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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014