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

Primary Purpose

Diabetes Mellitus, Type 2, Physical Activity, Motivation

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Portable monitoring device
Routine
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring Portable monitoring device

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GMF-UMF Laval-Québec

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FitBit

Routine

Arm Description

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.

Physical activity promotion supported by a kinesiologist

Outcomes

Primary Outcome Measures

Physical activity measurements
Godin Leisure-Time Exercise Questionnaire

Secondary Outcome Measures

Motivation and auto-regulation of physical activity
Behavioral Regulation in Exercise Questionnaire (BREQ) version 2

Full Information

First Posted
October 15, 2018
Last Updated
October 14, 2020
Sponsor
Laval University
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1. Study Identification

Unique Protocol Identification Number
NCT03709966
Brief Title
Portable Monitoring Device, Physical Activity Motivation and Patients With Type 2 Diabetes
Acronym
DBFitbit
Official Title
Using a Portable Monitoring Device to Increase Motivation for Physical Activity in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
December 7, 2017 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Physical Activity, Motivation
Keywords
Portable monitoring device

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FitBit
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine
Arm Type
Active Comparator
Arm Description
Physical activity promotion supported by a kinesiologist
Intervention Type
Device
Intervention Name(s)
Portable monitoring device
Other Intervention Name(s)
FitBit
Intervention Description
similar to a wrist-sport watch with many features including step calculations, distance traveled, calories burned, but also heart rate and sleep status
Intervention Type
Behavioral
Intervention Name(s)
Routine
Other Intervention Name(s)
PA promotion
Intervention Description
Physical activity promotion supported by a kinesiologist
Primary Outcome Measure Information:
Title
Physical activity measurements
Description
Godin Leisure-Time Exercise Questionnaire
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Motivation and auto-regulation of physical activity
Description
Behavioral Regulation in Exercise Questionnaire (BREQ) version 2
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Acceptability, satisfaction of the portable monitoring device and compliance
Description
Homade questionnaire with 10 questions
Time Frame
3 months
Title
Cardiometabolic measurements: glycated hemoglobin
Description
Blood test
Time Frame
Before and after the clinical intervention: 3 months
Title
Cardiometabolic measurements: systolic and diastolic blood pressure
Description
Taken with standard apparel
Time Frame
Before and after the clinical intervention: 3 months
Title
Cardiometabolic measurements: Weight
Description
measured with a bioimpedance balance InBody
Time Frame
Before and after the clinical intervention: 3 months
Title
Cardiometabolic measurements: fat percentage
Description
measured with a bioimpedance balance InBody
Time Frame
Before and after the clinical intervention: 3 months
Title
Cardiometabolic measurement: Triglycerides
Description
Blood test
Time Frame
Before and after the clinical intervention: 3 months
Title
Cardiometabolic measurement: High-density lipoprotein cholesterol (HDL)
Description
Blood test
Time Frame
Before and after the clinical intervention: 3 months
Title
Cardiometabolic measurement: Low-density lipoprotein cholesterol (LDL)
Description
Blood test
Time Frame
Before and after the clinical intervention: 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Rhéaume, MD-PhD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Caroline Rhéaume, MD-PhD
Organizational Affiliation
Laval University
Official's Role
Study Director
Facility Information:
Facility Name
GMF-UMF Laval-Québec
City
Québec
ZIP/Postal Code
G1V0B7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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