Autism Spectrum DisorderNCT05466617
Gamified App on Increasing Physical Activity and Reducing Anxiety in Autism
A study testing Mobile Health for Physical Activity Behavior Change in people with Autism Spectrum Disorder and Physical Activity, run by Indiana University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Physical Activity, Anxiety
- What is being tested?
- Mobile Health for Physical Activity Behavior Change
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 30 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Individuals with low cognitive function, co-occurring intellectual disabilities, or mobility impairments
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Public Health
Bloomington, Indiana, 47405
About this study
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
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.
- Conditions
- Autism Spectrum Disorder, Physical Activity, Anxiety, Mobile Health
- Being tested
- Mobile Health for Physical Activity Behavior Change
- Medical subject headings
- Autism Spectrum Disorder, Motor Activity, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Health for Physical Activity Behavior ChangeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mobile Health for Physical Activity Behavior Change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Physical Activity and Changes from Baseline Physical Activity at 4th and 8th weeks
Accelerometer-Measured Objective Physical Activity Levels
Measured: 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
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.
Measured: 7 days over three different data collection periods (total 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start1 Jul 2019
- Primary completion15 Mar 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-group Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Sports Medicine Foundation
- Responsible party
- Principal investigator, Georgia Frey, Indiana University
- Investigators
- Georgia Frey, Ph.D., Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466617
- Sponsor's protocol ID
- 1807483245
- Status last verified
- Jul 2022
- First submitted
- 11 Jul 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35900808
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05466617
- Acronym / sponsor ID
- 1807483245
- Conditions
- Autism Spectrum Disorder, Physical Activity, Anxiety, Mobile Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- American College of Sports Medicine Foundation
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two-group Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| PuzzleWalk | Experimental | Behavioral: Mobile Health for Physical Activity Behavior ChangePuzzleWalk 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 | Experimental | Behavioral: Mobile Health for Physical Activity Behavior ChangeGoogle 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Individuals with low cognitive function, co-occurring intellectual disabilities, or mobility impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Health for Physical Activity Behavior ChangeAll 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. | Behavioural | Google Fit, PuzzleWalk |
Primary outcome
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
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Derived from this study: PubMed 35900808Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgia Frey, Ph.D. principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Health for Physical Activity Behavior Change in people with Autism Spectrum Disorder and Physical Activity, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05466617, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.