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

Study Overview
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Brief Summary
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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.

Official Title
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Lifestyle and Pregnancy: The Clinical Effect of Lifestyle Intervention During Pregnancy in Obese Women

Conditions
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Maternal Obesity, Gestational Weight Gain, Obstetric Complications

Intervention / Treatment
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* Other: Lifestyle intervention
* Other: Control
* Behavioral: Physical activity, dietetic counselling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle intervention<br>physical activity, dietetic counselling | Other: Lifestyle intervention<br>* Dietician counselling and physical training<br>Behavioral: Physical activity, dietetic counselling<br>* 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.<br>|
| No Intervention: Control<br> | Other: Control<br>* Repeated measuring of maternal weight gain, blood samples and ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic Markers |  | Until 6 months post partum |