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Vaasa Childhood Obesity Primary Prevention Study (VACOPP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Vaasa Central Hospital, Vaasa, Finland
Pediatric Research Centre, Finland
Information provided by:
University of Tampere
ClinicalTrials.gov Identifier:
NCT00970710
First received: September 1, 2009
Last updated: August 4, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention
Childhood Obesity
 Behavioral: VACOPP

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Vaasa Childhood Obesity Primary Prevention Study

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by University of Tampere:

Primary Outcome Measures:
  • Preventing childhood obesity [ Time Frame: Seven years (six years of age) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • lower cholesterol values [ Time Frame: up to six years ] [ Designated as safety issue: No ]
  • lower HOMA-index [ Time Frame: up to six years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2009
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle counseling
Lifestyle counseling including physical activity and nutritional information.
 Behavioral: 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.

  Eligibility

Ages Eligible for Study:   up to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00970710

Locations
Finland
Health care center in Vaasa
Vaasa, Finland, 65320
Sponsors and Collaborators
University of Tampere
Vaasa Central Hospital, Vaasa, Finland
Pediatric Research Centre, Finland
Investigators
Principal Investigator: Taina E. Mustila, M.D. Tampere university
  More Information

No publications provided by University of Tampere

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Taina Mustila, Tampere university
ClinicalTrials.gov Identifier: NCT00970710     History of Changes
Other Study ID Numbers: 100454
Study First Received: September 1, 2009
Last Updated: August 4, 2011
Health Authority: Finland: Ethics Committee

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013