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

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ClinicalTrials.gov Identifier: NCT01345149
Recruitment Status : Completed
First Posted : April 29, 2011
Last Update Posted : September 6, 2012
Sponsor:
Information provided by (Responsible Party):
Kristina Renault, Hvidovre University Hospital

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.

Condition or disease Intervention/treatment
Obesity Behavioral: Diet + Exercise

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)


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
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
Study Start Date : April 2009
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 :
  1. Pregnancy complications [ Time Frame: At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012 ]
  2. Glucose tolerance in pregnancy [ Time Frame: At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012 ]
  3. Birth weight [ Time Frame: At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012 ]


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.

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