Clinical trial NCT00336128: Population Based Intervention to Prevent Obesity in Kindergartens (TigerKids)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: infant
kindergarten
obesity
adiposity
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Child Health Foundation
name: Bavarian State Ministry of Environment, Public Health and Consumer Protection
name: Bavarian Health and Food Safety Authority (LGL)
name: Institute for Social Paediatrics and Adolescent Medicine, Munich
name: State Institute of Early Childhood Research, Munich
name: AOK.Die Gesundheitskasse
name: Research Centre for Physical Education and Sports of Children and Adolescents, Karlsruhe
First posted: 2006-06-13
Enrollment: 30000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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?

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* infant of intervention- or control-kindergarten

Exclusion Criteria:

* absence of parenteral consent to participate

Primary outcomes:
measure: Body mass index
timeFrame: 2005, 2006, 2007, 2008
measure: nutrition behavior
timeFrame: 2005, 2006, 2007, 2008
measure: physical activity
timeFrame: 2005, 2006, 2007, 2008
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ludwig-Maximilians-Universitaet
name: Berthold Koletzko, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.