Project LIFT - Lifestyle Intervention to Promote Fitness in Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 4
- 主要终点
- Final Weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
Principal Investigators are neither given names of particular participants nor assignment to study arms.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Usual Care
Usual care: dietary and exercise counseling only at baseline, no other intervention.
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.
干预措施: Usual care and self-monitoring of physical activity (Behavioral)
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.
干预措施: Self-monitoring of physical activity with incentives (Behavioral)
结局指标
主要结局
Final Weight
时间窗: End of 4 month study period
Weight of patient at end of 4 month period of study.
次要结局
未报告次要终点