NCT03709966

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 7, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

March 14, 2025

Status Verified

October 1, 2020

Enrollment Period

1.3 years

First QC Date

October 15, 2018

Last Update Submit

March 11, 2025

Conditions

Diabetes Mellitus, Type 2Physical ActivityMotivation

Keywords

Portable monitoring device

Outcome Measures

Primary Outcomes (1)

  • Physical activity measurements

    Godin Leisure-Time Exercise Questionnaire

    3 months

Secondary Outcomes (1)

  • Motivation and auto-regulation of physical activity

    3 months

Other Outcomes (8)

  • Acceptability, satisfaction of the portable monitoring device and compliance

    3 months

  • Cardiometabolic measurements: glycated hemoglobin

    Before and after the clinical intervention: 3 months

  • Cardiometabolic measurements: systolic and diastolic blood pressure

    Before and after the clinical intervention: 3 months

  • +5 more other outcomes

Study Arms (2)

FitBit

EXPERIMENTAL

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

Routine

ACTIVE COMPARATOR

Physical activity promotion supported by a kinesiologist

Behavioral: Routine

Interventions

Portable monitoring deviceDEVICE

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

Also known as: FitBit
FitBit
RoutineBEHAVIORAL

Physical activity promotion supported by a kinesiologist

Also known as: PA promotion
Routine

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be in a stable medical condition, sedentary, type 2 diabetic man or woman between the ages of 18 and 90 years of age

You may not qualify if:

  • People with acute renal failure FG below 30 ml and those under 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GMF-UMF Laval-Québec

Québec, Quebec, G1V0B7, Canada

Location

Related Publications (1)

  • 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.

    PMID: 36897642DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Caroline Rhéaume, MD-PhD

    Laval University

    PRINCIPAL INVESTIGATOR

  • Caroline Rhéaume, MD-PhD

    Laval University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, MD, PhD

Study Record Dates

First Submitted

October 15, 2018

First Posted

October 17, 2018

Study Start

December 7, 2017

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

March 14, 2025

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)