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临床试验/NCT00530439
NCT00530439已完成不适用

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

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2007年10月最近更新:
适应症
干预措施

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

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

Experimental

physical activity, dietetic counselling

干预措施: Lifestyle intervention (Other)

Lifestyle intervention

Experimental

physical activity, dietetic counselling

干预措施: Physical activity, dietetic counselling (Behavioral)

Control

No Intervention

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)

研究者

申办方类型
Other

研究点 (2)

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