Promoting Water Consumption for Prevention of Overweight in School Children in a Controlled Intervention Trial (trinkfit)
Primary Purpose
Overweight
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
environmental and behavioral change
Sponsored by

About this trial
This is an interventional prevention trial for Overweight focused on measuring children, primary prevention, environmental change, behavioural change, school setting, changing of drinking habits, promotion of drinking tap water
Eligibility Criteria
Inclusion Criteria:
- All children in 2nd and 3rd grade of selected elementary schools
Exclusion Criteria:
- parental consent
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Intervention group
Arm Description
Control schools had school curriculum as usual and did not receive environmental intervention.
Intervention schools received water dispensers, drinking bottles and lessons as intervention.
Outcomes
Primary Outcome Measures
Overweight
Prevalence of overweight defined acording to the criteria of the International Obesity Task Force (IOTF)
Secondary Outcome Measures
Intake of Drinks
Physical Activity and Inactivity
Water Flow of the Water Dispensers
Parameters of Process Evaluation (Acceptance, Feasibility)
Full Information
NCT ID
NCT00554294
First Posted
November 5, 2007
Last Updated
May 27, 2009
Sponsor
Research Institute of Child Nutrition, Dortmund
1. Study Identification
Unique Protocol Identification Number
NCT00554294
Brief Title
Promoting Water Consumption for Prevention of Overweight in School Children in a Controlled Intervention Trial
Acronym
trinkfit
Official Title
Promoting Water Consumption for Prevention of Overweight in School Children in a Controlled Intervention Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Research Institute of Child Nutrition, Dortmund
4. Oversight
5. Study Description
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.
Detailed Description
Soft drinks and other caloric beverages are supposed to be involved in the development of overweight and obesity in children. The intervention strategy of our study was to promote water consumption by facilitating access to tap water in schools assuming a concomitant decrease in caloric soft drinks at least at school. The environmental modification of installing a water dispenser at school and delivering a special bottle to each child in the intervention schools was supported by a few educational lessons. These lessons were held by the class teachers who received a prepared 6-hour curriculum dealing with the importance of water for the body and of water intake. For the study 17 randomly selected schools were assigned to the intervention group, 15 schools to the control group that did not receive any intervention. Body weight and height to calculate BMI as primary outcome were assessed at baseline and after the intervention period of 1 school year. As secondary outcome drinking and physical activity habits were evaluated at baseline and after the intervention. The water flow of the dispenser was measured at regular intervals. In addition, data of process evaluation was collected to measure acceptance and feasibility of the intervention in the school setting.
To analyze the efficacy of this primarily environmental and behavioral intervention, incidence and prevalence was compared between intervention and control group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
children, primary prevention, environmental change, behavioural change, school setting, changing of drinking habits, promotion of drinking tap water
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2950 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control schools had school curriculum as usual and did not receive environmental intervention.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Intervention schools received water dispensers, drinking bottles and lessons as intervention.
Intervention Type
Behavioral
Intervention Name(s)
environmental and behavioral change
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overweight
Description
Prevalence of overweight defined acording to the criteria of the International Obesity Task Force (IOTF)
Time Frame
one school year
Secondary Outcome Measure Information:
Title
Intake of Drinks
Time Frame
one school year
Title
Physical Activity and Inactivity
Time Frame
one school year
Title
Water Flow of the Water Dispensers
Time Frame
one school year
Title
Parameters of Process Evaluation (Acceptance, Feasibility)
Time Frame
1,5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All children in 2nd and 3rd grade of selected elementary schools
Exclusion Criteria:
parental consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathilde Kersting, PhD
Organizational Affiliation
Research Insitute of Child Nutrition
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
19336356
Citation
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.
Results Reference
result
PubMed Identifier
19713953
Citation
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.
Results Reference
derived
Learn more about this trial
Promoting Water Consumption for Prevention of Overweight in School Children in a Controlled Intervention Trial
We'll reach out to this number within 24 hrs