CONSORT-EHEALTH Checklist V1.6.2 Report (based on CONSORT-EHEALTH V1.6), available at [http://tinyurl.com/consort-ehealth-v1-6]. 3794 Date completed 8/18/2014 5:01:37 by Henricus-Paul Cremers Is a Web-based Computer-tailored Smoking Prevention Program effective in Preventing Children to start Smoking after they transfer to Secondary School? Findings of a Randomized Controlled Trial at 12 and 25 Months of Follow-up TITLE 1a-i) Identify the mode of delivery in the title "web-based" 1a-ii) Non-web-based components or important co-interventions in title 1a-iii) Primary condition or target group in the title "preventing children to start smoking after they transfer to secondary school" ABSTRACT 1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT "A total of 3213 children (10 – 12 years) participated in the study and completed a web-based questionnaire assessing their smoking intention, smoking behavior and socio-cognitive factors (i.e. attitude, social influence and self-efficacy) related to smoking. After completion, children in the intervention groups received computer-tailored feedback letters that were sent by email and that could be accessed on the intervention website. Children in the prompt group received prompt messages (via email and SMS) to stimulate them to reuse the intervention website with non-smoking content." 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT 1b-iv) RESULTS section in abstract must contain use data 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials INTRODUCTION 2a-i) Problem and the type of system/solution "Smoking among children and adolescents remains a public health problem [1-3], potentially leading to chronic diseases, cardiovascular diseases or cancer at a later age [4, 5]. Although, smoking prevalence among Dutch primary school children at the age of 12 has decreased in the past decade from 2 – 5% to 0% [6, 7] this percentage still increases rapidly when children are in secondary school (13% is a daily smoker at age 15) [6]. One prevention strategy suggested is to start smoking prevention programs already at primary school, before positive beliefs toward smoking are formed [8]. Given the advantages of a web-based computer-tailored approach (i.e. reduced cost and an expanded reach of participants) [9-11] and the increasing use of the Internet among Dutch children (i.e. 96% Internet use at 11 – 14 years of age) [12] web-based computer-tailored smoking prevention programs may be helpful in decreasing smoking initiation rates among children." 2a-ii) Scientific background, rationale: What is known about the (type of) system "Previous studies [9, 10, 19] reported web-based computer-tailored programs to be effective in changing unhealthy behaviors both among adults, adolescents and children." "This requires the use of optimal strategies to improve adherence. According to previous research [25-29] prompt messages may be effective in stimulating participants to reuse a web-based intervention. However, using prompt messages in smoking prevention trials has not been studied among children before." METHODS 3a) CONSORT: Description of trial design (such as parallel, factorial) including allocation ratio "The aim of this study was to evaluate whether computer-tailored feedback letters with and without prompt messages are effective in decreasing the smoking intentions and smoking behavior of Dutch primary school children (aged 10 – 12 years) after 12 and 25 months of follow-up. Furthermore, it is known that children with a low socioeconomic status (SES) engage more often in smoking [30] and have a higher intention to start smoking [31], as compared to high SES children. Therefore it will also be assessed whether SES moderates the effects of the two versions of the intervention." 3b) CONSORT: Important changes to methods after trial commencement (such as eligibility criteria), with reasons Not applicable 3b-i) Bug fixes, Downtimes, Content Changes 4a) CONSORT: Eligibility criteria for participants "Children of all participating schools were all included in the intervention trial at T0, unless they or their parents refused to be involved (1.7% refused at T0). The participating children in the present study were Dutch primary school children of grade 7 (aged 10 – 11 years), they were followed in grade 8 (T1) and when they transferred to secondary school (T2)." 4a-i) Computer / Internet literacy 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: "For the present study approximately 3500 primary schools were approached by seven Dutch Municipal Health Promotion Organizations and Maastricht University." 4a-iii) Information giving during recruitment 4b) CONSORT: Settings and locations where the data were collected "At T0 and T1 children completed the web-based questionnaire at their primary school under supervision of their teacher. At T2 children made the transition to secondary school and had to complete the web-based questionnaire outside school on their own initiative. In this period all children who participated at T0 received an information letter sent by postal mail at their home address to complete the web-based questionnaire for the last time. If children had provided their email address and/or mobile phone number at T0 or T1, they also received email and/or short message service (SMS) messages to remind them to complete the final web-based questionnaire." 1