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OpenTrials
Completed

NCT Number: NCT05466617

Gamified App on Increasing Physical Activity and Reducing Anxiety in Autism

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University School of Public Health

Bloomington, Indiana, 47405, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Mobile Health for Physical Activity Behavior Change

Behavioral

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 outcomes

  1. 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)

    Accelerometer-Measured Objective Physical Activity Levels

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • American College of Sports Medicine Foundation

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 20, 2022
Registry last updated
Jul 20, 2022

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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