Lee Daehyoung, McNulty Lia, Kathiravan Swetha, Mauriello Matthew Louis, Vasudevan Vijay, Bhat Anjana, Obrusnikova Iva, Suminski Richard
Department of Health Behavior and Nutrition Sciences, College of Health Sciences, University of Delaware, Newark, DE, United States.
Department of Computer and Information Sciences, College of Engineering, University of Delaware, Newark, DE, United States.
JMIR Res Protoc. 2025 Jul 22;14:e71631. doi: 10.2196/71631.
Research indicates that many autistic adults are insufficiently active and overly sedentary. There is limited evidence on effective strategies to increase physical activity (PA) and reduce sedentary behavior (SB) in this population. Gamified mobile health (mHealth) interventions show promise for addressing these challenges by leveraging autistic individuals' strengths in visuospatial learning and their affinity for digital gaming. Despite this potential, it remains unclear how well these interventions translate to real-world settings. This gap is compounded by the lack of community-based participatory approaches in the development of mHealth intervention for autistic adults.
This study aims to (1) formulate gamification and behavior change strategies for the PuzzleWalk v2 app using a community-based participatory approach and (2) evaluate its feasibility and acceptability for increasing PA and reducing SB among autistic adults, including those with mild intellectual disability, in real-world settings.
This study, consisting of 2 sequential phases, will be conducted entirely remotely: (1) online community-based design workshops to refine the PuzzleWalk gamified mHealth system with input from key autism stakeholders, including autistic adults and caregivers, and (2) an 8-week field deployment to assess real-world usability and engagement. In Phase I (completed), weekly workshops and usability testing focused on understanding autistic adults' technology preferences, evaluating PuzzleWalk v1 and v2 prototypes, and incorporating stakeholder feedback into iterative app development (n=9). Phase II (in progress) will involve a single-arm clinical trial where approximately 70 participants will use the app alongside research-grade activity-tracking accelerometers to measure PA and SB. Outcome measures, including sedentary time, step counts, PA intensities, and app engagement (eg, time spent using the app), will be collected across 4 specific time points (ie, baseline and weeks 3, 5, and 8). Repeated measures ANCOVA will be performed to examine changes in participants' objective levels of PA and sedentary time before, during, and after the intervention.
Phase I of the study, involving community-based participatory design workshops and usability testing, was completed in November 2024. Key autism stakeholders recognized the gamified PuzzleWalk app as a viable tool for enhancing motivation toward PA and SB changes among autistic adults. Data collection for Phase II, the field deployment, is currently underway and is expected to end in August 2025. As of July 2025, we had enrolled 69 participants in the study. The findings of these studies will be shared in a subsequent peer-reviewed publication.
Results of the ongoing field deployment study (Phase II) will further clarify the app's effectiveness and real-world applicability.
ClinicalTrials.gov NCT06566131; https://clinicaltrials.gov/study/NCT06566131.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/71631.
研究表明，许多成年自闭症患者活动不足且久坐不动。关于增加这一人群身体活动（PA）和减少久坐行为（SB）的有效策略，证据有限。游戏化移动健康（mHealth）干预措施有望通过利用自闭症患者在视觉空间学习方面的优势以及他们对数字游戏的喜爱来应对这些挑战。尽管有这种潜力，但这些干预措施在现实世界中的效果仍不清楚。在为成年自闭症患者开发移动健康干预措施时，缺乏基于社区的参与式方法，这使这一差距更加突出。
本研究旨在（1）采用基于社区的参与式方法，为PuzzleWalk v2应用程序制定游戏化和行为改变策略；（2）评估其在现实世界中增加成年自闭症患者（包括轻度智力残疾患者）的身体活动和减少久坐行为方面的可行性和可接受性。
本研究包括两个连续阶段，将完全通过远程方式进行：（1）基于在线社区的设计研讨会，在包括成年自闭症患者和照顾者在内的关键自闭症利益相关者的参与下，完善PuzzleWalk游戏化移动健康系统；（2）进行为期8周的实地部署，以评估其在现实世界中的可用性和参与度。在第一阶段（已完成），每周的研讨会和可用性测试重点在于了解成年自闭症患者的技术偏好、评估PuzzleWalk v1和v2原型，并将利益相关者的反馈纳入应用程序的迭代开发（n = 9）。第二阶段（正在进行）将涉及一项单臂临床试验，约70名参与者将使用该应用程序，同时使用研究级活动追踪加速度计来测量身体活动和久坐行为。将在4个特定时间点（即基线以及第3、5和8周）收集包括久坐时间、步数、身体活动强度和应用程序参与度（如使用应用程序的时间）等结果指标。将进行重复测量协方差分析，以检查干预前、干预期间和干预后参与者身体活动和久坐时间的客观水平变化。
该研究的第一阶段，即基于社区的参与式设计研讨会和可用性测试，已于2024年11月完成。关键自闭症利益相关者认可游戏化的PuzzleWalk应用程序是增强成年自闭症患者对身体活动和久坐行为改变动机的可行工具。第二阶段实地部署的数据收集目前正在进行，预计于2025年8月结束。截至2025年7月，我们已招募了69名参与者。这些研究的结果将在后续的同行评审出版物中分享。
正在进行的实地部署研究（第二阶段）的结果将进一步阐明该应用程序的有效性和在现实世界中的适用性。
ClinicalTrials.gov NCT06566131；https://clinicaltrials.gov/study/NCT06566131。
国际注册报告识别码（IRRID）：DERR1-10.2196/71631。
