Overview

This trial has been completed.

Condition childhood obesity pevention
Treatment vaasa childhood obesity primary prevention study
Sponsor University of Tampere
Collaborator Foundation for Paediatric Research, Finland
Start date January 2009
End date January 2017
Trial size 185 participants
Trial identifier NCT00970710, 100454

Summary

This study aims to prevent childhood obesity with early life (pregnancy) intensified counselling. 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

Intervention model single group assignment
Intervention model description pragmatic controlled trial
Primary purpose prevention
Masking no masking
Arm
(Experimental)
VACOPP (Vaasa Childhood Obesity Primary Prevention Study): Intensified lifestyle counseling including physical activity and nutritional information beginning during maternity health care and continuing during child health care clinic visits.
vaasa childhood obesity primary prevention study VACOPP
Intensified counselling concerning healthy diet and suitable physical activity during pregnancy to mothers in the intervention group continuing in child health care clinic visits with the offspring until child's age of 5 year.

Primary Outcomes

Measure
Preventing childhood obesity
time frame: Offspring age until six years

Secondary Outcomes

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

Eligibility Criteria

All 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. Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by University of Tampere.