|- candidate number||10448|
|- NTR Number||NTR3116|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-okt-2011|
|- Secondary IDs||11-T-25 MEC Atrium-Orbis-Zuyd|
|- Public Title||Smoking prevention program (Fun without Smokes).|
|- Scientific Title||The implementation of 'Fun without Smokes' a smoking prevention program for primary school children.|
|- hypothesis||1. Providing children with tailored non-smoking advice will prevent them from becoming a smoker;|
2. Children receiving tailored non-smoking advice will have stronger cognitions in favour of non-smoking;
3. Prompting children through e-mail and SMS will have a stronger effect than non-prompting on smoking initiation;
4. Prompting children through e-mail and SMS will have a stronger effect than non-prompting on cognitions in favour of non-smoking;
5. Children in the prompting condition will visit the website more often than children in the non-prompting condition.
|- Healt Condition(s) or Problem(s) studied||Computer tailoring, Internet-interventions, Text-messaging reminder, Smoking prevention, Primary schools, Primary school children, Prompting, E-mail|
|- Inclusion criteria||1. Participants are primary school children in grade 7;|
2. Children have access to a computer and Internet at school and at home.
|- Exclusion criteria||1. Parents refuse their child(ren) to participate;|
2. Children refuse to participate;
3. Special education schools;
4. Schools using the program 'Ik (r)ook niet'.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2011|
|- planned closingdate||30-nov-2013|
|- Target number of participants||3600|
|- Interventions||The computer tailored intervention will consist of two experimental groups. After completing the online questionnaire regarding their attitudes, self-efficacy and other factors related to smoking the participants in the experimental groups will receive computer tailored feedback reports. These reports are based on the answers they filled out in the online questionnaire. The difference between these two groups is that one group will be proactively prompted (via SMS and e-mail) to revisit the website (prompt group), with information about smoking, whereas the other group will not be prompted (non-prompt group).
The control group will complete the online questionnaire but receives nothing (no computer tailored feedback reports and no prompts).
|- Primary outcome||The primary outcome measures will be: ever smoking and the level of utilization of the 'Fun without Smokes' website.|
|- Secondary outcome||The secondary outcomes will be: Attitudes, self-efficacy, intention not to smoke and monthly smoking.|
|- Timepoints||1. Baseline measurement;|
2. 12 months follow-up;
3. 24 months follow-up.
|- Trial web site||www.leukzonderpeuk.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Paul Cremers|
|- CONTACT for SCIENTIFIC QUERIES|| Paul Cremers|
|- Sponsor/Initiator ||University Maastricht (UM)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Smoking is a leading cause of morbidity and mortality. Tobacco use represents a major health risk and is a preventable cause of many chronic diseases, including coronary heart disease and various types of cancers. It is known from previous studies the earlier people start to smoke the more likely they will become regular smokers.
Especially the transition from primary school to secondary school is a period of risk to start smoking. In this period youngsters experience pressure and stress, and want to belong to a group. If someone offers them a cigarette they need positive attitudes, self-efficacy and skills to refuse that cigarette.|
The present study will include primary school students from grade 7 and will follow them to the first class of the secondary school. With computer tailored feedback we will give the youngsters (in the experimental groups) information about their attitudes, self-efficacy and social norms helping them not to start (experimenting with) smoking. Computer tailored feedback has shown to be effective in reaching adolescents, also in smoking prevention trials. Furthermore, we will test the efficacy of a proactive approach using prompts in order to maintain interest and attention of the pupils. Several studies suggest that the utilization of a proactive approach will yield higher participation rates.
|- Main changes (audit trail)|
|- RECORD||18-okt-2011 - 7-nov-2011|