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Completed

NCT Number: NCT01345149

Effect of Intervention 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.

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Key information

Conditions

Obesity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology, Hvidovre University Hospital

Copenhagen, DK-2650, Denmark

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diet + Exercise

Behavioral

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

Exercise: Individual counselling

Other names: Lifestyle intervention.

Primary outcomes

  1. Maternal weight gain

    Time frame: At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 29, 2011
Registry last updated
Sep 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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