Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/10/2005
Date assigned
22/11/2005
Last edited
06/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lukas Zahner

ORCID ID

Contact details

Institute for Exercise and Health Sciences
University of Basle
Brüglingen 33
Basel
4052
Switzerland
+41 (0)61 377 87 55
lukas.zahner@unibas.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SWI05-013 (KISS)

Study information

Scientific title

Acronym

KISS

Study hypothesis

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

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.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

1. Total physical activity
2. Aerobic fitness
3. Percentage body fat
4. Bone mineral density of the femur
5. Quality of life

Secondary outcome measures

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

Overall trial start date

31/10/2005

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy children

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

600

Participant exclusion criteria

Children with severe chronic disease (cyanotic heart disease, cystic fibrosis, asthma, motor disabilities)

Recruitment start date

31/10/2005

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Switzerland

Trial participating centre

Institute for Exercise and Health Sciences
Basel
4052
Switzerland

Sponsor information

Organisation

Swiss Federal Institute of Technology and University of Zurich (Switzerland)

Sponsor details

Exercise Physiology
Winterthurstr. 190
Zürich
8057
Switzerland
+41 (0)44 635 50 06
kriemler@access.unizh.ch

Sponsor type

Government

Website

http://www.unizh.ch/

Funders

Funder type

Government

Funder name

Federal Office of Sports, Magglingen (Switzerland) (ref: SWI05-013 [KISS])

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

1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16756652
2. 2009 crossvalidation of analysis techniques in http://www.ncbi.nlm.nih.gov/pubmed/18285806
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20179126
4. 2014 results in http://www.ncbi.nlm.nih.gov/pubmed/24498404

Publication citations

  1. Protocol

    Zahner L, Puder JJ, Roth R, Schmid M, Guldimann R, Pühse U, Knöpfli M, Braun-Fahrländer C, Marti B, Kriemler S, A school-based physical activity program to improve health and fitness in children aged 6-13 years ("Kinder-Sportstudie KISS"): study design of a randomized controlled trial [ISRCTN15360785]., BMC Public Health, 2006, 6, 147, doi: 10.1186/1471-2458-6-147.

  2. Crossvalidation of analysis techniques

    Kriemler S, Puder J, Zahner L, Roth R, Braun-Fahrländer C, Bedogni G, Cross-validation of bioelectrical impedance analysis for the assessment of body composition in a representative sample of 6- to 13-year-old children., Eur J Clin Nutr, 2009, 63, 5, 619-626, doi: 10.1038/ejcn.2008.19.

  3. Results

    Kriemler S, Zahner L, Schindler C, Meyer U, Hartmann T, Hebestreit H, Brunner-La Rocca HP, van Mechelen W, Puder JJ, Effect of school based physical activity programme (KISS) on fitness and adiposity in primary schoolchildren: cluster randomised controlled trial., BMJ, 2010, 340, c785.

  4. Results

    Meyer U, Schindler C, Zahner L, Ernst D, Hebestreit H, van Mechelen W, Rocca HP, Probst-Hensch N, Puder JJ, Kriemler S, Long-term effect of a school-based physical activity program (KISS) on fitness and adiposity in children: a cluster-randomized controlled trial., PLoS ONE, 2014, 9, 2, e87929, doi: 10.1371/journal.pone.0087929.

Additional files

Editorial Notes