Gestational Diabetes
Conditions
Keywords
Maternal Behaviour, Mobile Health, Blood Glucose, Emotional Wellbeing, Engagement
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.
Interventions
BEHAVIORALAdditional 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.
BEHAVIORALUsual care
Usual care provided by a diabetes nurse educator and dietitian.
Sponsors
KK Women's and Children's Hospital
Singapore Institute of Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptance levels | 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. |
| Satisfaction levels | 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
| Measure | Time frame | Description |
|---|---|---|
| Engagement levels | 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 |
| Appropriateness levels | 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. |
| Feasibility levels | 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. |
| Emotional wellbeing | 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. |
| Blood glucose levels | At the end of one month from baseline visit | Assessed by finger prick tests, in mmol/L |
| Proportion of participants with optimal blood glucose control | 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 |
Countries
Singapore
Contacts
PRINCIPAL_INVESTIGATORWee Meng Han, PhD
KK Women's and Children's Hospital
Outcome results
None listed