Tissue Composition of Newborn Infants of Obese and Lean Mothers

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: diet; Behavioral: Exercise

• Registration Number: NCT01235676
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

0-hypothesis: the tissue composition of newborn infants is not modified by lifestyle intervention during pregnancy

Detailed Description

Obese pregnant women (BMI \> 30) are randomized to exercise, diet or control (1:1:1) in order to reduce weight gain during pregnancy. Shortly after birth, tissue composition will be measured (DEXA)in 200 infants (65 from each group). The amount of fat tissue is subsequently analyzed between the groups and compared to results from another 65 infants of lean mothers

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-11-04
• Study First Submitted QC: 2010-11-04
• Study First Posted: 2010-11-05
• Primary Completion: 2012-07
• Study Completion: 2012-10
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-18
• Last Update Posted: 2013-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

Healthy term neonates Informed and written consent from both parents -

Exclusion Criteria

Sick or preterm infants No consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet	diet	Calorie restriction to reduce weight gain
Exercise	Exercise	Exercise to reduce weight gain

Primary Outcome Measures

Name	Time	Method
amount of fat tissue	at birth

Secondary Outcome Measures

Name	Time	Method
birth weight	at birth

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark