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

May 27, 2009 updated by: Research Institute of Child Nutrition, Dortmund
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

2950

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 9 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • parental consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overweight
Time Frame: one school year
Prevalence of overweight defined acording to the criteria of the International Obesity Task Force (IOTF)
one school year

Secondary Outcome Measures

Outcome Measure
Time Frame
Intake of Drinks
Time Frame: one school year
one school year
Physical Activity and Inactivity
Time Frame: one school year
one school year
Water Flow of the Water Dispensers
Time Frame: one school year
one school year
Parameters of Process Evaluation (Acceptance, Feasibility)
Time Frame: 1,5 years
1,5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research Institute of Child Nutrition, Dortmund

Investigators

  • Principal Investigator: Mathilde Kersting, PhD, Research Insitute of Child Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

November 5, 2007

First Submitted That Met QC Criteria

November 5, 2007

First Posted (Estimate)

November 6, 2007

Study Record Updates

Last Update Posted (Estimate)

July 16, 2009

Last Update Submitted That Met QC Criteria

May 27, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05HS026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Overweight

Clinical Trials on environmental and behavioral change

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe