NCT05466617

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

9 months

First QC Date

July 11, 2022

Last Update Submit

July 15, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Baseline Physical Activity and Changes from Baseline Physical Activity at 4th and 8th weeks

    Accelerometer-Measured Objective Physical Activity Levels

    7 days over three different data collection periods (total 21 days)

Secondary Outcomes (1)

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

    7 days over three different data collection periods (total 21 days)

Study Arms (2)

PuzzleWalk

EXPERIMENTAL

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.

Behavioral: Mobile Health for Physical Activity Behavior Change

Google Fit

EXPERIMENTAL

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.

Behavioral: Mobile Health for Physical Activity Behavior Change

Interventions

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.

Google FitPuzzleWalk

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Individuals with low cognitive function, co-occurring intellectual disabilities, or mobility impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University School of Public Health

Bloomington, Indiana, 47405, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Autism Spectrum DisorderMotor ActivityAnxiety Disorders

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Georgia Frey, Ph.D.

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-group Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Kinesiology

Study Record Dates

First Submitted

July 11, 2022

First Posted

July 20, 2022

Study Start

July 1, 2019

Primary Completion

March 15, 2020

Study Completion

May 30, 2020

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations