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| ID | Type | Description | Link |
|---|---|---|---|
| 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 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hamid Jan JM, PhD | Universiti Sains Malaysia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternal and Child Health Clinics, Penang | George Town | Pulau Pinang | 10250 | Malaysia |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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Model Description
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Masking Description
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| 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. |
|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |