Overview

This trial is active, not recruiting.

Condition obesity
Treatments attitude change, adiposity prevention program
Sponsor Ludwig-Maximilians - University of Munich
Collaborator Child Health Foundation
Start date October 2003
End date May 2006
Trial size 30000 participants
Trial identifier NCT00336128, UGV 03050904006

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?

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention

Primary Outcomes

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

Eligibility Criteria

Male or female participants from 3 years up to 7 years old.

Inclusion Criteria: - infant of intervention- or control-kindergarten Exclusion Criteria: - absence of parenteral consent to participate

Additional Information

Principal investigator Berthold Koletzko, Prof.
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2008.
Information provided to ClinicalTrials.gov by Ludwig-Maximilians - University of Munich.