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

Sponsor

University Medical Center Groningen (Other)

Overall Status

Completed

CT.gov ID

NCT01127412

Collaborator

(none)

228

Enrollment

Arms

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Overweight Physical Activity	Behavioral: Physical activity stimulating program	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

228 participants

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

Study Start Date :

Dec 1, 2006

Actual Primary Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 2 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)