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

Not Applicable

Completed

• Conditions: Overweight; Physical Activity

• Registration Number: NCT01127412
• Lead Sponsor: University Medical Center Groningen

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2009-12
• Status Verified: 2010-05
• Study First Submitted: 2010-05-19
• Study First Submitted QC: 2010-05-19
• Last Update Submitted: 2010-05-19
• Study First Posted: 2010-05-20
• Last Update Posted: 2010-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Growth	Regularly during the first year of life, at 2.5 years of age	Weight, length
Body composition	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

Name	Time	Method
Motor activity	At the age of 5 months, 8 months and 2.5 years of age	Accelerometer
Motor development	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