Project LIFT - Promoting Healthy Behavior Through a Wearable Fitness Device and Financial Incentives (LIFT)
2019年2月26日 更新者：University of Pennsylvania
Project LIFT - Lifestyle Intervention to Promote Fitness in Transplantation
Project LIFT is a randomized, controlled trial that tests the effectiveness of a remotely-monitored, home-based exercise program utilizing wearable fitness trackers to monitor steps taken per day, health engagement questions, and financial incentives.
120 subjects will be randomized into 3 arms: 1) usual care - no fitness tracker or incentive, 2) a fitness tracker + no incentives, and 3) fitness tracker plus financial incentives.
研究概览
地位
完全的
详细说明
Obesity is the most common diseases in the United States - an estimated 35% of adults are obese.
Among kidney (KT) and liver transplant (LT) recipients, weight gain and obesity is associated with poor graft function.
Yet, within a year of transplantation, habituation to a sedentary lifestyle, changes in metabolism, and immunosuppression drugs contribute to an average 4-10 kg weight gain for recipients.
Recent innovations in wearable device technology can passively monitor an individual's physical activity.
Additionally, incentives and health questions designed using insights from behavioral economics have been shown to motivate device engagement and improvements in health behaviors.
A remotely-monitored exercise program could improve behavior change and potentially be durable because it takes advantage of the high motivation for improving health in this population.
The objective of this study is to use a randomized, controlled trial to test the efficacy of a home-based exercise program using wearable devices, health engagement questions and financial incentives.
Participants in the intervention arm will establish a baseline step count during the first two weeks, followed by a 12-week intervention period and a 4-week follow-up period.
研究类型
介入性
注册 (实际的)
127
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Illinois
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Chicago、Illinois、美国、60611
- Northwestern University Comprehensive Transplant Center
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- Perelman Center for Advanced Medicine
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Adult Kidney transplant, Liver transplant, Simultaneous liver-kidney, or kidney-pancreas transplant recipients at the Hospital of the University of Pennsylvania within 2-24 months of transplantation
- Ability to read and provide informed consent in English to participate in the study
- Possess a smartphone with a data plan and willing to receive text messages
- Willing to walk and sync wearable daily during the 2-week run-in in order to determine baseline [for Arms 2 & 3]
- Willing to provide a final weight at study end.
Exclusion Criteria:
- Inability to provide informed consent
- Does not have daily access to a smartphone compatible with the wearable device
- Unable or unwilling to complete the baseline measurements and survey, or perform the exit interview and weigh-in
- Already enrolled in a financial incentive-based exercise program using a wearable device
- Use of a wearable accelerometer or pedometer outside of the study protocol for step-tracking; (e.g., Fitbit; using phone step-tracker is acceptable; using existing wearable for cycling or swimming is acceptable)
- Any other medical conditions that would prohibit participation in a physical activity program
- Severe vision, hearing, or mobility impairment precluding participation.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Usual Care
Usual care: dietary and exercise counseling only at baseline, no other intervention.
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有源比较器：Usual Care + self-monitoring of physical activity
Tracking Device control: The intervention applied is usual care and self-monitoring of physical activity.
Patients will receive a pedometer (e.g.
Misfit brand wrist pedometer) to allow for self-monitoring of physical activity.
They will be able to obtain daily feedback on step counts via the wearable device and their smartphones.
They will also have a 2-week run-in period like the incentive arm.
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Participants simply given a pedometer (e.g.
Misfit brand wrist pedometer) with no other intervention to allow self-monitoring of physical activity.
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实验性的：Self-monitoring + incentives of physical activity
The intervention applied is self-monitoring of physical activity with incentives.
Patients will receive a a pedometer (e.g.
Misfit brand wrist pedometer) to allow for self-monitoring of physical activity.
Participants will monitor daily step counts with automated feedback on goal attainment via text message.
We will establish a baseline step count for each participant (during a 2-week run-in period) and then recommend a 15 percentage point increase in daily step goal every 2 weeks during the 12-week intervention period (weeks 3-14) with a maximum goal of 7,000 steps.
Two health engagement questions will be sent per week to participants as well for the 12-week intervention period.
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Participants are given a pedometer (e.g.
Misfit brand wrist pedometer) to allow self-monitoring of physical activity and receive financial incentives.
Participants also answer two health questions a week for 12 weeks.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Final Weight
大体时间：End of 4 month study period
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Weight of patient at end of 4 month period of study.
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End of 4 month study period
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Marina Serper, MD、University of Pennsylvania Hospital System
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
- Patel MS, Asch DA, Rosin R, Small DS, Bellamy SL, Heuer J, Sproat S, Hyson C, Haff N, Lee SM, Wesby L, Hoffer K, Shuttleworth D, Taylor DH, Hilbert V, Zhu J, Yang L, Wang X, Volpp KG. Framing Financial Incentives to Increase Physical Activity Among Overweight and Obese Adults: A Randomized, Controlled Trial. Ann Intern Med. 2016 Mar 15;164(6):385-94. doi: 10.7326/M15-1635. Epub 2016 Feb 16.
- Patel MS, Asch DA, Volpp KG. Wearable devices as facilitators, not drivers, of health behavior change. JAMA. 2015 Feb 3;313(5):459-60. doi: 10.1001/jama.2014.14781. No abstract available.
- Case MA, Burwick HA, Volpp KG, Patel MS. Accuracy of smartphone applications and wearable devices for tracking physical activity data. JAMA. 2015 Feb 10;313(6):625-6. doi: 10.1001/jama.2014.17841. No abstract available.
- Richards J, Gunson B, Johnson J, Neuberger J. Weight gain and obesity after liver transplantation. Transpl Int. 2005 Apr;18(4):461-6. doi: 10.1111/j.1432-2277.2004.00067.x.
- Galanti G, Stefani L, Mascherini G, Petri C, Corsani I, Francini L, Cattozzo A, Gianassi M, Minetti E, Pacini A, Cala PG. Short-term prospective study of prescribed physical activity in kidney transplant recipients. Intern Emerg Med. 2016 Feb;11(1):61-7. doi: 10.1007/s11739-015-1294-5. Epub 2015 Sep 4.
- Tudor-Locke C, Hatano Y, Pangrazi RP, Kang M. Revisiting "how many steps are enough?". Med Sci Sports Exerc. 2008 Jul;40(7 Suppl):S537-43. doi: 10.1249/MSS.0b013e31817c7133.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年3月1日
初级完成 (实际的)
2018年5月16日
研究完成 (实际的)
2018年12月1日
研究注册日期
首次提交
2017年7月11日
首先提交符合 QC 标准的
2017年7月14日
首次发布 (实际的)
2017年7月18日
研究记录更新
最后更新发布 (实际的)
2019年2月28日
上次提交的符合 QC 标准的更新
2019年2月26日
最后验证
2019年2月1日
更多信息
与本研究相关的术语
其他研究编号
- 825784
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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