Effect of Intervention With Diet and Physical Activity in Obese Pregnant Women

Hvidovre University Hospital

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Diet + Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT01345149

H-D-2008-119

Details and patient eligibility

About

Purpose: To evaluate if lifestyle intervention (diet and exercise) can reduce maternal weight gain, the incidence of pregnancy complications and minimize the number of macrosomic infants.

Full description

Obese pregnant women with a BMI>30 are randomized to Diet + Exercise, Exercise or control (1:1:1) in order to reduce maternal weight gain to less than 5 kg during pregnancy.

The effect on the children of mothers in this study is evaluated in the study: Is it possible to reduce the Number of Macrosomic Infants With Abundant Fat Tissue by Lifestyle Intervention during Pregnancy (NCT01235676)

Enrollment: 420 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age >18 years
• BMI > 30
• Singleton pregnancy
• Must speak and understand Danish

Exclusion criteria

• Alcohol or drug abuse
• Diabetes type I or other critical medical disease.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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420 participants in 3 patient groups

Diet + Exercise

Experimental group

Description:

Diet: Intensive counselling about calorie restriction to reduce weight gain by dietician. Exercise: Individual counselling

Treatment:

Behavioral: Diet + Exercise

Exercise

Experimental group

Description:

Exercise: Individual counselling

Treatment:

Behavioral: Diet + Exercise

Control

No Intervention group

Description:

Standard treatment without intervention.