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

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
environmental and behavioral change
Sponsored by
Research Institute of Child Nutrition, Dortmund
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring children, primary prevention, environmental change, behavioural change, school setting, changing of drinking habits, promotion of drinking tap water

Eligibility Criteria

7 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • parental consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control group

    Intervention group

    Arm Description

    Control schools had school curriculum as usual and did not receive environmental intervention.

    Intervention schools received water dispensers, drinking bottles and lessons as intervention.

    Outcomes

    Primary Outcome Measures

    Overweight
    Prevalence of overweight defined acording to the criteria of the International Obesity Task Force (IOTF)

    Secondary Outcome Measures

    Intake of Drinks
    Physical Activity and Inactivity
    Water Flow of the Water Dispensers
    Parameters of Process Evaluation (Acceptance, Feasibility)

    Full Information

    First Posted
    November 5, 2007
    Last Updated
    May 27, 2009
    Sponsor
    Research Institute of Child Nutrition, Dortmund
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00554294
    Brief Title
    Promoting Water Consumption for Prevention of Overweight in School Children in a Controlled Intervention Trial
    Acronym
    trinkfit
    Official Title
    Promoting Water Consumption for Prevention of Overweight in School Children in a Controlled Intervention Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2006 (undefined)
    Primary Completion Date
    June 2007 (Actual)
    Study Completion Date
    December 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Research Institute of Child Nutrition, Dortmund

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight
    Keywords
    children, primary prevention, environmental change, behavioural change, school setting, changing of drinking habits, promotion of drinking tap water

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    2950 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Control schools had school curriculum as usual and did not receive environmental intervention.
    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    Intervention schools received water dispensers, drinking bottles and lessons as intervention.
    Intervention Type
    Behavioral
    Intervention Name(s)
    environmental and behavioral change
    Intervention Description
    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 Measure Information:
    Title
    Overweight
    Description
    Prevalence of overweight defined acording to the criteria of the International Obesity Task Force (IOTF)
    Time Frame
    one school year
    Secondary Outcome Measure Information:
    Title
    Intake of Drinks
    Time Frame
    one school year
    Title
    Physical Activity and Inactivity
    Time Frame
    one school year
    Title
    Water Flow of the Water Dispensers
    Time Frame
    one school year
    Title
    Parameters of Process Evaluation (Acceptance, Feasibility)
    Time Frame
    1,5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: All children in 2nd and 3rd grade of selected elementary schools Exclusion Criteria: parental consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mathilde Kersting, PhD
    Organizational Affiliation
    Research Insitute of Child Nutrition
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19336356
    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.
    Results Reference
    result
    PubMed Identifier
    19713953
    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.
    Results Reference
    derived

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

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