Skip to main content
OpenTrials
Completed

NCT Number: NCT07486908

Effectiveness of the M-FIGO Nutrition Checklist and Module in Women With Gestational Diabetes

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maternal and Child Health Clinics, Penang

George Town, Pulau Pinang, 10250, Malaysia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

M-FIGO Nutrition Checklist and Module

Behavioral

A culturally adapted nutrition checklist and educational module (M-FIGO Nutrition Checklist & Module) designed to support dietary management among women with gestational diabetes mellitus.

standard

Other

Participants receive routine antenatal care provided at maternal and child health clinics, including general dietary advice and standard clinical management for gestational diabetes mellitus, without the use of the M-FIGO Nutrition Checklist and Module.

Primary outcomes

  1. Gestational Weight Gain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universiti Sains Malaysia

Other

Registry information

Official study title

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

Acronym: MFIGO-GDM

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 23, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.