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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
  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 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:

U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • amount of fat tissue [ Time Frame: at birth ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • birth weight [ Time Frame: at birth ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235676

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

No publications provided

Responsible Party: Ole Pryds, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01235676     History of Changes
Other Study ID Numbers: DEXA-2650
Study First Received: November 4, 2010
Last Updated: March 18, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013