Back to resultsTissue Composition of Newborn Infants of Obese and Lean Mothers
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
diet
Exercise
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring obesity, lifestyle, pregnancy, newborn infant
Eligibility Criteria
Inclusion Criteria:
Healthy term neonates Informed and written consent from both parents -
Exclusion Criteria:
Sick or preterm infants No consent
-
Sites / Locations
- Hvidovre University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Diet
Exercise
Arm Description
Calorie restriction to reduce weight gain
Exercise to reduce weight gain
Outcomes
Primary Outcome Measures
amount of fat tissue
Secondary Outcome Measures
birth weight
Full Information
NCT ID
NCT01235676
First Posted
November 4, 2010
Last Updated
March 18, 2013
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01235676
Brief Title
Tissue Composition of Newborn Infants of Obese and Lean Mothers
Official Title
Is it Possible to Reduce the Number of Macrosomic Infants With Abundant Fat Tissue by Lifestyle Intervention During Pregnancy ?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, lifestyle, pregnancy, newborn infant
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
270 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diet
Arm Type
Experimental
Arm Description
Calorie restriction to reduce weight gain
Arm Title
Exercise
Arm Type
Experimental
Arm Description
Exercise to reduce weight gain
Intervention Type
Behavioral
Intervention Name(s)
diet
Intervention Description
calorie restriction to reduce weight gain
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Exercise to reduce weight gain
Primary Outcome Measure Information:
Title
amount of fat tissue
Time Frame
at birth
Secondary Outcome Measure Information:
Title
birth weight
Time Frame
at birth
10. Eligibility
Sex
All
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy term neonates Informed and written consent from both parents -
Exclusion Criteria:
Sick or preterm infants No consent
-
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Tissue Composition of Newborn Infants of Obese and Lean Mothers
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