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临床试验/NCT02109588
NCT02109588Unknown不适用

Early Prevention of Childhood Obesity: an Active Pregnancy

Technical University of Madrid2 个研究点 分布在 1 个国家目标入组 1,100 人开始时间: 2014年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
1,100
试验地点
2
主要终点
Placenta measurements

研究概览

简要总结

The main aim of this study was to examine the effect of a supervised physical exercise program on the prevention of childhood obesity and its impact on the motor development of the offspring.

详细描述

The environment where the fetus growths up is essential for the risk of developing some diseases in later life, such as obesity. Exercise has showed being useful in the prevention on excessive maternal weight gain which is linked to fetus weight.

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
Single (Investigator)

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 Torrejón, hospital Universitario de Puerta de Hierro and Hospital Universitario Severo Ochoa (Madrid).

排除标准

  • Multiparity
  • Obstetrician complications
  • Being interested in the study after 16 weeks
  • Not being regular in physical exercise program
  • Younger than 18 years old

研究组 & 干预措施

Control

No Intervention

Sedentary pregnant women

Exercise group

Experimental

Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training

Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60% of heart rate reserve. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate

干预措施: A supervised physical exercise program (Behavioral)

结局指标

主要结局

Placenta measurements

时间窗: At delivery

Placenta measurements were collected at labor

Body mass index of the offsprings

时间窗: 0-24 postpartum months

Body mass index was measured several times from 0 to 24 months

Fetus body composition

时间窗: 0-24 postpartum months

Fetus body composition (percentage of fat) was measured several times from 0 to 24 months

Glycemia level of the offsprings

时间窗: 0-24 postpartum months

Glycemia level of the offsprings was measured until 24 months

Recovery time to pre-gestational weight

时间窗: 6-12 postpartum months

The time needed to recovery the pre-gestational weight was assessed.

Changes in Baby motor development

时间窗: 0-24 postpartum months

Baby motor development was measured after delivery

Changes from baseline in maternal quality of life

时间窗: up to 36 weeks

Maternal quality of life was measured during and after pregnancy

Change from baseline in Maternal gestational weight gain

时间窗: 40-42 weeks of gestation

Maternal weight gain during pregnancy

Postpartum depression

时间窗: 0-12 postpartum months

The level of maternal depression was measured after delivery

Change from baseline in Body image satisfaction

时间窗: up to 36 weeks

Body image satisfaction was measured during and after pregnancy

次要结局

  • Maternal outcomes(At delivery)
  • Control of physical activity(up to 10 weeks)
  • Changes from delivery in Health of the offspring(0-24 postpartum months)
  • Fetus outcomes(At delivery)

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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