- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06292871
The Use of Social Media Platform to Continuously Support Pregnant Women With Gestational Diabetes Mellitus
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,
i. 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: See Ling Loy, PhD
- Phone Number: 65 63948105
- Email: loyseeling@duke-nus.edu.sg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- With known Type 1 or Type 2 diabetes
- Have multiple pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
Pregnant women with GDM receiving additional support via social media platform continuously for 1 month, in addition to the usual care management.
|
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 care provided by a diabetes nurse educator and dietitian.
|
Active Comparator: Control Group
Pregnant women with GDM under usual care management.
|
Usual care provided by a diabetes nurse educator and dietitian.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At the end of one month from baseline visit
|
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.
|
At the end of one month from baseline visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Engagement levels
Time Frame: At the end of one month from baseline visit
|
Assessed by frequency of interactions with the platform moderator and frequency of platform visits among women in the intervention group
|
At the end of one month from baseline visit
|
Appropriateness 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 greater appropriateness level.
|
At the end of one month from baseline visit
|
Feasibility 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 feasibility level.
|
At the end of one month from baseline visit
|
Emotional wellbeing
Time Frame: At the end of one month from baseline visit
|
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.
|
At the end of one month from baseline visit
|
Blood glucose levels
Time Frame: At the end of one month from baseline visit
|
Assessed by finger prick tests, in mmol/L
|
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
|
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
|
At the end of one month from baseline visit
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Confidence 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 confidence level.
|
At the end of one month from baseline visit
|
Meal skipping
Time Frame: At the end of one month from baseline visit
|
Assessed by frequency of breakfast, lunch and dinner skipping a week
|
At the end of one month from baseline visit
|
Proportion of participants with cigarette smoking
Time Frame: At the end of one month from baseline visit
|
Assessed by active and passive smoking exposure, yes/no
|
At the end of one month from baseline visit
|
Proportion of participants with alcohol intake
Time Frame: At the end of one month from baseline visit
|
Assessed by current alcohol consumption, yes/no
|
At the end of one month from baseline visit
|
Gestational weight gain rate
Time Frame: Throughout intervention period until delivery timepoint
|
Weight gain per week, in kg/week
|
Throughout intervention period until delivery timepoint
|
Proportion of participants with inappropriate weight gain
Time Frame: Throughout intervention period until delivery timepoint
|
Defined by Institution of Medicine guideline for gestational weight gain
|
Throughout intervention period until delivery timepoint
|
Motivational levels
Time Frame: At the end of one month from baseline visit
|
Assessed by a 5-point Likert-type scale, ranging from 1 (lowest) to 5 (highest).
|
At the end of one month from baseline visit
|
Proportion of participants with induced labour
Time Frame: At birth
|
Based on onset of labour, retrieved from medical records
|
At birth
|
Proportion of participants with caesarean delivery
Time Frame: At birth
|
Based on mode of delivery, retrieved from medical records
|
At birth
|
Birth weight
Time Frame: At birth
|
Retrieved from medical records, in gram
|
At birth
|
Birth length
Time Frame: At birth
|
Retrieved from medical records, in cm
|
At birth
|
Head circumference
Time Frame: At birth
|
Retrieved from medical records, in cm
|
At birth
|
Birth size-for-gestational age
Time Frame: At birth
|
Defined by percentile values, adjusted for gestational age at birth and sex
|
At birth
|
Gestational length at birth
Time Frame: At birth
|
Retrieved from medical records, in weeks
|
At birth
|
Proportion of participants with preterm delivery
Time Frame: At birth
|
Defined by gestational weeks at birth <37 weeks
|
At birth
|
Neonatal apgar score
Time Frame: At birth
|
Retrieved from medical records, ranging from 0 (lowest) to 10 (highest).
The higher the better.
|
At birth
|
Proportion of participants delivering healthy live birth
Time Frame: At birth
|
Retrieved from medical records
|
At birth
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Wee Meng Han, PhD, KK Women's and Children's Hospital
Publications and helpful links
General Publications
- Yew 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.
- 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.
- Leblalta 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.
- Nguyen 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/2712
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gestational Diabetes
-
IRCCS Burlo GarofoloCompletedGestational Diabetes | Gestational Diabetes Mellitus | Pregnancy-Induced Diabetes | Diabetes Mellitus, Gestational | Diabetes, Pregnancy InducedIsrael, Italy, Netherlands, Slovenia, Sri Lanka
-
UPECLIN HC FM Botucatu UnespCompletedGestational Diabetes Mellitus | Pregestational Diabetes Mellitus | Mild Gestational HyperglycemiaBrazil
-
Assistance Publique - Hôpitaux de ParisCompleted
-
University of Texas Southwestern Medical CenterCompletedMild Gestational DiabetesUnited States
-
Royal College of Surgeons, IrelandHealth Research Board, IrelandUnknownPre-Gestational Diabetes
-
University of Colorado, DenverKaiser PermanenteCompletedGestational Diabetes MellitusUnited States
-
Intermountain Health Care, Inc.Withdrawn
-
Baylor College of MedicineRecruitingGestational Diabetes MellitusUnited States
-
Joslin Diabetes CenterRoche DiagnosticsCompletedGestational Diabetes MellitusUnited States
-
Ludwig-Maximilians - University of MunichGerman Federal Ministry of Education and Research; Helmholtz Zentrum MünchenCompletedGestational Diabetes MellitusGermany
Clinical Trials on Additional GDM management through social media
-
Wills EyeCompleted