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

14 octobre 2020 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

30

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 90 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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
Autres noms:
  • FitBit
Comparateur actif: Routine
Physical activity promotion supported by a kinesiologist
Physical activity promotion supported by a kinesiologist
Autres noms:
  • PA promotion

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Physical activity measurements
Délai: 3 months
Godin Leisure-Time Exercise Questionnaire
3 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Motivation and auto-regulation of physical activity
Délai: 3 months
Behavioral Regulation in Exercise Questionnaire (BREQ) version 2
3 months

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Acceptability, satisfaction of the portable monitoring device and compliance
Délai: 3 months
Homade questionnaire with 10 questions
3 months
Cardiometabolic measurements: glycated hemoglobin
Délai: 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
Délai: Before and after the clinical intervention: 3 months
Taken with standard apparel
Before and after the clinical intervention: 3 months
Cardiometabolic measurements: Weight
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: Before and after the clinical intervention: 3 months
Blood test
Before and after the clinical intervention: 3 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

  • Chercheur principal: Caroline Rhéaume, MD-PhD, Laval University
  • Directeur d'études: Caroline Rhéaume, MD-PhD, Laval University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

7 décembre 2017

Achèvement primaire (Réel)

31 mars 2019

Achèvement de l'étude (Réel)

31 mars 2019

Dates d'inscription aux études

Première soumission

15 octobre 2018

Première soumission répondant aux critères de contrôle qualité

15 octobre 2018

Première publication (Réel)

17 octobre 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

19 octobre 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 octobre 2020

Dernière vérification

1 octobre 2020

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 2017-2018-07

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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