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
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 or disease||Intervention/treatment||Phase|
|Maternal Obesity Gestational Weight Gain Obstetric Complications||Other: Lifestyle intervention Other: Control Behavioral: Physical activity, dietetic counselling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lifestyle and Pregnancy: The Clinical Effect of Lifestyle Intervention During Pregnancy in Obese Women|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
Experimental: Lifestyle intervention
physical activity, dietetic counselling
Other: Lifestyle intervention
Dietician counselling and physical trainingBehavioral: 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||
Repeated measuring of maternal weight gain, blood samples and ultrasound
- 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
- Metabolic Markers [ Time Frame: Until 6 months post partum ]
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
|Odense University Hospital|
|Odense C, Denmark, DK-5000|
|Principal Investigator:||Christina A. Vinter, Ph.d. Student||Odense University Hospital|