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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01127412
First Posted: May 20, 2010
Last Update Posted: May 20, 2010
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.
Information provided by:
University Medical Center Groningen
  Purpose
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

Condition Intervention
Overweight Physical Activity Behavioral: Physical activity stimulating program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Early Obesity Intervention Program Within GECKO Drenthe; a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University Medical Center Groningen:

Primary Outcome Measures:
  • Growth [ Time Frame: Regularly during the first year of life, at 2.5 years of age ]
    Weight, length

  • Body composition [ Time Frame: Regularly during the first year of life, at 2.5 years of age ]
    Waist circumference, Hip circumference, Skin fold thickness, Bioelectrical impedance analyses (BIA)


Secondary Outcome Measures:
  • Motor activity [ Time Frame: At the age of 5 months, 8 months and 2.5 years of age ]
    Accelerometer

  • Motor development [ Time Frame: At the age of 5 months, 8 months and 2.5 years of age ]
    Albertha Infant Motor Scale, Bayley Scales of Infant and Toddler Development


Enrollment: 228
Study Start Date: December 2006
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Physical activity stimulating program
Advices to stimulate motor activity and motor development at the age of two weeks, two months, four months, eight months and eleven months
Behavioral: Physical activity stimulating program
No Intervention: Control

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: P.J.J. Sauer MD PhD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01127412     History of Changes
Other Study ID Numbers: EOIP-GECKO
First Submitted: May 19, 2010
First Posted: May 20, 2010
Last Update Posted: May 20, 2010
Last Verified: May 2010

Keywords provided by University Medical Center Groningen:
overweight
physical activity
infancy
body composition
motor development
motor activity

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms