Population Based Intervention to Prevent Obesity in Kindergartens (TigerKids)

April 5, 2022 updated by: Prof. Berthold Koletzko, Ludwig-Maximilians - University of Munich

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30000

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • infant of intervention- or control-kindergarten

Exclusion Criteria:

  • absence of parenteral consent to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body mass index
Time Frame: 2005, 2006, 2007, 2008
2005, 2006, 2007, 2008
nutrition behavior
Time Frame: 2005, 2006, 2007, 2008
2005, 2006, 2007, 2008
physical activity
Time Frame: 2005, 2006, 2007, 2008
2005, 2006, 2007, 2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

Bavarian State Ministry of Environment, Public Health and Consumer Protection
Child Health Foundation
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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

June 12, 2006

First Submitted That Met QC Criteria

June 12, 2006

First Posted (Estimate)

June 13, 2006

Study Record Updates

Last Update Posted (Actual)

April 13, 2022

Last Update Submitted That Met QC Criteria

April 5, 2022

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UGV 03050904006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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