ISRCTN ISRCTN79122411
DOI https://doi.org/10.1186/ISRCTN79122411
Secondary identifying numbers N/A
Submission date
07/12/2010
Registration date
07/02/2011
Last edited
17/07/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Mr Jens Troelsen
Scientific

Campusvej 55
Odense M
5230
Denmark

Email jtroelsen@health.sdu.dk

Study information

Study designControlled randomised block design with 2-year follow up
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleA block randomised controlled trial evaluating the effect of a multilevel intervention to promote physical activity in adolescents
Study acronymSpace
Study objectivesThe aim of the study is to assess the effect of a multilevel intervention on adolescent daily physical activity and physical fitness in seven intervention schools compared with seven control schools.
Ethics approval(s)The study has been considered by the Danish Ethical Committee and they concluded that formal ethics approval was not required. This project is registered at the Danish Data Protection Agency (Datatilsynet) (ref: 2009-41-3628).
Health condition(s) or problem(s) studiedPhysical activity and physical fitness
InterventionThe intervention will comprise four areas. The intervention areas will be aimed at:
1. Active transport
2. The school's outdoor areas
3. Playspots
4. Organised physical fitness

For each of the intervention areas, a number of physical improvements will be implemented in the districts to either modify existing structures or to establish new ones. Furthermore, the physical structural enhancement, distributed on the interventions, will be followed up by organisational interventions that support the possibilities of activity by use of, for instance, activity assistants, changed access conditions or traffic action plans. It is a common feature of the intervention areas that they will be manageable for a municipality to establish and maintain as far as size and financial level are concerned.
Intervention typeOther
Primary outcome measureAverage daily physical activity measured with accelerometer (counts/min/child/day).

The primary outcome will be supported by analyses of time spent in moderate to vigorous activity and time spent sedentary measured with accelerometer (min/day).
Secondary outcome measuresSecondary outcome measures:
1. Overweight measured with waist circumference (cm)
2. Physical fitness measured with 'the Andersen test' (metre)
3. Active transport to/from school measured with diary (times/week)
4. Physical activity in recess periods measured with accelerometer (counts/min)

Predefined explorative outcome measures:
1. The primary and secondary outcome measures will be analyzed for four different subpopulations defined by: physical activity at baseline, parental socioeconomic status, weight status at baseline and gender
2. Grip strength measured with digital hand dynamometer (kg)
3. Time spent on television viewing, computer or other sedentary activities measured with questionnaire (hours/day)
4. Time spent on biking measured with diary (times/week)
5. School satisfaction measured with questionnaire (index five categories of liking school)
6. Self-rated health measured with questionnaire (index four categories)
7. Social network measured with questionnaire (time spent with friends and family)
8. Experience of subjective health complaints measured with questionnaire (numbers and times of multiple experienced health complaints)
Overall study start date01/04/2010
Completion date30/06/2012

Eligibility

Participant type(s)Patient
Age groupChild
SexBoth
Target number of participants1348 in total (623 in the intervention group and 725 in the control group)
Key inclusion criteriaChildren attending 5th or 6th grade at one of the 14 participating schools in April 2010
Key exclusion criteriaChildren following special education classes
Date of first enrolment01/04/2010
Date of final enrolment30/06/2012

Locations

Countries of recruitment

  • Denmark

Study participating centre

Campusvej 55
Odense M
5230
Denmark

Sponsor information

Trygfonden (Denmark)
Industry

Lyngby Hovedgade 4,2
Kgs. Lyngby
2800
Denmark

Email info@trygfonden.dk
Website http://trygfonden.dk/
ROR logo "ROR" https://ror.org/02rcazp29

Funders

Funder type

Industry

Trygfonden (Denmark)

No information available

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?
Protocol article protocol 10/10/2011 Yes No
Results article results 12/06/2014 Yes No
Results article results 01/02/2017 Yes No

Editorial Notes

17/07/2018: Publication reference added.