Project LIFT - Promoting Healthy Behavior Through a Wearable Fitness Device and Financial Incentives (LIFT)
26 de febrero de 2019 actualizado por: University of Pennsylvania
Project LIFT - Lifestyle Intervention to Promote Fitness in Transplantation
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.
Descripción general del estudio
Estado
Terminado
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
127
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern University Comprehensive Transplant Center
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Perelman Center For Advanced Medicine
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Usual Care
Usual care: dietary and exercise counseling only at baseline, no other intervention.
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Comparador activo: Usual Care + self-monitoring of physical activity
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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Participants simply given a pedometer (e.g.
Misfit brand wrist pedometer) with no other intervention to allow self-monitoring of physical activity.
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Experimental: Self-monitoring + incentives of physical activity
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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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Final Weight
Periodo de tiempo: End of 4 month study period
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Weight of patient at end of 4 month period of study.
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End of 4 month study period
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Marina Serper, MD, University of Pennsylvania Hospital System
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de marzo de 2017
Finalización primaria (Actual)
16 de mayo de 2018
Finalización del estudio (Actual)
1 de diciembre de 2018
Fechas de registro del estudio
Enviado por primera vez
11 de julio de 2017
Primero enviado que cumplió con los criterios de control de calidad
14 de julio de 2017
Publicado por primera vez (Actual)
18 de julio de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de febrero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
26 de febrero de 2019
Última verificación
1 de febrero de 2019
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 825784
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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