Tissue Composition of Newborn Infants of Obese and Lean Mothers

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ole Pryds, Hvidovre University Hospital

ClinicalTrials.gov Identifier:

NCT01235676

First received: November 4, 2010

Last updated: March 18, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	November 4, 2010
Last Updated Date	March 18, 2013
Start Date ^ICMJE	February 2010
Primary Completion Date	July 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 4, 2010)	amount of fat tissue [ Time Frame: at birth ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01235676 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 4, 2010)	birth weight [ Time Frame: at birth ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Tissue Composition of Newborn Infants of Obese and Lean Mothers
Official Title ^ICMJE	Is it Possible to Reduce the Number of Macrosomic Infants With Abundant Fat Tissue by Lifestyle Intervention During Pregnancy ?
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 Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Obesity
Intervention ^ICMJE	Behavioral: diet calorie restriction to reduce weight gain Behavioral: Exercise Exercise to reduce weight gain
Study Arm (s)	Experimental: Diet Calorie restriction to reduce weight gain Intervention: Behavioral: diet Experimental: Exercise Exercise to reduce weight gain Intervention: Behavioral: Exercise
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	270
Completion Date	October 2012
Primary Completion Date	July 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Healthy term neonates Informed and written consent from both parents - Exclusion Criteria: Sick or preterm infants No consent -
Gender	Both
Ages	up to 3 Days
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Denmark

Administrative Information
NCT Number ^ICMJE	NCT01235676
Other Study ID Numbers ^ICMJE	DEXA-2650
Has Data Monitoring Committee	No
Responsible Party	Ole Pryds, Hvidovre University Hospital
Study Sponsor ^ICMJE	Hvidovre University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hvidovre University Hospital
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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