Vaasa Childhood Obesity Primary Prevention Study (VACOPP)

February 12, 2017 updated by: Taina Mustila, Tampere University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

185

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Vaasa, Finland, 65320
        • Health care center in Vaasa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • VACOPP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preventing childhood obesity
Time Frame: Offspring age until six years
Difference in offspring weight gain compared to control group
Offspring age until six years

Secondary Outcome Measures

Outcome Measure
Time Frame
lower cholesterol values
Time Frame: up to six years
up to six years
lower HOMA-index
Time Frame: up to six years
up to six years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University

Collaborators

Seinajoki Central Hospital
Tampere University Hospital
Foundation for Paediatric Research, Finland
Vaasa Health care center

Investigators

  • Principal Investigator: Taina E. Mustila, M.D. Ph.D., Seinäjoki Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2009

Primary Completion (ACTUAL)

January 31, 2017

Study Completion (ACTUAL)

January 31, 2017

Study Registration Dates

First Submitted

September 1, 2009

First Submitted That Met QC Criteria

September 1, 2009

First Posted (ESTIMATE)

September 2, 2009

Study Record Updates

Last Update Posted (ACTUAL)

February 14, 2017

Last Update Submitted That Met QC Criteria

February 12, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100454

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Study Data/Documents

  1. Study Protocol
  2. Clinical Study Report

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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