Lifestyle and Pregnancy: The Clinical Effect of Lifestyle Intervention During Pregnancy in Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Gestational Diabetes Mellitus
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •singleton pregnant
- •BMI >/= 30 and </= 45
排除标准
- •Chronic diseases
- •Not Danish speaking
- •Abuse of alcohol or drugs
- •Preterm delivery in earlier pregnancies
研究组 & 干预措施
Lifestyle intervention
physical activity, dietetic counselling
干预措施: Lifestyle intervention (Other)
Lifestyle intervention
physical activity, dietetic counselling
干预措施: Physical activity, dietetic counselling (Behavioral)
Control
干预措施: Control (Other)
结局指标
主要结局
Gestational Diabetes Mellitus
时间窗: Delivery
Preeclampsia/Pregnancy Induced Hypertension
时间窗: Delivery
Gestational Weight Gain
时间窗: Gestational week 35
Weight at gestational week 35 - weight by inclusion
Cesarean Section
时间窗: At delivery
Large for Gestational Age
时间窗: Delivery
Neonatal Intensive Care Unit
时间窗: Within 1 month postpartum
次要结局
- Metabolic Markers(Until 6 months post partum)
