Gestational DiabetesNCT06292871
The Use of Social Media Platform to Continuously Support Pregnant Women With Gestational Diabetes Mellitus
A study testing Additional GDM management through social media in people with Gestational Diabetes, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
To assess the efficacy of utilizing a social media platform for dietary and lifestyle management in improving acceptance and blood glucose control in patients with gestational diabetes mellitus (GDM), compared to the control group under usual care. Specifically, i. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Additional GDM management through social media
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- 30 Apr 2024to 31 Mar 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 21 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with GDM as confirmed by the Oral Glucose Tolerance Test during pregnancy
- Age ≥ 21 and ≤ 45 years
- Attended first (baseline) session of GDM diet counselling session
- Able to read and comprehend English
- Have a digital device accessible to social media platform
- Have SingPass access
- Able to provide informed consent
Who cannot join
- With known Type 1 or Type 2 diabetes
- Have multiple pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Acceptability and Feasibility of Using a Social Media Platform to Provide Continuous Support in the Follow-up Management of Gestational Diabetes: A Pilot Randomised Controlled Trial
To assess the efficacy of utilizing a social media platform for dietary and lifestyle management in improving acceptance and blood glucose control in patients with gestational diabetes mellitus (GDM), compared to the control group under usual care. Specifically,
- To measure the participants' acceptability and satisfaction levels of receiving intervention through the social media platform. ii. To measure the feasibility of using the social media platform to provide GDM support through participants' engagement levels and feedback questionnaire. iii. To measure the efficacy of using the social media platform to manage emotional responses in women with GDM. iv. To measure the efficacy of using the social media platform to optimize glycemic control in women with GDM.
Read the detailed description
Engaging pregnant women with GDM in dietary management over the gestation has been challenging. This pilot trial aims to assess the efficacy of utilizing a social media platform for dietary and lifestyle management in improving acceptance and blood glucose control among patients with GDM, compared to a control group receiving usual care. The study will employ a randomized controlled trial design, with GDM patients from KK Women's and Children's Hospital (KKH) randomly assigned to either the usual care (control; n=40) or to additional support via a dedicated social media platform for a period of 1 month, where a moderator will be available to address patients' queries and share relevant educational resources (intervention; n=40). Outcome measures include acceptance, satisfaction, and engagement levels, emotional well-being as well as the percentage achievement of time-in-range glucose readings for GDM patients. The independent t-test will be used to compare the outcome measures between groups. The findings from this study will provide valuable insights into the feasibility and efficacy of incorporating digital platforms into routine dietary counselling practices for improved patient outcomes and enhanced management of GDM.
- Conditions
- Gestational Diabetes
- Being tested
- Additional GDM management through social media, Usual care
- Keywords
- Maternal Behaviour, Mobile Health, Blood Glucose, Emotional Wellbeing, Engagement
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional GDM management through social mediaBehavioural
Usual care provided by a diabetes nurse educator and dietitian. Additional educational resources for dietary management care received, and for any queries to be addressed by dietitian via social media platform from baseline to one-month follow-up visit.
Usual careBehavioural
Usual care provided by a diabetes nurse educator and dietitian.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Pregnant women with GDM receiving additional support via social media platform continuously for 1 month, in addition to the usual care management. Receives: Behavioral: Additional GDM management through social media; Behavioral: Usual care |
| Control Group | Active comparator | Pregnant women with GDM under usual care management. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance levels
Assessed by a 5-point Likert-type scale, ranging from 1 (completely disagree) to 5 (completely agree). A higher score indicates a higher acceptance level.
Measured: At the end of one month from baseline visit
Satisfaction levels
Assessed by a 5-point Likert-type scale, ranging from 1 (completely disagree) to 5 (completely agree). A higher score indicates a higher satisfaction level.
Measured: At the end of one month from baseline visit
Secondary outcomes (6)
Engagement levels
Assessed by frequency of interactions with the platform moderator and frequency of platform visits among women in the intervention group
Measured: At the end of one month from baseline visit
Appropriateness levels
Assessed by a 5-point Likert-type scale, ranging from 1 (completely disagree) to 5 (completely agree). A higher score indicates a greater appropriateness level.
Measured: At the end of one month from baseline visit
Feasibility levels
Assessed by a 5-point Likert-type scale, ranging from 1 (completely disagree) to 5 (completely agree). A higher score indicates a higher feasibility level.
Measured: At the end of one month from baseline visit
Emotional wellbeing
Assessed by the Perceived Stress Scale on a 5-point Likert-type scale, ranging from 0 (never) to 4 (very often). A higher score indicates a higher perceived stress level.
Measured: At the end of one month from baseline visit
Blood glucose levels
Assessed by finger prick tests, in mmol/L
Measured: At the end of one month from baseline visit
Proportion of participants with optimal blood glucose control
Based on recommended pre-meal range of 4.4-5.5 mmol/L and 2h post-meal range of 5.5-6.6 mmol/L
Measured: At the end of one month from baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start30 Apr 2024
- Primary completion30 Nov 2024
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will employ a randomized controlled trial design, with GDM patients from KKH randomly assigned to either the intervention or control group. Randomization will be conducted via the electronic randomization list.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- Singapore Institute of Technology
- Responsible party
- Principal investigator, Loy See Ling, KK Women's and Children's Hospital
- Investigators
- Wee Meng Han, PhD, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292871
- Sponsor's protocol ID
- 2023/2712
- Status last verified
- Sep 2026
- First submitted
- 21 Feb 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hewage S, Audimulam J, Sullivan E, Chi C, Yew TW, Yoong J. Barriers to Gestational Diabetes Management and Preferred Interventions for Women With Gestational Diabetes in Singapore: Mixed Methods Study. JMIR Form Res. 2020 Jun 30;4(6):e14486. doi: 10.2196/14486.
PubMed 32602845Leblalta B, Kebaili H, Sim R, Lee SWH. Digital health interventions for gestational diabetes mellitus: A systematic review and meta-analysis of randomised controlled trials. PLOS Digit Health. 2022 Feb 24;1(2):e0000015. doi: 10.1371/journal.pdig.0000015. eCollection 2022 Feb.
PubMed 36812531Nguyen CL, Pham NM, Binns CW, Duong DV, Lee AH. Prevalence of Gestational Diabetes Mellitus in Eastern and Southeastern Asia: A Systematic Review and Meta-Analysis. J Diabetes Res. 2018 Feb 20;2018:6536974. doi: 10.1155/2018/6536974. eCollection 2018.
PubMed 29675432Yew TW, Chi C, Chan SY, van Dam RM, Whitton C, Lim CS, Foong PS, Fransisca W, Teoh CL, Chen J, Ho-Lim ST, Lim SL, Ong KW, Ong PH, Tai BC, Tai ES. A Randomized Controlled Trial to Evaluate the Effects of a Smartphone Application-Based Lifestyle Coaching Program on Gestational Weight Gain, Glycemic Control, and Maternal and Neonatal Outcomes in Women With Gestational Diabetes Mellitus: The SMART-GDM Study. Diabetes Care. 2021 Feb;44(2):456-463. doi: 10.2337/dc20-1216. Epub 2020 Nov 12.
PubMed 33184151
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acceptability and Feasibility of Using a Social Media Platform to Provide Continuous Support in the Follow-up Management of Gestational Diabetes: A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06292871
- Acronym / sponsor ID
- 2023/2712
- Conditions
- Gestational Diabetes
- Keywords
- Maternal Behaviour, Mobile Health, Blood Glucose, Emotional Wellbeing, Engagement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- Singapore Institute of Technology
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 5 Mar 2024 (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.
To assess the efficacy of utilizing a social media platform for dietary and lifestyle management in improving acceptance and blood glucose control in patients with gestational diabetes mellitus (GDM), compared to the control group under usual care. Specifically,
- To measure the participants' acceptability and satisfaction levels of receiving intervention through the social media platform. ii. To measure the feasibility of using the social media platform to provide GDM support through participants' engagement levels and feedback questionnaire. iii. To measure the efficacy of using the social media platform to manage emotional responses in women with GDM. iv. To measure the efficacy of using the social media platform to optimize glycemic control in women with GDM.
Detailed description
Engaging pregnant women with GDM in dietary management over the gestation has been challenging. This pilot trial aims to assess the efficacy of utilizing a social media platform for dietary and lifestyle management in improving acceptance and blood glucose control among patients with GDM, compared to a control group receiving usual care. The study will employ a randomized controlled trial design, with GDM patients from KK Women's and Children's Hospital (KKH) randomly assigned to either the usual care (control; n=40) or to additional support via a dedicated social media platform for a period of 1 month, where a moderator will be available to address patients' queries and share relevant educational resources (intervention; n=40). Outcome measures include acceptance, satisfaction, and engagement levels, emotional well-being as well as the percentage achievement of time-in-range glucose readings for GDM patients. The independent t-test will be used to compare the outcome measures between groups. The findings from this study will provide valuable insights into the feasibility and efficacy of incorporating digital platforms into routine dietary counselling practices for improved patient outcomes and enhanced management of GDM.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will employ a randomized controlled trial design, with GDM patients from KKH randomly assigned to either the intervention or control group. Randomization will be conducted via the electronic randomization list.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Additional GDM management through social media, Behavioral: Usual carePregnant women with GDM receiving additional support via social media platform continuously for 1 month, in addition to the usual care management. |
| Control Group | Active comparator | Behavioral: Usual carePregnant women with GDM under usual care management. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Diagnosed with GDM as confirmed by the Oral Glucose Tolerance Test during pregnancy
- Age ≥ 21 and ≤ 45 years
- Attended first (baseline) session of GDM diet counselling session
- Able to read and comprehend English
- Have a digital device accessible to social media platform
Key exclusion criteria (2 listed)
- With known Type 1 or Type 2 diabetes
- Have multiple pregnancy
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 |
|---|---|---|
| Additional GDM management through social mediaUsual care provided by a diabetes nurse educator and dietitian. Additional educational resources for dietary management care received, and for any queries to be addressed by dietitian via social media platform from baseline to one-month follow-up visit. | Behavioural | Intervention Group |
| Usual careUsual care provided by a diabetes nurse educator and dietitian. | Behavioural | Control Group, Intervention Group |
Primary outcome
Acceptance levels
Time frame: At the end of one month from baseline visit
Assessed by a 5-point Likert-type scale, ranging from 1 (completely disagree) to 5 (completely agree). A higher score indicates a higher acceptance level.
Satisfaction levels
Time frame: At the end of one month from baseline visit
Assessed by a 5-point Likert-type scale, ranging from 1 (completely disagree) to 5 (completely agree). A higher score indicates a higher satisfaction level.
6 secondary outcomes
Engagement levels
Time frame: At the end of one month from baseline visit
Appropriateness levels
Time frame: At the end of one month from baseline visit
Feasibility levels
Time frame: At the end of one month from baseline visit
Emotional wellbeing
Time frame: At the end of one month from baseline visit
Blood glucose levels
Time frame: At the end of one month from baseline visit
Proportion of participants with optimal blood glucose control
Time frame: At the end of one month from baseline visit
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 15 Sep 2026.
- Background: PubMed 32602845Hewage S, Audimulam J, Sullivan E, Chi C, Yew TW, Yoong J. Barriers to Gestational Diabetes Management and Preferred Interventions for Women With Gestational Diabetes in Singapore: Mixed Methods Study. JMIR Form Res. 2020 Jun 30;4(6):e14486. doi: 10.2196/14486.
- Background: PubMed 36812531Leblalta B, Kebaili H, Sim R, Lee SWH. Digital health interventions for gestational diabetes mellitus: A systematic review and meta-analysis of randomised controlled trials. PLOS Digit Health. 2022 Feb 24;1(2):e0000015. doi: 10.1371/journal.pdig.0000015. eCollection 2022 Feb.
- Background: PubMed 29675432Nguyen CL, Pham NM, Binns CW, Duong DV, Lee AH. Prevalence of Gestational Diabetes Mellitus in Eastern and Southeastern Asia: A Systematic Review and Meta-Analysis. J Diabetes Res. 2018 Feb 20;2018:6536974. doi: 10.1155/2018/6536974. eCollection 2018.
- Background: PubMed 33184151Yew TW, Chi C, Chan SY, van Dam RM, Whitton C, Lim CS, Foong PS, Fransisca W, Teoh CL, Chen J, Ho-Lim ST, Lim SL, Ong KW, Ong PH, Tai BC, Tai ES. A Randomized Controlled Trial to Evaluate the Effects of a Smartphone Application-Based Lifestyle Coaching Program on Gestational Weight Gain, Glycemic Control, and Maternal and Neonatal Outcomes in Women With Gestational Diabetes Mellitus: The SMART-GDM Study. Diabetes Care. 2021 Feb;44(2):456-463. doi: 10.2337/dc20-1216. Epub 2020 Nov 12.
- Individual participant dataSharing planned: No
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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.
Wee Meng Han, PhD principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional GDM management through social media in people with Gestational Diabetes, run by KK Women's and Children's Hospital at 1 site in Singapore.
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 7 inclusion and 2 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 15 Sep 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 Singapore. 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?
Acceptance levels (time frame: At the end of one month from baseline visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06292871, which also lists 4 linked publications.
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 15 Sep 2026.