Gestational Diabetes
Conditions
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.
Interventions
BEHAVIORALM-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.
OTHERStandard
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.
Sponsors
Universiti Sains Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Masking Description
Intervention model description
Model Description
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gestational Weight Gain | 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. |
Countries
Malaysia
Contacts
STUDY_CHAIRHamid Jan JM, PhD
Universiti Sains Malaysia
Outcome results
None listed