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CompletedNCT01235676Updated Mar 20, 2013

Tissue Composition of Newborn Infants of Obese and Lean Mothers

An interventional study of diet and Exercise in Obesity, sponsored by Hvidovre University Hospital. Completed at 1 site in Denmark. Open to participants aged Up to 3 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-03-20.

Sponsored by Hvidovre University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
270
Allocation
Randomized
Ages
Up to 3 Days
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Obesity

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Keywords

  • obesity
  • lifestyle
  • pregnancy
  • newborn infant
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.

This study's enrollment of 270 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Hvidovre University Hospital is the lead sponsor of 295 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 3 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Healthy term neonates Informed and written consent from both parents -

Exclusion criteria

Exclusion Criteria:

Sick or preterm infants No consent

-

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
270 participants (actual)

Study arms

  • Experimental
    Diet

    Calorie restriction to reduce weight gain

    Behavioral: diet

  • Experimental
    Exercise

    Exercise to reduce weight gain

    Behavioral: Exercise

Interventions

  • Behavioraldiet

    calorie restriction to reduce weight gain

  • BehavioralExercise

    Exercise to reduce weight gain

06

What researchers measure

Primary outcomes

  1. amount of fat tissue

    Time frame: at birth

Secondary outcomes

  1. birth weight

    Time frame: at birth

07

Study locations

1 site
  • Hvidovre University Hospital
    Hvidovre, 2650, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01235676
Lead sponsor
Hvidovre University Hospital
Responsible party
Ole Pryds (MD, Hvidovre University Hospital) — Principal investigator
First posted
Nov 5, 2010
Start date
Feb 2010
Primary completion
Jul 2012
Completion
Oct 2012
Last update
Mar 20, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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