Gestational DiabetesMFIGO-GDMNCT07486908
Effectiveness of the M-FIGO Nutrition Checklist and Module in Women With Gestational Diabetes
A study testing M-FIGO Nutrition Checklist and Module and Standard in people with Gestational Diabetes, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- M-FIGO Nutrition Checklist and Module and Standard
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 May 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Pre-existing diabetes mellitus
- Gestational diabetes mellitus requiring insulin therapy
- Use of metformin therapy
- Steroid-dependent medical conditions
- Known psychiatric illness
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Maternal and Child Health Clinics, Penang
George Town, Pulau Pinang, 10250
About this study
Official title: 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
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.
Read more
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
- Being tested
- M-FIGO Nutrition Checklist and Module, Standard
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-FIGO Nutrition Checklist and ModuleBehavioural
A culturally adapted nutrition checklist and educational module (M-FIGO Nutrition Checklist \& Module) designed to support dietary management among women with gestational diabetes mellitus.
StandardOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From recruitment until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 May 2024
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Model Description
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamid Jan, Universiti Sains Malaysia
- Investigators
- Hamid Jan JM, PhD, Study chair, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486908
- Sponsor's protocol ID
- MFIGO-GDM-RCT-2025
- Other IDs
- R501-LR-RND002-0000001278-0000, NMRR ID-23-02754-2FH [IIR], USM/JEPeM/14100354, JKNPP 500-5/8/29 Jld.2 [27]
- Acronym
- MFIGO-GDM
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07486908
- Acronym / sponsor ID
- MFIGO-GDM / MFIGO-GDM-RCT-2025
- Conditions
- Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| M-FIGO Nutrition Checklist and Module | Experimental | Behavioral: M-FIGO Nutrition Checklist and ModuleParticipants 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 | Other: StandardParticipants receive standard antenatal care provided at maternal and child health clinics without the M-FIGO Nutrition Checklist and Module. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Pre-existing diabetes mellitus
- Gestational diabetes mellitus requiring insulin therapy
- Use of metformin therapy
- Steroid-dependent medical conditions
- Known psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M-FIGO Nutrition Checklist and ModuleA culturally adapted nutrition checklist and educational module (M-FIGO Nutrition Checklist \& Module) designed to support dietary management among women with gestational diabetes mellitus. | Behavioural | M-FIGO Nutrition Checklist and Module |
| StandardParticipants 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. | Other | Standard Antenatal Care |
Primary outcome
Gestational Weight Gain
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamid Jan JM, PhD study chair
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M-FIGO Nutrition Checklist and Module and Standard in people with Gestational Diabetes, run by Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational Weight Gain (time frame: From recruitment until delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.