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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Usual care: dietary and exercise counseling only at baseline, no other intervention. | |
| Usual Care + self-monitoring of physical activity | Active Comparator | 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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| Self-monitoring + incentives of physical activity | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-monitoring of physical activity with incentives | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Final Weight | Weight of patient at end of 4 month period of study. | End of 4 month study period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marina Serper, MD | University of Pennsylvania Hospital System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Comprehensive Transplant Center | Chicago | Illinois | 60611 | United States | ||
| Perelman Center for Advanced Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24570244 | Background | 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. | |
| 26341217 | Background | 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. |
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Principal Investigators are neither given names of particular participants nor assignment to study arms.
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| Usual care and self-monitoring of physical activity | Behavioral | Participants simply given a pedometer (e.g. Misfit brand wrist pedometer) with no other intervention to allow self-monitoring of physical activity. |
|
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| 26881417 | Background | 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. |
| 15773968 | Background | 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. |
| 25569175 | Background | 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. |
| 25668268 | Background | 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. |
| 18562971 | Background | 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. |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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