PROTOCOL TIMELINE
A. Pre-study Eligibility Criteria Confirmation and Study Review and Scheduling of
Participant
The research coordinator will phone potential participants to answer any questions about
the study and confirm eligibility criteria. One the same call, the research coordinator
will be setting up a phone call time (within the week) to review the LOI with the
potential participant. After the phone call, the research coordinator will send the LOI
for review via email. The time from this call to program start may vary between
participants. This is due to the need to fill the group capacity of 6-8
participants/class before initiating a participant.
If a patient self-refers from the community, we will access OLIS for recent blood work.
If an A1c has not been completed in the last 3 months, we will need to consent them over
the phone using the e-consent via REDCap first and then they will be given an OHIP lab
requisition to complete the test within one week. This is done so that potential
participants are not having to go through the entire onboarding testing before knowing if
they are eligible to participate in the study.
On the phone call (within the week of the pre-screening call), we will review the Letter
of Information and Consent with the participant. We will answer any questions they may
have.
B. Time 1: ORIENTATION SESSION
The first group session will hopefully be in-person. If however we are unable to do so,
we will use the WebEx platform to orient and teach participants about the technology they
will be using during the study. This session will be run by a CDNE and the research
coordinator.
We will review study expectations briefly at the session, answer any remaining questions
about the LOI. Then, informed consent will be obtained virtually using individualized
REDCap links to sign the board approved e-consent method.
Topics to be covered during this session will include; how to set-up and use the wearable
fitness tracker (FitBit Inspire 2™) and FreeStyle® Libre, and their associated smartphone
apps. To ensure safety to participate in exercise, the modified Physical Activity
Readiness Questionnaire (PAR-Q) will also be administered by either and RN or MD at this
time (Freehan et al., 2018). If they pass the PAR-Q, baseline fitness testing (see "other
measures section" for description of the six-minute walk test (6MWT) and handgrip testing
protocol) will also occur during this session. Participants will also complete their
baseline stride length assessment, weight, and height, blood pressure and waist
circumference assessments. Baseline questionnaires will be completed via online surveys.
Once consent is obtained, and medical suitability is confirmed baseline physiological
data (glycated hemoglobin (HbA1c), medications, past medical history) will be extracted
from the PCDSP electronic medical record (EMR) WebDR. If the patient is referred to us by
a family physician we will ask them to include these details in the referral.
C. Intervention Week 1-12 (IW2-12): Biweekly Virtual Sessions
Within Intervention week 1, participants will be randomly prompted to complete a
24h-hour dietary recall through the ASA-24 2018, completed 3 times within the week.
All participants will complete this measurement; each participant will be assigned
to a random day within the week to avoid planning healthy meals (and creating biased
results).
Baseline Step Count and FreeStyle Libre Data Collection (2 weeks) after attending
the on-boarding session
Then after the two week baseline, participants will attend biweekly virtual coaching
sessions (total of six (6) classes including the on-boarding session). Please see below
for an outline of the proposed content delivered during the classes (coaching program:
behavioural, nutrition and exercise). Prior to each virtual group i.e. the night before,
participants will be required to email: 1) wearable fitness tracker data (screen shot of
their exercise/step summary), 2) resistance training log if engaging with resistance
exercise as a method of glucose regulation and 3) uploaded sensor data to LibreView. This
information will then be reviewed by a clinic exercise specialist/registered nurse/
physician prior to the group to determine individualized exercise progression, and
suggested modifications to diet. Wearable fitness study-related data will NOT be
collected via these means (email), but rather via data export from the fitbit.com desktop
platform completed by the research co-ordinator. Participants will provide us an email
address to use on their behalf, and we will provide a password for participants to use to
log on to their smartphone app (or desktop platform, if they wish) during the course of
the study. After the study, participants will be granted permission to change their
password to a desired password, and study investigators will lose access to this account.
At the end of the 12 weeks, participants will be asked to go have their blood tested
within (given a blood requisition for A1c testing). They will also be asked to come into
the clinic to have their weight, height, and waist circumference measured. Participants
will also re-complete the 6MWT and handgrip strength test. At the same time, participants
will be given their final three FreeStyle Libre 2 sensors.
Within Intervention week 12, participants will be randomly prompted to complete a
24h-hour dietary recall through the ASA-24 2018, three times within the week. All
participants will complete these measurements; each participant will be assigned to a
random day within the week. When prompted via email, participant will be asked to
complete a recall of the past day from midnight to midnight of all that they ate and
drank.
D. Intervention Week 12-24 (IW12-24): Monthly Virtual Sessions Coaching during the
remaining 3 virtual group education classes (on Microsoft Teams) of the last 3 months of
the intervention will be similar in design to IW2-12, but will focus on creating lasting
behaviour change. Participants will be given the choice whether to wear any or all of
their three (3) Libre 2 sensors and/for continue to wear the loaned FitBit Inspire 2™.
Sensor usage will be tracked (i.e., Participant 3 used 2/3 sensors).
E. Follow-up Period (Week 24) Participants will be contacted to set up an appointment to
review the follow-up questionnaires in clinic with the research coordinator. The
questionnaires to be completed are: the Stanford Diabetes Self-Efficacy Scale, EQ-5D-5L,
and an exit survey. Participants will also return the FitBit Inspire 2™ back to the
clinic. Participants will also attend their fitness testing (6MWT and handgrip strength
test) at the clinics. Participants will receive a A1c requisition again to have A1c
tested again within the week.
Within Intervention week 24, participants will be randomly prompted to complete a
24h-hour dietary recall through the ASA-24 2018, completed 3 times within the week. All
participants will complete this measurement; each participant will be assigned to a
random day within the week. When prompted via email, participant will be asked to
complete a recall of the past day from midnight to midnight of all that they ate and
drank.
Intervention Description:
A. Intervention Week 2-12 (IW2-12): Biweekly Virtual Sessions
Participants will attend biweekly virtual coaching sessions (total of five (5) classes).
Prior to each virtual group i.e. the night before, participants will be required to
email: wearable fitness tracker information (resistance exercise log if applicable) and
uploaded sensor data to LibreView. This information will be reviewed by a clinic
registered nurse or physician prior to the group to determine individualized exercise
progression, and suggested modifications to diet.
B. Intervention Week 12-24 (IW12-24): Monthly Virtual Sessions
Coaching during the remaining 3 classes of the last 3 months of the intervention will be
similar in design to IW2-12, but will focus on creating lasting behaviour change.
Participants will be given the choice whether or not to wear any or all of their three
(3) Libre sensors.
C. Coaching Program Description
At the beginning of each class, participants will be given their new exercise AND
nutrition goal or prescription. For the remainder of the 1-hour class, the focus will be
to coach participants to infer and draw connections between their food/activity choices
and glycemic responses. This will be done using motivational interviewing guided by Self
Determination Theory and Kolb's cycle of experiential learning and Libre glycemic
examples from volunteering participants. Participants will be encouraged to have their
Libre results from the previous two weeks in front of them to use during these exercises.
Focusing on habit formation will also be a key coaching goal.
Participants will for the most part lead the direction of the group discussion, with
questions raised at the start of each session by the group facilitator(s): barriers or
motivators in the last two weeks, goals achieved, etc. The clinical group facilitators
coaching the group will provide suggestions or solutions to issues i.e. technology
issues, how to safely exercise in a pandemic environment, how to reduce glycemic
variability by choosing lower glycemic foods, etc. Didactic teaching will be kept to a
minimum to optimize adult learning behaviour and theory.
D. FreeStyle Libre Assisted Nutrition Coaching Description
Focus of the material presented during these classes will be to guide participants
towards the consumption of lower carbohydrate and lower glycemic foods, while maintaining
adequate nutritional needs for activity and health. General principles will be provided
at the start of the program, with participants then learning, based on their FreeStyle
Libre glycemic readings which foods affect their blood sugars in both positive and
negative ways. The goal will be to empower participants to not only find day-to-day foods
that work for their diabetes, but also to be able to critically evaluate food choices
when the foods consumed either raise or lower blood sugars to undesired levels.
E. Exercise Prescriptions
Step, aerobic and resistance training prescriptions will be updated biweekly for
baseline-month 3 (within one day of group classes) and will continue on the same schedule
(biweekly) after month 3 to month 6.
Participants will be encouraged to interrupt their prolonged sitting with frequently
(every 20 to 45 minutes, under an hour) with 2-3 minutes light-intensity physical
activity and to decrease overall daily sedentary time. To give participants daily
feedback and reminders to get up and move every hour, participants are advised to achieve
their hourly movement goals (defined as an hour with 250 steps or more, defined and
measured by the FitBit Inspire 2™) or 2 to 3 minutes of light physical activity.
