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临床试验/NCT04868110
NCT04868110已完成不适用

Preventing Excessive Weight Gain and Maternal and Infant Fat Accretion by Increasing Fiber Intake and Changing the Maternal Microbiome During Pregnancy

University of Kansas Medical Center2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2021年6月28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
51
试验地点
2
主要终点
Maternal Weight Changes

研究概览

简要总结

The purpose of this study is to learn if consuming a high fiber diet will reduce gestational weight gain and maternal and infant fat accretion.

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
None

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

  • Pre-pregnancy BMI 18.5 - 45.0 kg/m2

排除标准

  • Comsuming more than 20 g/day of fiber
  • No phone and internet access
  • Pre-gestational diabetes
  • Diagnosed with diabetes
  • Pre-eclampsia
  • Hypertension
  • Other metabolic abnormalities
  • Heart disease
  • Drug abuse
  • Recent antibiotic use
  • Pregnancies of multiples

结局指标

主要结局

Maternal Weight Changes

时间窗: Baseline through 2-mounths postpartum

Assess weight change between groups

Maternal Fat Accretion Changes

时间窗: Baseline through 2-mounths postpartum

Assess fat accretion change between groups using the Selinger four-compartment model

Identify Changes in Fiber Intake

时间窗: Baseline through 2-months postpartum

Compare fiber intake between groups by using 24-hour dietary recalls

Identify Changes in Dietary Quality

时间窗: Baseline through 2-months postpartum

Compare dietary quality between groups using the Alternative Healthy Eating Index (AHEI) scoring ranges from 0 to 100 (higher score means a better diet quality).

次要结局

  • Maternal Weight(2-months through 12-months postpartum)
  • Infant Fat Accrual(Birth to 12-month old)
  • Maternal Fat Accretion(2-months through 12-months postpartum)
  • Dietary Fiber Intake(2-months through 12-months postpartum)
  • Dietary Quality(2-months through 12-months postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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