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

NCT03221465 | Completed

• 1 other identifier: 825784
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 2

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.

Conditions

Kidney Transplant; Complications; Liver Transplant; Complications; Obesity

Outcome Measures

Primary Outcomes (1)

• Final Weight

  Weight of patient at end of 4 month period of study.

  End of 4 month study period

Study Arms (3)

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.

Behavioral: Usual care and self-monitoring of physical activity

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.

Behavioral: Self-monitoring of physical activity with incentives

Interventions

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.

Self-monitoring + incentives of physical activity

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.

Usual Care + self-monitoring of physical activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (2)

Northwestern University Comprehensive Transplant Center

Chicago, Illinois, 60611, United States

Location

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (7)

• 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.

  PMID: 24570244 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.

  PMID: 26341217 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.

  PMID: 26881417 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.

  PMID: 15773968 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.

  PMID: 25569175 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.

  PMID: 25668268 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.

  PMID: 18562971 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marina Serper, MD

  University of Pennsylvania Hospital System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Principal Investigators are neither given names of particular participants nor assignment to study arms.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 18, 2017
• Study Start: March 1, 2017
• Primary Completion: May 16, 2018
• Study Completion: December 1, 2018
• Last Updated: February 28, 2019

Record last verified: 2019-02

Locations

US (2)