Condition category
Not Applicable
Date applied
07/12/2010
Date assigned
07/02/2011
Last edited
13/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://trygfonden.dk/

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

Results - basic reporting

Publication summary

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21985278
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24921948

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes