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Completed

NCT Number: NCT06292871

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

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.

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Key information

Conditions

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

Age range

21 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

KK Women's and Children's Hospital

Singapore

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Usual Care

Behavioral

Usual care provided by a diabetes nurse educator and dietitian.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. Blood glucose levels

    Time frame: At the end of one month from baseline visit

    Assessed by finger prick tests, in mmol/L

  6. 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

Other outcomes

  1. 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.

  2. Meal skipping

    Time frame: At the end of one month from baseline visit

    Assessed by frequency of breakfast, lunch and dinner skipping a week

  3. 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

  4. Proportion of participants with alcohol intake

    Time frame: At the end of one month from baseline visit

    Assessed by current alcohol consumption, yes/no

  5. Gestational weight gain rate

    Time frame: Throughout intervention period until delivery timepoint

    Weight gain per week, in kg/week

  6. 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

  7. 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).

  8. Proportion of participants with induced labour

    Time frame: At birth

    Based on onset of labour, retrieved from medical records

  9. Proportion of participants with caesarean delivery

    Time frame: At birth

    Based on mode of delivery, retrieved from medical records

  10. Birth weight

    Time frame: At birth

    Retrieved from medical records, in gram

  11. Birth length

    Time frame: At birth

    Retrieved from medical records, in cm

  12. Head circumference

    Time frame: At birth

    Retrieved from medical records, in cm

  13. Birth size-for-gestational age

    Time frame: At birth

    Defined by percentile values, adjusted for gestational age at birth and sex

  14. Gestational length at birth

    Time frame: At birth

    Retrieved from medical records, in weeks

  15. Proportion of participants with preterm delivery

    Time frame: At birth

    Defined by gestational weeks at birth <37 weeks

  16. Neonatal apgar score

    Time frame: At birth

    Retrieved from medical records, ranging from 0 (lowest) to 10 (highest). The higher the better.

  17. Proportion of participants delivering healthy live birth

    Time frame: At birth

    Retrieved from medical records

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Collaborators

  • Singapore Institute of Technology

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 5, 2024
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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