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

Gestational Weight Gain Clinical Trial

— LiP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00530439
• Other study ID #: 029
• Status: Completed
• Phase: N/A
• First received: September 13, 2007
• Last updated: July 15, 2011
• Start date: October 2007
• Est. completion date: October 2010

Study information

• Verified date: April 2008
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Gestational Weight Gain
• Maternal Obesity
• Obstetric Complications
• Weight Gain

Intervention

Other:
• Lifestyle intervention
Dietician counselling and physical training
• Control
Repeated measuring of maternal weight gain, blood samples and ultrasound

Behavioral:
• Physical activity, dietetic counselling
The active intervention consisted of two major components: dietary counseling and physical activity. Dietary counseling was performed by trained dieticians on four separate occasions at 15, 20, 28 and 35 weeks gestation. Energy requirements for each participant were individually estimated according to weight and level of activity during pregnancy. Women in the active intervention group were encouraged to be moderately physically active 30-60 minutes a day.Women in this group also had free full time membership in a fitness center for six months. In the fitness centers they had closed training classes with trained physiotherapists for one hour each week.

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense C

Sponsors (2)

Lead Sponsor	Collaborator
Odense University Hospital	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cesarean Section		At delivery	No
Primary	Preeclampsia/Pregnancy Induced Hypertension		Delivery	No
Primary	Gestational Diabetes Mellitus		Delivery	No
Primary	Large for Gestational Age		Delivery	No
Primary	Neonatal Intensive Care Unit		Within 1 month postpartum	No
Primary	Gestational Weight Gain	Weight at gestational week 35 - weight by inclusion	Gestational week 35	No
Secondary	Metabolic Markers		Until 6 months post partum	No