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

This study has been completed.
Sponsor:
Information provided by:
Research Institute of Child Nutrition, Dortmund
ClinicalTrials.gov Identifier:
NCT00554294
First received: November 5, 2007
Last updated: May 27, 2009
Last verified: May 2009
  Purpose

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 Intervention
Overweight
Behavioral: environmental and behavioral change

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Promoting Water Consumption for Prevention of Overweight in School Children in a Controlled Intervention Trial

Resource links provided by NLM:


Further study details as provided by Research Institute of Child Nutrition, Dortmund:

Primary Outcome Measures:
  • Overweight [ Time Frame: one school year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intake of Drinks [ Time Frame: one school year ] [ Designated as safety issue: No ]
  • Physical Activity and Inactivity [ Time Frame: one school year ] [ Designated as safety issue: No ]
  • Water Flow of the Water Dispensers [ Time Frame: one school year ] [ Designated as safety issue: No ]
  • Parameters of Process Evaluation (Acceptance, Feasibility) [ Time Frame: 1,5 years ] [ Designated as safety issue: No ]

Enrollment: 2950
Study Start Date: April 2006
Study Completion Date: December 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   7 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • parental consent
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554294

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

Publications:
Additional 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
Study First Received: November 5, 2007
Results First Received: March 31, 2009
Last Updated: May 27, 2009
Health Authority: Germany: Federal Ministry of Food, Agriculture and Consumer Protection

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

ClinicalTrials.gov processed this record on October 22, 2014