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

Tracking Information

First Received Date ^ICMJE

September 1, 2009

Last Updated Date

August 4, 2011

Start Date ^ICMJE

January 2009

Estimated Primary Completion Date

June 2017 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00970710 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Vaasa Childhood Obesity Primary Prevention Study

Official Title ^ICMJE

Vaasa Childhood Obesity Primary Prevention Study

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Childhood Obesity

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: Lifestyle counseling

Lifestyle counseling including physical activity and nutritional information.

Intervention: Behavioral: VACOPP

Publications *

Mustila T, Keskinen P, Luoto R. Behavioral counseling to prevent childhood obesity--study protocol of a pragmatic trial in maternity and child health care. BMC Pediatr. 2012 Jul 3;12:93. doi: 10.1186/1471-2431-12-93.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

December 2017

Estimated Primary Completion Date

June 2017 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 6 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Finland

Administrative Information

NCT Number ^ICMJE

NCT00970710

Other Study ID Numbers ^ICMJE

100454

Has Data Monitoring Committee

Yes

Responsible Party

Taina Mustila, Tampere university

Study Sponsor ^ICMJE

University of Tampere

Collaborators ^ICMJE

Vaasa Central Hospital, Vaasa, Finland
Pediatric Research Centre, Finland

Investigators ^ICMJE

Principal Investigator:

Taina E. Mustila, M.D.

Tampere university

Information Provided By

University of Tampere

Verification Date

July 2011

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

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