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

Using a Portable Monitoring Device to Increase Motivation for Physical Activity in 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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Physical Activity; Motivation
• Intervention / Treatment: Device: Portable monitoring device; Behavioral: Routine

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1V0B7
      • GMF-UMF Laval-Québec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FitBit; Portable technological support to monitor physical activity, similar to a wrist-sport watch with many features including step calculations, distance traveled, calories burned, but also heart rate and sleep status.	Device: Portable 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; Other Names: FitBit
Active Comparator: Routine; Physical activity promotion supported by a kinesiologist	Behavioral: Routine; Physical activity promotion supported by a kinesiologist; Other Names: PA promotion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity measurements	Godin Leisure-Time Exercise Questionnaire	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motivation and auto-regulation of physical activity	Behavioral Regulation in Exercise Questionnaire (BREQ) version 2	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability, satisfaction of the portable monitoring device and compliance	Homade questionnaire with 10 questions	3 months
Cardiometabolic measurements: glycated hemoglobin	Blood test	Before and after the clinical intervention: 3 months
Cardiometabolic measurements: systolic and diastolic blood pressure	Taken with standard apparel	Before and after the clinical intervention: 3 months
Cardiometabolic measurements: Weight	measured with a bioimpedance balance InBody	Before and after the clinical intervention: 3 months
Cardiometabolic measurements: fat percentage	measured with a bioimpedance balance InBody	Before and after the clinical intervention: 3 months
Cardiometabolic measurement: Triglycerides	Blood test	Before and after the clinical intervention: 3 months
Cardiometabolic measurement: High-density lipoprotein cholesterol (HDL)	Blood test	Before and after the clinical intervention: 3 months
Cardiometabolic measurement: Low-density lipoprotein cholesterol (LDL)	Blood test	Before and after the clinical intervention: 3 months

Collaborators and Investigators

• Sponsor: Laval University
• Investigators: Principal Investigator: Caroline Rhéaume, MD-PhD, Laval University; Study Director: Caroline Rhéaume, MD-PhD, Laval University

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2017
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: October 15, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Portable monitoring device
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: 2017-2018-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No