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

NCT06292871 | Recruiting

• 1 other identifier: 2023/2712
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes

Keywords

Maternal Behaviour; Mobile Health; Blood Glucose; Emotional Wellbeing; Engagement

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Engagement levels

  At the end of one month from baseline visit

• Appropriateness levels

  At the end of one month from baseline visit

• Feasibility levels

  At the end of one month from baseline visit

• Emotional wellbeing

  At the end of one month from baseline visit

• Blood glucose levels

  At the end of one month from baseline visit

Other Outcomes (17)

• Confidence levels

  At the end of one month from baseline visit

• Meal skipping

  At the end of one month from baseline visit

• Proportion of participants with cigarette smoking

  At the end of one month from baseline visit

Study Arms (2)

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.

Behavioral: Additional GDM management through social media; Behavioral: Usual care

Control Group

ACTIVE COMPARATOR

Pregnant women with GDM under usual care management.

Behavioral: Usual care

Interventions

Additional GDM management through social media BEHAVIORAL

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.

Intervention Group

Usual care BEHAVIORAL

Usual care provided by a diabetes nurse educator and dietitian.

Control Group; Intervention Group

Eligibility Criteria

• Age: 21 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• With known Type 1 or Type 2 diabetes
• Have multiple pregnancy

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead
• Singapore Institute of Technology: collaborator

Study Sites (1)

KK Women's and Children's Hospital

Singapore, Singapore

RECRUITING

Related 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.

  PMID: 32602845 BACKGROUND

• 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.

  PMID: 36812531 BACKGROUND

• 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.

  PMID: 29675432 BACKGROUND

• 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.

  PMID: 33184151 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Wee Meng Han, PhD

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

See Ling Loy, PhD

CONTACT

63948105; loyseeling@duke-nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 5, 2024
• Study Start: April 30, 2024
• Primary Completion: March 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)