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

NCT ID: NCT06292871

Last Updated: 2024-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2025-06-30

Brief Summary

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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

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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

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Gestational Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention Group

Pregnant women with GDM receiving additional support via social media platform continuously for 1 month, in addition to the usual care management.

Group Type EXPERIMENTAL

Additional GDM management through social media

Intervention Type 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.

Usual care

Intervention Type BEHAVIORAL

Usual care provided by a diabetes nurse educator and dietitian.

Control Group

Pregnant women with GDM under usual care management.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

Usual care provided by a diabetes nurse educator and dietitian.

Interventions

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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.

Intervention Type BEHAVIORAL

Usual care

Usual care provided by a diabetes nurse educator and dietitian.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Singapore Institute of Technology

OTHER

Sponsor Role collaborator

KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wee Meng Han, PhD

Role: PRINCIPAL_INVESTIGATOR

KK Women's and Children's Hospital

Locations

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KK Women's and Children's Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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See Ling Loy, PhD

Role: CONTACT

63948105 ext. 65

Facility Contacts

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See Ling Loy, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 32602845 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36812531 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29675432 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33184151 (View on PubMed)

Other Identifiers

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2023/2712

Identifier Type: -

Identifier Source: org_study_id

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