Project LIFT - Promoting Healthy Behavior Through a Wearable Fitness Device and Financial Incentives

Obesity Clinical Trial

— LIFT  

Official title:

Project LIFT - Lifestyle Intervention to Promote Fitness in Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03221465
• Other study ID #: 825784
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: February 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Kidney Transplant; Complications
• Liver Transplant; Complications
• Obesity

Intervention

Behavioral:
• Self-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.
• Usual 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.

Locations

Country	Name	City	State
United States	Northwestern University Comprehensive Transplant Center	Chicago	Illinois
United States	Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (7)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Final Weight	Weight of patient at end of 4 month period of study.	End of 4 month study period