Clinical trial NCT05466617: 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
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Physical Activity
Anxiety
Mobile Health
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: American College of Sports Medicine Foundation
First posted: 2022-07-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-group Randomized Controlled Trial
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Baseline Physical Activity and Changes from Baseline Physical Activity at 4th and 8th weeks
timeFrame: 7 days over three different data collection periods (total 21 days)
Secondary outcomes:
measure: Baseline Anxiety and Changes from Baseline Anxiety at 4th and 8th weeks
timeFrame: 7 days over three different data collection periods (total 21 days)
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Indiana University School of Public Health
state: Indiana
Study officials:
affiliation: Indiana University
name: Georgia Frey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.