NCT06566131

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

August 29, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2025

Completed
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

10 months

First QC Date

August 19, 2024

Last Update Submit

July 29, 2025

Conditions

Keywords

Mobile healthGamificationPhysical activitySedentary behavior

Outcome Measures

Primary Outcomes (1)

  • Changes in MVPA levels

    Objective accelerometer-measured MVPA (min/day)

    Baseline, 3 weeks, 5 weeks, and 8 weeks

Secondary Outcomes (6)

  • Changes in self-reported PA

    Baseline, 3 weeks, 5 weeks, and 8 weeks

  • Engagement with the PW app

    3 weeks, 5 weeks, and 8 weeks

  • Changes in light PA levels

    Baseline, 3 weeks, 5 weeks, and 8 weeks

  • Changes in steps

    Baseline, 3 weeks, 5 weeks, and 8 weeks

  • Changes in sedentary time

    Baseline, 3 weeks, 5 weeks, and 8 weeks

  • +1 more secondary outcomes

Study Arms (1)

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.

Behavioral: Gamified mobile health app

Interventions

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
PuzzleWalk (Gamified mHealth)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carpenter Sports Building

Newark, Delaware, 19716, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Autism Spectrum DisorderMotor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBehavior

Study Officials

  • Daehyoung Lee, PhD

    University of Delaware

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All study participants will get the same mobile health intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 19, 2024

First Posted

August 22, 2024

Study Start

August 29, 2024

Primary Completion

July 2, 2025

Study Completion

July 2, 2025

Last Updated

July 30, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

IPD will not be shared publicly as it will be used for refereed publications.

Locations