ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00554294
Recruitment Status : Completed
First Posted : November 6, 2007
Results First Posted : July 16, 2009
Last Update Posted : July 16, 2009
Sponsor:
Information provided by:
Research Institute of Child Nutrition, Dortmund

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.

Condition or disease Intervention/treatment Phase
Overweight Behavioral: environmental and behavioral change Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2950 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Promoting Water Consumption for Prevention of Overweight in School Children in a Controlled Intervention Trial
Study Start Date : April 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Overweight [ Time Frame: one school year ]

Secondary Outcome Measures :
  1. Intake of Drinks [ Time Frame: one school year ]
  2. Physical Activity and Inactivity [ Time Frame: one school year ]
  3. Water Flow of the Water Dispensers [ Time Frame: one school year ]
  4. Parameters of Process Evaluation (Acceptance, Feasibility) [ Time Frame: 1,5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   7 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • parental consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00554294


Sponsors and Collaborators
Research Institute of Child Nutrition, Dortmund
Investigators
Principal Investigator: Mathilde Kersting, PhD Research Insitute of Child Nutrition

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Research Institute of Child Nutrition, Dortmund
ClinicalTrials.gov Identifier: NCT00554294     History of Changes
Other Study ID Numbers: 05HS026
First Posted: November 6, 2007    Key Record Dates
Results First Posted: July 16, 2009
Last Update Posted: July 16, 2009
Last Verified: May 2009

Keywords provided by Research Institute of Child Nutrition, Dortmund:
children
primary prevention
environmental change
behavioural change
school setting
changing of drinking habits
promotion of drinking tap water

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms