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临床试验/NCT03191331
NCT03191331已完成不适用

Intervention Study on Dietary Changes in Relation to Weight Gain and Prevalence of Gestational Diabetes During Pregnancy

University of Eastern Finland2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2017年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
gestational weight gain (GWG)

研究概览

简要总结

The aim of this pilot study is to conduct a dietary intervention for overweight (body maas index BMI≥25) and obese (BMI≥30) pregnant women in two maternity care clinics and explore the effect of the intervention on gestational weight gain and the prevalence of gestational diabetes between the intervention and control groups.

详细描述

Half of the women are allocated to the intervention group and another half for the control group. The intervention group will get written material of healthy diet during pregnancy as well as emphasized nutritional guidance given by public health nurses at each visit in the maternity care clinic. There will also be two group meetings with a dietitian. The control group will get the same written material, but otherwise basic care and guidance at each visit in the maternity care clinics. The collected data of both groups include the information on weight gain, the result of an oral glucose tolerance test and 4 day food records, Three factor eating questionnaire (TFEQ R-18) and Binge Eating Scale (BES).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age less than 35 years
  • BMI 25 or over
  • healthy, no chronic medical conditions
  • singleton pregnancy
  • first trimester of pregnancy at the time of recruitment

排除标准

  • Age 35 and older
  • BMI less than 25
  • chronic medical conditions
  • multiple pregnancy
  • pregnancy at second or third trimester at the time of recruitment

结局指标

主要结局

gestational weight gain (GWG)

时间窗: from first to third trimester of pregnancy, gestational weeks

gestational weight gain from 1st trimester of pregnancy until childbirth, measured at each maternity clinic visit

次要结局

  • gestational diabetes mellitus (GDM),(gestational weeks 12-16)
  • Eating habits(1st, 2nd and 3rd trimester, gestational weeks)
  • eating habits(1st, 2nd and 3rd trimester, gestational weeks)

研究者

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

Reeta Lamminpää

post doctoral researcher

University of Eastern Finland

研究点 (2)

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