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临床试验/NCT01329835
NCT01329835Unknown不适用

Effect of Psycho-education on Gestational Weight Gain and Anxiety/Depression in Obese Pregnant Women

Limburg Catholic University College6 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2008年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
180
试验地点
6
主要终点
Gestational weight gain

研究概览

简要总结

Prepregnancy obesity, defined as a body mass index (BMI) of 30kg/m² or more, shows a strong association with pregnancy and birth complications for both the mother and her child. Most consequently reported maternal risks include an increased risk for gestational diabetes, hypertension and pre-eclampsia, increased incidence of induction of labour, operative delivery, postpartum haemorrhage, anaesthetic risks as well as risk for infections and thromboembolic complications. Fetal risks include miscarriage, neural-tube defects, heart defects, macrosomia and stillbirth. Initiation and continuation of breastfeeding is more complicated in obese women than in normal weight women. Also in later life chronic diseases can put the mother and her baby's health at risk. The Institute Of Medicine (IOM) guidelines suggest a gestational weight gain (GWG) to be limited to 5 - 9 kg (11-19,8 lb) in obese women in order to minimize the synergetic negative health consequences of excessive weight gain for both the obese mother and her child. Preventing excessive weight gain during pregnancy and postpartum weight retention is also important in the prevention of overweight and obesity among women of reproductive age. Obese women in general have a poor diet quality and are more exposed to psychosocial factors like anxiety and feelings of depression than normal weight women.

The aim of this project is to perform a randomized controlled trial (RCT) in order to evaluate the effects of life-style intervention (psycho-education by a midwife during 4 prenatal sessions) on pregnancy and birth outcomes. Main dependent variables are gestational weight gain and anxiety and depression. Obesity is a modifiable risk factor and optimizing an adequate gestational weight gain with attention to psycho-social factors, can reduce the need for adverse perinatal outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Less than 15 weeks pregnant

排除标准

  • Multiple pregnancy
  • Preexisting diabetes
  • Primary need for nutritional advice
  • Inadequate knowledge of Dutch language

结局指标

主要结局

Gestational weight gain

时间窗: For the duration of pregnancy, an expected average of 40 weeks

Weight just before delivery minus prepregnancy weight

次要结局

  • Evolutions in anxiety and depression during pregnancy(During pregnancy on fixed time points: trimester 1 (before 15 weeks of gestation), trimester 2 (between 18 and 28 weeks of gestation) and trimester 3 (between 30 - 34 weeks of gestation))

研究者

发起方
Limburg Catholic University College
申办方类型
Other

研究点 (6)

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