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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01345149
First Posted: April 29, 2011
Last Update Posted: September 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kristina Renault, Hvidovre University Hospital
  Purpose
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.

Condition Intervention
Obesity Behavioral: Diet + Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Lifestyleintervention With Diet and Physical Activity in Obese Pregnant Women

Resource links provided by NLM:


Further study details as provided by Kristina Renault, Hvidovre University Hospital:

Primary Outcome Measures:
  • Maternal weight gain [ Time Frame: At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012 ]

Secondary Outcome Measures:
  • Pregnancy complications [ Time Frame: At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012 ]
  • Glucose tolerance in pregnancy [ Time Frame: At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012 ]
  • Birth weight [ Time Frame: At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012 ]

Enrollment: 420
Study Start Date: April 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diet + Exercise

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

Exercise: Individual counselling

Behavioral: Diet + Exercise

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

Exercise: Individual counselling

Other Name: Lifestyle intervention.
Experimental: Exercise
Exercise: Individual counselling
Behavioral: Diet + Exercise

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

Exercise: Individual counselling

Other Name: Lifestyle intervention.
No Intervention: Control
Standard treatment without intervention.

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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01345149


Locations
Denmark
Department of Obstetrics and Gynecology, Hvidovre University Hospital
Copenhagen, Denmark, DK-2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kristina Renault, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01345149     History of Changes
Other Study ID Numbers: H-D-2008-119
First Submitted: April 27, 2011
First Posted: April 29, 2011
Last Update Posted: September 6, 2012
Last Verified: September 2012

Keywords provided by Kristina Renault, Hvidovre University Hospital:
Obesity
Pregnancy
Intervention
Diet
Physical activity