Diabetes Research Group, Medizinische Klinik und Poliklinik IV, Klinikum der Universität München, Munich, Germany.
CCG Type 2 Diabetes, Helmholtz Zentrum München, Munich, Germany.
JMIR Mhealth Uhealth. 2021 May 11;9(5):e26163. doi: 10.2196/26163.
Gestational diabetes mellitus (GDM) is the most common complication during pregnancy and is associated with an increased risk for the development of cardiometabolic diseases. Behavioral interventions can reduce this risk, but current solutions insufficiently address the requirements for such a program. The systematic development of a scalable mobile health (mHealth) promotion program for mothers during the first years post-GDM may contribute to solving this problem.
The aim of this project was to systematically plan and develop a theory- and evidence-based mHealth intervention to change cardiometabolic risk behaviors in women during the first 5 years post-GDM that meets women's expected standards of commercial health apps.
The intervention mapping steps 1 to 4 structured the systematic planning and development of the mHealth program described in this paper. Steps 1 and 2 led to a theory- and evidence-based logic model of change for cardiometabolic health. Based on this model, the prevention program was designed (step 3) and produced (step 4) in cooperation with industrial partners to ensure a high technological standard of the resulting smartphone app for the iPhone (Apple Inc). Step 4 included a user study with women during the first 5 years post-GDM once a beta version of the app ("TRIANGLE") was available. The user study comprised 2 test rounds of 1 week (n=5) and 4 weeks (n=6), respectively. The tests included validated questionnaires on user acceptance, user logs, and think-alouds with semistructured interviews.
The novel TRIANGLE app is among the first self-paced smartphone apps for individual habit change in the 3 lifestyle areas of physical activity, nutrition, and psychosocial well-being. The 3 core features-a challenge system, human coaching, and a library-address 11 behavioral determinants with 39 behavior change methods to support lifestyle changes. Participants in the user study showed a high acceptance, high perceived quality, and high perceived impact of the TRIANGLE app on their health behaviors. Participants tested the app regularly, used it intuitively, and suggested improvements. We then adapted the TRIANGLE app according to the insights from the user study before the full TRIANGLE program production.
The intervention mapping approach was feasible to plan and develop an innovative and scalable smartphone solution for women during the first 5 years post-GDM. The resulting TRIANGLE intervention has the potential to support behavior change for cardiometabolic disease prevention. However, the app needs further refinement and testing in clinical trials. Intervention mapping steps 5 (implementation plan) and 6 (evaluation plan) may support the integration of the TRIANGLE intervention into routine care.
German Clinical Trials Register DRKS00012736; https://www.drks.de/DRKS00012736.
妊娠糖尿病（GDM）是怀孕期间最常见的并发症，与发生心血管代谢疾病的风险增加有关。行为干预可以降低这种风险，但目前的解决方案不能充分满足该方案的要求。在 GDM 后最初几年系统地开发针对母亲的可扩展移动健康（mHealth）促进计划，可能有助于解决这个问题。
本项目旨在系统地规划和开发一种基于理论和循证的 mHealth 干预措施，以改变 GDM 后最初 5 年内女性的心血管代谢风险行为，满足女性对商业健康应用程序的预期标准。
干预映射步骤 1 到 4 对本文所述 mHealth 计划的系统规划和开发进行了结构化。步骤 1 和 2 导致了心血管代谢健康变化的基于理论和循证的逻辑模型。基于该模型，与工业合作伙伴合作设计（步骤 3）并制作（步骤 4）了预防计划，以确保由此产生的适用于 iPhone（Apple Inc.）的智能手机应用程序具有很高的技术标准。步骤 4 包括在应用程序的测试版（“TRIANGLE”）可用后，对 GDM 后最初 5 年内的女性进行用户研究。用户研究包括两轮为期 1 周（n=5）和 4 周（n=6）的测试，分别进行。测试包括关于用户接受度、用户日志和使用大声思考进行的半结构化访谈的验证问卷。
新颖的 TRIANGLE 应用程序是首批用于个体在身体活动、营养和心理社会健康三个生活方式领域进行习惯改变的自定步速智能手机应用程序之一。该应用程序的 3 个核心功能——挑战系统、人工教练和图书馆——解决了 39 种行为改变方法的 11 个行为决定因素，以支持生活方式的改变。用户研究中的参与者表现出对 TRIANGLE 应用程序的高度接受、高度感知质量和高度感知对其健康行为的影响。参与者定期测试该应用程序，直观地使用它，并提出改进建议。然后，我们根据用户研究的见解，在完全生产 TRIANGLE 程序之前对 TRIANGLE 应用程序进行了调整。
干预映射方法可用于规划和开发针对 GDM 后最初 5 年内女性的创新和可扩展的智能手机解决方案。由此产生的 TRIANGLE 干预措施有可能支持心血管代谢疾病预防的行为改变。然而，该应用程序需要在临床试验中进一步改进和测试。干预映射步骤 5（实施计划）和 6（评估计划）可以支持将 TRIANGLE 干预措施整合到常规护理中。
德国临床试验注册处 DRKS00012736；https://www.drks.de/DRKS00012736。
