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Lifestyle and Pregnancy: The Clinical Effect of Lifestyle Intervention During Pregnancy in Obese Women (LiP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00530439
First Posted: September 17, 2007
Last Update Posted: July 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Aarhus University Hospital
Information provided by:
Odense University Hospital
  Purpose

Obesity is a serious and increasing health problem in the Western World with about one third of all pregnant women in Denmark being overweight. Among these are more than 11% severe obese.

Obesity in pregnancy is related to higher maternal morbidity and perinatal morbidity and mortality. Observational studies indicate that the rate of pregnancy complications among obese pregnant women can be limited if weight gain during pregnancy is restricted.

Aims of the trial is to study the effects of diet and physical training during pregnancy among Danish obese women. Also to describe the metabolic effects of lifestyle intervention during pregnancy.

360 obese pregnant women with Body Mass Index (BMI) > 30 are randomized to lifestyle intervention group or control group. The intervention is composed of individual dietician counselling and physical training. The physical training includes weekly aerobic exercises in a fitness center and lifestyle coaching in small groups.

Both groups will be examined during pregnancy with extra ultrasound scanning of the fetus, blood pressure, and metabolic markers. All women receive vitamin supplementation to assure sufficient intake.


Condition Intervention
Maternal Obesity Gestational Weight Gain Obstetric Complications Other: Lifestyle intervention Other: Control Behavioral: Physical activity, dietetic counselling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Lifestyle and Pregnancy: The Clinical Effect of Lifestyle Intervention During Pregnancy in Obese Women

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Cesarean Section [ Time Frame: At delivery ]
  • Preeclampsia/Pregnancy Induced Hypertension [ Time Frame: Delivery ]
  • Gestational Diabetes Mellitus [ Time Frame: Delivery ]
  • Large for Gestational Age [ Time Frame: Delivery ]
  • Neonatal Intensive Care Unit [ Time Frame: Within 1 month postpartum ]
  • Gestational Weight Gain [ Time Frame: Gestational week 35 ]
    Weight at gestational week 35 - weight by inclusion


Secondary Outcome Measures:
  • Metabolic Markers [ Time Frame: Until 6 months post partum ]

Enrollment: 360
Study Start Date: October 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle intervention
physical activity, dietetic counselling
Other: Lifestyle intervention
Dietician counselling and physical training
Behavioral: Physical activity, dietetic counselling

The active intervention consisted of two major components: dietary counseling and physical activity. Dietary counseling was performed by trained dieticians on four separate occasions at 15, 20, 28 and 35 weeks gestation.

Energy requirements for each participant were individually estimated according to weight and level of activity during pregnancy. Women in the active intervention group were encouraged to be moderately physically active 30-60 minutes a day.Women in this group also had free full time membership in a fitness center for six months. In the fitness centers they had closed training classes with trained physiotherapists for one hour each week.

No Intervention: Control Other: Control
Repeated measuring of maternal weight gain, blood samples and ultrasound

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • singleton pregnant
  • BMI >/= 30 and </= 45

Exclusion Criteria:

  • Chronic diseases
  • Not Danish speaking
  • Abuse of alcohol or drugs
  • Preterm delivery in earlier pregnancies
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530439


Locations
Denmark
Odense University Hospital
Odense C, Denmark, DK-5000
Sponsors and Collaborators
Odense University Hospital
Aarhus University Hospital
Investigators
Principal Investigator: Christina A. Vinter, Ph.d. Student Odense University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Christina Vinter, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00530439     History of Changes
Other Study ID Numbers: 029
First Submitted: September 13, 2007
First Posted: September 17, 2007
Results First Submitted: June 13, 2011
Results First Posted: July 14, 2011
Last Update Posted: July 22, 2011
Last Verified: April 2008

Additional relevant MeSH terms:
Weight Gain
Body Weight Changes
Body Weight
Signs and Symptoms