Promoting Water Consumption for Prevention of Overweight in School Children in a Controlled Intervention Trial

Overweight Clinical Trial

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Official title:

Promoting Water Consumption for Prevention of Overweight in School Children in a Controlled Intervention Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554294
• Other study ID #: 05HS026
• Status: Completed
• Phase: N/A
• First received: November 5, 2007
• Last updated: May 27, 2009
• Start date: April 2006
• Est. completion date: December 2008

Study information

• Verified date: May 2009
• Source: Research Institute of Child Nutrition, Dortmund
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Food, Agriculture and Consumer Protection
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2950
• Est. completion date: December 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 9 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• parental consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Overweight

Intervention

Behavioral:
• environmental and behavioral change
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Research Institute of Child Nutrition, Dortmund

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overweight		one school year	No
Secondary	Intake of Drinks		one school year	No
Secondary	Physical Activity and Inactivity		one school year	No
Secondary	Water Flow of the Water Dispensers		one school year	No
Secondary	Parameters of Process Evaluation (Acceptance, Feasibility)		1,5 years	No