Effectiveness of the M-FIGO Nutrition Checklist and Module in Women With Gestational Diabetes (MFIGO-GDM)

March 16, 2026 updated by: Hamid Jan, Universiti Sains Malaysia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

206

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10250
        • Maternal and Child Health Clinics, Penang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: M-FIGO Nutrition Checklist and Module
Participants receive the M-FIGO Nutrition Checklist and Module in addition to standard antenatal care. The intervention includes structured nutrition counselling focusing on diet quality, carbohydrate choices, and portion sizes.
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.
Active Comparator: Standard Antenatal Care
Participants receive standard antenatal care provided at maternal and child health clinics without the M-FIGO Nutrition Checklist and Module.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From recruitment until delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Sains Malaysia

Investigators

  • Study Chair: Hamid Jan JM, PhD, Universiti Sains Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

May 30, 2025

Study Completion (Actual)

May 30, 2025

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MFIGO-GDM-RCT-2025
  • R501-LR-RND002-0000001278-0000 (Other Grant/Funding Number: Universiti Sains Malaysia)
  • NMRR ID-23-02754-2FH [IIR] (Registry Identifier: Ministry of Health Malaysia's Medical Research and Ethics Committee)
  • USM/JEPeM/14100354 (Other Identifier: Human Ethics Committee of Universiti Sains Malaysia)
  • JKNPP 500-5/8/29 Jld.2 [27] (Other Identifier: Penang State Health Department)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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