Autism Spectrum DisorderNCT06566131
Development and Evaluation of A Game-Based Mobile App for Increasing Physical Activity in Autistic Adults
A study testing Gamified mobile health app in people with Autism Spectrum Disorder, run by University of Delaware at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Gamified mobile health app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2024to 2 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- adults aged 18 to 55 years
- individuals diagnosed with an autism spectrum disroder by a medical professional or self-identify as neurodivergent
- individuals who have regular access to a supported smartphone (iOS 13+ operating system)
Who cannot join
- individuals with a moderate-to-profound intellectual disability
- individuals with orthopedic conditions that significantly interfere with independent ambulation (e.g., using a wheelchair or crutches)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gamified Mobile Health for Physical Activity Promotion in Autistic Adults
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.
Read the detailed description
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).
- Conditions
- Autism Spectrum Disorder
- Being tested
- Gamified mobile health app
- Keywords
- Mobile health, Gamification, Physical activity, Sedentary behavior
- Medical subject headings
- Autism Spectrum Disorder, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamified mobile health appBehavioural
Also called PuzzleWalk
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.
| Study group | Role | What they receive |
|---|---|---|
| PuzzleWalk (Gamified mHealth) | Experimental | 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. Receives: Behavioral: Gamified mobile health app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in MVPA levels
Objective accelerometer-measured MVPA (min/day)
Measured: Baseline, 3 weeks, 5 weeks, and 8 weeks
Secondary outcomes (6)
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).
Measured: 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.
Measured: 3 weeks, 5 weeks, and 8 weeks
Changes in light PA levels
Objective accelerometer-measured light PA (min/day)
Measured: Baseline, 3 weeks, 5 weeks, and 8 weeks
Changes in steps
Objective accelerometer-measured steps (counts/day)
Measured: Baseline, 3 weeks, 5 weeks, and 8 weeks
Changes in sedentary time
Objective accelerometer-measured sedentary time (min/day)
Measured: 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).
Measured: Baseline, 3 weeks, 5 weeks, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start29 Aug 2024
- Primary completion2 Jul 2025
- Study completion2 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All study participants will get the same mobile health intervention.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- Autism Intervention Research Network on Physical Health
- Responsible party
- Principal investigator, Daehyoung Lee, PhD, University of Delaware
- Investigators
- Daehyoung Lee, PhD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566131
- Sponsor's protocol ID
- 2098388
- Status last verified
- Jul 2025
- First submitted
- 19 Aug 2024
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared publicly as it will be used for refereed publications.
Publications
Lee D, McNulty L, Kathiravan S, Mauriello ML, Vasudevan V, Bhat A, Obrusnikova I, Suminski R. A Gamified mHealth App to Promote Physical Activity and Reduce Sedentary Behavior in Autistic Adults: Protocol for a Remotely Delivered Pilot Intervention Study. JMIR Res Protoc. 2025 Jul 22;14:e71631. doi: 10.2196/71631.
PubMed 40694837
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gamified Mobile Health for Physical Activity Promotion in Autistic Adults
- ClinicalTrials.gov ID
- NCT06566131
- Acronym / sponsor ID
- 2098388
- Conditions
- Autism Spectrum Disorder
- Keywords
- Mobile health, Gamification, Physical activity, Sedentary behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- Autism Intervention Research Network on Physical Health
- Study start
- 29 Aug 2024 (actual)
- Primary completion
- 2 Jul 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All study participants will get the same mobile health intervention.
| Arm | Type | Receives |
|---|---|---|
| PuzzleWalk (Gamified mHealth) | Experimental | Behavioral: Gamified mobile health appPuzzleWalk 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- adults aged 18 to 55 years
- individuals diagnosed with an autism spectrum disroder by a medical professional or self-identify as neurodivergent
- individuals who have regular access to a supported smartphone (iOS 13+ operating system)
Key exclusion criteria (2 listed)
- individuals with a moderate-to-profound intellectual disability
- individuals with orthopedic conditions that significantly interfere with independent ambulation (e.g., using a wheelchair or crutches)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamified mobile health appAlso: PuzzleWalkParticipants 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. | Behavioural | PuzzleWalk (Gamified mHealth) |
Primary outcome
Changes in MVPA levels
Time frame: Baseline, 3 weeks, 5 weeks, and 8 weeks
Objective accelerometer-measured MVPA (min/day)
6 secondary outcomes
Changes in self-reported PA
Time frame: Baseline, 3 weeks, 5 weeks, and 8 weeks
Engagement with the PW app
Time frame: 3 weeks, 5 weeks, and 8 weeks
Changes in light PA levels
Time frame: Baseline, 3 weeks, 5 weeks, and 8 weeks
Changes in steps
Time frame: Baseline, 3 weeks, 5 weeks, and 8 weeks
Changes in sedentary time
Time frame: Baseline, 3 weeks, 5 weeks, and 8 weeks
Changes in self-reported sedentary time
Time frame: Baseline, 3 weeks, 5 weeks, and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Derived from this study: PubMed 40694837Lee D, McNulty L, Kathiravan S, Mauriello ML, Vasudevan V, Bhat A, Obrusnikova I, Suminski R. A Gamified mHealth App to Promote Physical Activity and Reduce Sedentary Behavior in Autistic Adults: Protocol for a Remotely Delivered Pilot Intervention Study. JMIR Res Protoc. 2025 Jul 22;14:e71631. doi: 10.2196/71631.
- Individual participant dataSharing planned: No. IPD will not be shared publicly as it will be used for refereed publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daehyoung Lee, PhD principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamified mobile health app in people with Autism Spectrum Disorder, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in MVPA levels (time frame: Baseline, 3 weeks, 5 weeks, and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06566131, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.