMO), delivered in public secondary schools to reduce adolescents' intention to vape at 3-month follow-up. METHODS AND ANALYSIS: Parallel cluster-randomised controlled trial with schools as clusters. Eight public secondary schools in an urban Southeast Asian district (Klang, Malaysia) will be randomised 1:1 to intervention or attention-matched online flash game. The intervention is a single 90 min, facilitator-led module grounded in the Theory of Planned Behaviour. Surveys at baseline, immediately postintervention and 3 months. The primary outcome is intention to vape at 3 months. Secondary outcomes are knowledge, attitudes, injunctive norms and refusal self-efficacy (perceived behavioural control). Prespecified implementation outcomes include acceptability, fidelity, reach, time-on-task and cost per student. Primary analysis will use generalised estimating equations with cluster-robust SEs, adjusted for baseline covariates; the intra-cluster correlation coefficient and design effect will be reported; intention-to-treat will be applied. ETHICS AND DISSEMINATION: Universiti Putra Malaysia JKEUPM-2024-887; approvals from the Ministry of Education, Malaysia. Findings will be disseminated in peer-reviewed outlets and shared with education and health authorities to inform school-health programming. De-identified data and code will be made available on publication, subject to approvals. TRIAL REGISTRATION NUMBER: Thai Clinical Trial Registry (TCTR20241222001).

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