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
  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: 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Kristina Renault, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01345149     History of Changes
Other Study ID Numbers: H-D-2008-119
Study First Received: April 27, 2011
Last Updated: September 5, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014