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

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01127412
• Other study ID #: EOIP-GECKO
• Status: Completed
• Phase: N/A
• First received: May 19, 2010
• Last updated: May 19, 2010
• Start date: December 2006

Study information

• Verified date: May 2010
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 2 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Overweight
• Physical Activity

Intervention

Behavioral:
• Physical activity stimulating program

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth	Weight, length	Regularly during the first year of life, at 2.5 years of age	No
Primary	Body composition	Waist circumference, Hip circumference, Skin fold thickness, Bioelectrical impedance analyses (BIA)	Regularly during the first year of life, at 2.5 years of age	No
Secondary	Motor activity	Accelerometer	At the age of 5 months, 8 months and 2.5 years of age	No
Secondary	Motor development	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	No