ObesityNCT00336128
Population Based Intervention to Prevent Obesity in Kindergartens (TigerKids)
A study testing attitude change and adiposity prevention program in people with Obesity, run by Ludwig-Maximilians - University of Munich.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- attitude change and adiposity prevention program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30,000 participants
- Where
- No sites listed yet
- Study dates
- Oct 2003to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- infant of intervention- or control-kindergarten
Who cannot join
- absence of parenteral consent to participate
About this study
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:
Read more
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?
Read the 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.
- Conditions
- Obesity
- Being tested
- attitude change, adiposity prevention program
- Keywords
- infant, kindergarten, obesity, adiposity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
attitude changeBehavioural
TigerKids: setting based prevention program to reduce obesity risk factors in children
adiposity prevention programBehavioural
The behavioral intervention aimed at modifying physical activity and food and drink choices at the kindergarten setting
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
Measured: 2005, 2006, 2007, 2008
nutrition behavior
Measured: 2005, 2006, 2007, 2008
physical activity
Measured: 2005, 2006, 2007, 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2006 (estimated)
- Study startOct 2003
- Primary completionMay 2006
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Prof. Berthold Koletzko, Ludwig-Maximilians - University of Munich
- Investigators
- Berthold Koletzko, Prof., Principal investigator, Ludwig-Maximilians-Universitaet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336128
- Sponsor's protocol ID
- UGV 03050904006
- Status last verified
- Sep 2020
- First submitted
- 12 Jun 2006
- Last updated
- 13 Apr 2022
- Results posted
- No
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. doi: 10.1016/j.clnu.2009.01.001. Epub 2009 Mar 20.
PubMed 19303675
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Based Intervention to Prevent Obesity in Kindergartens (TigerKids)
- ClinicalTrials.gov ID
- NCT00336128
- Acronym / sponsor ID
- UGV 03050904006
- Conditions
- Obesity
- Keywords
- infant, kindergarten, obesity, adiposity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- 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
- Study start
- Oct 2003
- Primary completion
- May 2006 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 13 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- infant of intervention- or control-kindergarten
Key exclusion criteria (1 listed)
- absence of parenteral consent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| attitude changeTigerKids: setting based prevention program to reduce obesity risk factors in children | Behavioural | – |
| adiposity prevention programThe behavioral intervention aimed at modifying physical activity and food and drink choices at the kindergarten setting | Behavioural | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Derived from this study: PubMed 19303675Bayer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berthold Koletzko, Prof. principal investigator
Ludwig-Maximilians-Universitaet
Questions about this trial
What is this clinical trial studying?
A study testing attitude change and adiposity prevention program in people with Obesity, run by Ludwig-Maximilians - University of Munich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (time frame: 2005, 2006, 2007, 2008). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00336128, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.