Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04498819 |
Other study ID # |
116071 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 9, 2020 |
Est. completion date |
May 7, 2021 |
Study information
Verified date |
October 2021 |
Source |
Western University, Canada |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
This study will assess the feasibility of integrating tailored aerobic exercise prescriptions
and wearable activity trackers into a virtually delivered lifestyle medicine program in an
outpatient clinic for adult patients with T2D.
This will be a 6-week single-group cohort study assessing the feasibility of delivering a
lifestyle medicine program in a virtual setting with the incorporation of wearable activity
trackers and personalized aerobic exercise prescriptions. STAND is a lifestyle medicine
program that is currently run by the St. Joseph's Primary Care Diabetes Support Program
(PCDSP). Participants will be new clinic, adult (aged ≤18 years old) patients with T2DM.
Routinely, all new patients at the PCDSP are referred by their practitioner to a general
1-hour STAND informational class after their initial intake. Starting in June 2020, these
classes will be offered virtually on the WebEx video platform. As such, participating
patients must have access to technology that enables WebEx participation. At the end of this
class, patients will be invited to participate in the study, STAND-VAT (Virtual Aerobic
Therapy). If they agree, they will be contacted by a study investigator. Patients will be
emailed the letter of information to review, along with copies of four brief surveys they
will later be answering, to review. Once confirmed, the investigator will review the study
details and answer any questions. Participants will authorize consent to participate through
e-signature on REDCap. After consent, the study investigator will verbally go through the
four short surveys (a brief demographics review, the PAID-5, the Stanford Self-Efficacy
Scale, and a technology use survey). If patients do not wish to participate in the study,
they will still be offered the opportunity to receive standard, biweekly virtual STAND
classes delivered by SJHC staff (certified diabetes nurses, nurse practitioner, physician and
dietician). These classes use motivational coaching and focus on practicing low carbohydrate
nutrition, teaching patients to recognize glucose patterns using wearable flash glucose
monitors (Libre Freestyle (Abbott Ltd., Canada)), and general advice and suggestion to get
active, and reduce and break daily sitting.
The intervention, STAND-VAT will take the same format as STAND, but instead of general advice
for exercise, patients will be provided with individualized exercise prescriptions and
exercise goal setting/counselling via an exercise specialist (UWO School of Kinesiology MSc
Student). This study will comprise her Master's thesis. The intervention program will also
offer the opportunity to loan a wearable activity tracker to track steps and physical
activity levels.
To ensure participants are medical safe to participate in exercise, after informed consent is
obtained, two PCDSP staff and study co-investigators will review the patients electronic
medical record to ensure inclusion criteria are met. A modified PAR-Q will be completed by a
PCDSP clinician to ensure the patient does not suffer from unstable heart disease, vascular
disease, etc. If they are not eligible, the PCDSP staff will inform them and work on
optimizing their health as per routine clinical care. A functional fitness test (the 2-minute
Step Test; number of steps completed during a 2-minute time period) will be completed in
clinic at baseline after the participant has been medically cleared to exercise, but before
the first group session. The test will be conducted one-on-one with the participant and the
Master's student, but monitored by either a physician or nurse practitioner.
The virtual intervention STAND-VAT classes will occur biweekly and be co-led by a Certified
Diabetes Educator and Master's Kinesiology student. The classes will flow based on patient
questions, issues, or concerns; this format will not be didactic. The classes will review
everyone's exercise prescription as created by the exercise specialist and deliver exercise
progression recommendations. It will also include an opportunity for participants to reflect
on exercise barriers and successes, and the resultant glucose patterns from adjusting diet
and exercise (using data from their glucose monitors). One day prior to each class,
participants will always be medically screened (by completing a modified PAR-Q) by a clinic
nurse practitioner or physician for contraindications to exercise/participation.
Study participants will be given FitBit Inspire©'s to wear daily, using them to track daily
step counts, exercise minutes and hourly movement goals (250 or more steps in an hour is a
completed hour move goal). The aerobic exercise prescription will be individually tailored,
adjusted bi-weekly and be prescribed as a daily step count goal. The daily step count goal
will be progressed up to a maximum of 3,000 steps above baseline. Bi-weekly prescription
adjustments will be prescribed using the mean or median daily step count from the past two
weeks (whichever number is lower) plus an additional 500 steps. Participants will be strongly
advised to exercise for a minimum of 10 minute bouts at least 3 times a day (or i.e. 30
minutes a day) at a brisk walking pace (Haskell et al., 2007) (utilizing the "talk test
strategy" which elicits a moderate intensity (Reed & Pipe, 2014)). Participants will be given
instructions on how to use their FitBits© prior to the first virtual group class by the
Master's Student.
Immediately before class, participants will receive a summary email of their new step count
prescription. Since temporal landmarks have been shown to influence health behaviours (e.g.,
January 1, Mondays, etc.), referred to as the fresh start effect (Dai et al., 2014). It will
be emphasized to participants in class and in the email that they will get to "start over"
(get a 'clean slate') every two weeks, to increase motivation. This is timed at the same time
the FreeStyle Libre patch needs replacing, and with a new step count prescription.
The week in between classes, the Master's student will call participants to ensure exercise
adherence and resolve any issues. If a medical question or safety issue arises, the student
will contact a PCDSP nurse practitioner or physician to follow-up with the patient. One day
prior to the bi-weekly classes, participants will be required to sync and share FitBit
Inspire HR© data to the FitBit© app, then sync/connect the app to the internet. Once synced,
participants will log on to online desktop (https://www.fitbit.com) and export their weekly
FitBit© data to a Microsoft Excel file. The exported file will be uploaded via the SJHC
secure file transfer website, https://filesafe.lhsc.on.ca; the Master's student will review
the step count information and create initial exercise step prescription Simultaneously,
participants will also re-complete the modified PAR-Q (bi-weekly) to ensure continued medical
safety.
Baseline demographics and a Technology Use survey will be completed at time of consent. The
Stanford Self-Efficacy Scale, and the PAID-5 will also be completed over the phone with a
study investigator at time of consent, and over video call within one week after week six
(the end of the intervention). Outcomes related to step count data will be collected daily
throughout the study by the FitBit Inspire HR©. The 2-minute Step Test will be completed in
clinic at baseline and again immediately after the intervention. Glycemic control (measured
by the Freestyle Libre) will be assessed using bi-weekly average time in glycemic target and
estimated A1c (glycated hemoglobin, a clinical measure of longer-term glucose levels). These
averages will be collected throughout the six-week intervention from flash glucose monitor
data. The change in exercise volume will be measured using repeated, average daily step
counts each week collected by the FitBit Inspire HR© during baseline, week one to week six.
Data analysis will performed on SPSS version 25 (SPSS Inc., Chicago, Illinois, USA).
Recruitment levels will be defined as the number of people signed up over number of eligible
people approached, presented as a percentage of sign up rate. Retention will be assessed as
number of participants completing the post-intervention follow up divided by number of
initial sample size, presented as a percentage retention rate. Acceptability data gathered
from the exit survey will be analyzed in a qualitative or descriptive fashion, using
frequencies and means (i.e. "this many rated the lottery draw as a motivation to get them to
attend class as "strongly agree": 93%"). Additionally, number of reported technology issues
will be reported as a total in addition to average mean # of technology issues per person.
Counting will be used based on type of issue using categories like a) lost/disrupted internet
connection or unable to connect or hear or see during class; b) issues utilizing
FitBit/FitBit app c) Issues with uploading FitBit data; d) other.
Adherence will be measured by the percent of biweekly classes attended and check-in phone
calls answered, number of data submissions (all out of three) as well as percent of days with
FitBit worn (>500 steps) and average percent Libre sensor is active. Change in weekly average
step counts and sedentary minutes will be analyzed using a one-way repeated measures ANOVA.
Exercise prescription adherence will be calculated as percent of step goals achieved compared
to total days participated in the study over the course of the six weeks. Weekly averages
(over the six weeks) of estimated A1c, percent coefficient of variation, and "time in target"
from the FreeStyle Libre data will be analyzed using a one-way repeated measures ANOVA.
Changes of functional fitness levels from baseline to post-intervention will be compared
using a paired t-test. The change in scores from baseline to week six for the Stanford
Self-Efficacy Scale and PAID-5 will be evaluated using paired t-tests.