Effect of a school-based physical activity intervention program on fitness and health in Swiss 7 to 11 year old children

ISRCTN	ISRCTN15360785
DOI	https://doi.org/10.1186/ISRCTN15360785
Protocol serial number	SWI05-013 (KISS)
Sponsor	Swiss Federal Institute of Technology and University of Zurich (Switzerland)
Funder	Federal Office of Sports, Magglingen (Switzerland) (ref: SWI05-013 [KISS])

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Lukas Zahner
Scientific

Institute for Exercise and Health Sciences
University of Basle
Brüglingen 33
Basel
4052
Switzerland

Phone	+41 (0)61 377 87 55
Email	lukas.zahner@unibas.ch

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	KISS
Study objectives	It is hypothesised that the intervention will result in an increase of physical activity, fitness and health in the intervention group compared to the controls.
Ethics approval(s)	Approved by the Ethics Committees of the University of Basel, the University of Zürich, as well as by the Cantonal Ethical Committee of Aargau, Switzerland.
Health condition(s) or problem(s) studied	Healthy children with about 20% obese children included
Intervention	The intervention will comprise environmental changes at school (i.e. daily physical activity) and individual components at home aiming at improving pattern and extent of physical activity and the control will have a usual school physical activity curriculum.
Intervention type	Other
Primary outcome measure(s)	1. Total physical activity 2. Aerobic fitness 3. Percentage body fat 4. Bone mineral density of the femur 5. Quality of life
Key secondary outcome measure(s)	1. Body composition (total lean and fat mass) 2. Body fat distribution 3. Additional cardiovascular risk factors 4. Bone mineral density of total body and lumbar spine and as well as bone mineral content of all measured sites 5. Bone metabolism 6. Overall fitness 7. Psychosocial health, social coping, stress coping, social anxiety, self esteem and addiction 8. Nutritional behaviour
Completion date	31/12/2009

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	600
Key inclusion criteria	Healthy children
Key exclusion criteria	Children with severe chronic disease (cyanotic heart disease, cystic fibrosis, asthma, motor disabilities)
Date of first enrolment	31/10/2005
Date of final enrolment	31/12/2009

Institute for Exercise and Health Sciences

Basel
4052
Switzerland

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

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	23/02/2010	Yes	No
Results article	results	03/02/2014	Yes	No
Protocol article	protocol	06/06/2006	Yes	No
Other publications	crossvalidation of analysis techniques	01/05/2009	Yes	No