Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06566131
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Development and Evaluation of A Game-Based Mobile App for Increasing Physical Activity in Autistic Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Gamified Mobile Health for Physical Activity Promotion in Autistic Adults
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The clinical study aims to develop and test a gamified mobile health app called PuzzleWalk PW to promote physical activity PA and reduce sedentary behavior SB in autistic adults including those with mild intellectual disabilities ID The study addresses the need for tailored interventions in this population who are at higher risk for lifestyle-related chronic health conditions due to lower PA and higher SB The upgraded version of PuzzleWalk integrates behavior change techniques and gamification strategies such as translating step counts into puzzle game playtime to encourage regular PA and reduce SB The study will evaluate the apps effectiveness on preventive health behavior changes in real-world settings The ultimate goal is to create an effective sustainable and scientifically validated mobile health tool to improve the health and well-being of autistic adults
Detailed Description:
The specific aim of this study is to evaluate the feasibility and acceptability of the upgraded PW in increasing PA and reducing SB in autistic adults with and without mild ID For this field deployment study we will employ a pre-post-test design to examine any changes in participants objective levels of PA and sedentary time before during and after the 6-week intervention The working hypothesis is that the 6-week PW intervention will yield significant increases in accelerometer-measured daily step counts and moderate-to-vigorous PA MVPA up to 5 increases from baseline and decreases in sedentary time up to 10 decreases from baseline High levels of user engagement with PW app during the intervention period will be significantly associated with sustained positive behavior changes in daily step counts MVPA and sedentary time among participants
We will conduct screening interviews with an emphasis on history of diagnosis and level of intellectual functioning to verify the eligibility of prospective participants After they consent to participate in the study we will provide them with study materials including an accelerometer ie wristwatch a cable charger and study instruction sheets via shipping or in-person meetings Prior to baseline data collection we will use a rubric to assess participant comfort and knowledge of study procedures After an initial 2-3-day accelerometer familiarization period we will start the data collection including demographics technology and medication use and accelerometer-derived PA and sedentary time From week 3 participants will start to freely use the upgraded PW app after receiving visualized step-by-step user instructions and will continue to use the app until the end of week 8 total 6-week intervention supported by periodic reminders and reinforcement messages based on Behavior Change Techniques PA and sedentary time measures will be collected during four time periods Week 1 baseline Week 3 intervention start Week 5 mid-intervention and Week 8 intervention end
We will conduct screening interviews with an emphasis on history of diagnosis and level of intellectual functioning to verify the eligibility of prospective participants After they consent to participate in the study we will provide them with study materials including an accelerometer ie wristwatch a cable charger and study instruction sheets via shipping or in-person meetings Prior to baseline data collection we will use a rubric to assess participant comfort and knowledge of study procedures After an initial 2-3-day accelerometer familiarization period we will start the data collection including demographics technology and medication use and accelerometer-derived PA and sedentary time From week 3 participants will start to freely use the upgraded PW app after receiving visualized step-by-step user instructions and will continue to use the app until the end of week 8 total 6-week intervention supported by periodic reminders and reinforcement messages based on Behavior Change Techniques PA and sedentary time measures will be collected during four time periods Week 1 baseline Week 3 intervention start Week 5 mid-intervention and Week 8 intervention end
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None