Official 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
Brief Summary

Gestational diabetes mellitus (GDM) is a common condition during pregnancy that increasesthe risk of adverse maternal and birth outcomes. Effective dietary management isessential, but practical and structured tools to support nutrition counselling in routinecare are limited.This study aims to evaluate the effectiveness of the M-FIGO Nutrition Checklist andModule, a culturally adapted nutrition tool developed for use in Malaysia, among womendiagnosed with GDM.In this randomized controlled trial, pregnant women with GDM attending selected maternaland child health clinics were assigned to either an intervention group receiving theM-FIGO Nutrition Checklist and Module alongside standard care, or a control groupreceiving standard antenatal care alone. The intervention focuses on improving dietquality, including appropriate carbohydrate choices and portion sizes.The primary outcome is gestational weight gain, while secondary outcomes include bloodglucose control and birth outcomes. The findings of this study will provide evidence onthe effectiveness of a structured nutrition intervention in improving maternal andneonatal health among women with GDM.

Detailed Description

Not Provided

Completed
Gestational Diabetes

Behavioral: M-FIGO Nutrition Checklist and Module

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

Other: Standard

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.

Eligibility Criteria

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

Eligibility Gender
Female
Eligibility Age
Minimum: 18 Years ~ Maximum: 45 Years
Countries
Malaysia
Locations

Maternal and Child Health Clinics, Penang
George Town, Pulau Pinang, Malaysia

Hamid Jan JM, PhD, Study Chair
Universiti Sains Malaysia

Universiti Sains Malaysia
NCT Number
MeSH Terms
Diabetes, Gestational