Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-27 @ 6:37 PM
Study NCT ID:
NCT03709966
Status:
COMPLETED
Last Update Posted:
2025-03-14
First Post:
2018-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Portable Monitoring Device, Physical Activity Motivation and Patients with Type 2 Diabetes
Sponsor:
Laval University
Organization:
Study Overview
Official Title:
Using a Portable Monitoring Device to Increase Motivation for Physical Activity in Patients with Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DBFitbit
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: