- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03709966
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
Status
Fullført
Intervensjon / Behandling
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:
|
Aktiv komparator: Routine
Physical activity promotion supported by a kinesiologist
|
Physical activity promotion supported by a kinesiologist
Andre navn:
|
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.
Sponsor
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2017-2018-07
Plan for individuelle deltakerdata (IPD)
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