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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
  Purpose
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.

Condition Intervention
Childhood Obesity Pevention Behavioral: Vaasa Childhood Obesity Primary Prevention Study

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Pragmatic controlled trial
Masking: No masking
Primary Purpose: Prevention
Official Title: Vaasa Childhood Obesity Primary Prevention Study

Resource links provided by NLM:


Further study details as provided by Taina Mustila, Seinajoki Central Hospital:

Primary Outcome Measures:
  • Preventing childhood obesity [ Time Frame: Offspring age until six years ]
    Difference in offspring weight gain compared to control group


Secondary Outcome Measures:
  • lower cholesterol values [ Time Frame: up to six years ]
  • lower HOMA-index [ Time Frame: up to six years ]

Enrollment: 185
Actual Study Start Date: January 1, 2009
Study Completion Date: January 31, 2017
Primary Completion Date: January 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

  Eligibility

Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Foundation for Paediatric Research, Finland
Vaasa Health care center
Seinajoki Central Hospital
Tampere University Hospital
Investigators
Principal Investigator: Taina E. Mustila, M.D. Ph.D. Seinajoki Central Hospital
  More Information

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Taina Mustila, M.D. Ph.D., Seinajoki Central Hospital
ClinicalTrials.gov Identifier: NCT00970710     History of Changes
Other Study ID Numbers: 100454
Study First Received: September 1, 2009
Last Updated: February 12, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

ClinicalTrials.gov processed this record on June 28, 2017