Portable Monitoring Device, Physical Activity Motivation and Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2; Physical Activity; Motivation
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Portable monitoring device; Routine
Intervention type(s): Device; Behavioral
Intervention description(s): similar to a wrist-sport watch with many features including step calculations, distance traveled, calories burned, but also heart rate and sleep status; Physical activity promotion supported by a kinesiologist
Other intervention name(s): FitBit; PA promotion
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The methodology used for this study consists of a pilot randomized controlled trial of 30 Type 2 diabetes patients already followed by health professionals from GMF-U Quatre-Bourgeois
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Portable monitoring device