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临床试验/NCT03563027
NCT03563027已完成不适用

Evaluating Connected Health Approaches to Improving the Health of Veterans (CDA 15-065)

VA Office of Research and Development4 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2019年3月19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
180
试验地点
4
主要终点
Change in Mean Daily Steps From Baseline Relative to Control

研究概览

简要总结

In this randomized, controlled trial the investigators will compare the use of social and financial incentive-based interventions to increase physical activity among overweight and obese Veterans during a 12-week intervention with 8 weeks of follow-up.

详细描述

In this 3-arm randomized trial, the investigators will compare the effectiveness of a social incentive-based gamification intervention with and without loss-framed financial incentives to increase physical activity relative to a control among overweight and obese adults Veterans. All Veterans will use a Fitbit wearable device to establish a baseline step count, select a step goal increase of 33% to 50% above baseline and then participate in a 12-week intervention and 8-week follow-up period. The two intervention arms will be entered into a game with points and levels designed using insights from behavioral economics. They will be asked to select a social support partner who will receive weekly updates on their progress in the game. Veterans in one arm will also receive loss-framed financial incentives allocated to an account each week during the intervention and financial incentives taken away each day the step goal was not achieved.

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)

盲法说明

Investigator and Outcomes assessor will be masked until the trial is completed and all analyses are finished.

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

  • Body mass index of 25 or greater
  • Access to smartphone or tablet to sync wearable device data
  • Interest in participating in a 20-week physical activity program

排除标准

  • Already participating in a physical activity research study
  • Unable to provide informed consent
  • Unsafe or infeasible to participate
  • No access to smartphone or table to sync wearable device data

结局指标

主要结局

Change in Mean Daily Steps From Baseline Relative to Control

时间窗: Intervention period of weeks 5 to 12 which excludes the 4-week ramp-up

Daily steps counts

次要结局

  • Change in Mean Daily Steps From Baseline Relative to Control(Follow-up period of weeks 13 to 20)
  • Proportion of Participant-days Step Counts Were Achieved Relative to Control(Intervention period of weeks 5 to 12 which excludes the 4-week ramp-up)
  • Proportion of Participant-days Step Counts Were Achieved(Follow-up period of weeks 13 to 20)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (4)

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