Population Based Intervention to Prevent Obesity in Kindergartens (TigerKids)
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | June 12, 2006 | ||||
| Last Updated Date | May 6, 2008 | ||||
| Start Date ICMJE | October 2003 | ||||
| Primary Completion Date | May 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00336128 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Population Based Intervention to Prevent Obesity in Kindergartens (TigerKids) | ||||
| Official Title ICMJE | Not Provided | ||||
| 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? |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Obesity | ||||
| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||
| Publications * | 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. Epub 2009 Mar 20. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 30000 | ||||
| Estimated Completion Date | July 2009 | ||||
| Primary Completion Date | May 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 3 Years to 7 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00336128 | ||||
| Other Study ID Numbers ICMJE | UGV 03050904006 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Berthold Koletzko, M.D., Professor of Paediatrics, Dr. von Hauner Children´s Hospital, Ludwig-Maximilians-University, Munich, Germany | ||||
| Study Sponsor ICMJE | Ludwig-Maximilians - University of Munich | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Ludwig-Maximilians - University of Munich | ||||
| Verification Date | May 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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