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
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
- Type 2 Diabetes
- Comorbidities and Coexisting 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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