Characterizing type II diabetes and physical activity with seasonal changes in the

Upper Peninsula, Michigan

Research Proposal

Stacy Harwood, SPT

Paige Papineau, SPT
ABSTRACT
Type II diabetes (T2D) is becoming increasingly common amongst individuals in the United
States and often leads to other health issues such as cardiovascular disease and injuries from falls
associated with peripheral neuropathy. While current research has shown the benefits of
physical activity in management and reduction of symptoms of T2D, availability and
participation can greatly vary. Much of this variance has been associated with location of
residence. Recent studies have characterized the diabetic population in urban areas, but little is
known about the characterization of physical activity in rural areas, such as the western upper
peninsula of Michigan. To fill this void, the purpose of the study is to describe the relationship
between T2D, physical activity, and other health related behaviors for individuals residing in
rural upper peninsula, Michigan. This study will include 60 elderly participants—30 healthy and
30 diagnosed with T2D—who will wear a Fitbit activity tracker for four months. Over this
period, participants’ heart rate, activity duration, and step count will be monitored. Data
collected via activity tracker on the above parameters and through questionnaires will be
compared between groups. By gaining these insights, researchers hope to promote the
development of facilities and programs to meet the needs of individuals with T2D in rural
regions around the U.S.

KEY WORDS: activity tracker, Fitbit, rural, chronic disease

INTRODUCTION
According to the Centers for Disease Control (CDC), over 30 million Americans have diabetes,
with over 90% being type II diabetes (T2D). 1 T2D has been linked to increased incidence of
cardiovascular disease, the leading cause of death globally, which has been illustrated to be the
cause of death amongst 50% of the T2D population worldwide. 2 When compared with healthy
individuals in the same age group, older individuals with T2D are noted to present with a greater
risk of falling, the second leading cause of accidental death worldwide.3,4 In fact, results of a
cohort study carried out in 2013 identified T2D as a risk factor for falling despite accounting for
balance loss, with fall rates higher amongst older adults with T2D than healthy older adults. 5
Increased fall risk and incidence of cardiovascular disease-related-death amongst the T2D
population have been attributed to various complications. These complications develop with age
and progression of the disease, including weakness, decreased cognition, peripheral neuropathy,
poor glycemic control, and high blood pressure and cholesterol.4,6
The current literature suggests exercise has minimal impact on blood pressure in T2D due to the
presence of anatomical alterations with T2D progression, such as arterial stiffness.7 However,
several studies have demonstrated physical activity as a benefit to individuals living with T2D.
Exercise hinders the onset of diabetic peripheral neuropathy, which is a significant contributor to
fall incidence. Exercise can also improve glycemic control, improving individuals’ lipid
profiles, and thereby reduces incidence of cardiovascular disease.7–11
While the benefits of exercise to T2D have been observed, accessibility and participation is
widely variable depending on the characteristics of an individual’s particular geographical
location and climate. Recent studies characterizing rural versus urban regions have tied exercise
participation to the concentration and financial assets associated with public services in given
areas, noting a prevalence of inactivity in these areas, as well as a need for increased volume of
exercise-based facilities.12 Rural-focused decreases in exercise participation is in-part due to a
lack of accessibility to means of exercising. This includes designated sidewalks and public areas,
exercise centers, as well as cultural norms that negatively affect older adults’ enthusiasm to
participate.13 Furthermore, observations of seasonal changes have been illustrated to reflect
poorly on exercise participation amongst older adults in rural locations, noting a decrease in
physical activity with the onset of the winter season.14 Some current literature indirectly assesses
exercise participation amongst the older T2D population in warmer climates while examining
exercise status of rural older adults with T2D. 13 However the rate of exercise participation
amongst older individuals living with T2D in remote, rural areas with extended winter seasons
such as the upper peninsula of Michigan remains unknown.
Preventable deaths constitute the majority of deaths in Michigan’s upper peninsula, often being
caused by negative lifestyle behaviors that ultimately lead to disease. In reference to the current
study, approximately 19% of adults greater than sixty-five years old in the western upper
peninsula of Michigan have been diagnosed with diabetes. Demographics and risk factors

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speaking to those illustrated in previous studies include low educational attainment (22.3%),
household incomes below the Michigan poverty line (15.6%), limited adult participation in
individual healthcare (~26%), and shockingly high overweight-obesity rates (~70%),15 which
cumulatively define a glaring public health problem for Michigan’s western upper peninsula
residents. Therefore, the proposed study aims to characterize the relationship between T2D,
exercise participation and health behaviors, seasonal changes, and falls among residents in
Michigan’s western upper peninsula. The researchers of the current study hypothesize that when
compared with a non-T2D population, the T2D population will demonstrate decreased exercise
participation and positive health behaviors in relation to seasonal changes, and increased
incidence of falls. By collecting data on these factors over a four-month period (September-
December) via wireless activity monitors, researchers hope to obtain the information required to
facilitate greater efforts to provide adequate facilities and programs to meet the needs of the T2D
population.
PROPOSED METHOLOGY
Participants: Participants will be 60 male and female community members between the ages of
65-80 years old, 30 with T2D and 30 without T2D. This sample size was selected to provide
statistical power of at least 80% and significance level of 0.05 to be consistent with similar
studies. However, limited availability of Fitbit activity monitoring devices, hindered participant
recruitment by the COVID-19 pandemic and lack of accessibility to required technology for the
study will result in a significantly smaller sample size than those of prior studies including
greater than three hundred participants.13,14,16,17 One month data analysis for power and
significance levels of at least 80% and 0.05, respectively, will be performed on the first ten
participants, which will then be used to adjust sample size as needed.
Participants with T2D will be eligible for the study if they meet the following inclusion
criteria :1) be between 65-80 years of age; 2) have access to a smartphone or tablet capable of
running the Fitbit Application; 3) have an official T2D diagnosis that has been verified by their
healthcare provider. To be included in the study, healthy individuals without T2D must meet
inclusion criteria 1-2 from the list above and have no history or current diagnosis of T2D.
Participants will be excluded from the current study based on the following criteria: 1) have a
previous history of amputations, foot ulcers, blindness, or type I diabetes; 2) have cancer for
which they are currently seeking treatment; 3) have been diagnosed with a neurological disorder
including, but not limited to Parkinson’s disease, multiple sclerosis, dementia, stroke, brain
injury, or spinal injuries.
Participant Recruitment: Participants local to Houghton-Baraga-Keweenaw counties in
Michigan’s upper peninsula will be recruited from both the public and healthcare agencies via
word of mouth, publicly accessed flyers, and social media. Participants will complete a first
stage telephone interview executed by researchers of current study to determine eligibility for the
study. First stage interviews will be completed. Interviews will include the following
components: 1) explanation of study procedure and opportunity for questions; 2) review of
inclusion/exclusion criteria; 3) collection of demographic information including age, gender,
T2D status (verbal confirmation of healthcare provider diagnosis); 4) follow-up questions

2
regarding medication use for diabetes or high blood sugar. Initial interviewing is voluntary, and
participants will be given the opportunity to withdraw at any stage of the interview process.
Selected participants will be provided with a consent form via email or postal mail to be read and
signed prior to advancing to the second stage of the recruitment process. At the second stage,
participants will complete a second interview via Zoom, HIPAA-compliant video service, to
receive verbal information about the study including the following: 1) creation of confidential,
numerically coded email account per participant for programming Fitbit activity trackers and
receiving study pre-and-post questionnaires (see research design); 2) retrieval of mailing address
for delivery of pre-programmed Fitbit activity tracking device, charging apparatus, and physical
instructions for using the device including user name and password for confidential Fitbit
accounts. To ensure privacy and confidentiality, eligible participants will receive a personal
Zoom link through their given email address and will be encouraged to attend meetings in a
private location. Researchers will be in a designated, private area, will introduce themselves, and
clearly identify their role in the study while emphasizing volunteer participation, in which
participants can withdrawal from at any point in the study.
Research Design
Experimental procedure: After signing informed consent, eligible sex- and age-matched
participants from the Houghton-Baraga-Keweenaw will be assigned to one of two research
groups: individuals with T2D (T2D group) and individuals without T2D (non-T2D group) for the
purposes of characterizing the activity levels within remote-rural areas in the western upper
peninsula of Michigan and the activity levels of individuals with T2D. Participants will be
instructed to wear a Fitbit wrist-worn activity monitoring device (Model FB418; Fitbit, Inc., San
Francisco, CA) over the period of four consecutive months (September – December) to obtain
physical activity data including heart rate, step count, and activity duration. 18 The data then will
be compared both with the results of prior studies, and between non-T2D and T2D groups to
determine the effect of T2D, seasonal changes, and time of day on activity levels. Fitbit devices
will be required to be worn continuously, with the exceptions of bathing and charging of the
device to maintain consistent data collection. Participants will also be instructed to complete
several questionnaires at the beginning and end of the four-month study to obtain further
subjective details regarding participants’ general health status, diabetes control and medication
use, history of falls, physical activity, and lifestyle habits. Upon conclusion of the study,
participants will be allowed to keep the Fitbit device designated to them for study purposes and
will be provided with a full synopsis of results upon completion of data analysis.
Device setup and questionnaire completion: In accordance with Fitbit application setup
requirements, once consent has been obtained per participant, a Fitbit Inspire 2 wireless, wrist-
worn activity monitor (Model FB418; Fitbit, Inc., San Francisco, CA) will be pre-programmed
with all available software updates, and each participants’ age, height, and weight. The device,
charging apparatus, and physical instructions for using the device including username and
password for confidential Fitbit accounts will then be delivered via mail to respective
participants.

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Upon receiving the device, participants will complete a device setup meeting with a designated
member of the research team via Zoom or telephone call that includes the following components:
1) download, set up, and ensured access to Fitbit application software (Fitbit, Inc; San Francisco,
CA) onto the participants mobile device/tablet; 2) instruction on connecting, cleaning, charging,
and synching Fitbit device to Fitbit application software; 3) familiarization to Fitbit device and
application features for account users; 4) testing to ensure Fitbit device syncs with both the
participant’s mobile device/tablet and the study’s data collection software (Fitabase 2021, Small
Steps Labs, LLC, San Diego, CA).
While meeting with participants to setup respective Fitbit devices, researchers will administer
pre-study questionnaires designed to obtain specific details regarding medication use, physical
activity, lifestyle behaviors, diabetes regulation, and fall history (see Table 1) for
characterization and insight on potential differences between the T2D and non-T2D groups. The
questionnaires were designed based on the previous studies’ observations. 13,14,19–21 Participants
will be given the option to receive questionnaires via www.surveymonkey.com, an online,
anonymous survey platform, or paper copy, depending on preference.
Physical activity monitoring: Constant, 24-hour Fitbit device wearing was designed as a protocol
to capture robust and accurate data to illustrate the physical activity patterns amongst T2D and
non-T2D groups in the current study. Participants will be instructed to wear Fitbit device on their
wrist continuously for four months (September-December 2021) with exceptions of during
bathing or when charging. Each of the participants’ Fitbit devices will keep continuous record of
heart rate, step count, and activity duration data, which will be uploaded to Fitabase data
collection software (Fitabase 2021, Small Steps Labs, LLC, San Diego, CA) each time the
participant’s Fitbit device is synched to its respective Fitbit application on the participant’s
mobile device/tablet. Participants will be instructed to sync Fitbit devices to the corresponding
Fitbit applications on a weekly basis and charge the Fitbit device at regularly scheduled intervals
to avoid loss of data collected by the Fitbit devices. Researchers will remotely monitor synching
and Fitbit device battery levels and will contact the participant through text message, phone call,
or email to remind them to charge and sync as necessary. Participant privacy will be maintained
throughout the duration of the study by instructing participants to refrain from sharing Fitbit data
on internal (Fitbit) or external (Facebook, other) social media platforms.
Post-study questionnaires: Upon concluding the four-month Fitbit device data collection,
participants will be asked to complete another set of questionnaires regarding, diabetes control,
health behaviors, and fall history to be compared with the participants’ initial pre-study
questionnaires.
*Insert Table 1*
Safety considerations: Wireless wrist worn activity monitors may potentially cause skin irritation
in some participants, and due to the electrical components of the Fitbit device, improper handling
has the potential to result in injury.22 To minimize this risk, participants will be instructed on
proper wearing and care of their device as outlined in the “Wear & Care” section of the official
Fitbit website.23 If skin irritation including redness and itchiness does develop, the participant
will be instructed to remove the watch immediately and contact the research team. If irritation

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does not resolve in forty-eight hours, the participant will be withdrawn from the study. Finally,
wireless wrist worn activity monitors pose a potential distraction while driving, which may result
in serious injury or death. Participants will be instructed not to check calls, notifications, GPS, or
other features of the Fitbit device while operating a vehicle.
Data Analysis
The differences in fall risk, activity levels, lifestyle habits, and diabetes management between
non-T2D and T2D groups will be evaluated via comparison of self-reported questionnaires and
objective data collected from participants’ Fitbit devices. Objective data include heart rate, step
count, activity duration, and time of activity between non-T2D and T2D groups. Synchronized
Fitbit data illustrating the weekly differences between non-T2D and T2D groups over the span of
four months will be evaluated using SPSS 25 software (IBM® SPSS® Statistics, Chicago, IL).
Two-way, repeated measure analysis of variance (ANOVA) with factors group (non-T2D and
T2D) and time (weeks) will be used for analysis of the above-mentioned parameters. A Chi-
Square test will be used to evaluate and compare independence of differences in participant
characteristics,14,17 and statistical significance will be defined as P < .05, with calculated 95%
confidence intervals.13 Should data distribution fail to meet normal distribution and homogeneity
requirements for parametric testing, researchers will use an analysis of covariance (ANCOVA)
for multivariate analysis of synchronized Fitbit data to evaluate the differences between non-T2D
and T2D groups.
DISCUSSION
The researchers of the proposed study hypothesize that activity levels and exercise participation
across non-T2D and T2D groups will be hindered by seasonal changes between the months of
September and December.14 A consistent finding from prior studies has been a decrease in
activity level in older adults with T2D when compared with a healthy population of the same age
group.13,16 Therefore, it is predicted that over the four-month period, a cumulative decrease in
exercise participation will be observed across groups, with a greater discrepancy between non-
T2D and T2D groups. Researchers predict that the T2D population will follow an expected
pattern of decreased activity and negative health behaviors consistent with unconstructive factors
of rural geographical locations. These factors include decreased participation in routine
healthcare, lower education and employment, and high rates of overweight-obesity.
The ability to collect and evaluate physical activity data via Fitbit device to guide researchers’
understanding of the T2D population may result in many benefits for the residents of the
Western Upper Peninsula of Michigan. However, potential barriers through utilization of this
type of technology must be acknowledged. Considering the age of the study’s participants, most
did not grow up in the technology centered world that is today. This may lead to difficulties with
understanding and proper use of the activity trackers, Fitbit tracker application, Zoom video
calling, and electronic communications. To combat these potential limitations, members of the
research team will be available to guide participants throughout the entirety of the study.
Additionally, being in the midst of the COVID-19 pandemic, many of the common avenues of
participant recruitment such as informational handouts, posters with pull-tabs, and community
events are not feasible. As a result, other methods of recruitment (i.e., social media, word of

5
mouth) are planned to be utilized. These methods may be less accessible for individuals in the
age group of interest due to lack of social media presence and limited opportunities for social
interaction due to COVID-19. This, along with being in a rural area with a smaller population,
may impact the study’s ability to recruit the target number of participants.
Despite the proposed study’s potential shortcomings, understanding the impact of seasonal
changes and characterizing the health behaviors, fall risk, and exercise participation of the T2D
population in the western upper peninsula of Michigan will be beneficial. Researchers involved
in the current study will offer justification for increased support in the effort to develop the
availability of exercise programs and facilities to meet the needs of residents. To facilitate
success with behavioral modification programs in the rural population of the proposed
participant sample, increased knowledge of factors influencing exercise participation, including
time of day, activity duration, seasonal impact, and fall history is required. Finally, by obtaining
data regarding educational and income levels, researchers and healthcare teams alike may be able
assist residents toward increased health literacy via avenues that are consistent with the realities
of the majority of upper peninsula inhabitants.

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care

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Table 1: Overview of questionnaire content
T2D Characterization Questionnaires
Demographics Age, gender, education, insurance,
employment
General Health Medical history
Fall History Incidence of falls in the past year
Physical Activity Self-reported activity levels by type (IPAQ)
Health Behaviors Hospital visits and stays, routine check-ups by
healthcare provider, alcohol/tobacco
consumption
Diabetes Control Current methods of controlling T2D including
medications, exercise, behavioral
modifications

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