N/A
N=360
Lifestyle and Pregnancy: The Clinical Effect of Lifestyle Intervention During Pregnancy in Obese Women
Maternal Obesity · Gestational Weight Gain · Obstetric Complications
Bottom Line
View on ClinicalTrials.gov: NCT00530439 ↗Enrolled (actual)
360
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcome: Primary: Cesarean Section
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lifestyle intervention (Other); Control (Other); Physical activity, dietetic counselling (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Odense University Hospital
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cesarean Section |
— | — |
| PRIMARY Preeclampsia/Pregnancy Induced Hypertension |
— | — |
| PRIMARY Gestational Diabetes Mellitus |
— | — |
| PRIMARY Large for Gestational Age |
— | — |
| PRIMARY Neonatal Intensive Care Unit |
— | — |
| PRIMARY Gestational Weight Gain |
7.0; 8.6 | 0.014 sig |
| SECONDARY Metabolic Markers |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00530439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.