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临床试验/NCT04942535
NCT04942535已完成不适用

STEP Together: A Hybrid Type 1 Effectiveness-Implementation Study of Social Incentives Strategies to Increase Physical Activity

Abramson Cancer Center at Penn Medicine2 个研究点 分布在 1 个国家目标入组 779 人开始时间: 2021年9月21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
779
试验地点
2
主要终点
Change in mean daily step counts during the 12 month intervention

研究概览

简要总结

Higher levels of physical activity have been demonstrated to improve health across a wide range of contexts and reduce cognitive decline as adults become older, but more than half of all adults in the United States do not meet their physical activity goals. One type of physical activity that is broadly applicable to people of all ages is walking. This study will use a Hybrid Type 1 effectiveness-implementation design to adapt and test the effectiveness of two successful social incentive-based interventions, a gamification strategy and financial incentives donated to charity on the participants behalf, to increase physical activity among low-income, mostly minority families in community settings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Able to read and speak English;
  • Has a smartphone or tablet;
  • Lives in the Philadelphia area;
  • Age 14 or older;
  • Able to provide informed consent;
  • Enrolled as a member of a 2 to 10 member family team with least one member 60 years or older.

排除标准

  • Already participating in another physical activity study;
  • An 18-month physical activity program is infeasible (e.g., metastatic cancer, unable to ambulate or provide informed consent) or unsafe (currently pregnant or told by a physician not to exercise);
  • Do not have sufficient eyesight or dexterity to operate device;
  • Average step count greater than 7,500 steps/day during the run-in period.

结局指标

主要结局

Change in mean daily step counts during the 12 month intervention

时间窗: Months 1-12

Change in mean daily steps from baseline to the end of the 12 month intervention period. Steps will be measured using the Fitbit Inspire 2 wearable device.

次要结局

  • Change in mean daily step counts during the 12 month intervention and 6 month follow up(Months 1-18)
  • Change in mean minutes of moderate-to-vigorous physical activity (MVPA) during the 12 month intervention(Months 1-12)
  • Difference in proportion of weeks physical activity guidelines were achieved during the 12 month intervention(Months 1-12)
  • Difference in proportion of weeks physical activity guidelines were achieved during the 12 month intervention and 6 month follow up(Months 1-18)
  • Change in mean minutes of moderate-to-vigorous physical activity (MVPA) during the 12 month intervention and 6 month follow up(Months 1-18)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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