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Early Obesity Intervention Program Within GECKO Drenthe; a Randomized Controlled Trial

Primary Purpose

Overweight, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical activity stimulating program
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring overweight, physical activity, infancy, body composition, motor development, motor activity

Eligibility Criteria

undefined - 2 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • date of birth (December 2006-February 2008)
  • area of living (around Meppel and Hoogeveen in the province of Drenthe, one of the Northern provinces of the Netherlands)

Exclusion Criteria:

  • Children under care of child physiotherapists will be excluded from the program

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Physical activity stimulating program

    Control

    Arm Description

    Advices to stimulate motor activity and motor development at the age of two weeks, two months, four months, eight months and eleven months

    Outcomes

    Primary Outcome Measures

    Growth
    Weight, length
    Body composition
    Waist circumference, Hip circumference, Skin fold thickness, Bioelectrical impedance analyses (BIA)

    Secondary Outcome Measures

    Motor activity
    Accelerometer
    Motor development
    Albertha Infant Motor Scale, Bayley Scales of Infant and Toddler Development

    Full Information

    First Posted
    May 19, 2010
    Last Updated
    May 19, 2010
    Sponsor
    University Medical Center Groningen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01127412
    Brief Title
    Early Obesity Intervention Program Within GECKO Drenthe; a Randomized Controlled Trial
    Official Title
    Early Obesity Intervention Program Within GECKO Drenthe; a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2006 (undefined)
    Primary Completion Date
    December 2009 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University Medical Center Groningen

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to investigate whether stimulating physical activity during the first year of life influences growth and body composition, and stimulates motor activity and motor development

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight, Physical Activity
    Keywords
    overweight, physical activity, infancy, body composition, motor development, motor activity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    228 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Physical activity stimulating program
    Arm Type
    Active Comparator
    Arm Description
    Advices to stimulate motor activity and motor development at the age of two weeks, two months, four months, eight months and eleven months
    Arm Title
    Control
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Physical activity stimulating program
    Primary Outcome Measure Information:
    Title
    Growth
    Description
    Weight, length
    Time Frame
    Regularly during the first year of life, at 2.5 years of age
    Title
    Body composition
    Description
    Waist circumference, Hip circumference, Skin fold thickness, Bioelectrical impedance analyses (BIA)
    Time Frame
    Regularly during the first year of life, at 2.5 years of age
    Secondary Outcome Measure Information:
    Title
    Motor activity
    Description
    Accelerometer
    Time Frame
    At the age of 5 months, 8 months and 2.5 years of age
    Title
    Motor development
    Description
    Albertha Infant Motor Scale, Bayley Scales of Infant and Toddler Development
    Time Frame
    At the age of 5 months, 8 months and 2.5 years of age

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    2 Weeks
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: date of birth (December 2006-February 2008) area of living (around Meppel and Hoogeveen in the province of Drenthe, one of the Northern provinces of the Netherlands) Exclusion Criteria: Children under care of child physiotherapists will be excluded from the program

    12. IPD Sharing Statement

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    Early Obesity Intervention Program Within GECKO Drenthe; a Randomized Controlled Trial

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