The Use of Social Media Platform to Continuously Support Pregnant Women With Gestational Diabetes Mellitus

Gestational Diabetes Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06292871
• Other study ID #: 2023/2712
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: May 2025

Study information

• Verified date: February 2024
• Source: KK Women's and Children's Hospital
• Contact: See Ling Loy, PhD
• Phone: 63948105
• Email: loyseeling[@]duke-nus.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: May 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Behavioral:
• Additional GDM management through social media
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
Usual care provided by a diabetes nurse educator and dietitian.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital	Singapore Institute of Technology

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Confidence levels	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
Other	Meal skipping	Assessed by frequency of breakfast, lunch and dinner skipping a week	At the end of one month from baseline visit
Other	Proportion of participants with cigarette smoking	Assessed by active and passive smoking exposure, yes/no	At the end of one month from baseline visit
Other	Proportion of participants with alcohol intake	Assessed by current alcohol consumption, yes/no	At the end of one month from baseline visit
Other	Gestational weight gain rate	Weight gain per week, in kg/week	Throughout intervention period until delivery timepoint
Other	Proportion of participants with inappropriate weight gain	Defined by Institution of Medicine guideline for gestational weight gain	Throughout intervention period until delivery timepoint
Other	Motivational levels	Assessed by a 5-point Likert-type scale, ranging from 1 (lowest) to 5 (highest).	At the end of one month from baseline visit
Other	Proportion of participants with induced labour	Based on onset of labour, retrieved from medical records	At birth
Other	Proportion of participants with caesarean delivery	Based on mode of delivery, retrieved from medical records	At birth
Other	Birth weight	Retrieved from medical records, in gram	At birth
Other	Birth length	Retrieved from medical records, in cm	At birth
Other	Head circumference	Retrieved from medical records, in cm	At birth
Other	Birth size-for-gestational age	Defined by percentile values, adjusted for gestational age at birth and sex	At birth
Other	Gestational length at birth	Retrieved from medical records, in weeks	At birth
Other	Proportion of participants with preterm delivery	Defined by gestational weeks at birth <37 weeks	At birth
Other	Neonatal apgar score	Retrieved from medical records, ranging from 0 (lowest) to 10 (highest). The higher the better.	At birth
Other	Proportion of participants delivering healthy live birth	Retrieved from medical records	At birth
Primary	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.	At the end of one month from baseline visit
Primary	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.	At the end of one month from baseline visit
Secondary	Engagement levels	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
Secondary	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.	At the end of one month from baseline visit
Secondary	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.	At the end of one month from baseline visit
Secondary	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.	At the end of one month from baseline visit
Secondary	Blood glucose levels	Assessed by finger prick tests, in mmol/L	At the end of one month from baseline visit
Secondary	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	At the end of one month from baseline visit