Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03709966 |
| Other study ID # |
2017-2018-07 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 7, 2017 |
| Est. completion date |
March 31, 2019 |
Study information
| Verified date |
October 2020 |
| Source |
Laval University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
