NCT01127412

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 20, 2010

Completed
Last Updated

May 20, 2010

Status Verified

May 1, 2010

Enrollment Period

3 years

First QC Date

May 19, 2010

Last Update Submit

May 19, 2010

Conditions

OverweightPhysical Activity

Keywords

overweightphysical activityinfancybody compositionmotor developmentmotor activity

Outcome Measures

Primary Outcomes (2)

  • Growth

    Weight, length

    Regularly during the first year of life, at 2.5 years of age

  • 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

Secondary Outcomes (2)

  • Motor activity

    At the age of 5 months, 8 months and 2.5 years of age

  • Motor development

    At the age of 5 months, 8 months and 2.5 years of age

Study Arms (2)

Physical activity stimulating program

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

Interventions

Physical activity stimulating programBEHAVIORAL
Physical activity stimulating program

Eligibility Criteria

AgeUp to 2 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • Children under care of child physiotherapists will be excluded from the program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OverweightMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 19, 2010

First Posted

May 20, 2010

Study Start

December 1, 2006

Primary Completion

December 1, 2009

Last Updated

May 20, 2010

Record last verified: 2010-05