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

NCT ID: NCT03709966

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-07
• Study Completion Date: 2019-03-31

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.

Conditions

Diabetes Mellitus, Type 2; Physical Activity; Motivation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Portable monitoring device

Intervention Type: DEVICE

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

Routine

Physical activity promotion supported by a kinesiologist

Group Type: ACTIVE_COMPARATOR

Routine

Intervention Type: BEHAVIORAL

Physical activity promotion supported by a kinesiologist

Interventions

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

Intervention Type: DEVICE

Routine

Physical activity promotion supported by a kinesiologist

Intervention Type: BEHAVIORAL

Other Intervention Names

FitBit; PA promotion

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Caroline Rhéaume

Principal investigator, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Caroline Rhéaume, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Caroline Rhéaume, MD-PhD

Role: STUDY_DIRECTOR

Laval University

Locations

GMF-UMF Laval-Québec

Québec, Quebec, Canada

Countries

Canada

References

Pelletier C, Chabot C, Gagnon MP, Rheaume C. Implementing an Activity Tracker to Increase Motivation for Physical Activity in Patients With Diabetes in Primary Care: Strengths, Weaknesses, Opportunities and Threats (SWOT) Analysis. JMIR Form Res. 2023 Mar 10;7:e44254. doi: 10.2196/44254.

Reference Type: DERIVED

PMID: 36897642 (View on PubMed)

Other Identifiers

2017-2018-07

Identifier Type: -

Identifier Source: org_study_id