Plain English Summary
Not provided at time of registration
Trial website
http://www.forebyggelsescenter.dk/side.asp?side=8&id=12&ver=uk
Contact information
Type
Scientific
Primary contact
Mr Jens Troelsen
ORCID ID
Contact details
Campusvej 55
Odense M
5230
Denmark
-
jtroelsen@health.sdu.dk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A block randomised controlled trial evaluating the effect of a multilevel intervention to promote physical activity in adolescents
Acronym
Space
Study hypothesis
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
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).
Study design
Controlled randomised block design with 2-year follow up
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measure
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).
Secondary outcome measures
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)
Overall trial start date
01/04/2010
Overall trial end date
30/06/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Children attending 5th or 6th grade at one of the 14 participating schools in April 2010
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
1348 in total (623 in the intervention group and 725 in the control group)
Participant exclusion criteria
Children following special education classes
Recruitment start date
01/04/2010
Recruitment end date
30/06/2012
Locations
Countries of recruitment
Denmark
Trial participating centre
Campusvej 55
Odense M
5230
Denmark
Sponsor information
Organisation
Trygfonden (Denmark)
Sponsor details
Lyngby Hovedgade 4,2
Kgs. Lyngby
2800
Denmark
-
info@trygfonden.dk
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Trygfonden (Denmark)
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
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21985278
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24921948
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28115424
Publication citations
-
Protocol
Toftager M, Christiansen LB, Kristensen PL, Troelsen J, SPACE for physical activity--a multicomponent intervention study: study design and baseline findings from a cluster randomized controlled trial., BMC Public Health, 2011, 11, 777, doi: 10.1186/1471-2458-11-777.
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Results
Toftager M, Christiansen LB, Ersbøll AK, Kristensen PL, Due P, Troelsen J, Intervention effects on adolescent physical activity in the multicomponent SPACE study: a cluster randomized controlled trial., PLoS ONE, 2014, 9, 6, e99369, doi: 10.1371/journal.pone.0099369.