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Tissue Composition of Newborn Infants of Obese and Lean Mothers

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ClinicalTrials.gov Identifier: NCT01235676
Recruitment Status : Completed
First Posted : November 5, 2010
Last Update Posted : March 20, 2013
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Obesity Behavioral: diet Behavioral: Exercise

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Is it Possible to Reduce the Number of Macrosomic Infants With Abundant Fat Tissue by Lifestyle Intervention During Pregnancy ?
Study Start Date : February 2010
Primary Completion Date : July 2012
Study Completion Date : October 2012
Arms and Interventions

Arm Intervention/treatment
Experimental: Diet
Calorie restriction to reduce weight gain
Behavioral: diet
calorie restriction to reduce weight gain
Experimental: Exercise
Exercise to reduce weight gain
Behavioral: Exercise
Exercise to reduce weight gain


Outcome Measures

Primary Outcome Measures :
  1. amount of fat tissue [ Time Frame: at birth ]

Secondary Outcome Measures :
  1. birth weight [ Time Frame: at birth ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy term neonates Informed and written consent from both parents -

Exclusion Criteria:

Sick or preterm infants No consent

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01235676


Locations
Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
More Information

Responsible Party: Ole Pryds, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01235676     History of Changes
Other Study ID Numbers: DEXA-2650
First Posted: November 5, 2010    Key Record Dates
Last Update Posted: March 20, 2013
Last Verified: March 2013

Keywords provided by Ole Pryds, Hvidovre University Hospital:
obesity
lifestyle
pregnancy
newborn infant