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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00970710
Other study ID # 100454
Secondary ID
Status Completed
Phase N/A
First received September 1, 2009
Last updated February 12, 2017
Start date January 1, 2009
Est. completion date January 31, 2017

Study information

Verified date February 2017
Source University of Tampere
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 185
Est. completion date January 31, 2017
Est. primary completion date January 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 6 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Finland Health care center in Vaasa Vaasa

Sponsors (5)

Lead Sponsor Collaborator
University of Tampere Foundation for Paediatric Research, Finland, Seinajoki Central Hospital, Tampere University Hospital, Vaasa Health care center

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Preventing childhood obesity Difference in offspring weight gain compared to control group Offspring age until six years
Secondary lower cholesterol values up to six years
Secondary lower HOMA-index up to six years