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Vaasa Childhood Obesity Primary Prevention Study (VACOPP)

Primary Purpose

Childhood Obesity Pevention

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Vaasa Childhood Obesity Primary Prevention Study
Sponsored by
Tampere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity Pevention

Eligibility Criteria

undefined - 6 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Health care center in Vaasa

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lifestyle counseling

Arm Description

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.

Outcomes

Primary Outcome Measures

Preventing childhood obesity
Difference in offspring weight gain compared to control group

Secondary Outcome Measures

lower cholesterol values
lower HOMA-index

Full Information

First Posted
September 1, 2009
Last Updated
February 12, 2017
Sponsor
Tampere University
Collaborators
Foundation for Paediatric Research, Finland, Vaasa Health care center, Seinajoki Central Hospital, Tampere University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00970710
Brief Title
Vaasa Childhood Obesity Primary Prevention Study
Acronym
VACOPP
Official Title
Vaasa Childhood Obesity Primary Prevention Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2009 (Actual)
Primary Completion Date
January 31, 2017 (Actual)
Study Completion Date
January 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University
Collaborators
Foundation for Paediatric Research, Finland, Vaasa Health care center, Seinajoki Central Hospital, Tampere University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity Pevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pragmatic controlled trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Vaasa Childhood Obesity Primary Prevention Study
Other Intervention Name(s)
VACOPP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Preventing childhood obesity
Description
Difference in offspring weight gain compared to control group
Time Frame
Offspring age until six years
Secondary Outcome Measure Information:
Title
lower cholesterol values
Time Frame
up to six years
Title
lower HOMA-index
Time Frame
up to six years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taina E. Mustila, M.D. Ph.D.
Organizational Affiliation
Seinajoki Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health care center in Vaasa
City
Vaasa
ZIP/Postal Code
65320
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29486763
Citation
Mustila T, Raitanen J, Keskinen P, Luoto R. A pragmatic controlled trial to prevent childhood obesity within a risk group at maternity and child health-care clinics: results up to six years of age (the VACOPP study). BMC Pediatr. 2018 Feb 27;18(1):89. doi: 10.1186/s12887-018-1065-3.
Results Reference
derived
PubMed Identifier
23688259
Citation
Mustila T, Raitanen J, Keskinen P, Saari A, Luoto R. Pragmatic controlled trial to prevent childhood obesity in maternity and child health care clinics: pregnancy and infant weight outcomes (the VACOPP Study). BMC Pediatr. 2013 May 20;13:80. doi: 10.1186/1471-2431-13-80.
Results Reference
derived
PubMed Identifier
22759439
Citation
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.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://bmcpediatr.biomedcentral.com/articles/10.1186/1471-2431-12-93
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
http://www.ncbi.nlm.nih.gov/pubmed/?term=mustila+taina+vacopp

Learn more about this trial

Vaasa Childhood Obesity Primary Prevention Study

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