Population Based Intervention to Prevent Obesity in Kindergartens (TigerKids)

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	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
Information provided by:	Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:	NCT00336128

Purpose

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?

Condition	Intervention
Obesity	Behavioral: attitude change Behavioral: adiposity prevention program

MedlinePlus related topics: Obesity Obesity in Children

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:

Body mass index [ Time Frame: 2005, 2006, 2007, 2008 ] [ Designated as safety issue: Yes ]
nutrition behavior [ Time Frame: 2005, 2006, 2007, 2008 ] [ Designated as safety issue: Yes ]
physical activity [ Time Frame: 2005, 2006, 2007, 2008 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30000
Study Start Date:	October 2003
Estimated Study Completion Date:	July 2009
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Intervention Details:

TigerKids: setting based prevention program to reduce obesity risk factors in children

The behavioral intervention aimed at modifying physical activity and food and drink choices at the kindergarten setting

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

Ages Eligible for Study:	3 Years to 7 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

infant of intervention- or control-kindergarten

Exclusion Criteria:

absence of parenteral consent to participate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336128

Sponsors and Collaborators

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

Investigators

Principal Investigator:

Berthold Koletzko, Prof.

Ludwig-Maximilians-Universitaet

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Dr. von Hauner Children´s Hospital, Ludwig-Maximilians-University, Munich, Germany ( Berthold Koletzko, M.D., Professor of Paediatrics )
Study ID Numbers:	UGV 03050904006
Study First Received:	June 12, 2006
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00336128
Health Authority:	Germany: Ethics Commission

Keywords provided by Ludwig-Maximilians - University of Munich:

infant
kindergarten
obesity
adiposity

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on January 16, 2009