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OpenTrials
Completed

NCT Number: NCT06566131

Development and Evaluation of A Game-Based Mobile App for Increasing Physical Activity 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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carpenter Sports Building

Newark, Delaware, 19716, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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)

Treatment and study plan

Gamified mobile health app

Behavioral

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.

Other names: PuzzleWalk

Primary outcomes

  1. Changes in MVPA levels

    Time frame: Baseline, 3 weeks, 5 weeks, and 8 weeks

    Objective accelerometer-measured MVPA (min/day)

Secondary outcomes

  1. Changes in self-reported PA

    Time frame: Baseline, 3 weeks, 5 weeks, and 8 weeks

    Measured using the Activities Completed over Time in 24-hours (ACT24). This is a web-based previous-day recall instrument (min/day).

  2. Engagement with the PW app

    Time frame: 3 weeks, 5 weeks, and 8 weeks

    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.

  3. Changes in light PA levels

    Time frame: Baseline, 3 weeks, 5 weeks, and 8 weeks

    Objective accelerometer-measured light PA (min/day)

  4. Changes in steps

    Time frame: Baseline, 3 weeks, 5 weeks, and 8 weeks

    Objective accelerometer-measured steps (counts/day)

  5. Changes in sedentary time

    Time frame: Baseline, 3 weeks, 5 weeks, and 8 weeks

    Objective accelerometer-measured sedentary time (min/day)

  6. Changes in self-reported sedentary time

    Time frame: Baseline, 3 weeks, 5 weeks, and 8 weeks

    Measured using the Activities Completed over Time in 24-hours (ACT24). This is a web-based previous-day recall instrument (min/day).

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Collaborators

  • Autism Intervention Research Network on Physical Health

Registry information

Official study title

Gamified Mobile Health for Physical Activity Promotion in Autistic Adults

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2024
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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