Early Obesity Intervention Program Within GECKO Drenthe; a Randomized Controlled Trial
May 19, 2010 updated by: University Medical Center Groningen
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
228
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 2 weeks (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Growth
Time Frame: Regularly during the first year of life, at 2.5 years of age
|
Weight, length
|
Regularly during the first year of life, at 2.5 years of age
|
|
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)
|
Regularly during the first year of life, at 2.5 years of age
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motor activity
Time Frame: At the age of 5 months, 8 months and 2.5 years of age
|
Accelerometer
|
At the age of 5 months, 8 months and 2.5 years of age
|
|
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
|
At the age of 5 months, 8 months and 2.5 years of age
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
May 19, 2010
First Submitted That Met QC Criteria
May 19, 2010
First Posted (Estimate)
May 20, 2010
Study Record Updates
Last Update Posted (Estimate)
May 20, 2010
Last Update Submitted That Met QC Criteria
May 19, 2010
Last Verified
May 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EOIP-GECKO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.