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Gamified App on Increasing Physical Activity and Reducing Anxiety in Autism

Primary Purpose

Autism Spectrum Disorder, Physical Activity, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Health for Physical Activity Behavior Change
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Indiana University School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PuzzleWalk

Google Fit

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Baseline Physical Activity and Changes from Baseline Physical Activity at 4th and 8th weeks
Accelerometer-Measured Objective Physical Activity Levels

Secondary Outcome Measures

Baseline Anxiety and Changes from Baseline Anxiety at 4th and 8th weeks
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.

Full Information

First Posted
July 11, 2022
Last Updated
July 15, 2022
Sponsor
Indiana University
Collaborators
American College of Sports Medicine Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05466617
Brief Title
Gamified App on Increasing Physical Activity and Reducing Anxiety in Autism
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
May 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
American College of Sports Medicine Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Physical Activity, Anxiety, Mobile Health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-group Randomized Controlled Trial
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PuzzleWalk
Arm Type
Experimental
Arm Description
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.
Arm Title
Google Fit
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Health for Physical Activity Behavior Change
Intervention Description
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.
Primary Outcome Measure Information:
Title
Baseline Physical Activity and Changes from Baseline Physical Activity at 4th and 8th weeks
Description
Accelerometer-Measured Objective Physical Activity Levels
Time Frame
7 days over three different data collection periods (total 21 days)
Secondary Outcome Measure Information:
Title
Baseline Anxiety and Changes from Baseline Anxiety at 4th and 8th weeks
Description
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.
Time Frame
7 days over three different data collection periods (total 21 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georgia Frey, Ph.D.
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University School of Public Health
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35900808
Citation
Lee D, Frey GC, Cothran DJ, Harezlak J, Shih PC. 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. JMIR Form Res. 2022 Jul 28;6(7):e35701. doi: 10.2196/35701.
Results Reference
derived

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Gamified App on Increasing Physical Activity and Reducing Anxiety in Autism

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