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

This study has been completed.
Sponsor:
Information provided by:
University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01127412
First received: May 19, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 Centre Groningen:

Primary Outcome Measures:
  • Growth [ Time Frame: Regularly during the first year of life, at 2.5 years of age ] [ Designated as safety issue: No ]
    Weight, length

  • Body composition [ Time Frame: Regularly during the first year of life, at 2.5 years of age ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Accelerometer

  • Motor development [ Time Frame: At the age of 5 months, 8 months and 2.5 years of age ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   up to 2 Weeks
Genders Eligible for Study:   Both
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
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.

No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: May 19, 2010
Last Updated: May 19, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 11, 2014