An interventional study of Gamified mobile health app in Autism Spectrum Disorder, sponsored by University of Delaware. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-30.
Sponsored by University of Delaware · Not applicable, Interventional, and Treatment
The clinical study aims to develop and test a gamified mobile health app called PuzzleWalk (PW) to promote physical activity (PA) and reduce sedentary behavior (SB) in autistic adults, including those with mild intellectual disabilities (ID). The study addresses the need for tailored interventions in this population, who are at higher risk for lifestyle-related chronic health conditions due to lower PA and higher SB. The upgraded version of PuzzleWalk integrates behavior change techniques and gamification strategies, such as translating step counts into puzzle game playtime, to encourage regular PA and reduce SB. The study will evaluate the app's effectiveness on preventive health behavior changes in real-world settings. The ultimate goal is to create an effective, sustainable, and scientifically validated mobile health tool to improve the health and well-being of autistic adults.
The specific aim of this study is to evaluate the feasibility and acceptability of the upgraded PW in increasing PA and reducing SB in autistic adults with and without mild ID. For this field deployment study, we will employ a pre-/post-test design to examine any changes in participants' objective levels of PA and sedentary time before, during, and after the 6-week intervention. The working hypothesis is that the 6-week PW intervention will yield significant increases in accelerometer-measured daily step counts and moderate-to-vigorous PA (MVPA) (up to 5% increases from baseline) and decreases in sedentary time (up to 10% decreases from baseline). High levels of user engagement with PW app during the intervention period will be significantly associated with sustained positive behavior changes in daily step counts, MVPA, and sedentary time among participants.
We will conduct screening interviews with an emphasis on history of diagnosis and level of intellectual functioning to verify the eligibility of prospective participants. After they consent to participate in the study, we will provide them with study materials, including an accelerometer (i.e., wristwatch), a cable charger, and study instruction sheets, via shipping or in-person meetings. Prior to baseline data collection, we will use a rubric to assess participant comfort and knowledge of study procedures. After an initial 2-3-day accelerometer familiarization period, we will start the data collection, including demographics, technology and medication use, and accelerometer-derived PA and sedentary time. From week 3, participants will start to freely use the upgraded PW app after receiving visualized step-by-step user instructions and will continue to use the app until the end of week 8 (total 6-week intervention), supported by periodic reminders and reinforcement messages based on Behavior Change Techniques. PA and sedentary time measures will be collected during four time periods: Week 1 (baseline), Week 3 (intervention start), Week 5 (mid-intervention), and Week 8 (intervention end).
1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.
This study's enrollment of 70 is above the median of 52 across 1,371 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →University of Delaware is the lead sponsor of 125 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
PuzzleWalk integrates gamification strategies and incentivization of walking behaviors to induce target behavior changes. Capitalizing on the distinctive attributes and preferences of autistic adults, PW emphasizes the advantages of visual learning while minimizing the need for undesired face-to-face social interactions. A novel feature is its conversion algorithm that translates daily step counts into playtime for "spot the difference" puzzle games, which leverages the psychological satisfactions of autonomy, relatedness, and competence.
Behavioral: Gamified mobile health app
Participants will receive visualized instructions about the PW use (e.g., search and download the app on App Store, navigate and understand key features, play puzzle games, and track step counts). During the 6-week intervention period, participants will receive reminders on wearing the accelerometer, using the app for potential incentives, and engaging in regular physical activities for health promotion.
Also known as: PuzzleWalk
Changes in MVPA levels
Objective accelerometer-measured MVPA (min/day)
Time frame: Baseline, 3 weeks, 5 weeks, and 8 weeks
Changes in self-reported PA
Measured using the Activities Completed over Time in 24-hours (ACT24). This is a web-based previous-day recall instrument (min/day).
Time frame: Baseline, 3 weeks, 5 weeks, and 8 weeks
Engagement with the PW app
The level of user engagement in the PW app will be measured using a webmaster server that keeps track of user logs and timestamps (e.g., frequency and duration of app use and leaderboard scores). Time spent on the app in a min/day format will be calculated to represent each participant's level of user engagement.
Time frame: 3 weeks, 5 weeks, and 8 weeks
Changes in light PA levels
Objective accelerometer-measured light PA (min/day)
Time frame: Baseline, 3 weeks, 5 weeks, and 8 weeks
Changes in steps
Objective accelerometer-measured steps (counts/day)
Time frame: Baseline, 3 weeks, 5 weeks, and 8 weeks
Changes in sedentary time
Objective accelerometer-measured sedentary time (min/day)
Time frame: Baseline, 3 weeks, 5 weeks, and 8 weeks
Changes in self-reported sedentary time
Measured using the Activities Completed over Time in 24-hours (ACT24). This is a web-based previous-day recall instrument (min/day).
Time frame: Baseline, 3 weeks, 5 weeks, and 8 weeks
Plan to share: No — IPD will not be shared publicly as it will be used for refereed publications.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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University of Delaware