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Vaasa Childhood Obesity Primary Prevention Study (VACOPP)

This study has been completed.
Sponsor:
Collaborators:
Foundation for Paediatric Research, Finland
Vaasa Health care center
Seinajoki Central Hospital
Tampere University Hospital
Information provided by (Responsible Party):
Taina Mustila, Seinajoki Central Hospital
ClinicalTrials.gov Identifier:
NCT00970710
First received: September 1, 2009
Last updated: February 12, 2017
Last verified: February 2017
September 1, 2009
February 12, 2017
January 1, 2009
January 31, 2017   (Final data collection date for primary outcome measure)
Preventing childhood obesity [ Time Frame: Offspring age until six years ]
Difference in offspring weight gain compared to control group
Preventing childhood obesity [ Time Frame: Seven years (six years of age) ]
Complete list of historical versions of study NCT00970710 on ClinicalTrials.gov Archive Site
  • lower cholesterol values [ Time Frame: up to six years ]
  • lower HOMA-index [ Time Frame: up to six years ]
Not Provided
Not Provided
Not Provided
 
Vaasa Childhood Obesity Primary Prevention Study
Vaasa Childhood Obesity Primary Prevention Study
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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Intervention Model Description:
Pragmatic controlled trial
Masking: No masking
Primary Purpose: Prevention
Childhood Obesity Pevention
Behavioral: Vaasa Childhood Obesity Primary Prevention Study
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.
Other Name: VACOPP
Experimental: Lifestyle counseling
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.
Intervention: Behavioral: Vaasa Childhood Obesity Primary Prevention Study

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
185
January 31, 2017
January 31, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 6 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
 
NCT00970710
100454
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Undecided
Not Provided
Taina Mustila, Seinajoki Central Hospital
University of Tampere
  • Foundation for Paediatric Research, Finland
  • Vaasa Health care center
  • Seinajoki Central Hospital
  • Tampere University Hospital
Principal Investigator: Taina E. Mustila, M.D. Ph.D. Seinajoki Central Hospital
University of Tampere
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP