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Clinical Trials/NCT01918423
NCT01918423
Completed
Not Applicable

The Effects of Lifestyle Intervention During Pregnancy in Obese Women on Offspring Adiposity and Metabolic Risk Factors- Comparison With Offspring of Normal Weight Women Not Participating in a Lifestyle Intervention Programme.

Odense University Hospital1 site in 1 country258 target enrollmentFebruary 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Childhood Obesity
Sponsor
Odense University Hospital
Enrollment
258
Locations
1
Primary Endpoint
Child body mass standard deviation score
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

Children born to obese women are at risk of increased adiposity and later adverse metabolic outcomes. We have conducted a follow-up study on an existing clinical trial, called the LiP study (Lifestyle in Pregnancy), registration number NCT00530439,in which 360 obese pregnant women were randomized to either lifestyle intervention or routine obstetric care. This present study follows the children until 3 years of age. We have the hypothesis, that the intervention during pregnancy results in a lower degree of adiposity and metabolic risk factors in the offspring. Clinical examination is taking place at age 2.5-3 years including anthropometric measurements, Dual energy x-ray (DXA) scans and blood samples measuring metabolic markers.In addition, we have included an extra control group of children born to normal weight women, who were not part of a lifestyle intervention program during pregnancy. We have the hypothesis that the children of the normal weight women have a better metabolic profile than the children born to the obese women.

Registry
clinicaltrials.gov
Start Date
February 2011
End Date
November 2012
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mette Tanvig

Medical Doctor

Odense University Hospital

Eligibility Criteria

Inclusion Criteria

  • All children born to obese women who participated in the LiP study (a randomized controlled trial of lifestyle intervention during pregnancy) and children born at term to healthy women with a normal pregestational BMI.

Exclusion Criteria

  • The children born to normal weight women only: preterm birth, congenital anomalies, maternal gestational diabetes, maternal diabetes mellitus, severe medical conditions in either child or mother.

Outcomes

Primary Outcomes

Child body mass standard deviation score

Time Frame: On average 2.9 years of age

Secondary Outcomes

  • anthropometric outcomes(On average 2.9 years of age)

Study Sites (1)

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