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临床试验/NCT05069155
NCT05069155已完成不适用

Gamification to Improve Physical Activity in Older Adults at Risk for Alzheimer's: the STEP 4Life Trial

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2021年11月1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
240
试验地点
2
主要终点
Change in Mean Daily Steps From the Baseline Period to the End of the 12 Week Intervention Period.

研究概览

简要总结

The objective of this study is to test the feasibility of using behavioral economic interventions (gamification with social incentives) targeting daily step counts to prevent or delay the development of Alzheimer's Disease and Related Dementias (ADRD).

详细描述

Increased physical activity by walking further or more vigorously may prevent or delay the development of Alzheimer's Disease and Related Dementias (ADRD) but reaching higher levels of activity and maintaining it as a long-term habit is difficult to do. This project will use concepts from behavioral science to create a game older adults can play in order to increase their levels of activity while having fun doing it. The game is played with a support partner who is a spouse, family member, or close friend who provides feedback and encouragement to help the game-player reach activity goals and maintain them as habits over time. Participants in the game will use their own smartphone and a wristwatch that tracks activity (such as a FitBit, provided by this study) to set goals, get feedback, and play the game for 12 weeks. Participants will be asked to continue wearing the wristwatch for another 6 weeks to track activity after the game is over. To determine the effectiveness of this game, investigators will randomly assign 50 people to the game and 50 people to only get the wristwatch but no game component. All participants in this study will be recruited from an online registry of adults age 55-75 who have not been diagnosed with Alzheimer's (GeneMatch) which offers genetic testing on risk for ADRD to all participants. Investigators will recruit participants who have elevated genetic risk as well as those without specific genetic risks for the study to see if either group responds differently to the game.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
55 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • own a smartphone
  • be enrolled in GeneMatch
  • know their genetic testing results (APOE4)
  • able to provide informed consent

排除标准

  • Inability to provide informed consent
  • does not have daily access to a smartphone compatible with the wearable device and not willing to use a device that we can provide them
  • already enrolled in another physical activity study
  • unable to ambulate independently
  • any other medical conditions that would prohibit participation in physical activity program

结局指标

主要结局

Change in Mean Daily Steps From the Baseline Period to the End of the 12 Week Intervention Period.

时间窗: Baseline to 12 week intervention period (Weeks 1 - 12)

The primary outcome of the study is the change in mean daily steps from the baseline period to the end of the 12 week intervention period collected by Fitbit Inspire device.

次要结局

  • Change in Mean Daily Step Counts During the 6 Week Follow-up Period After the End of the Intervention Period Tracked by Fitbit Inspire Device.(6 week follow-up period (Weeks 13 - 18))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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