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Effect of Intervention With Diet and Physical Activity in Obese Pregnant Women

Effect of Lifestyleintervention With Diet and Physical Activity in Obese Pregnant Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01345149
Enrollment
420
Registered
2011-04-29
Start date
2009-04-30
Completion date
2012-06-30
Last updated
2012-09-06

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

Conditions

Obesity

Keywords

Obesity, Pregnancy, Intervention, Diet, Physical activity

Brief summary

Purpose: To evaluate if lifestyle intervention (diet and exercise) can reduce maternal weight gain, the incidence of pregnancy complications and minimize the number of macrosomic infants.

Detailed description

Obese pregnant women with a BMI\>30 are randomized to Diet + Exercise, Exercise or control (1:1:1) in order to reduce maternal weight gain to less than 5 kg during pregnancy. The effect on the children of mothers in this study is evaluated in the study: Is it possible to reduce the Number of Macrosomic Infants With Abundant Fat Tissue by Lifestyle Intervention during Pregnancy (NCT01235676)

Interventions

BEHAVIORALDiet + Exercise

Diet: Intensive counselling about calorie restriction to reduce weight gain by dietician. Exercise: Individual counselling

Sponsors

Hvidovre University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age \>18 years * BMI \> 30 * Singleton pregnancy * Must speak and understand Danish

Exclusion criteria

* Alcohol or drug abuse * Diabetes type I or other critical medical disease.

Design outcomes

Primary

MeasureTime frame
Maternal weight gainAt delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012

Secondary

MeasureTime frame
Pregnancy complicationsAt delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012
Glucose tolerance in pregnancyAt delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012
Birth weightAt delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026