NCT00554294

Brief Summary

A major goal in public health is to find effective, feasible and simple programs for overweight prevention among children. This controlled intervention study evaluates a simple environmental and behavioral modification for its efficacy in preventing overweight of children in the school setting. The intervention strategy focuses solely on the promotion of drinking tap water. The study was conducted in 32 elementary schools including about 3000 children in two German cities over 1 school year.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,950

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2006

Typical duration for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2007

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
8 months until next milestone

Results Posted

Study results publicly available

July 16, 2009

Completed
Last Updated

July 16, 2009

Status Verified

May 1, 2009

Enrollment Period

1.2 years

First QC Date

November 5, 2007

Results QC Date

March 31, 2009

Last Update Submit

May 27, 2009

Conditions

Overweight

Keywords

childrenprimary preventionenvironmental changebehavioural changeschool settingchanging of drinking habitspromotion of drinking tap water

Outcome Measures

Primary Outcomes (1)

  • Overweight

    Prevalence of overweight defined acording to the criteria of the International Obesity Task Force (IOTF)

    one school year

Secondary Outcomes (4)

  • Intake of Drinks

    one school year

  • Physical Activity and Inactivity

    one school year

  • Water Flow of the Water Dispensers

    one school year

  • Parameters of Process Evaluation (Acceptance, Feasibility)

    1,5 years

Study Arms (2)

Control group

NO INTERVENTION

Control schools had school curriculum as usual and did not receive environmental intervention.

Intervention group

EXPERIMENTAL

Intervention schools received water dispensers, drinking bottles and lessons as intervention.

Behavioral: environmental and behavioral change

Interventions

environmental and behavioral changeBEHAVIORAL

In intervention schools a water dispenser was installed and children received water bottles as environmental intervention. Children also received a 6-hour-curriculum about the importance of water for the body that were held by the teachers.

Intervention group

Eligibility Criteria

Age7 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All children in 2nd and 3rd grade of selected elementary schools

You may not qualify if:

  • parental consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Muckelbauer R, Libuda L, Clausen K, Toschke AM, Reinehr T, Kersting M. Promotion and provision of drinking water in schools for overweight prevention: randomized, controlled cluster trial. Pediatrics. 2009 Apr;123(4):e661-7. doi: 10.1542/peds.2008-2186.

    PMID: 19336356RESULT

  • Muckelbauer R, Libuda L, Clausen K, Toschke AM, Reinehr T, Kersting M. Immigrational background affects the effectiveness of a school-based overweight prevention program promoting water consumption. Obesity (Silver Spring). 2010 Mar;18(3):528-34. doi: 10.1038/oby.2009.270. Epub 2009 Aug 27.

    PMID: 19713953DERIVED

MeSH Terms

Conditions

Overweight

Interventions

Environment

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ecological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Results Point of Contact

Title
Dr. Mathilde Kersting
Organization
Research Institute of Child Nutrition, Dortmund
kersting@fke-do.de
0049 231 79221013

Study Officials

  • Mathilde Kersting, PhD

    Research Insitute of Child Nutrition

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 5, 2007

First Posted

November 6, 2007

Study Start

April 1, 2006

Primary Completion

June 1, 2007

Study Completion

December 1, 2008

Last Updated

July 16, 2009

Results First Posted

July 16, 2009

Record last verified: 2009-05