Wearable Technology and a Virtual Lifestyle Program for Type 2 Diabetics

NCT04498819 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-10-06

No results posted yet for this study

Summary

The Primary Care Diabetes Support Program (PCDSP) offers a lifestyle medicine program, STAND, that patients can self-select themselves to participate. STAND offers biweekly, one-hour educational classes. With the onset of COVID-19, the clinic has moved virtually, but has yet to offer an individualized exercise program. Little evidence is available on utilizing telemedicine and wearable technologies combined in a clinical exercise setting. This is a 6-week single cohort prospective study assessing the feasibility of incorporating wearable activity trackers and individualized exercise prescriptions in the PCDSP's virtually delivered, STAND program in an adult population with type 2 diabetes mellitus. Roughly 15-20 participants will be recruited. Participants will attend the bi-weekly STAND classes and track their step counts daily using FitBits, trying to achieve individually prescribed step counts. Participants receive a brief follow up phone call every other week. The primary outcomes assessed will be recruitment and retention rates, as well as acceptability of, and adherence to, the virtual program. Acceptability will be assessed by an exit survey and mean number of reported technological issues. Adherence will be number of classes attended and percent of days with FitBit worn (\>500 steps) and average percent Libre sensor is active. Change in self-efficacy levels, diabetes emotional related distress, exercise volume, glucose control and fitness levels will secondarily be assessed.

Conditions

Interventions

BEHAVIORAL

Wearable Activity Trackers, Exercise Prescription and Virtual Care

The intervention is merging wearable activity trackers and tailored aerobic exercise prescriptions into the PCDSP's virtual STAND (a biweekly, evidence based, lifestyle medicine) program. Participants will wear activity trackers for a week to collect baseline step data (used to create tailored step prescriptions). Biweekly, new step prescriptions will be tailored to each participant based on the previous two week's step count data. The intervention will add onto STAND classes by using activity tracker data into the class discussion for learning opportunities, as well as goal setting and action planning. The day of class, participants will receive a summary email new prescription and encouragement to continue to work hard, using the previous weeks' data to reinforce motivation. The activity tracker will provide instant feedback about step goals, sedentary behaviour and exercise minutes. Individual calls every other week will ensure adherence to exercise regime.

Sponsors & Collaborators

  • Western University, Canada

    lead OTHER

Principal Investigators

  • Marc S Mitchell, PhD · Western University

  • Sonja Reichert, MD MSc CCFP · SJHC Primary Care for Diabetes Support Program

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-09
Primary Completion
2021-04-02
Completion
2021-05-07

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04498819 on ClinicalTrials.gov