The Effect of Lifestyle Intervention in Pregnancy - Follow-up on the Offspring in Early Childhood.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Childhood Obesity
- Sponsor
- Odense University Hospital
- Enrollment
- 157
- Locations
- 1
- Primary Endpoint
- Body Mass Index standard deviation score
- Status
- Completed
- Last Updated
- 6 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.
Investigators
Mette Tanvig
Medical Doctor
Odense University Hospital
Eligibility Criteria
Inclusion Criteria
- •children born to women who were part of the preceding LiP study and who completed the LiP study until birth. Inclusion criteria for the LiP study:
- •singleton pregnant
- •BMI \>/= 30 and \</= 45 E xclusion Criteria for preceding LiP study:
- •Chronic diseases
- •Not Danish speaking
- •Abuse of alcohol or drugs
- •Preterm delivery in earlier pregnancies
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Body Mass Index standard deviation score
Time Frame: On average 2.9 years of age
Secondary Outcomes
- Fat mass percent(On average 2.9 years of age)