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

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Diet + Exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet + Exercise<br>Diet: Intensive counselling about calorie restriction to reduce weight gain by dietician. Exercise: Individual counselling | Behavioral: Diet + Exercise<br>* Diet: Intensive counselling about calorie restriction to reduce weight gain by dietician. Exercise: Individual counselling<br>* Other names: Lifestyle intervention.;|
| Experimental: Exercise<br>Exercise: Individual counselling | Behavioral: Diet + Exercise<br>* Diet: Intensive counselling about calorie restriction to reduce weight gain by dietician. Exercise: Individual counselling<br>* Other names: Lifestyle intervention.;|
| No Intervention: Control<br>Standard treatment without intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal weight gain |  | At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy complications |  | At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012 | 
| Glucose tolerance in pregnancy |  | At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012 | 
| Birth weight |  | At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Pregnancy, Intervention, Diet, Physical activity