|- candidate number||6138|
|- NTR Number||NTR1923|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-jul-2009|
|- Secondary IDs||71100003 ZonMW|
|- Public Title||YouR Action.|
|- Scientific Title||YouR Action: Development and evaluation of interventions to promote moderate to vigorous PA in adolescents, tailored to
personal motivations and environmental opportunities |
|- hypothesis||1. The intervention groups will have more favourable outcomes on the targeted behaviours and BMI, compared to the control group at follow-up;|
2. The "motivational and environmental" tailored intervention group will have more favourable outcomes on the targeted behaviours, compared to the motivational only tailored group at follow-up;
3. The intervention groups will be more aware of their risk behaviours, having more favorable perceptions of the opportunities to be active in their neighbourhood and have more positive attitudes, perceived behavioural control and intentions for their physical activity behaviours, compared to the control group at follow-up;
4. The "motivational and environmental" tailored intervention group will have more favorable outcomes on perceptions of opportunities to be active in their neighbourhood compared to the motivational only intervention group.
In addition to testing these main hypotheses, secondary analysis will be performed to answer other relevant research questions.
|- Healt Condition(s) or Problem(s) studied||Adolescents, Moderate to Vigorous Physical Activity, Sports|
|- Inclusion criteria||Secondary schools (locations) in the municipal health organization regions: Rotterdam and surrounding areas, Zuid-Holland Zuid and Zuid-Hollandse Eilanden.|
|- Exclusion criteria||Schools were pupils have very low reading skills (i.e. pupils that are not able to fill in a questionnaire).|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2009|
|- planned closingdate||31-jul-2010|
|- Target number of participants||1605|
|- Interventions||Motivational only tailored group:|
The pupils in the motivational only tailored group will receive a computer tailored intervention targetting motivational factors (attitude, perceived behavioral control, subjective norm, awareness, implementation intentions).
Environmental and motivational tailored group:
Pupils in the environmental and motivational tailored group will receive the same intervention as the motivational only tailored group, but this is extended by use of GoogleMaps to target perceptions of opportunities to be active in their environment.
The control group will receive a non-tailored webbased intervention on physical activity and sports.
All pupils will have the same exposure to the interventions. The interventions will be used during 3 schoolhours (45 minutes each).
|- Primary outcome||1. Physical activity measured with self-report questionnaires;|
2. Physical activity sub-behaviours measured with self-reported questionnaires.
|- Secondary outcome||1. Objectively measured physical activity by using an accelerometer at baseline, 1 month follow-up and 6 months follow-up;|
2. BMI calculated from measured height and weight, at baseline and at 6 months follow-up;
3. Waist circumference measured between hipbone and lowest rib, at baseline and at 6 months follow-up;
4. Awareness of physical activity levels, physical activity attitudes, perceived behavioral control, and motivation to engage in physical activity behaviours, measured with self-report questionnaires at baseline, one month and 6 months follow-up;
5. Perceived opportunities to be active in the neighborhood, measured with self-reported questionnaires at baseline, one month and 6 months folllow-up.
|- Timepoints||1. September-October 2009: Baseline measurements;|
2. October-November 2009: Intervention use;
3. November-December 2009: Short term follow-up measurements;
4. May-June 2010: Long term follow-up measurements.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||PhD. R.G. Prins|
|- CONTACT for SCIENTIFIC QUERIES||PhD. Anke Oenema|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Background:|
Computer-tailored health education may be especially suited to address complicated health-related behaviors such as physical activity (PA). PA is associated with important public health issues of today such as overweight, cardio-vascular diseases, and certain cancers. Furthermore, web-based computer-tailored health education might best appeal to the -Internet generation-, i.e. younger people, including children and adolescents. Physical activity patterns are established in childhood and adolescence and declines in PA have been observed between first year of secondary school and third year of secondary school. Therefore PA should be encouraged in young people. Most intervention to date have focussed only on motivational factors to be active. However, recent theory and evidence suggests that environmental opportunities to be active might also be important.
The present study proposes to test the effectiveness of web-based computer-tailored PA interventions aimed at adolescents in the first year of secondary school (12-13 years old). One version will target only motivational determinants, the other on top of that also environmental opportunities to be physically active Methods: We will test this application in a real-life implementation environment in a cluster randomized controlled trial with randomization on class level. The follow-up periods will be one month and six months. Primary outcome indicators will be physical activity and physical activity sub-behaviours measured by a self-administered questionnaire. Secondary outcomes will be objectively meaured PA, Body Mass Index and Waist circumference, measured by trained research staff and psychosocial determinants of PA behaviours, and perceptions of opportunities to be physically active measured with self-administered questionnaires.
|- Main changes (audit trail)|
|- RECORD||23-jul-2009 - 10-okt-2009|