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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01345149
• Other study ID #: H-D-2008-119
• Status: Completed
• Phase: N/A
• First received: April 27, 2011
• Last updated: September 5, 2012
• Start date: April 2009
• Est. completion date: June 2012

Study information

• Verified date: September 2012
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Obstetrics and Gynecology, Hvidovre University Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal weight gain		At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012	No
Secondary	Pregnancy complications		At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012	No
Secondary	Glucose tolerance in pregnancy		At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012	No
Secondary	Birth weight		At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012	No