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临床试验/NCT01628835
NCT01628835已完成不适用

Low Glycemic Index Diet Intervention on Insulin Resistance of Overweight Pregnant Women.

Children's Hospital of Fudan University2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2012年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
2
主要终点
Maternal weight gain

研究概览

简要总结

The study is a randomized, single-blinded, controlled intervention trial to compare the effect of a low glycemic index diet versus diet recommended by the Chinese Dietary Guide for Pregnant Women on maternal and neonatal insulin resistance and adverse gestational events.

详细描述

Overweight in pregnant women increases maternal insulin resistance and risk of adverse pregnancy outcomes. Recent evidence from both animal studies and human subject studies shows that adverse environmental exposures during pregnancy result in adverse influence on offsprings. The hypothesis of the current study is that the healthy intervention during pregnancy to overweight pregnant women--low glycemic diet, may improve the maternal and neonatal insulin resistance at birth.

The current study adopts randomized, single-blinded, controlled intervention trial, gives low glycemic index diet intervention based on the national diet and physical activity recommendations for pregnant women to the intervention group and only national diet recommendations to the control group. Four diet consultation interviews will be done,at baseline (first prenatal examination), the end of the 1st trimester, the 2nd trimester and the 3rd trimester respectively, including diet assessment and diet consultation specifically to adopting low glycemic diet. Glycemic load of diet will be calculated based on 24 hour diet recall data for each individual at every visit to help to lower their diet glycemic load by modifying some daily foods. The effect of intervention is investigated by comparing the insulin resistance levels between the two arms at birth and when infants are at age 2. For discrete traits, such as incidence of gestational diabetes and gestational hypertension, Person's chi-square tests were used. For continuous traits, such as insulin resistance index, maternal weight gain and neonatal birth weight, we use t-tests for comparisons between two groups. The study expects that long-term low GI diet intervention have beneficial effects on controlling maternal and neonatal insulin resistance to overweight women and long term health.

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 45 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Singleton pregnancy;
  • •Pregnant women with BMI≥24 kg/m2 at first antenatal examination;
  • •aged 18 years to 45 years;
  • •The week of first prenatal examination equal to or less than 12 weeks;
  • •Take routine prenatal examination;
  • •Willing and able to give informed consent. Exclusion
  • •Artificial impregnation;
  • •History of hypertension, diabetes, coronary heart disease or mental disorder;
  • •With Special diet habit(e.g. vegetarianism/ veganism).

排除标准

  • 未提供

研究组 & 干预措施

Low dietary glycemic index diet

Experimental

Based on the national diet and physical activity recommendations for pregnant women (total energy intake, protein and vitamin etc.), counseling for a low dietary glycemic index diet will be provided.

干预措施: Low dietary glycemic index diet (Behavioral)

National recommendation diet

Active Comparator

Provision of food and dietary counseling according to the national prenatal nutrition recommendation without GI information

干预措施: National recommendation diet (Behavioral)

结局指标

主要结局

Maternal weight gain

时间窗: measured before delivery

measured before delivery (minus pre-conceptual body weight)

Cord blood C-peptide

时间窗: at delivery

Incidence of gestational diabetes

时间窗: during pregnancy

from 1st antenatal visit to delivery

Incidence of macrosomia

时间窗: at delivery

birth weight \>= 4000g

Maternal insulin resistance

时间窗: During pregnancy

次要结局

  • head circumference(at delivery)
  • Incidence of gestational hypertension(during pregnancy)
  • cesarean(at delivery)
  • Mean infant birth weight(at delivery)
  • Incidence of premature delivery(at delivery)
  • Mean gestational age(at delivery)

研究者

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

Weili Yan

Professor, Director

Children's Hospital of Fudan University

研究点 (2)

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