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OpenTrials
Completed

NCT Number: NCT01235676

Tissue Composition of Newborn Infants of Obese and Lean Mothers

0-hypothesis: the tissue composition of newborn infants is not modified by lifestyle intervention during pregnancy

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hvidovre University Hospital

Hvidovre, 2650, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy term neonates Informed and written consent from both parents -

Exclusion criteria

Sick or preterm infants No consent

-

Treatment and study plan

Diet

Behavioral

calorie restriction to reduce weight gain

Exercise

Behavioral

Exercise to reduce weight gain

Primary outcomes

  1. amount of fat tissue

    Time frame: at birth

Secondary outcomes

  1. birth weight

    Time frame: at birth

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

Is it Possible to Reduce the Number of Macrosomic Infants With Abundant Fat Tissue by Lifestyle Intervention During Pregnancy ?

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 5, 2010
Registry last updated
Mar 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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