Clinical trial NCT00554294: Promoting Water Consumption for Prevention of Overweight in School Children in a Controlled Intervention Trial
Official title: Promoting Water Consumption for Prevention of Overweight in School Children in a Controlled Intervention Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: children
primary prevention
environmental change
behavioural change
school setting
changing of drinking habits
promotion of drinking tap water
Lead sponsor: Research Institute of Child Nutrition, Dortmund
Sponsor class: OTHER
First posted: 2007-11-06
Enrollment: 2950
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* parental consent

Primary outcomes:
measure: Overweight
timeFrame: one school year
Secondary outcomes:
measure: Intake of Drinks
timeFrame: one school year
measure: Physical Activity and Inactivity
timeFrame: one school year
measure: Water Flow of the Water Dispensers
timeFrame: one school year
measure: Parameters of Process Evaluation (Acceptance, Feasibility)
timeFrame: 1,5 years
Other outcomes:
Locations:
Study officials:
affiliation: Research Insitute of Child Nutrition
name: Mathilde Kersting, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.