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Portable Monitoring Device, Physical Activity Motivation and Patients with Type 2 Diabetes

Using a Portable Monitoring Device to Increase Motivation for Physical Activity in Patients with Type 2 Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03709966
Acronym
DBFitbit
Enrollment
30
Registered
2018-10-17
Start date
2017-12-07
Completion date
2019-03-31
Last updated
2025-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Physical Activity, Motivation

Keywords

Portable monitoring device

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.

Interventions

DEVICEPortable monitoring device

similar to a wrist-sport watch with many features including step calculations, distance traveled, calories burned, but also heart rate and sleep status

BEHAVIORALRoutine

Physical activity promotion supported by a kinesiologist

Sponsors

Laval University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Physical activity measurements3 monthsGodin Leisure-Time Exercise Questionnaire

Secondary

MeasureTime frameDescription
Motivation and auto-regulation of physical activity3 monthsBehavioral Regulation in Exercise Questionnaire (BREQ) version 2

Other

MeasureTime frameDescription
Cardiometabolic measurements: systolic and diastolic blood pressureBefore and after the clinical intervention: 3 monthsTaken with standard apparel
Cardiometabolic measurements: WeightBefore and after the clinical intervention: 3 monthsmeasured with a bioimpedance balance InBody
Cardiometabolic measurements: fat percentageBefore and after the clinical intervention: 3 monthsmeasured with a bioimpedance balance InBody
Acceptability, satisfaction of the portable monitoring device and compliance3 monthsHomade questionnaire with 10 questions
Cardiometabolic measurement: High-density lipoprotein cholesterol (HDL)Before and after the clinical intervention: 3 monthsBlood test
Cardiometabolic measurement: Low-density lipoprotein cholesterol (LDL)Before and after the clinical intervention: 3 monthsBlood test
Cardiometabolic measurement: TriglyceridesBefore and after the clinical intervention: 3 monthsBlood test
Cardiometabolic measurements: glycated hemoglobinBefore and after the clinical intervention: 3 monthsBlood test

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026