NCT07486908

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Universiti Sains Malaysia · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2026-03-23
• Last updated: 2026-03-23

Locations

1 site across 1 country: Malaysia