Aim: To assess the efficacy of World Wide Web-based tailored behavioral smoking cessation materials among nicotine patch users.

Design: Two-group randomized controlled trial.

Setting: World Wide Web in England and Republic of Ireland.

Participants: A total of 3971 subjects who purchased a particular brand of nicotine patch and logged-on to use a free web-based behavioral support program.

Intervention: Web-based tailored behavioral smoking cessation materials or web-based non-tailored materials.

Measurements: Twenty-eight-day continuous abstinence rates were assessed by internet-based survey at 6-week follow-up and 10-week continuous rates at 12-week follow-up.

Findings: Using three approaches to the analyses of 6- and 12-week outcomes, participants in the tailored condition reported clinically and statistically significantly higher continuous abstinence rates than participants in the non-tailored condition. In our primary analyses using as a denominator all subjects who logged-on to the treatment site at least once, continuous abstinence rates at 6 weeks were 29.0% in the tailored condition versus 23.9% in the non-tailored condition (OR = 1.30; P = 0.0006); at 12 weeks continuous abstinence rates were 22.8% versus 18.1%, respectively (OR = 1.34; P = 0.0006). Moreover, satisfaction with the program was significantly higher in the tailored than in the non-tailored condition.

Conclusions: The results of this study demonstrate a benefit of the web-based tailored behavioral support materials used in conjunction with nicotine replacement therapy. A web-based program that collects relevant information from users and tailors the intervention to their specific needs had significant advantages over a web-based non-tailored cessation program.