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Tissue Composition of Newborn Infants of Obese and Lean Mothers

This study has been completed.
Information provided by (Responsible Party):
Ole Pryds, Hvidovre University Hospital Identifier:
First received: November 4, 2010
Last updated: March 18, 2013
Last verified: March 2013
0-hypothesis: the tissue composition of newborn infants is not modified by lifestyle intervention during pregnancy

Condition Intervention
Behavioral: diet
Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ?

Resource links provided by NLM:

Further study details as provided by 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

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

Inclusion Criteria:

Healthy term neonates Informed and written consent from both parents -

Exclusion Criteria:

Sick or preterm infants No consent

  Contacts and Locations
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Please refer to this study by its identifier: NCT01235676

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

Responsible Party: Ole Pryds, MD, Hvidovre University Hospital Identifier: NCT01235676     History of Changes
Other Study ID Numbers: DEXA-2650
Study First Received: November 4, 2010
Last Updated: March 18, 2013

Keywords provided by Hvidovre University Hospital:
newborn infant processed this record on April 28, 2017