- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05466617
Gamified App on Increasing Physical Activity and Reducing Anxiety in Autism
Effects of a Gamified, Behavior Change Technique-Based Mobile App on Increasing Physical Activity and Reducing Anxiety in Adults With Autism Spectrum Disorder: Feasibility Randomized Controlled Trial
Background: Physical activity (PA) has an impact on physical and mental health in neurotypical populations, and addressing these variables may improve the prevalent burden of anxiety in adults with autism spectrum disorder (ASD). Gamified mobile apps using behavior change techniques present a promising way of increasing PA and reducing sedentary time, thus reducing anxiety in adults with ASD.
Objective: This study aimed to compare the effectiveness of a gamified and behavior change technique-based mobile app, PuzzleWalk, versus a commercially available app, Google Fit, on increasing PA and reducing sedentary time as an adjunct anxiety treatment for this population.
Methods: A total of 24 adults with ASD were assigned to either the PuzzleWalk or Google Fit group for 5 weeks using a covariate-adaptive randomization design. PA and anxiety were assessed over 7 days at 3 different data collection periods (ie, baseline, intervention start, and intervention end) using triaxial accelerometers and the Beck Anxiety Inventory. Group differences in outcome variables were assessed using repeated-measures analysis of covariance, adjusting for age, sex, and BMI.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Indiana
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Bloomington, Indiana, United States, 47405
- Indiana University School of Public Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Self-reported medical diagnosis of anxiety or self-identification of experiencing anxiety symptoms for the past 3 or more months
- Access to a supported device (smartphones with Android 4.4 and higher or iOS 9.0 and higher operating system)
- Cognitive ability to understand the purpose of the study
- No prior experience using the PA mobile apps used in the study
Exclusion Criteria:
- Individuals with low cognitive function, co-occurring intellectual disabilities, or mobility impairments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PuzzleWalk
PuzzleWalk incorporates behavior change techniques (BCTs), a theory-based method of promoting healthy behavior change by leveraging psychological determinants. The example techniques included in PuzzleWalk are a comprehensive, visualized user guide, self-monitoring of target performance, contingent rewards, and goal setting. It is a spot the difference puzzle game comprising 660 major city images around the world. This format was chosen because it is easy to understand the purpose of the game, and it can quickly capture the user's interests without a complex comprehension process. Moreover, this visual image-based game facilitates visual interaction, which is a unique strength of individuals with ASD. The most unique design element of PuzzleWalk is the conversion algorithm between steps and game-solving time. Specifically, the user's accumulated steps are directly converted to game-solving time to motivate PA participation. |
All participants received visualized step-by-step instructions (eg, search and download on Google Play or App Store, user registration, goal setting, and PA behavior tracking) on the assigned PA app (PuzzleWalk or Google Fit) and used it from the beginning of the intervention start (fourth week) until the end of the intervention (eighth week).
Both the PuzzleWalk and Google Fit groups received reminders regarding the use of the PA app during the first week of the intervention period and autonomously continued to use the app until the intervention ended.
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Experimental: Google Fit
Google Fit (Google LLC) is a PA-tracking platform developed by Google for Android and Apple iOS.
The app uses a sensor built into a smartphone device to automatically track PA, including steps and active minutes.
It also allows users to journal and record a variety of forms of PA (eg, cycling, weightlifting, and yoga) by manually setting the activity tracking mode.
Google Fit uses a heart point-based reward system as a gamification strategy to provide users with individualized exercise tips incorporated with PA recommendations outlined by the American Heart Association.
The number of heart points received based on active minutes is the app's primary gamification strategy.
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All participants received visualized step-by-step instructions (eg, search and download on Google Play or App Store, user registration, goal setting, and PA behavior tracking) on the assigned PA app (PuzzleWalk or Google Fit) and used it from the beginning of the intervention start (fourth week) until the end of the intervention (eighth week).
Both the PuzzleWalk and Google Fit groups received reminders regarding the use of the PA app during the first week of the intervention period and autonomously continued to use the app until the intervention ended.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline Physical Activity and Changes from Baseline Physical Activity at 4th and 8th weeks
Time Frame: 7 days over three different data collection periods (total 21 days)
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Accelerometer-Measured Objective Physical Activity Levels
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7 days over three different data collection periods (total 21 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline Anxiety and Changes from Baseline Anxiety at 4th and 8th weeks
Time Frame: 7 days over three different data collection periods (total 21 days)
|
Beck Anxiety Inventory (BAI; Beck, Epstein, Brown, & Steer, 1988) was used to assess participants' prolonged state of anxiety.
The Beck Anxiety Inventory is a self-report scale comprising 21 items that measure the severity of anxiety symptoms during the past week.
The score range is 0-63, with higher scores indicating greater degrees of anxiety.
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7 days over three different data collection periods (total 21 days)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Georgia Frey, Ph.D., Indiana University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1807483245
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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