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临床试验/NCT07486908
NCT07486908已完成不适用

The Effectiveness of the M-FIGO Nutrition Checklist and Module on Pregnancy and Birth Outcomes Among Women With Gestational Diabetes Mellitus: A Randomized Controlled Trial in Malaysia

Universiti Sains Malaysia1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2024年5月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
206
试验地点
1
主要终点
Gestational Weight Gain

研究概览

简要总结

Gestational diabetes mellitus (GDM) is a common condition during pregnancy that increases the risk of adverse maternal and birth outcomes. Effective dietary management is essential, but practical and structured tools to support nutrition counselling in routine care are limited.

This study aims to evaluate the effectiveness of the M-FIGO Nutrition Checklist and Module, a culturally adapted nutrition tool developed for use in Malaysia, among women diagnosed with GDM.

In this randomized controlled trial, pregnant women with GDM attending selected maternal and child health clinics were assigned to either an intervention group receiving the M-FIGO Nutrition Checklist and Module alongside standard care, or a control group receiving standard antenatal care alone. The intervention focuses on improving diet quality, including appropriate carbohydrate choices and portion sizes.

The primary outcome is gestational weight gain, while secondary outcomes include blood glucose control and birth outcomes. The findings of this study will provide evidence on the effectiveness of a structured nutrition intervention in improving maternal and neonatal health among women with GDM.

研究设计

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

盲法说明

Masking Description

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

  • Pregnant women diagnosed with gestational diabetes mellitus (GDM)
  • Attending selected maternal and child health clinics in Malaysia
  • Able to communicate in Bahasa Malaysia
  • Willing to adhere to study procedures

排除标准

  • Pre-existing diabetes mellitus
  • Gestational diabetes mellitus requiring insulin therapy
  • Use of metformin therapy
  • Steroid-dependent medical conditions
  • Known psychiatric illness

结局指标

主要结局

Gestational Weight Gain

时间窗: From recruitment until delivery

Gestational weight gain measured as the total weight gained during pregnancy from study enrolment to delivery, assessed using routine clinical measurements recorded in maternal health records.

次要结局

未报告次要终点

研究者

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

Hamid Jan

Professor

Universiti Sains Malaysia

研究点 (1)

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