Effect of mobile interventions with nicotine replacement therapy sampling on long-term smoking cessation in community smokers: A pragmatic randomized clinical trial

INTRODUCTION: Mobile interventions enable personalized behavioral support that could improve smoking cessation (SC) in smokers ready to quit. Scalable interventions, including unmotivated smokers, are needed. We evaluated the effect of personalized behavioral support through mobile interventions plus nicotine replacement therapy sampling (NRT-S) on SC in Hong Kong community smokers. METHODS: A total of 664 adult daily cigarette smokers (74.4% male, 51.7% not ready to quit in 30 days) were proactively recruited from smoking hotspots and individually randomized (1:1) to the intervention and control groups (each, n=332). Both groups received brief advice and active referral to SC services. The intervention group received 1-week NRT-S at baseline and 12-week personalized behavioral support through SC advisor-delivered Instant Messaging (IM) and a fully automated chatbot. The control group received regular text messages regarding general health at a similar frequency. Primary outcomes were carbon monoxide-validated smoking abstinence at 6 and 12 months post-treatment initiation. Secondary outcomes included self-reported 7-day point-prevalence and 24-week continuous abstinence, quit attempts, smoking reduction, and SC service use at 6 and 12 months. RESULTS: By intention-to-treat, the intervention group did not significantly increase validated abstinence at 6 months (3.9% vs 3.0%, OR=1.31; 95% CI: 0.57–3.04) and 12 months (5.4% vs 4.5%, OR=1.21; 95% CI: 0.60–2.45), as were self-reported 7-day point-prevalence abstinence, smoking reduction, and SC service use at 6 and 12 months. More participants in the intervention than control group made a quit attempt by 6 months (47.0% vs 38.0%, OR=1.45; 95% CI: 1.06–1.97). Intervention engagement rates were low, but engagement in IM alone or combined with chatbot showed higher abstinence at 6 months (adjusted odds ratios, AORs=4.71 and 8.95, both p<0.05). CONCLUSIONS: Personalized behavioral support through mobile interventions plus NRT-S did not significantly improve abstinence in community smokers compared to text only messaging. The suboptimal intervention engagement needs to be addressed in future studies. TRIAL REGISTRATION: ClinicalTrials.gov NCT04001972.