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Clinical Trials/NCT06566131
NCT06566131CompletedNot Applicable

Gamified Mobile Health for Physical Activity Promotion in Autistic Adults

University of Delaware1 site in 1 country70 target enrollmentStarted: August 29, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
70
Locations
1
Primary Endpoint
Changes in MVPA levels

Study Overview

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.

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

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Arms & Interventions

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.

Intervention: Gamified mobile health app (Behavioral)

Outcomes

Primary Outcomes

Changes in MVPA levels

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

Objective accelerometer-measured MVPA (min/day)

Secondary Outcomes

  • Changes in self-reported sedentary time(Baseline, 3 weeks, 5 weeks, and 8 weeks)
  • Changes in light PA levels(Baseline, 3 weeks, 5 weeks, and 8 weeks)
  • Engagement with the PW app(3 weeks, 5 weeks, and 8 weeks)
  • Changes in sedentary time(Baseline, 3 weeks, 5 weeks, and 8 weeks)
  • Changes in steps(Baseline, 3 weeks, 5 weeks, and 8 weeks)
  • Changes in self-reported PA(Baseline, 3 weeks, 5 weeks, and 8 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Daehyoung Lee, PhD

Assistant Professor

University of Delaware

Study Sites (1)

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