Clinical trial NCT03709966: Portable Monitoring Device, Physical Activity Motivation and Patients with Type 2 Diabetes
Official title: Using a Portable Monitoring Device to Increase Motivation for Physical Activity in Patients with Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Physical Activity
Motivation
Keywords: Portable monitoring device
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physical activity measurements
timeFrame: 3 months
Secondary outcomes:
measure: Motivation and auto-regulation of physical activity
timeFrame: 3 months
Other outcomes:
measure: Acceptability, satisfaction of the portable monitoring device and compliance
timeFrame: 3 months
measure: Cardiometabolic measurements: glycated hemoglobin
timeFrame: Before and after the clinical intervention: 3 months
measure: Cardiometabolic measurements: systolic and diastolic blood pressure
timeFrame: Before and after the clinical intervention: 3 months
measure: Cardiometabolic measurements: Weight
timeFrame: Before and after the clinical intervention: 3 months
measure: Cardiometabolic measurements: fat percentage
timeFrame: Before and after the clinical intervention: 3 months
measure: Cardiometabolic measurement: Triglycerides
timeFrame: Before and after the clinical intervention: 3 months
measure: Cardiometabolic measurement: High-density lipoprotein cholesterol (HDL)
timeFrame: Before and after the clinical intervention: 3 months
measure: Cardiometabolic measurement: Low-density lipoprotein cholesterol (LDL)
timeFrame: Before and after the clinical intervention: 3 months
Locations:
city: Québec
country: Canada
facility: GMF-UMF Laval-Québec
state: Quebec
Study officials:
affiliation: Laval University
name: Caroline Rhéaume, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Laval University
name: Caroline Rhéaume, MD-PhD
role: STUDY_DIRECTOR
References: