Promoting Water Consumption for Prevention of Overweight in School Children in a Controlled Intervention Trial (trinkfit)
|ClinicalTrials.gov Identifier: NCT00554294|
Recruitment Status : Completed
First Posted : November 6, 2007
Results First Posted : July 16, 2009
Last Update Posted : July 16, 2009
|Condition or disease||Intervention/treatment|
|Overweight||Behavioral: environmental and behavioral change|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2950 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Promoting Water Consumption for Prevention of Overweight in School Children in a Controlled Intervention Trial|
|Study Start Date :||April 2006|
|Primary Completion Date :||June 2007|
|Study Completion Date :||December 2008|
No Intervention: Control group
Control schools had school curriculum as usual and did not receive environmental intervention.
Experimental: Intervention group
Intervention schools received water dispensers, drinking bottles and lessons as 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.
- Overweight [ Time Frame: one school year ]
- Intake of Drinks [ Time Frame: one school year ]
- Physical Activity and Inactivity [ Time Frame: one school year ]
- Water Flow of the Water Dispensers [ Time Frame: one school year ]
- Parameters of Process Evaluation (Acceptance, Feasibility) [ Time Frame: 1,5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00554294
|Principal Investigator:||Mathilde Kersting, PhD||Research Insitute of Child Nutrition|