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Tissue Composition of Newborn Infants of Obese and Lean Mothers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01235676
First Posted: November 5, 2010
Last Update Posted: March 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ole Pryds, Hvidovre University Hospital
  Purpose
0-hypothesis: the tissue composition of newborn infants is not modified by lifestyle intervention during pregnancy

Condition Intervention
Obesity Behavioral: diet Behavioral: Exercise

Study Type: Interventional
Study Design: 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 ?

Further study details as provided by Ole Pryds, Hvidovre University Hospital:

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

Secondary Outcome Measures:
  • birth weight [ Time Frame: at birth ]

Enrollment: 270
Study Start Date: February 2010
Study Completion Date: October 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

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 Submitted: November 4, 2010
First Posted: November 5, 2010
Last Update Posted: March 20, 2013
Last Verified: March 2013

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