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临床试验/NCT04989634
NCT04989634Unknown不适用

Effects of Dietary and Weight Management on Pregnancy Outcomes in Mobile Medical Platform

Capital Medical University2 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2019年7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
2,000
试验地点
2
主要终点
Incidence of gestational diabetes mellitus

研究概览

简要总结

With the opening up of the two-child policy , the composition of pregnant women in China has changed significantly . The proportion of high-risk pregnant women in the elderly has increased significantly , and the risk of adverse pregnancy outcomes has also increased . Among them , gestational diabetes mellitus ( GDM ) is the most common complication during pregnancy . The incidence of GDM in China is as high as 18 % due to the economic growth , lifestyle changes and dietary habits . GDM not only threatens perinatal maternal and child health , but also increases the risk of offspring insulin resistance , obesity and metabolic diseases in adulthood . But it is still lack of experience on intervening and managing them effectively. Therefore , on the basis of previous studies , this study intends to explore the effects of intensive diet and exercise intervention by obstetricians and nutritionists on pregnancy weight gain , pregnancy outcome , glucose and lipid metabolism and postpartum weight retention under the mobile medical platform through a large sample cluster intervention test in the real world. In order to supervise and improve the compliance of the intervention subjects and realize the ultimate change of their behaviors, this study intends to use the APP software, the mobile medical technology, to monitor and evaluate diet , exercise and weight. Through the above research , it aims to improve the current management schemes of diet and weight during pregnancy , not only helps to optimize and improve the quality of perinatal health care , but also prevents the adult chronic diseases from the fetal period. This research has important theoretical and practical value .

详细描述

This is a cluster intervention study. A randomized controlled trial in pregnant women will be initiated at 8-12 weeks of gestation util delivery. Pregnant women who received routine antenatal examination in Beijing Obstetrics and Gynecology Hospital will be divided into two groups . One group contained 1000 cases as the control group , and the other group contained 1000 cases as a whole . The intervention contents included health education , nutritional analysis and individualized dietary guidance combined with mobile medical treatment and face-to-face teaching during the early , middle and late pregnancy stages. The primary outcome will be the incidence of GDM and the secondary outcome will be the incidence of hypertensive disorders of pregnancy , cesarean section , premature delivery , macrosomia, large for gestational age and so on.

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 (Participant)

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Regular check-ups in our hospital
  • 18-44 years old
  • 8-12 gestational weeks

排除标准

  • Patients with incomplete medical records

结局指标

主要结局

Incidence of gestational diabetes mellitus

时间窗: From enrollment to 24-28 weeks of gestation

次要结局

  • Incidence of gestational hypertension(From date of randomization until the date of delivery, assessed up to 9 months)
  • Incidence of cesarean section(From date of randomization until the date of delivery, assessed up to 9 months)
  • Incidence of premature birth(From date of randomization until the date of delivery, assessed up to 9 months)

研究者

发起方
Capital Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guanghui Li

Associate Professor

Capital Medical University

研究点 (2)

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