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临床试验/NCT03749473
NCT03749473已完成不适用

Evaluation of the Novel Use of Gamification With Alternative Goal-setting Experiences

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年1月14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
500
试验地点
2
主要终点
Change in mean daily steps from baseline to maintenance period.

研究概览

简要总结

To use a randomized controlled trial to test the effectiveness of four goal-setting strategies within a gamification intervention to increase physical activity among adults at elevated risk for ASCVD.

详细描述

Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of mortality in the United States. While increased physical activity can reduce this risk, less than half of adults in the United States meet the minimum recommendation guidelines for physical activity. Gamification, or the application of game design elements to non-game settings, has demonstrated promise in increasing physical activity when designed using insights from behavioral economics. However, the best way to design goal-setting within these interventions has not been well-examined. In this randomized controlled trial, the investigators will evaluate the effectiveness of four different goal-setting strategies within a gamification intervention to increase physical activity among adults with elevated risk for ASCVD. The trial will include a 2-week run-in period to estimate a baseline, followed by an 8-week introductory phase, an 8-week maintenance phase, and then after the intervention is completed an 8-week follow-up period.

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
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Age 18 years or older;
  • ability to read and provide informed consent to participate in the study;
  • diagnosis of clinical ASCVD or a 10-year ASCVD risk score ≥ 7.5% calculated according to the 2013 ACC/AHA guidelines;
  • Smartphone or tablet compatible with application for the wearable activity tracking device.

排除标准

  • Conditions that would make participation infeasible such as inability to provide informed consent, illiteracy or inability to speak, read, and write English;
  • conditions that would make participation unsafe such as pregnancy or being told by a physician not to exercise;
  • already enrolled in another study targeting physical activity;
  • any other medical conditions or reasons he or she is unable to participate in a physical activity study for 24 weeks;
  • baseline step count of 10,000 steps or greater.

结局指标

主要结局

Change in mean daily steps from baseline to maintenance period.

时间窗: Baseline to weeks 9-16

The primary outcome is change in mean daily steps from baseline to weeks 9-16 (maintenance period).

次要结局

  • Change in mean daily steps from baseline to follow-up period.(Baseline to the weeks 17 to 24)

研究者

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

Mitesh Patel

Assistant Professor

University of Pennsylvania

研究点 (2)

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