Lifestyle and Pregnancy: The Clinical Effect of Lifestyle Intervention During Pregnancy in Obese Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Odense University Hospital
- Enrollment
- 360
- Locations
- 1
- Primary Endpoint
- Gestational Diabetes Mellitus
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Lifestyle intervention
physical activity, dietetic counselling
Intervention: Lifestyle intervention (Other)
Lifestyle intervention
physical activity, dietetic counselling
Intervention: Physical activity, dietetic counselling (Behavioral)
Control
Intervention: Control (Other)
Outcomes
Primary Outcomes
Gestational Diabetes Mellitus
Time Frame: Delivery
Preeclampsia/Pregnancy Induced Hypertension
Time Frame: Delivery
Gestational Weight Gain
Time Frame: Gestational week 35
Weight at gestational week 35 - weight by inclusion
Cesarean Section
Time Frame: At delivery
Large for Gestational Age
Time Frame: Delivery
Neonatal Intensive Care Unit
Time Frame: Within 1 month postpartum
Secondary Outcomes
- Metabolic Markers(Until 6 months post partum)