Obesity Clinical Trial
— LIFTOfficial title:
Project LIFT - Lifestyle Intervention to Promote Fitness in Transplantation
NCT number | NCT03221465 |
Other study ID # | 825784 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2017 |
Est. completion date | December 1, 2018 |
Verified date | February 2019 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 127 |
Est. completion date | December 1, 2018 |
Est. primary completion date | May 16, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University Comprehensive Transplant Center | Chicago | Illinois |
United States | Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
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. — View Citation
Galanti G, Stefani L, Mascherini G, Petri C, Corsani I, Francini L, Cattozzo A, Gianassi M, Minetti E, Pacini A, Calà 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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Richards J, Gunson B, Johnson J, Neuberger J. Weight gain and obesity after liver transplantation. Transpl Int. 2005 Apr;18(4):461-6. — View Citation
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. — View Citation
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---|---|---|---|---|
Primary | Final Weight | Weight of patient at end of 4 month period of study. | End of 4 month study period |
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