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临床试验/NCT01753622
NCT01753622Unknown不适用

Effect of a Supervised Exercise Program in Obese and Overweight Pregnant Women on Outcomes and Level of Depression. A Randomized Controlled Trial

Technical University of Madrid2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
2
主要终点
Change from level of depression at the end of the pregnancy

研究概览

简要总结

Obesity and overweight have become an epidemic in the world and its prevalence between pregnant women is especially dangerous. Having a high Body Mass Index (BMI) is also associated with depression disorders and its serious complications during this period.

详细描述

The aim of our study is to assess whether a specific exercise program during pregnancy has a positive effect on maternal mood and other pregnancy outcomes.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
  • Being able to communicate in spanish
  • Giving birth at Hospital Universitario de Fuenlabrada
  • Having a Body Mass Index (BMI) greater than 24.9

排除标准

  • Multiparity
  • Obstetrician complications
  • Being interested in the study after 18 weeks
  • Not being regular in physical exercise program (minimum adherence 80%)
  • Younger than 18 years old

结局指标

主要结局

Change from level of depression at the end of the pregnancy

时间窗: Up to 36 weeks

The Center for Epidemiological Studies-Depression scale (CES-D) was administered to all obese and overweight pregnant women at the beginning and at the end of their pregnancies

次要结局

  • Maternal gestational weight gain(40-42 weeks)
  • Maternal outcomes(After labor)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

María Perales Santaella

PhD student

Technical University of Madrid

研究点 (2)

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