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临床试验/NCT03803345
NCT03803345已完成不适用

The Association of Maternal Night-Eating Pattern With Glucose Tolerance During Pregnancy

KK Women's and Children's Hospital2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年3月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
2
主要终点
Maternal glucose tolerance

研究概览

简要总结

This study aims to assess the associations of maternal food timing with glucose levels during pregnancy.

详细描述

A novel line of research has emerged, suggesting that synchronizing the timing of food intake with body's circadian rhythms or day-night cycle has metabolic implications. Eating at the inappropriate time can disrupt circadian system which might induce metabolic perturbations, including glucose abnormalities. Recent evidence showed that circadian timing of eating was associated with glucose regulation in pregnant women. However, little is known about night-eating pattern during pregnancy, particularly the influence of nocturnal snacking on glycaemic control.

This cross-sectional study aims to recruit 400 pregnant women at 18-21 weeks' gestation. The investigators will assess maternal dietary intake, monitor 24-hour activity-rest pattern and light-dark exposure, and measure glucose and insulin profiles during the second trimester of pregnancy. Maternal socio-demographic status, lifestyle characteristics, health conditions and pregnancy outcomes will be asked through interview or retrieved from medical notes.

This study allows understanding the importance of circadian eating pattern, which is a modifiable behavior, in glycaemic control during pregnancy, and help to provide evidence for developing nutritional guidelines which can ameliorate metabolic health for mothers.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • 18-21 week's gestation
  • Singapore citizens or Singapore Permanent Residents
  • Age 18-45 years
  • Plan to follow-up for antenatal care in KK Women's and Children's Hospital
  • Intend to deliver in KK Women's and Children's Hospital
  • Provide written informed consent

排除标准

  • Type 1 or 2 diabetes
  • Diabetes in pregnancy as confirmed by oral glucose tolerance test
  • Use of medications such as anticonvulsant medications or oral steroids in the past 1 month
  • Multiple pregnancy
  • On routine night-shift work for at least 3x/week over the past 1 month
  • Known or suspected allergy to medical grade adhesives
  • Chronic kidney diseases
  • Preeclampsia
  • Eventual miscarriage or undergo termination event

结局指标

主要结局

Maternal glucose tolerance

时间窗: Up to 4 weeks, during second trimester of pregnancy

Maternal glucose tolerance based on plasma glucose levels as assessed by the Oral Glucose Tolerance Test.

Maternal night-eating pattern

时间窗: Up to 4 days, during second trimester of pregnancy

Maternal night-eating pattern as assessed by the food diary and food record app.

Maternal meal and snack distribution

时间窗: Up to 4 days, during second trimester of pregnancy

Maternal meal and snack distribution as assessed by the food diary and food record app.

次要结局

  • Maternal eating frequency(Up to 4 days, during second trimester of pregnancy)
  • Maternal meal and snack regularity(Up to 1 month, during second trimester of pregnancy)
  • Maternal glycemic variability(Up to 10 days, during second trimester of pregnancy)
  • Maternal nutritional intake(Up to 4 days, during second trimester of pregnancy)
  • Maternal physical activity(Up to 1 week, during second trimester of pregnancy)
  • Maternal sedentary behavior(Up to 1 week, during second trimester of pregnancy)
  • Maternal insulin profile(Up to 4 weeks, during second trimester of pregnancy)
  • Maternal gestational diabetes status(up to 4 weeks, during second trimester of pregnancy)
  • Maternal diet quality(up to 1 month, during second trimester of pregnancy)
  • Maternal type of food intake(up to 10 weeks, during second trimester of pregnancy)
  • Maternal sleep related behavior(Up to 1 month, during second trimester of pregnancy)
  • Maternal light exposure(Up to 1 week, during second trimester of pregnancy)
  • Maternal electronic media use before bedtime(up to 1 week, during second trimester of pregnancy)
  • Maternal mood(Up to 1 week, during second trimester of pregnancy)
  • Maternal gestational weight gain(Up to 42 weeks, throughout pregnancy)
  • Dietary data from food record app.(up to 4 days, during second trimester of pregnancy)
  • Maternal physical activity(Up to 10 days, during second trimester of pregnancy)
  • Maternal sedentary behavior(Up to 10 days, during second trimester of pregnancy)
  • Maternal sleep related behavior(Up to 10 days, during second trimester of pregnancy)
  • Maternal light exposure(Up to 10 days, during second trimester of pregnancy)

研究者

发起方
KK Women's and Children's Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Loy See Ling

Junior Principal Investigator

KK Women's and Children's Hospital

研究点 (2)

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