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Tissue Composition of Newborn Infants of Obese and Lean Mothers

H

Hvidovre University Hospital

Status

Completed

Conditions

Obesity

Treatments

Behavioral: Exercise
Behavioral: diet

Study type

Interventional

Funder types

Other

Identifiers

NCT01235676
DEXA-2650

Details and patient eligibility

About

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

Full 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

Enrollment

270 patients

Sex

All

Ages

Under 3 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy term neonates Informed and written consent from both parents -

Exclusion criteria

Sick or preterm infants No consent

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

270 participants in 2 patient groups

Diet
Experimental group
Description:
Calorie restriction to reduce weight gain
Treatment:
Behavioral: diet
Exercise
Experimental group
Description:
Exercise to reduce weight gain
Treatment:
Behavioral: Exercise

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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