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

O

Odense University Hospital

Status

Completed

Conditions

Obstetric Complications
Maternal Obesity
Gestational Weight Gain

Treatments

Other: Control
Other: Lifestyle intervention
Behavioral: Physical activity, dietetic counselling

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

360 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

360 participants in 2 patient groups

Lifestyle intervention
Experimental group
Description:
physical activity, dietetic counselling
Treatment:
Other: Lifestyle intervention
Behavioral: Physical activity, dietetic counselling
Control
No Intervention group
Treatment:
Other: Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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