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临床试验/NCT06566131
NCT06566131已完成不适用

Gamified Mobile Health for Physical Activity Promotion in Autistic Adults

University of Delaware2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年8月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Changes in MVPA levels

研究概览

简要总结

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 app's 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.

详细描述

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 (i.e., 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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • adults aged 18 to 55 years
  • individuals diagnosed with an autism spectrum disroder by a medical professional or self-identify as neurodivergent
  • individuals who have regular access to a supported smartphone (iOS 13+ operating system)

排除标准

  • individuals with a moderate-to-profound intellectual disability
  • individuals with orthopedic conditions that significantly interfere with independent ambulation (e.g., using a wheelchair or crutches)

结局指标

主要结局

Changes in MVPA levels

时间窗: Baseline, 3 weeks, 5 weeks, and 8 weeks

Objective accelerometer-measured MVPA (min/day)

次要结局

  • Changes in self-reported PA(Baseline, 3 weeks, 5 weeks, and 8 weeks)
  • Engagement with the PW app(3 weeks, 5 weeks, and 8 weeks)
  • Changes in sedentary time(Baseline, 3 weeks, 5 weeks, and 8 weeks)
  • Changes in steps(Baseline, 3 weeks, 5 weeks, and 8 weeks)
  • Changes in self-reported sedentary time(Baseline, 3 weeks, 5 weeks, and 8 weeks)
  • Changes in light PA levels(Baseline, 3 weeks, 5 weeks, and 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daehyoung Lee, PhD

Assistant Professor

University of Delaware

研究点 (2)

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