Project LIFT - Promoting Healthy Behavior Through a Wearable Fitness Device and Financial Incentives (LIFT)
26. februar 2019 oppdatert av: 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.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
127
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Illinois
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Chicago, Illinois, Forente stater, 60611
- Northwestern University Comprehensive Transplant Center
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- Perelman Center For Advanced Medicine
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: Usual Care
Usual care: dietary and exercise counseling only at baseline, no other intervention.
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Aktiv komparator: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Final Weight
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Marina Serper, MD, University of Pennsylvania Hospital System
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mars 2017
Primær fullføring (Faktiske)
16. mai 2018
Studiet fullført (Faktiske)
1. desember 2018
Datoer for studieregistrering
Først innsendt
11. juli 2017
Først innsendt som oppfylte QC-kriteriene
14. juli 2017
Først lagt ut (Faktiske)
18. juli 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. februar 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. februar 2019
Sist bekreftet
1. februar 2019
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 825784
Plan for individuelle deltakerdata (IPD)
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