Effect of Lifestyleintervention With Diet and Physical Activity in Obese Pregnant Women
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Hvidovre University Hospital
- Enrollment
- 420
- Locations
- 1
- Primary Endpoint
- Maternal weight gain
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
Purpose: To evaluate if lifestyle intervention (diet and exercise) can reduce maternal weight gain, the incidence of pregnancy complications and minimize the number of macrosomic infants.
Detailed Description
Obese pregnant women with a BMI\>30 are randomized to Diet + Exercise, Exercise or control (1:1:1) in order to reduce maternal weight gain to less than 5 kg during pregnancy. The effect on the children of mothers in this study is evaluated in the study: Is it possible to reduce the Number of Macrosomic Infants With Abundant Fat Tissue by Lifestyle Intervention during Pregnancy (NCT01235676)
Investigators
Kristina Renault
MD
Hvidovre University Hospital
Eligibility Criteria
Inclusion Criteria
- •Age \>18 years
- •BMI \> 30
- •Singleton pregnancy
- •Must speak and understand Danish
Exclusion Criteria
- •Alcohol or drug abuse
- •Diabetes type I or other critical medical disease.
Outcomes
Primary Outcomes
Maternal weight gain
Time Frame: At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012
Secondary Outcomes
- Pregnancy complications(At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012)
- Glucose tolerance in pregnancy(At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012)
- Birth weight(At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012)