Development and Testing of a Mobile Health Application for Management of Gestational Diabetes

项目摘要 妊娠期糖尿病(GDM)的患病率在全球范围内迅速上升，特别是在低血糖和低血糖人群中。 中等收入国家(LMIC)。通过饮食和生活方式的改变严格控制血糖是治疗妊娠期糖尿病的关键 以及预防其不利的健康后果，包括增加妇女和 他们的孩子。然而，在包括尼泊尔在内的许多资源有限的国家，经常有时间进行饮食/生活方式咨询 与产前护理的其他组成部分竞争。可以利用移动健康(MHealth)技术来促进 健康的行为，并支持妊娠期糖尿病的自我管理和治疗，但这种方法尚未尝试 以前在任何LMIC中都有。采取以用户为中心的设计方法，在这里我们建议开发一种文化- 适当的智能手机应用程序(APP)以支持GDM(MGDM)的自我管理，并测试其可用性和 尼泊尔加德满都大学医院三级患者的初步疗效。基于 行为改变的社会认知理论框架，这款应用程序将通过以下方式帮助GDM进行自我管理 增加患者的知识和自我效能，以坚持推荐的饮食和体力活动 养生法。该应用程序还将通过生成易于理解的患者数据和可视化显示来帮助临床医生 行为，这有助于他们的临床决策和咨询。在需求收集阶段，6 GDM患者将被招募到一个焦点小组，观看纸质原型并就其特点和 功能。其他问题将被问及他们感知到的障碍、促进者和生活方式策略 修改。还将与5名临床医生(妇科医生、营养师、体检医生)进行关键信息提供人面谈 治疗师)和3名家庭成员，请他们提供关于mGDM原型的反馈，特别是关于 患者数据的图形摘要的有用性和格式。修改了纸质原型并开发了 第一个数字原型，将招募另外六名GDM患者进行两轮可用性测试，包括 大声思考-礼仪和焦点小组讨论。最终的原型将在以下迭代过程中开发 产品设计和用户测试。开发这款应用程序后，我们将招募60名新诊断为 GDM，并随机将他们分配到两种治疗条件之一：(A)mGDM APP+标准护理，或(B) 仅标准护理，从怀孕28周到分娩。在这项概念验证试验中，可行性结果将是 应用程序使用率、自我监控遵从性以及应用程序可用性和可接受性。探索性治疗结果将是 产后6周血糖控制措施、新生儿出生体重、引产率和剖宫产率 送货。拟议中的研究结果将为未来的随机对照试验提供经验性的指导，该试验将完全 有能力测试mGDM应用程序在改善治疗结果方面的有效性和成本效益，使用 R01机制。我们期望这项申请中提出的研究活动和能力建设倡议 将建立支持未来移动健康研究所需的机构技能和组织结构 加德满都大学的倡议，甚至超出了这一拟议项目的范围。

Project Summary The prevalence of gestational diabetes mellitus (GDM) is rapidly increasing worldwide, particularly in low- and middle-income countries (LMICs). Tight glycemic control via diet and lifestyle modification is critical to treating GDM and preventing its adverse health consequences, including increased risk of type 2 diabetes (T2D), in women and their children. However, in many resource-limited countries including Nepal, time for diet/lifestyle counseling often competes with other components of antenatal care. Mobile health (mHealth) technology can be leveraged to promote healthy behaviors, and support self-management and treatment of GDM, but this approach has not been tried previously in any LMICs. Taking a user-centered design approach, here we propose to develop a culturally- appropriate smartphone application (app) to support self-management of GDM (mGDM), and test its usability and preliminary efficacy, among patients in a tertiary level, university hospital of Kathmandu University, Nepal. Based on the Social Cognitive Theory framework for behavior change, this app will assist in self-management of GDM by increasing the patient's knowledge and self-efficacy to adhere to the recommended diet and physical activity regimens. The app will also help clinicians by generating easily digestible visual displays of patient data and behaviors, which can aid in their clinical decision-making and counseling. In the requirements gathering phase, 6 GDM patients will be recruited into a focus group to view paper prototypes and provide feedback on its features and functions. Additional questions will be asked about their perceived barriers, facilitators, and strategies for lifestyle modification. Key informant interviews will also be conducted with 5 clinicians (gynecologists, dietician, physical therapist) and 3 family members, asking them to provide feedback on the mGDM prototype, especially pertaining to the usefulness and format of the graphic summaries of patient data. After revising paper prototypes and developing the first digital prototype, six additional patients with GDM will be recruited for two rounds of usability testing including think-aloud protocol and focus group discussions. Final prototype will be developed following an iterative process of product design and user testing. After developing the app, we will recruit 60 women who are newly diagnosed with GDM, and randomly assign them to one of two treatment conditions: either (A) mGDM app + standard care, or (B) standard care alone, from 28 weeks of gestation to delivery. In this proof-of-concept trial, feasibility outcomes will be app usage, self-monitoring adherence, and app usability and acceptability. Exploratory treatment outcomes will be glycemic control measures at 6 weeks postpartum, neonatal birthweight, and rates of labor induction and caesarean delivery. Findings from the proposed study will empirically inform a future randomized control trial that will be fully powered to test the efficacy and cost-effectiveness of the mGDM app in improving treatment outcomes, using an R01 mechanism. We expect that the research activities and capacity building initiatives proposed in this application will build the institutional skills and create the organizational structure needed to enable future mHealth research initiatives at Kathmandu University, even beyond the scope of this proposed project.