NCT00336128

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?

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30,000

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Oct 2003

Longer than P75 for not_applicable obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 13, 2006

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

April 13, 2022

Status Verified

September 1, 2020

Enrollment Period

2.6 years

First QC Date

June 12, 2006

Last Update Submit

April 5, 2022

Conditions

Keywords

infantkindergartenobesityadiposity

Outcome Measures

Primary Outcomes (3)

  • Body mass index

    2005, 2006, 2007, 2008

  • nutrition behavior

    2005, 2006, 2007, 2008

  • physical activity

    2005, 2006, 2007, 2008

Interventions

attitude changeBEHAVIORAL

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

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • infant of intervention- or control-kindergarten

You may not qualify if:

  • absence of parenteral consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Berthold Koletzko, Prof.

    Ludwig-Maximilians-Universitaet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

June 12, 2006

First Posted

June 13, 2006

Study Start

October 1, 2003

Primary Completion

May 1, 2006

Study Completion

July 1, 2009

Last Updated

April 13, 2022

Record last verified: 2020-09