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Population Based Intervention to Prevent Obesity in Kindergartens (TigerKids)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by Ludwig-Maximilians - University of Munich.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00336128
First Posted: June 13, 2006
Last Update Posted: May 7, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Child Health Foundation
Bavarian State Ministry of Environment, Public Health and Consumer Protection
Bavarian Health and Food Safety Authority (LGL)
Institute for Social Paediatrics and Adolescent Medicine, Munich
State Institute of Early Childhood Research, Munich
AOK.Die Gesundheitskasse
Research Centre for Physical Education and Sports of Children and Adolescents, Karlsruhe
Information provided by:
Ludwig-Maximilians - University of Munich
June 12, 2006
June 13, 2006
May 7, 2008
October 2003
May 2006   (Final data collection date for primary outcome measure)
  • Body mass index [ Time Frame: 2005, 2006, 2007, 2008 ]
  • nutrition behavior [ Time Frame: 2005, 2006, 2007, 2008 ]
  • physical activity [ Time Frame: 2005, 2006, 2007, 2008 ]
  • Body mass index
  • nutrition behavior
  • physical activity
Complete list of historical versions of study NCT00336128 on ClinicalTrials.gov Archive Site
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Population Based Intervention to Prevent Obesity in Kindergartens (TigerKids)
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Behavioral intervention at Kindergarten setting aiming at increased fruit and vegetable consumption, decreased intake of high energy foods, snacks, sweets, increased intake of water/low energy drinks, decreased intake of high energy drinks. Physical activity should be more than 1 hour/day and TV/media consumption less than 1 hour/day.

Main questions are:

Do children differ in intervention and control kindergartens according to their nutrition behaviour? Do children in the intervention kindergartens have a higher physical training than such in the control kindergartens? Data were collected with a standardised questionnaire.

Do children differ in intervention and control kindergartens according to their body mass index?

The program is based on actual cognitions and methods of the early education science. In the initial phase study part I (2003-2006) we will study over three years in 75 kindergartens of four administrative districts in Bavaria, Germany: Bamberg, Günzburg, Ingolstadt and Schwandorf.

The objective of the study part II is to evaluate the effects of the TigerKids intervention program on overweight prevalence in childhood. Data concerning BMI, nutrition behavior and physical activity are assessed both at baseline (September/October 2007) and after 10 months intervention in > 450 control- and intervention-kindergartens in Bavaria.

Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Obesity
  • Behavioral: attitude change
    TigerKids: setting based prevention program to reduce obesity risk factors in children
  • Behavioral: adiposity prevention program
    The behavioral intervention aimed at modifying physical activity and food and drink choices at the kindergarten setting
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Bayer O, von Kries R, Strauss A, Mitschek C, Toschke AM, Hose A, Koletzko BV. Short- and mid-term effects of a setting based prevention program to reduce obesity risk factors in children: a cluster-randomized trial. Clin Nutr. 2009 Apr;28(2):122-8. doi: 10.1016/j.clnu.2009.01.001. Epub 2009 Mar 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30000
July 2009
May 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • infant of intervention- or control-kindergarten

Exclusion Criteria:

  • absence of parenteral consent to participate
Sexes Eligible for Study: All
3 Years to 7 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
Germany
 
NCT00336128
UGV 03050904006
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Berthold Koletzko, M.D., Professor of Paediatrics, Dr. von Hauner Children´s Hospital, Ludwig-Maximilians-University, Munich, Germany
Ludwig-Maximilians - University of Munich
  • Child Health Foundation
  • Bavarian State Ministry of Environment, Public Health and Consumer Protection
  • Bavarian Health and Food Safety Authority (LGL)
  • Institute for Social Paediatrics and Adolescent Medicine, Munich
  • State Institute of Early Childhood Research, Munich
  • AOK.Die Gesundheitskasse
  • Research Centre for Physical Education and Sports of Children and Adolescents, Karlsruhe
Principal Investigator: Berthold Koletzko, Prof. Ludwig-Maximilians-Universitaet
Ludwig-Maximilians - University of Munich
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP