Tissue Composition of Newborn Infants of Obese and Lean Mothers

NCT ID: NCT01235676

Last Updated: 2013-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-10-31

Brief Summary

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

Detailed Description

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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

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Diet

Calorie restriction to reduce weight gain

Group Type EXPERIMENTAL

diet

Intervention Type BEHAVIORAL

calorie restriction to reduce weight gain

Exercise

Exercise to reduce weight gain

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Exercise to reduce weight gain

Interventions

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diet

calorie restriction to reduce weight gain

Intervention Type BEHAVIORAL

Exercise

Exercise to reduce weight gain

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Healthy term neonates Informed and written consent from both parents -

Exclusion Criteria

Sick or preterm infants No consent

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Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ole Pryds

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hvidovre University Hospital

Hvidovre, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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DEXA-2650

Identifier Type: -

Identifier Source: org_study_id

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