Clinical trial NCT06292871: The Use of Social Media Platform to Continuously Support Pregnant Women With Gestational Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gestational Diabetes
Keywords: Maternal Behaviour
Mobile Health
Blood Glucose
Emotional Wellbeing
Engagement
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Singapore Institute of Technology
First posted: 2024-03-05
Enrollment: 80
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptance levels
timeFrame: At the end of one month from baseline visit
measure: Satisfaction levels
timeFrame: At the end of one month from baseline visit
Secondary outcomes:
measure: Engagement levels
timeFrame: At the end of one month from baseline visit
measure: Appropriateness levels
timeFrame: At the end of one month from baseline visit
measure: Feasibility levels
timeFrame: At the end of one month from baseline visit
measure: Emotional wellbeing
timeFrame: At the end of one month from baseline visit
measure: Blood glucose levels
timeFrame: At the end of one month from baseline visit
measure: Proportion of participants with optimal blood glucose control
timeFrame: At the end of one month from baseline visit
Other outcomes:
measure: Confidence levels
timeFrame: At the end of one month from baseline visit
measure: Meal skipping
timeFrame: At the end of one month from baseline visit
measure: Proportion of participants with cigarette smoking
timeFrame: At the end of one month from baseline visit
measure: Proportion of participants with alcohol intake
timeFrame: At the end of one month from baseline visit
measure: Gestational weight gain rate
timeFrame: Throughout intervention period until delivery timepoint
measure: Proportion of participants with inappropriate weight gain
timeFrame: Throughout intervention period until delivery timepoint
measure: Motivational levels
timeFrame: At the end of one month from baseline visit
measure: Proportion of participants with induced labour
timeFrame: At birth
measure: Proportion of participants with caesarean delivery
timeFrame: At birth
measure: Birth weight
timeFrame: At birth
measure: Birth length
timeFrame: At birth
measure: Head circumference
timeFrame: At birth
measure: Birth size-for-gestational age
timeFrame: At birth
measure: Gestational length at birth
timeFrame: At birth
measure: Proportion of participants with preterm delivery
timeFrame: At birth
measure: Neonatal apgar score
timeFrame: At birth
measure: Proportion of participants delivering healthy live birth
timeFrame: At birth
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Wee Meng Han, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.