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

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ClinicalTrials.gov Identifier: NCT00530439
Recruitment Status : Completed
First Posted : September 17, 2007
Results First Posted : July 14, 2011
Last Update Posted : July 22, 2011
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by:
Odense University Hospital

Tracking Information
First Submitted Date  ICMJE September 13, 2007
First Posted Date  ICMJE September 17, 2007
Results First Submitted Date  ICMJE June 13, 2011
Results First Posted Date  ICMJE July 14, 2011
Last Update Posted Date July 22, 2011
Study Start Date  ICMJE October 2007
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2011)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2007)
cesarean section, gestational diabetes mellitus, hypertension/preeclampsia, Large for gestational age and admission to neonatal intensive care unit [ Time Frame: Until 6 months post partum ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2011)
Metabolic Markers [ Time Frame: Until 6 months post partum ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2007)
Metabolic markers [ Time Frame: Until 6 months post partum ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lifestyle and Pregnancy: The Clinical Effect of Lifestyle Intervention During Pregnancy in Obese Women
Official Title  ICMJE Lifestyle and Pregnancy: The Clinical Effect of Lifestyle Intervention During Pregnancy in Obese Women
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Maternal Obesity
  • Gestational Weight Gain
  • Obstetric Complications
Intervention  ICMJE
  • Other: Lifestyle intervention
    Dietician counselling and physical training
  • Other: Control
    Repeated measuring of maternal weight gain, blood samples and ultrasound
  • 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.

Study Arms  ICMJE
  • Experimental: Lifestyle intervention
    physical activity, dietetic counselling
    Interventions:
    • Other: Lifestyle intervention
    • Behavioral: Physical activity, dietetic counselling
  • No Intervention: Control
    Intervention: Other: Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2007)
360
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00530439
Other Study ID Numbers  ICMJE 029
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christina Vinter, Odense University Hospital
Study Sponsor  ICMJE Odense University Hospital
Collaborators  ICMJE Aarhus University Hospital
Investigators  ICMJE
Principal Investigator: Christina A. Vinter, Ph.d. Student Odense University Hospital
PRS Account Odense University Hospital
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP