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| Name | Class |
|---|---|
| Singapore Institute of Technology | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control Group | Active Comparator | Pregnant women with GDM under usual care management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Appropriateness levels |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Meal skipping |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| See Ling Loy, PhD | Contact | 63948105 | 65 | loyseeling@duke-nus.edu.sg |
| Name | Affiliation | Role |
|---|---|---|
| Wee Meng Han, PhD | KK Women's and Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KK Women's and Children's Hospital | Recruiting | Singapore | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32602845 | Background | 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. | |
| 36812531 | 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. |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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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.
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| Usual care | Behavioral | Usual care provided by a diabetes nurse educator and dietitian. |
|
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 |
| 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 |
| 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 |
| Blood glucose levels | Assessed by finger prick tests, in mmol/L | At the end of one month from baseline visit |
| 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 |
Assessed by frequency of breakfast, lunch and dinner skipping a week
| At the end of one month from baseline visit |
| Proportion of participants with cigarette smoking | Assessed by active and passive smoking exposure, yes/no | At the end of one month from baseline visit |
| Proportion of participants with alcohol intake | Assessed by current alcohol consumption, yes/no | At the end of one month from baseline visit |
| Gestational weight gain rate | Weight gain per week, in kg/week | Throughout intervention period until delivery timepoint |
| Proportion of participants with inappropriate weight gain | Defined by Institution of Medicine guideline for gestational weight gain | Throughout intervention period until delivery timepoint |
| 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 |
| Proportion of participants with induced labour | Based on onset of labour, retrieved from medical records | At birth |
| Proportion of participants with caesarean delivery | Based on mode of delivery, retrieved from medical records | At birth |
| Birth weight | Retrieved from medical records, in gram | At birth |
| Birth length | Retrieved from medical records, in cm | At birth |
| Head circumference | Retrieved from medical records, in cm | At birth |
| Birth size-for-gestational age | Defined by percentile values, adjusted for gestational age at birth and sex | At birth |
| Gestational length at birth | Retrieved from medical records, in weeks | At birth |
| Proportion of participants with preterm delivery | Defined by gestational weeks at birth <37 weeks | At birth |
| Neonatal apgar score | Retrieved from medical records, ranging from 0 (lowest) to 10 (highest). The higher the better. | At birth |
| Proportion of participants delivering healthy live birth | Retrieved from medical records | At birth |
| 29675432 | 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. |
| 33184151 | 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. |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |