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Vaasa Childhood Obesity Primary Prevention Study (VACOPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00970710
Recruitment Status : Completed
First Posted : September 2, 2009
Last Update Posted : February 14, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Childhood Obesity Pevention Behavioral: Vaasa Childhood Obesity Primary Prevention Study

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Pragmatic controlled trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Vaasa Childhood Obesity Primary Prevention Study
Actual Study Start Date : January 1, 2009
Primary Completion Date : January 31, 2017
Study Completion Date : January 31, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00970710

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
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
First Posted: September 2, 2009    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
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:
Pediatric Obesity
Nutrition Disorders
Body Weight
Signs and Symptoms