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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00530439
Other study ID # 029
Secondary ID
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


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
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