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Portable Monitoring Device, Physical Activity Motivation and Patients With Type 2 Diabetes (DBFitbit)

14. oktober 2020 oppdatert av: Caroline, Laval University

Using a Portable Monitoring Device to Increase Motivation for Physical Activity in Patients With Type 2 Diabetes

The intervention proposed for this project aims to improve the practice of physical activity (PA) for people with type 2 diabetes by increasing their motivation using a portable device to monitor PA (FitBit). This study will provide preliminary data to assess the feasibility of the intervention, its acceptability for patients with type 2 diabetes, and its potential impact of PA motivation and PA level.

Studieoversikt

Detaljert beskrivelse

It is recognized that the adoption of healthy lifestyle habits, such as the practice of physical activity (PA) on a regular and constant basis, contributes significantly to reducing the prevalence of diabetes and its complications. The use of portable technological support to monitor PA can contribute to a favorable behavioral change in people with chronic diseases such as diabetes. Objective: The intervention proposed for this project aims to improve the practice of PA for people with type 2 diabetes, by increasing their motivation using a portable device tracking of PA (FitBit). The device is similar to a wrist-sport watch with many features including step calculations, distance traveled, calories burned, but also heart rate and sleep status. The information recorded by the watch can be synchronized and transmitted directly to the FitBit application, allowing it to be viewed and tracked on a daily basis, and also the ability to produce weekly and monthly reports and adjust personal goals. Methods: This study consists in a pilot randomized controlled trial of 30 Type 2 diabetes patients already followed by health professionals from a University-affiliated Family Medicine Group (GMF-U Quatre-Bourgeois). Patients are randomly assigned to one of these two conditions: routine follow-up, including a PA promotion intervention supported by a kinesiologist from the research center of the Institut de cardiologie et de pneumologie de Québec (CRIUCPQ) or FitBit follow-up, which consists of routine follow-up with the adding the portable PA tracking device. We plan to recruit 15 patients per group. The randomization is done by a statistician from CRIUCPQ. Inclusion and Exclusion Criteria: To participate in the study, participants must meet the following inclusion criteria: to be in a stable medical condition, sedentary and type 2 diabetic man or woman between the ages of 18 and 90 years of age. People with acute renal failure, FG below 30 ml and those under 18 years of age are excluded. Intervention: The intervention lasts 3 months and involves a total of 3 appointments. The first appointment takes place with the physician in charge of the study in order to evaluate the patient's record and to validate their eligibility. The glycated hemoglobin data and cardiometabolic measurements taken by the attending physician of each participant will be collected by the physician and clinical researcher in charge of the project. These same measures will be taken at the 3-month follow-up prescribed to each participant and this data will be collected a second and last time by the physician in charge of the project, at the very end of the intervention. Following their visit to the physician in charge of the study, the participants will meet the research professional who will be responsible for explaining the project in more details and obtaining their consent. The second appointment is attended by a kinesiologist who will distribute a physical activity motivation questionnaire, a physical activity questionnaire and a logbook to the participants. A personalized physical activity program will also be proposed to all participants. At the 6th week of the intervention, the kinesiologist will follow up with all participants to verify the integration of the physical activity program. A third appointment is planned at the very end of the intervention with the kinesiologist. Participants will be asked to complete the same questionnaires as for visit # 2 and submit their completed logbook. The participants in the experimental group will have a satisfaction questionnaire / appreciation of the technology to be completed in addition to the other questionnaires. They will also have to bring back their Fitbit material during this appointment.

Studietype

Intervensjonell

Registrering (Faktiske)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Québec, Canada, G1V0B7
        • GMF-UMF Laval-Québec

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 til 90 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • To be in a stable medical condition, sedentary, type 2 diabetic man or woman between the ages of 18 and 90 years of age

Exclusion Criteria:

  • People with acute renal failure FG below 30 ml and those under 18 years of age.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: FitBit
Portable technological support to monitor physical activity, similar to a wrist-sport watch with many features including step calculations, distance traveled, calories burned, but also heart rate and sleep status.
similar to a wrist-sport watch with many features including step calculations, distance traveled, calories burned, but also heart rate and sleep status
Andre navn:
  • FitBit
Aktiv komparator: Routine
Physical activity promotion supported by a kinesiologist
Physical activity promotion supported by a kinesiologist
Andre navn:
  • PA promotion

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Physical activity measurements
Tidsramme: 3 months
Godin Leisure-Time Exercise Questionnaire
3 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Motivation and auto-regulation of physical activity
Tidsramme: 3 months
Behavioral Regulation in Exercise Questionnaire (BREQ) version 2
3 months

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Acceptability, satisfaction of the portable monitoring device and compliance
Tidsramme: 3 months
Homade questionnaire with 10 questions
3 months
Cardiometabolic measurements: glycated hemoglobin
Tidsramme: Before and after the clinical intervention: 3 months
Blood test
Before and after the clinical intervention: 3 months
Cardiometabolic measurements: systolic and diastolic blood pressure
Tidsramme: Before and after the clinical intervention: 3 months
Taken with standard apparel
Before and after the clinical intervention: 3 months
Cardiometabolic measurements: Weight
Tidsramme: Before and after the clinical intervention: 3 months
measured with a bioimpedance balance InBody
Before and after the clinical intervention: 3 months
Cardiometabolic measurements: fat percentage
Tidsramme: Before and after the clinical intervention: 3 months
measured with a bioimpedance balance InBody
Before and after the clinical intervention: 3 months
Cardiometabolic measurement: Triglycerides
Tidsramme: Before and after the clinical intervention: 3 months
Blood test
Before and after the clinical intervention: 3 months
Cardiometabolic measurement: High-density lipoprotein cholesterol (HDL)
Tidsramme: Before and after the clinical intervention: 3 months
Blood test
Before and after the clinical intervention: 3 months
Cardiometabolic measurement: Low-density lipoprotein cholesterol (LDL)
Tidsramme: Before and after the clinical intervention: 3 months
Blood test
Before and after the clinical intervention: 3 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Caroline Rhéaume, MD-PhD, Laval University
  • Studieleder: Caroline Rhéaume, MD-PhD, Laval University

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)

7. desember 2017

Primær fullføring (Faktiske)

31. mars 2019

Studiet fullført (Faktiske)

31. mars 2019

Datoer for studieregistrering

Først innsendt

15. oktober 2018

Først innsendt som oppfylte QC-kriteriene

15. oktober 2018

Først lagt ut (Faktiske)

17. oktober 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. oktober 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. oktober 2020

Sist bekreftet

1. oktober 2020

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Diabetes mellitus, type 2

Kliniske studier på Portable monitoring device

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