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

NCT07486908 | Completed

• 5 other identifiers: MFIGO-GDM-RCT-2025R501-LR-RND002-0000001278-0000NMRR ID-23-02754-2FH [IIR]USM/JEPeM/14100354JKNPP 500-5/8/29 Jld.2 [27]
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• Gestational Weight Gain

  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

Study Arms (2)

M-FIGO Nutrition Checklist and Module

EXPERIMENTAL

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

Standard Antenatal Care

ACTIVE COMPARATOR

Participants receive standard antenatal care provided at maternal and child health clinics without the M-FIGO Nutrition Checklist and Module.

Other: Standard

Interventions

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.

M-FIGO Nutrition Checklist and Module

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.

Standard Antenatal Care

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Maternal and Child Health Clinics, Penang

George Town, Pulau Pinang, 10250, Malaysia

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Hamid Jan JM, PhD

  Universiti Sains Malaysia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking Description
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Model Description

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 23, 2026
• Study Start: May 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)