Clinical Trial

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

Study acronym: MFIGO-GDM
Completed
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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.
Trial Details
NCT Number NCT07486908
Lead Sponsor Universiti Sains Malaysia
Conditions Gestational Diabetes
Enrollment 206 participants
Start Date 2024-05-01
Primary Completion 2025-05-30 (estimated)
Study Completion 2025-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-23