Effect of Intervention With Diet and Physical Activity in Obese Pregnant Women

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Diet + Exercise

• Registration Number: NCT01345149
• Lead Sponsor: Hvidovre University Hospital

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)

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2011-04-27
• Study First Submitted QC: 2011-04-28
• Study First Posted: 2011-04-29
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-05
• Last Update Posted: 2012-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 420

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet + Exercise	Diet + Exercise	Diet: Intensive counselling about calorie restriction to reduce weight gain by dietician. Exercise: Individual counselling
Exercise	Diet + Exercise	Exercise: Individual counselling

Primary Outcome Measures

Name	Time	Method
Maternal weight gain	At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Hvidovre University Hospital; 🇩🇰 Copenhagen, Denmark