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Population Based Intervention to Prevent Obesity in Kindergartens (TigerKids)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Ludwig-Maximilians - University of Munich.
Recruitment status was  Active, not recruiting
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00336128
First received: June 12, 2006
Last updated: May 6, 2008
Last verified: May 2008
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


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:
    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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided by Ludwig-Maximilians - University of Munich

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Berthold Koletzko, M.D., Professor of Paediatrics, Dr. von Hauner Children´s Hospital, Ludwig-Maximilians-University, Munich, Germany
ClinicalTrials.gov Identifier: NCT00336128     History of Changes
Other Study ID Numbers: UGV 03050904006
Study First Received: June 12, 2006
Last Updated: May 6, 2008
Health Authority: Germany: Ethics Commission

Keywords provided by Ludwig-Maximilians - University of Munich:
infant
kindergarten
obesity
adiposity

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014