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Completed

NCT Number: NCT03709966

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GMF-UMF Laval-Québec

Québec, Quebec, G1V0B7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Portable monitoring device

Device

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

Other names: FitBit

Routine

Behavioral

Physical activity promotion supported by a kinesiologist

Other names: PA promotion

Primary outcomes

  1. Physical activity measurements

    Time frame: 3 months

    Godin Leisure-Time Exercise Questionnaire

Secondary outcomes

  1. Motivation and auto-regulation of physical activity

    Time frame: 3 months

    Behavioral Regulation in Exercise Questionnaire (BREQ) version 2

Other outcomes

  1. Acceptability, satisfaction of the portable monitoring device and compliance

    Time frame: 3 months

    Homade questionnaire with 10 questions

  2. Cardiometabolic measurements: glycated hemoglobin

    Time frame: Before and after the clinical intervention: 3 months

    Blood test

  3. Cardiometabolic measurements: systolic and diastolic blood pressure

    Time frame: Before and after the clinical intervention: 3 months

    Taken with standard apparel

  4. Cardiometabolic measurements: Weight

    Time frame: Before and after the clinical intervention: 3 months

    measured with a bioimpedance balance InBody

  5. Cardiometabolic measurements: fat percentage

    Time frame: Before and after the clinical intervention: 3 months

    measured with a bioimpedance balance InBody

  6. Cardiometabolic measurement: Triglycerides

    Time frame: Before and after the clinical intervention: 3 months

    Blood test

  7. Cardiometabolic measurement: High-density lipoprotein cholesterol (HDL)

    Time frame: Before and after the clinical intervention: 3 months

    Blood test

  8. Cardiometabolic measurement: Low-density lipoprotein cholesterol (LDL)

    Time frame: Before and after the clinical intervention: 3 months

    Blood test

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

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

Acronym: DBFitbit

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 17, 2018
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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