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临床试验/NCT03322059
NCT03322059已完成不适用

Randomized Trial of Charity-based Incentives to Increase Physical Activity Among Cancer Survivors

California Polytechnic State University-San Luis Obispo2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2017年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
51
试验地点
2
主要终点
Daily steps

研究概览

简要总结

The investigators propose to examine whether linking daily activity with charity-based incentives motivates cancer survivors to initiate and maintain physical activity. Linking daily physical activity goals with a cancer specific charity incentive may provide a uniquely salient motivator that promotes increased physical activity among cancer survivors. The investigators will examine whether using activity monitors in combination with charitable incentives leads to greater increases in physical activity compared to activity monitors alone. Target participants includes cancer survivors who are not already active. Physical activity (e.g., steps per day, time in moderate-intensity activity) will be examined at baseline and following a 12-week intervention period using an activPAL accelerometer. After the baseline assessment, both groups will receive a fitbit monitor and informational material designed to increase physical activity. Participants in the fitbit+charity group will have donations made in their name to a cancer charity if they meet daily step goals. Physical activity levels will be monitored using the fitbit device for 6-weeks following the formal intervention period.

详细描述

The study is a Randomized Controlled Trial (RCT) of a 12-week physical activity intervention. Fifty cancer survivors will be recruited and allocated to one of two research arms: Fitbit+Only Group or Fitbit+Charity Incentives Group. Participants in both intervention arms will be asked to track their physical activities using Fitbit One, an activity monitor that monitors steps and physical activity and will receive basic educational materials about increasing physical activity. Those in the Fitbit+charity incentives Group will raise money for cancer charities if they meet weekly step targets.

The key outcome variable of the RCT is steps as measured by an activPAL accelerometer. Data will be collected at baseline and 12-weeks. Fitbit data will also be collected for the duration of the 12-week intervention and for 6-weeks following the end of the intervention period to have an initial examination of behavior change maintenance (total 18-weeks).

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
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults ≥ 18 years and <50 y, with diagnosed Adolescent or Young Adult cancer (diagnosed between 15-39y of age);
  • ≥ 6 months post-cancer treatment
  • English speaking
  • Participate in <60 minutes of MVPA/week
  • Own a smartphone
  • Have access to computer
  • Participants must also pass a physical activity readiness questionnaire or receive medical clearance from their primary care physician or oncologist.

排除标准

  • Joint, cardiovascular, or respiratory problem(s) precluding physical activity
  • Metastatic disease
  • Planned elective surgery or pregnancy during intervention/follow-up that would interfere with participation (e.g., breast reconstructive surgery).
  • Already using a wearable device >5 days per week

研究组 & 干预措施

Control

Active Comparator

The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.

Participants will receive a weekly email with a step goal that will increase 10% beyond the previous weeks values.

干预措施: Control (Behavioral)

Intervention

Experimental

The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Participants will receive a weekly email with a step goal that will increase 10% beyond the previous weeks values.

Participants will be in the form of a charitable donation in their name to a cancer charity.

干预措施: Experimental (Behavioral)

结局指标

主要结局

Daily steps

时间窗: 12 weeks - change from baseline to 12 weeks

Daily steps as measured by activPAL

次要结局

  • Sedentary time(Change from baseline to 12 weeks)
  • Fatigue(Change from baseline to 12 weeks)
  • Depression(Change from baseline to 12 weeks)
  • Behavioral Regulation in Exercise Questionnaire(Change from baseline to 12 weeks)
  • Exercise Goal Setting(Change from baseline to 12 weeks)
  • Participant retention(12 weeks)
  • Barriers Self-efficacy Scale(Change from baseline to 12 weeks)
  • Attitudes Toward Charitable Giving(Change from baseline to 12 weeks)
  • Daily Steps(baseline to 12 weeks)
  • Moderate-vigorous intensity physical activity (MVPA) time(Change from baseline to 12 weeks)
  • Physical Activity Enjoyment(Change from baseline to 12 weeks)
  • Intervention Maintenance(12-18 weeks)
  • Duration wore Fitbit(12-18 weeks)
  • Exercise outcome expectations(Change from baseline to 12 weeks)
  • Stepping time(Change from baseline to 12 weeks)
  • Intervention Reach(Baseline)
  • Step goal adherence(1-12 weeks)
  • Sleep(baseline to 12 weeks)
  • Standing time(Change from baseline to 12 weeks)
  • Sedentary breaks/patterns(Change from baseline to 12 weeks)
  • Physical Function(Change from baseline to 12 weeks)
  • Pittsburg Sleep Quality Questionnaire(Change from baseline to 12 weeks)
  • Exercise Self-efficacy Scale(Change from baseline to 12 weeks)
  • Sleep disturbance(Change from baseline to 12 weeks)

研究者

发起方
California Polytechnic State University-San Luis Obispo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah K Keadle

Assistant Professor

California Polytechnic State University-San Luis Obispo

研究点 (2)

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