ISRCTN ISRCTN34562078
DOI https://doi.org/10.1186/ISRCTN34562078
Secondary identifying numbers 223254
Submission date
29/07/2011
Registration date
11/10/2011
Last edited
16/05/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Background and study aims
The aim of this study is to test a school-based, family-involved scheme to promote health behaviours that help to prevent obesity in children aged 10-12 years old across Europe. The scheme, called Up4fun, aims to reduce sitting time in school and at home (with special emphasis on TV and PC/electronic games)

Who can participate?
10-12 year old children at selected schools.

What does the study involve?
Participating schools will be randomly allocated to either the intervention group or the control group. The control group schools were asked to continue with their usual school curriculum. The intervention group schools took part in the Up4fun scheme for 6 weeks in the fall semester of 2011.
The teachers involved will be given training and are requested to spend one school hour (45 minutes) to teach a pre-planned lesson each week for 5 weeks. Weekly newsletters (6 in total) for the parents and pre-planned homework for the children will be handed out by the teacher. The parents will be fully informed about the contents and the aims of the study and will be asked for consent for the participation of their child. The pupils will complete questionnaires about their sedentary (sitting) behaviours, physical activity and dietary habits. Additionally, some of the children’s physical activity levels will be measured using accelerometers. The parents will also complete a questionnaire about their own and their child’s nutritional and physical activity.

What are the possible benefits and risks of participating?
The scheme may help to reduce the prevalence of obesity and improve public health. No risks are involved, but the questionnaires take time and might be boring to fill out, a few questions might be uncomfortable for some to answer.

Where is the study run from?
The study is run from centres in Belgium, Germany, Greece, Hungary and Norway. The lead centre is University of Agder, Norway. The project leader is based in VU University Medical Center, Amsterdam, the Netherlands.

When is the study starting and how long is it expected to run for?
From September 2011 to run for 6 weeks.

Who is funding the study?
The European Commission.

Who is the main contact?
Amika Singh

Contact information

Prof Johannes Brug
Scientific

VU University Medical Center Amsterdam
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Email j.brug@vumc.nl

Study information

Study designMulticenter randomized intervention study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)School
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEuropean ENERGY balance research to prevent excessive weight gain among youth: WP9 evaluating the evidence-based intervention promoting healthy energy balance among 10-12 year olds
Study acronymENERGY Up4fun
Study hypothesisConduct a process and outcome evaluation of the Up4fun intervention.
Ethics approval(s)Belgium: Ghent University Hospital, 30/11/2009, ref. EC UZG 2009/545
Germany: State Medical Chamber of Baden-Württemberg
Greece: Harokopio University Bioethics Committee
Hungary: Scientific and Ethics Committee of Health Sciences Council, 28 May 2010, ref: 4979-0/2010-1018 EKU, valid until 31/01/2012
Norway: Regional Committees for Medical and Health Research Ethics, 5 July 2011, ref: 2011/919b, valid until 30/06/2012
ConditionPrevention of excessive weight gain by reducing sedentary behaviour
InterventionThe intervention, including about 10 schools (5 intervention schools and 5 control schools) in each of the 5 participating countries primarily aiming at reducing sitting time in school and at home (with special emphasis on television and personal computer (PC)/electronic games), will last for 6 weeks in the fall semester of 2011 in the intervention schools. The teachers involved will be given training (1.5 hours) as week 0 of the intervention, and completed materials to be used are provided by project workers. During the project period teachers are requested to spend one school hour (45 minutes) to teach a pre-planned lesson each week for 5 weeks. Weekly newsletters (6 in total) for the parents and pre-planned homework for the children will be handed out by the teacher.
Intervention typeBehavioural
Primary outcome measureScreen time behaviours (TV/DVD watching and computer/games consol usage) measured with frequency questions (hours/day). Measured pre and post intervention.
Secondary outcome measures1. Determinants of screen time behaviours measured pre and post intervention
2. Sedentary time and breaking up of sedentary time measured with accelerometers measured pre and post intervention
Overall study start date01/09/2011
Overall study end date31/12/2011

Eligibility

Participant type(s)Healthy volunteer
Age groupChild
Lower age limit10 Years
Upper age limit12 Years
SexBoth
Target number of participants2500 pupils and parents
Participant inclusion criteriaAll school children in two grade levels (age 10-12) in the included schools, and one of their parents
Participant exclusion criteriaNo parental consent
Recruitment start date01/09/2011
Recruitment end date31/12/2011

Locations

Countries of recruitment

  • Belgium
  • Germany
  • Greece
  • Hungary
  • Netherlands
  • Norway

Study participating centre

VU University Medical Center Amsterdam
Amsterdam
1081 BT
Netherlands

Sponsor information

European Commission (Belgium)
Government

Research Directorate-General
F2
Brussels
B-1049
Belgium

ROR logo "ROR" https://ror.org/00k4n6c32

Funders

Funder type

Government

Seventh Framework Programme
Government organisation / National government
Alternative name(s)
EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 18/08/2014 Yes No
Results article results 31/03/2015 Yes No
Results article results 01/10/2015 Yes No

Editorial Notes

16/05/2016: publication reference added.