Space - for physical activity

ISRCTN	ISRCTN79122411
DOI	https://doi.org/10.1186/ISRCTN79122411
Protocol serial number	N/A
Sponsor	Trygfonden (Denmark)
Funder	Trygfonden (Denmark)

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

Contact information

Mr Jens Troelsen
Scientific

Campusvej 55
Odense M
5230
Denmark

Email	jtroelsen@health.sdu.dk

Study information

Primary study design	Interventional
Study design	Controlled randomised block design with 2-year follow up
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A block randomised controlled trial evaluating the effect of a multilevel intervention to promote physical activity in adolescents
Study acronym	Space
Study objectives	The 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) studied	Physical activity and physical fitness
Intervention	The 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 type	Other
Primary outcome measure(s)	Average 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).
Key secondary outcome measure(s)	Secondary 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)
Completion date	30/06/2012

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	1348
Key inclusion criteria	Children attending 5th or 6th grade at one of the 14 participating schools in April 2010
Key exclusion criteria	Children following special education classes
Date of first enrolment	01/04/2010
Date of final enrolment	30/06/2012

Locations

Countries of recruitment

Denmark

Study participating centre

Campusvej 55

Odense M
5230
Denmark

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	12/06/2014		Yes	No
Results article	results	01/02/2017		Yes	No
Protocol article	protocol	10/10/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

17/07/2018: Publication reference added.