Overview

This trial is active, not recruiting.

Condition childhood obesity
Treatment vacopp
Sponsor University of Tampere
Collaborator Vaasa Central Hospital, Vaasa, Finland
Start date January 2009
End date June 2017
Trial size 200 participants
Trial identifier NCT00970710, 100454

Summary

This study aims to prevent childhood obesity. The recruited intervention group is pregnant mothers who are at risk to get gestational diabetes. Lifestyle intervention (nutritional and physical activity) begins during pregnancy in maternity clinics and continues in child wellfare clinics until the child is 5 years of age.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Lifestyle counseling including physical activity and nutritional information.
vacopp
Information about healthy diet and suitable physical activity during pregnancy of mothers to intervention group children and during childhood from 1 year of age to 5 years of age. Information is given by a health nutritionist,a physiotherapist and maternity clinic and child wellfare clinic nurses.

Primary Outcomes

Measure
Preventing childhood obesity
time frame: Seven years (six years of age)

Secondary Outcomes

Measure
lower cholesterol values
time frame: up to six years
lower HOMA-index
time frame: up to six years

Eligibility Criteria

Male or female participants up to 6 years old.

Inclusion Criteria: - Pregnant women who are at risk to get gestational diabetes. Exclusion Criteria: - Foreigner with language problems - Major psychosocial problems - Diabetes mellitus type I or II - Physical disability, - Major medical problems in pregnancy

Additional Information

Official title Vaasa Childhood Obesity Primary Prevention Study
Principal investigator Taina E. Mustila, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in August 2011.
Information provided to ClinicalTrials.gov by University of Tampere.