Tissue Composition of Newborn Infants of Obese and Lean Mothers

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01235676

Enrollment

270

Registered

2010-11-05

Start date

2010-02-28

Completion date

2012-10-31

Last updated

2013-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

obesity, lifestyle, pregnancy, newborn infant

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

Interventions

BEHAVIORALdiet

calorie restriction to reduce weight gain

BEHAVIORALExercise

Exercise to reduce weight gain

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 3 Days

Healthy volunteers

Yes

Inclusion criteria

Healthy term neonates Informed and written consent from both parents -

Exclusion criteria

Sick or preterm infants No consent \-

Design outcomes

Primary

Measure	Time frame
amount of fat tissue	at birth

Secondary

Measure	Time frame
birth weight	at birth

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026