Kidney Transplant; Complications, Liver Transplant; Complications, Obesity
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSelf-monitoring of physical activity with incentives
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.
BEHAVIORALUsual care and self-monitoring of physical activity
Participants simply given a pedometer (e.g. Misfit brand wrist pedometer) with no other intervention to allow self-monitoring of physical activity.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Masking description
Principal Investigators are neither given names of particular participants nor assignment to study arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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 2. Ability to read and provide informed consent in English to participate in the study 3. Possess a smartphone with a data plan and willing to receive text messages 4. Willing to walk and sync wearable daily during the 2-week run-in in order to determine baseline \[for Arms 2 & 3\] 5. Willing to provide a final weight at study end.
Exclusion criteria
1. Inability to provide informed consent 2. Does not have daily access to a smartphone compatible with the wearable device 3. Unable or unwilling to complete the baseline measurements and survey, or perform the exit interview and weigh-in 4. Already enrolled in a financial incentive-based exercise program using a wearable device 5. 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) 6. Any other medical conditions that would prohibit participation in a physical activity program 7. Severe vision, hearing, or mobility impairment precluding participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Final Weight | End of 4 month study period | Weight of patient at end of 4 month period of study. |
Countries
United States
Outcome results
None listed