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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 Center1 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
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
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
是

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

研究组 & 干预措施

Usual Care

No Intervention

Women in the usual care group, will received standard care from the obstetrician.

High fiber

Experimental

Women in high fiber group will receive education on consuming a high fiber diet, including weekly lessons and daily snacks.

干预措施: High fiber diet (Behavioral)

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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