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临床试验/NCT06292871
NCT06292871已完成不适用

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

KK Women's and Children's Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年4月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Acceptance levels

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
21 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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.

干预措施: Additional GDM management through social media (Behavioral)

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.

干预措施: Usual care (Behavioral)

Control Group

Active Comparator

Pregnant women with GDM under usual care management.

干预措施: Usual care (Behavioral)

结局指标

主要结局

Acceptance levels

时间窗: 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

时间窗: 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.

次要结局

  • Engagement levels(At the end of one month from baseline visit)
  • Appropriateness levels(At the end of one month from baseline visit)
  • Blood glucose 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)
  • Proportion of participants with optimal blood glucose control(At the end of one month from baseline visit)

研究者

发起方
KK Women's and Children's Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Loy See Ling

Junior Principal Investigator

KK Women's and Children's Hospital

研究点 (2)

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