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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kristina Renault, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01345149
First received: April 27, 2011
Last updated: September 5, 2012
Last verified: September 2012
History of Changes

April 27, 2011
September 5, 2012
April 2009
June 2012   (final data collection date for primary outcome measure)
Maternal weight gain [ Time Frame: At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01345149 on ClinicalTrials.gov Archive Site
  • Pregnancy complications [ Time Frame: At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012 ] [ Designated as safety issue: No ]
  • Glucose tolerance in pregnancy [ Time Frame: At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012 ] [ Designated as safety issue: No ]
  • Birth weight [ Time Frame: At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Intervention With Diet and Physical Activity in Obese Pregnant Women
Effect of Lifestyleintervention With Diet and Physical Activity in Obese Pregnant Women

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.

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)
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Obesity
Behavioral: Diet + Exercise

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

Exercise: Individual counselling

Other Name: Lifestyle intervention.
  • Experimental: Diet + Exercise

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

    Exercise: Individual counselling

    Intervention: Behavioral: Diet + Exercise
  • Experimental: Exercise
    Exercise: Individual counselling
    Intervention: Behavioral: Diet + Exercise
  • No Intervention: Control
    Standard treatment without intervention.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
420
June 2012
June 2012   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01345149
H-D-2008-119
Yes
Kristina Renault, Hvidovre University Hospital
Hvidovre University Hospital
Not Provided
Study Chair: Niels Jørgen Secher, Professor Department of Obstetrics and Gynecology, Hvidovre University Hospital
Study Chair: Lisbeth Nilas, Prof. DMSc Department of Obstetrics and Gynecology, Hvidovre University Hospital
Hvidovre University Hospital
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP