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

Not Applicable

Completed

• Conditions: Obstetric Complications; Maternal Obesity; Gestational Weight Gain
• Interventions: Other: Control; Other: Lifestyle intervention; Behavioral: Physical activity, dietetic counselling

• Registration Number: NCT00530439
• Lead Sponsor: Odense University Hospital

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 available

Study Timeline

• Study First Submitted: 2007-09-13
• Study First Submitted QC: 2007-09-13
• Study First Posted: 2007-09-17
• Study Start: 2007-10
• Status Verified: 2008-04
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Results First Submitted: 2011-06-13
• Results First Submitted QC: 2011-06-13
• Results First Posted: 2011-07-14
• Last Update Submitted: 2011-07-15
• Last Update Posted: 2011-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 360

Inclusion Criteria

• singleton pregnant
• BMI >/= 30 and </= 45

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Exclusion Criteria

• Chronic diseases
• Not Danish speaking
• Abuse of alcohol or drugs
• Preterm delivery in earlier pregnancies

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	-
Lifestyle intervention	Lifestyle intervention	physical activity, dietetic counselling
Lifestyle intervention	Physical activity, dietetic counselling	physical activity, dietetic counselling

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Metabolic Markers	Until 6 months post partum

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense C, Denmark