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

September 5, 2012 updated by: Kristina Renault, Hvidovre University Hospital

Effect of Lifestyleintervention 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, DK-2650
        • Department of Obstetrics and Gynecology, Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Lifestyle intervention.
No Intervention: Control
Standard treatment without intervention.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

April 27, 2011

First Submitted That Met QC Criteria

April 28, 2011

First Posted (Estimate)

April 29, 2011

Study Record Updates

Last Update Posted (Estimate)

September 6, 2012

Last Update Submitted That Met QC Criteria

September 5, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-D-2008-119

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Diet + Exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe