Contact information
Type
Scientific
Contact name
Ms Nicole Ezendam
ORCID ID
Contact details
Erasmus Medical Centre
Department of Public Health
Room AE-139
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 408 9253
n.ezendam@erasmusmc.nl
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
ZonMw: 3138
Study information
Scientific title
Acronym
Study hypothesis
1. The intervention group will have a lower Body Mass Index (BMI)/waist circumference, compared to the control group at follow-up
2. The intervention group will have more favourable outcomes on the targeted behaviours, compared to the control group at follow-up
3. The intervention group will be more aware of their risk behaviours and have more positive attitudes, perceived behavioural control and intentions to change for their risk behaviours, compared to the control group at follow-up
4. Availability and accessibility of foods and physical activity opportunities moderates the intervention effects
In addition to testing these main hypotheses, secondary analysis will be performed to answer other relevant research questions.
Ethics approval(s)
Approval received from the local medical ethics committee (Medisch Ethische Toetsings Commissie Erasmus MC [METC]) on the 7th June 2006 (ref: MEC-2005-364).
Study design
Randomised, controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
No condition, healthy person
Intervention
Intervention group:
The pupils in the intervention schools will use a computer-tailored intervention on weight gain related behaviours (physical activity, sedentary behaviour, snack, fruit and vegetable, fibre and soft-drink consumption) during their first year of secondary school. The intervention will be used during school hours as part of the education program. The intervention will be used for an average of two hours (preferably divided by eight times 15 minutes) within ten subsequent weeks.
Control group:
The control group will receive regular school lessons. After two years the intervention will be available for the control group as well.
Intervention type
Other
Primary outcome measure
1. BMI calculated from measured height and weight, at baseline and two year follow-up
2. Waist circumference measured between hip bone and lowest rib, at baseline and two year follow-up
Secondary outcome measures
1. Physical activity measured with self-report questionnaires plus pedometer counts (for part of the participants) at baseline, three months and two year follow-up
2. Physical condition measured with a shuttle-run-test at baseline and two year follow-up
3. Various dietary sub-behaviours, i.e. fruit and vegetable consumption, soft-drink consumption, snack consumption and fibre consumption measured with self-report questionnaires at baseline, three months and two year follow-up
4. Amount of television viewing/time spend with the computer measured with self-report questionnaires at baseline, three month and two year follow-up
5. Awareness of personal bodyweight status, overweight-related risk perceptions, weight maintenance attitudes, perceived behavioural control, and motivation to engage in weight maintenance behaviours, measured with self-report questionnaires at baseline, three months and two year follow-up
6. Determinants of change for the separate dietary, physical activity and sedentary behaviours, as measured by self-report questionnaires, distributed at baseline, three months and two year follow-up
Overall study start date
01/06/2006
Overall study end date
30/06/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Secondary schools (locations) in the municipal health organisation regions: Rotterdam and surrounding areas and Nieuwe Waterweg Noord.
Participant type(s)
Patient
Age group
Child
Sex
Not Specified
Target number of participants
1200
Participant exclusion criteria
1. Schools (locations) where pupils have very low reading capacity (i.e. pupils that are not able to fill in a questionnaire)
2. Schools (locations) that offer special sports education (i.e. special sports schools)
3. Schools (locations) where the pupils could not be followed-up to the third year, i.e. schools that only provide education for the first two years of secondary education (onderbouw) and where the pupils could not be tracked to other
Recruitment start date
01/06/2006
Recruitment end date
30/06/2009
Locations
Countries of recruitment
Netherlands
Study participating centre
Erasmus Medical Centre
Rotterdam
3000 CA
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (The Netherlands)
Sponsor details
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | study protocol | 12/11/2007 | Yes | No | |
| Results article | results | 01/03/2012 | Yes | No | |
| Other publications | evaluation | 01/03/2013 | Yes | No |