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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:
Collaborator:
Aarhus University Hospital
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00530439
First received: September 13, 2007
Last updated: July 15, 2011
Last verified: April 2008
History of Changes
  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: Open Label
Primary Purpose: Prevention
Official Title: Lifestyle and Pregnancy: The Clinical Effect of Lifestyle Intervention During Pregnancy in Obese Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Cesarean Section [ Time Frame: At delivery ] [ Designated as safety issue: No ]
  • Preeclampsia/Pregnancy Induced Hypertension [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Gestational Diabetes Mellitus [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Large for Gestational Age [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Neonatal Intensive Care Unit [ Time Frame: Within 1 month postpartum ] [ Designated as safety issue: No ]
  • Gestational Weight Gain [ Time Frame: Gestational week 35 ] [ Designated as safety issue: No ]
    Weight at gestational week 35 - weight by inclusion


Secondary Outcome Measures:
  • Metabolic Markers [ Time Frame: Until 6 months post partum ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Odense University Hospital

Additional 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
Study First Received: September 13, 2007
Results First Received: June 13, 2011
Last Updated: July 15, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Obesity
Weight Gain
Obstetric Labor Complications
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes
Pregnancy Complications

ClinicalTrials.gov processed this record on May 21, 2013