跳至主要内容
临床试验/NCT04060056
NCT04060056进行中(未招募)不适用

Westlake Precision Birth Cohort

Westlake University1 个研究点 分布在 1 个国家目标入组 2,001 人开始时间: 2019年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
2,001
试验地点
1
主要终点
Continuous blood glucose change over 2 weeks

研究概览

简要总结

The Westlake Precision Birth Cohort (WeBirth) is a prospective cohort study among women with hyperglycemia during pregnancy and their offspring living in Hangzhou, China. The primary aim of this cohort is to characterize the continuous blood glucose response to dietary intake and physical activity among pregnant women with gestational diabetes mellitus (GDM) over 2 weeks, and to facilitate the development of personalized nutritional/lifestyle recommendation among these patients. Another aim of WeBirth is to investigate the association of dietary intake and physical activity together with continuous glucose change during pregnancy on the adverse birth outcomes including preterm birth, macrosomia and large-for-gestational-age birth. The secondary aim is to investigate the prospective associations of diet, physical activity and continuous glucose change over 2 weeks among the participants with long-term metabolic health of these women and their offspring.

详细描述

In China, an alarming increase in the prevalence of GDM has been observed in the past decade. GDM is of concern because it is associated with several maternal and fetal medical disorders. Lifestyle changes such as diet and physical activity modifications are key for the prevention and treatment of GDM. However, the associations between dietary intake and physical activity and health outcomes for GDM women and their children remain unclear due to subjective measurements of diet and physical activity. Recently, the development of objective measurements such as food image identification and wearable activity trackers give an opportunity to gain more precise insight into these associations. In addition, for the same food and physical activity exposures, GDM women may have different blood glucose responses, but the nature of variation is currently poorly characterized. Therefore, the present WeBirth design incorporates three unique components, 1) objective measurement of physical activity during pregnancy using accelerometer; 2) measurement of dietary intake using both the Food Frequency Questionnaire and dietary records; 3) measurement of blood glucose levels over 2 weeks using continuous glucose monitors, with three standardized test meals during the 2 weeks. We will then follow up these women participants during and after this pregnancy, and also follow up their offspring.

研究设计

研究类型
Interventional
分配方式
Non 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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 18 years or older
  • Women with GDM at 24-28 weeks of gestation
  • Women intended to deliver at Hangzhou Women's Hospital
  • Women intended to remain in Hangzhou with their child for ≥4 years

排除标准

  • ● Women with cancer and other serious medical disorders

结局指标

主要结局

Continuous blood glucose change over 2 weeks

时间窗: Two weeks after enrollment

Glucose levels are assessed by continuous glucose monitoring over 2 weeks.

Adverse birth outcomes

时间窗: 9-12 weeks after enrollment

Number of participants with adverse birth outcomes, such as, preterm birth, macrosomia and neonatal hypoglycemia.

次要结局

  • Body fat of the maternal participants(6 months and 3 years after delivery)
  • Weight changes of the children during early childhood(at delivery, age of 6 months, 1 year, 3 years and 6 years)
  • Number of participants developing type 2 diabetes(6 years and 10 years after delivery)

研究者

发起方
Westlake University
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验