A Multiple Technology-Based and Individually Tailored Sit Less Program for Patients With Type 2 Diabetes: A Randomized Controlled Trial
Phase: NA
Conditions: Type 2 Diabetes, Sedentary Behavior, Sedentary Time, Physical Activity
Sponsor: Vanderbilt University

Document: 
Protocol 
Official Study Title: 
A Multiple Technology-Based and Individually Tailored Sit Less Program for patients with Type 2 
Diabetes: A randomized controlled trial 
NCT06457802 
Document Date: 
May 15, 2024 

Date: May 15th, 2024 
A Multiple Technology-Based and Individually Tailored Sit Less Program for 
patients with Type 2 Diabetes: A randomized controlled trial 
Principal Investigator: 
Chorong Park, PhD, RN 
Assistant Professor 
School of Nursing, Vanderbilt University 
511 Godchaux Hall/21st Avenue South 
Nashville, TN 37240 
Phone: 615-875-5226 
Email: chorong.park@vanderbilt.edu 
Co-Investigators: 
Soojung Ahn, PhD, RN 
Postdoctoral Scholar 
School of Nursing, Vanderbilt University 
Shelagh Mulvaney, PhD 
Associate Professor 
School of Nursing, Vanderbilt University 
Mary Dietrich, PhD, MS 
Associate Professor 
School of Nursing, Vanderbilt University 

Date: May 15th, 2024 
 
 
 
Table of Contents: 
Study Schema 
1.0 
Background 
2.0 
Rationale and Specific Aims 
3.0 
Inclusion/Exclusion Criteria 
4.0 
Enrollment/Randomization 
5.0 
Study Procedures 
6.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk to 
Participants or Others 
7.0 
Study Withdrawal/Discontinuation 
8.0 
Statistical Considerations 
9.0 
Privacy/Confidentiality Issues 
10.0 
Follow-up and Record Retention 

Date: May 15th, 2024 
 
 
 
1.0 
Background 
Sedentary behavior (SB) is a strong modifiable risk factor for developing type 2 diabetes 
(T2D) and cardiovascular disease, even after controlling for daily physical activity.(1-3) 
During sedentary behavior, there is no muscle contraction of the legs, which causes 
decreasing insulin sensitivity, glucose uptake, vascular dysfunction, and promotes low- 
grade inflammatory cascades.(4) Despite the important role of sedentary behavior in 
managing T2D, people with T2D remain highly sedentary. They spend on average 11-15 
hours per day sitting,(5, 6) which comprises 65-75% of waking time.(5, 7, 8) Moderate-to- 
vigorous levels of physical activity or exercise can attenuate cardiometabolic risk but 
does not eliminate the increased risk associated with high sedentary time.(1, 9) 
Considering T2D patients’ low cardiorespiratory fitness and low activity levels,(10, 11) they 
may be at greater risk than others for the negative cardiometabolic consequences of 
sedentary behavior.(12) Therefore, there is a pressing need to develop novel strategies to 
reduce SB and improve daily activity in patients with T2D. Targeting SB, which occupies 
most of a T2D patient’s waking time, can be a new target behavior for secondary 
prevention in this population. 
 
2.0 
Rationale and Specific Aims 
Frequent standing/walking can reduce the total SB time and change prolonged patterns 
to interrupted patterns. Since leg muscles do not contract during SB, sedentary breaks 
such as standing/walking (requiring muscle contractions) may change physiological 
pathways and improve cardiometabolic outcomes. A recent meta-analysis found that 
while controlling for total sedentary time and MVPA time, short sedentary breaks (2-5 
minutes of standing/walking for every 20-60 minutes of sitting) were beneficially 
associated with cardiometabolic markers; adding one break decreases 0.05 unit of BMI, 
0.2 cm of WC, 0.002 mg/dl of hsCRP, and 1.8 mmHG of systolic blood pressure (BP).(13, 14) 
Many intervention studies have also shown that breaking prolonged sedentary time with 
short periods of light PA or standing improves glucose (2-17%) and insulin (15%). (13, 15) 
Moreover, emerging evidence shows that reducing SB time with frequent breaks is 
safe(16-18) in other chronic health conditions and applicable to T2D patients. 
 
SB breaks can be achieved through self-monitoring and prompts from a wearable 
device. In addition, the use of a smart water bottle may be a promising strategy to 
naturally break sedentary time due to the impact of increased water intake on kitchen 
and restroom breaks. A smart water bottle can sync with an activity tracker, which could 
synergistically motivate the T2D patients to reduce SB. This new technique is a 
potentially low-cost and sustainable strategy to deliver SB reduction interventions. 
 
Because there is no SB reduction program specifically focusing on sedentary breaks in 
T2D patients, we propose to develop and conduct a pilot study RCT to test a wearable 

Date: May 15th, 2024 
 
 
 
technology-based SB reduction intervention in T2D patients. The 8-week intervention 
includes: 1) one instructional and goal setting session; 2) the use of a wearable device 
(Fitbit) that provides stand/walk prompts and self-monitoring; 3) a smart water bottle 
(HidrateSpark) that syncs with the Fitbit; 4) weekly tailored text messages for behavior 
reinforcement and weekly goal monitoring, and 5) one mid-program counseling session. 
Since text messages and wearable device-based intervention requires a complex and 
multiple iterative process to customize research participants’ needs and refine the 
contents and frequency of the text messages. 
Outcomes will be measured at baseline and post-intervention. Specifically, we aim to: 
Aim 1: Determine the acceptability of the SB reduction intervention in T2D patients by 
evaluating satisfaction and compliance with the intervention. 
Aim 2: Evaluate the preliminary efficacy of the SB reduction intervention on changes in 
total SB time and numbers of prolonged SB bouts. 
Aim 3 (Exploratory Aim): Explore preliminary effects of the SB reduction intervention on 
light physical activity (total standing and stepping times), cardiometabolic markers (24- 
hour glycemic control, BMI, waist circumference, blood pressure, and patient-centered 
outcomes (confidence in reducing SB, habit strength for SB, and quality of life). 
 
3.0 
Inclusion/Exclusion Criteria 
Inclusion criteria: 1) ages 18 and above, 2) diagnosed with type 2 diabetes, 3) self- 
reported HbA1C<13, 4) self-report of sitting ≥ 8hr/day, 5) ability to stand and walk, 6) 
ownership of a smartphone. 
Exclusion criteria: 1) currently using an activity tracker; 2) currently participating in 
exercise or other research programs; 3) random blood glucose >300; 4) non-English 
speaking; 5) patients who are classified as unstable (e.g., heart failure, uncontrolled 
arrhythmia) or have kidney disease that limits daily water intake; 6) any conditions that 
prevent standing or walking due to physical or cognitive limitations, such as cognitive 
impairment, severe pain, problems with lower limbs, or a history of surgeries that limit 
movement (19, 20); 7) participation in Sit Less Program V1 (IRB #221566); and 8) currently 
pregnant. 
 
4.0 
Enrollment/Recruitment 
 
We will use three recruitment strategies: 
 
1) Research Notification Distribution List 
Email distribution list allows researchers to email IRB-approved participant 
recruitment announcements to the Vanderbilt community. Members of the 
distribution list have the option to subscribe/unsubscribe with each email. The 

Date: May 15th, 2024 
 
 
 
potential participants will click the pre-screening consent. The detailed procedure 
regarding pre-screening prospective participants is described below 
 
2) Reporting Workbench 
Reporting Workbench Reports are available/viewable in eStar. These reports are 
developed using real-time data and can be customized to meet study-specific 
inclusion/exclusion criteria that are computable in the EHR. The reports often 
include additional variables to facilitate study team outreach, such as Research 
OK to Contact status, MHAV account status, contact information, next upcoming 
appointment in a specific clinic. While the report displays certain variables/data, it 
provides easy access to a patient's record for additional screening and 
confirmation of eligibility. Research team members with appropriate eStar access 
can view/run the reports as frequently as needed. 
We plan to use the results from our custom Reporting Workbench report to 
facilitate outreach in the following way: To send My Health at Vanderbilt (MHAV) 
recruitment requests, as detailed below in recruiting strategy 3. KSP do not have 
an existing provider relationship with the patients being approached about study 
participation. Results will be restricted to those marked as ‘OK to Contact’. We 
will not be reaching out to employees or persons of interest. 
 
3) My Health at Vanderbilt (MHAV) Recruitment Requests 
Participants will be recruited through My Health at Vanderbilt. My Health at 
Vanderbilt (MHAV) is VUMC's patient portal where the patient may sign up and 
participate in managing his/her health care. MHAV can also be used for sending 
recruitment requests to a predefined cohort of patients who meet certain study- 
specific inclusion/exclusion criteria, have an activated MHAV account and are 
marked as OK to Contact in eStar. The recruitment requests are sent by a central 
VICTR team on behalf of the study team. The notification preferences for the 
recruitment requests can be managed by the patients in MHAV. The system 
default is an email notification like clinical notifications (see attached MHAV 
Recruitment Request messaging). If the patient has turned off notifications, the 
study will just be listed on their research studies page in MHAV. 
 
Once the Recruitment Requests are sent, the patient's enrollment status is 
automatically updated to (IT Use Only) Identified - RWB Recruitment Message or 

Date: May 15th, 2024 
 
 
 
Auto DL. If the patient clicks ‘No Thank You’, the patient's enrollment status in 
eStar is automatically updated to (IT Use Only) Not Interested - Pt. answered 
in MHAV. The study team does not get a notification in Epic In-Basket or in 
REDCap. 
 
If the patient clicks ‘I'm Interested’, the designated KSP (with eStar access) 
receive an In Basket message in eStar indicating the patient is interested 
 
The patient's enrollment status is automatically updated to (IT Use Only) 
Interested - Pt. answered in MHAV. The REDCap Participant Updater Module 
looks for the patient's MRN in the study specific database. If a matching MRN is 
not found, the Participant Updater Module creates a record in the study-specific 
database with the following information from eStar: 
1) Patient's MRN 
2) Patient's enrollment status - (IT Use Only) Interested - Pt. answered in 
MHAV 
3) Study ID (IRB#) 
REDCap CDIS is then triggered to pull in the patient email address from eStar if 
available for all patients who click I’m Interested. This will trigger an email from 
REDCap to the patient which contains a link to the IRB approved pre-screening 
and eConsent surveys on REDCap. 
 
If the patient responds to the email from REDCap or completes a pre-screening 
survey or eConsent, the study team will update the patient's enrollment status 
accordingly in eStar or REDCap. Once the patient's enrollment status has been 
updated in the study specific record in REDCap, the Participant Updater Module 
will automatically update the enrollment status in eStar. The study team will 
contact the interested patient by telephone call or email to confirm their 
eligibility and schedule an in-person baseline visit 
 
5.0 Study Procedures 
 
5.1 Baseline visit 1: Initial contact, screening, and consent 

Date: May 15th, 2024 
 
 
 
Interested respondents will be screened by a trained research staff over the phone or in- 
person, depending on the recruitment methods. For this research, no aspect of the 
participant’s diabetes treatment regimen will be modified. 
 
Those who are eligible for the study will be invited to the in-person visit. The first visit 
(i.e., Baseline visit 1) will be conducted at VUSN (Vanderbilt School of Nursing)’s lab at 
Wesley building. 
 
At the Baseline visit 1, individuals will check their blood glucose level via finger prick. If 
their random glucose levels are between 80-300, they will complete the informed 
consent with assistance from the trained research staff. The trained research staff will 
complete baseline biometric assessment, including measure of height, weight, waist 
circumference, and blood pressure. Those who are consented will participate in: 1) 
completing survey questionnaires (30 minutes), 2) a baseline biometric assessment, 3) 
brief instruction regarding the wear of activPAL and continuous glucose monitoring 
(CGM) devices (30minutes), and 4) start to wear two devices for 7 days. The activPAL3 
device (PAL Technologies Ltd., Scotland, UK) will be worn on the thigh and a CGM 
(Abbott FreeStyle Libre) will be attached to the upper arm. The research staff will 
provide: 1) a copy of the informed consent form; 2) instructions with photos and 5 
waterproof dressings (Tegaderm) for attaching the activPAL on the thigh; 3) information 
about the CGM; and 4) daily sleep diary and wear log for 7 days. Participants will receive 
$25 for baseline visit 1. 
1. Biometric assessments 
Participants will undergo a basic physical examination (e.g., height, weight, blood 
pressure, hip circumference, waist circumference) and blood collection. 
A) Anthropometrics: Height, weight, and waist and hip circumferences will be 
measured using a validated stadiometer, digital scale, and flexible tape 
measure, respectively. All measurements will be recorded to the nearest 0.1 
cm and 0.1 kg. 
B) Blood pressure: Blood pressure will be measured using an automated and 
validated BP monitor. In a private room, participants will be seated 
comfortably for 5 minutes with feet flat on the ground prior to 
measurements.32 The device will take three readings at 2-minute intervals 
and the mean of three BP readings will be recorded.(21) 

Date: May 15th, 2024 
 
 
 
2. Questionnaires 
Participants will be given an iPad to answer questions about their demographics, 
socioeconomic characteristics, and a series of questionnaires detailed below. All 
responses will be recorded in REDCap. 
A) Demographics: demographics and socio-economic status will be self- 
reported by the patients. 
B) Health behavior: Questions about their tobacco use, alcohol intake, physical 
activity will be measured using the 27-item International Physical Activity 
Questionnaire (IPAQ)(22), and diet measured using the 16-item Rapid Eating 
and Activity Assessment for Participants Short Version (REAP-S)(23). Sleep 
quality (measured using the 10- item Pittsburgh sleep quality index)(24) will be 
answered with the assistance of the study team member. 
C) Confidence in reducing SB and increasing PA: Confidence in reducing SB 
and increasing physical activity will be measured using 12 items from the Self- 
Efficacy Questionnaire for Physical Activity and Sedentary Behavior 
(Cronbach’s alpha = 0.79).(25) 
D) Habit strength for SB: Habit strength for SB will be assessed by using a 
validated measure, Self-Report Habit Index (Cronbach’s alpha = 0.91).(26) This 
7- item index was adapted to sedentary breaks (standing/walking) to assess 
the degree to which sedentary breaks become habitual. 
E) Quality of life: Quality of life will be measured using the Patient-Reported 
Outcomes Measurement Information System (PROMIS)-Global Health, a 10- 
item measure developed by the NIH as an indicator for Healthy People.(27) 
F) Medical history and current medication: Medical history and current 
medication will be self-reported by the patients through the Self- 
Administered Comorbidity Questionnaire (SCQ).(28) 
G) Diabetes self-management: Self-efficacy of diabetes self-management will 
be measured by the Diabetes Self-Management Questionnaire (DSMQ).(29) 
H) Diabetes-related emotional distress: The emotional impact of living with 
diabetes will be assessed using the Diabetes Distress Scale (DDS)(30). 
I) Barriers to Physical Activity: Barriers to PA will be assessed using 11 items 
from the Barriers to Physical Activity in Diabetes (BAPAD1) questionnaire 
which asks about various factors such as the fear of hypoglycemia, concerns 
about losing control over diabetes, fear of fatigue, fear of injury, and other 
perceived barriers related to diabetes and physical health(31). Participants will 

Date: May 15th, 2024 
 
 
 
be asked to rate the likelihood of each item impeding their regular physical 
activity over the next 6 months on a scale ranging from 1 (extremely unlikely) 
to 7 (extremely likely). 
 
3. ActivPAL 
The activPAL is a non-invasive method of monitoring activity and rest cycles 
through an inclinometer. The device will be worn on the anterior upper thigh of 
the dominant leg and kept in place by an adhesive pad (Tegaderm). If the 
participants have hair on the upper thigh, shaving an area of the thigh will be 
considered; we will provide a disposable shaving razor and foam as well as a 
private room with a sink. The participant will apply the device by themselves in a 
private room. The participants will wear the activPAL 24hours over a 7-day period. 
There is no need to charge the device. The activPAL monitor has been validated 
against direct observation and is the most sensitive device to detect sitting-to- 
standing transitions.(32) At a follow-up visit (Baseline visit 2), the activPAL data will 
be downloaded to the secured PI’s computer and summary reports will be 
reviewed by the study team member and the participants. 
 
4. Continuous Glucose Monitor (CGM) 
The device (FreeStyle Libre Pro™; Abbott Diabetes Care, Witney, Oxon, UK) will be 
worn on the back of the upper arm to measure their 24-hours glucose levels for 7 
days. The CGM has one sensor applicator, one sensor, and one reader. Skin will 
be prepared using an alcohol wipe and the sensor applicator will be placed over 
the application site. The research staff will press firmly, hold for a few seconds, 
and gently pull the sensor applicator away from the site. A sensor applicator has 
an introducer needle which will be retracted after application. Only a thin, flexible 
filament will remain under the skin and the sensor is held in place by an adhesive. 
The sensor applicator serves as a container for disposal. The water-proof sensor, 
worn on the upper arm, is factory calibrated. The reader is retained by the PI and 
data are not visible to participants during sensor wear. The sensor automatically 
captures and stores glucose data every 15 min (96 glucose readings/day). 
 
5. Sleep diary and wear log 
The participants will be asked to complete a daily sleep diary each morning while 
they are wearing the monitor, which takes about 2 minutes. The participant will 

Date: May 15th, 2024 
 
 
 
also complete a daily wear log each evening. The information about sleep onset 
and offset and wear time will be used to validate the activPAL wearing protocol. 
 
Once they complete the 7 days of activPAL and CGM monitoring, they will be 
scheduled for the in-person visit (Baseline visit 2) and will return the devices and 
log to the study team at the visit. 
 
6. Fitbit 
We will provide Fitbit (Inspire 3) to each participant. The Fitbit is not intended to 
be used as a medical device. All participants will have the ability to monitor 
physical activity, sleep, and heart rate with the Fitbit. All data from the Fitbit will 
be continuously streamed to the secure Fitbit servers. The study team member 
will assist participants in downloading the app and creating an account and will 
instruct them on how to use the device, with the official Fitbit user manual. When 
we create Fitbit accounts for research subjects, we do not use their real name or 
email address and default their account settings to the most privacy-protective 
option available. 
Fitbit accounts require a unique email address for each user. To ensure 
participants’ anonymity and privacy when creating Fitbit accounts, we will (1) set 
up anonymous Gmail accounts and (2) set up de-identified Fitbit accounts for the 
purpose of the study. This individualized email address will then be linked to a 
Fitbit account in which personal identifiers should not be used. Importantly, 
research staff and participants will be advised that the email and Fitbit accounts 
should be used strictly for the study’s purpose. 
Moreover, account information will be stored in protected PI’s computer within 
encrypted documents. Once the intervention is concluded, Fitbit data will not be 
collected. Also, Fitbit and Fitbit app will be reset for the participant to keep using 
the Fitbit after study completion. 
 
5.2 Baseline visit 2 
5.2.1 Baseline assessment 
The in-person baseline visit 2 will take place at the VUSN Clinic in the Wesley building. 
Participants will return the activPAL and the continuous glucose monitoring devices at 
Baseline visit 2. Participants will receive $25 for baseline visit 2. 
1. ActivPAL data download 

Date: May 15th, 2024 
 
 
 
The 7 days of activPAL data will be downloaded and stored in the secured PI’s 
computer. The variables of interest from the activPAL data are listed below: 
A) Sedentary behavior: SB will be objectively measured as time spent sedentary 
(sitting or lying, minutes/day) and number of prolonged sedentary bouts (>30 
minutes and >60 minutes) using the activPAL3. ActivPAL data will be 
downloaded and processed using activPAL software. 
B) Physical activity: Time spent standing and walking (stepping), number of 
sitting- to-standing transitions, and daily step counts will be measured using 
the activPAL. 
 
2. Continuous glucose monitoring data download 
The 7 days of CGM data will be downloaded via Libreview and stored in the PI’s 
computer. The variables of interest from the CGM data are listed below: 
The 24-hour glucose control: the 24-hour glucose control will be evaluated by 
mean 24-hour glucose levels and numbers of events and time in hypoglycaemia 
(glucose < 3.9 mmol/l), euglycaemia (glucose 3.9–7.8 mmol/l), hyperglycaemia 
(glucose > 7.8 mmol/l) and above target (glucose > 9 mmol/l). 
 
5.2.2 Randomization 
Once the data is downloaded and reviewed by the PI, the Study Team Member will use 
the REDCap randomization function and will inform participants of their group 
assignment (1:1 ratio). 
 
5.2.3 Blinding 
Participants, the interventionist and the PI will be aware of the participants’ treatment 
assignments. However, data collectors will be blinded. 
 
5.3 Intervention 
The 8-week intervention will consist of four components. After the intervention, the 
intervention group will keep their Fitbit and the HidrateSpark smart water bottle. 
 
5.3.1 Instructional/goal setting session 
The study team member will provide an orientation at the baseline visit 2. The study 
team member will review the activPAL data and identify targetable prolonged SB bouts. 
The study team member and the participant will set two goals: 

Date: May 15th, 2024 
 
 
 
1) a SB reduction goal will be set as reducing daily sedentary time gradually until 
they reach the goal of ≥ 120 minutes SB reduction; and 
2) a sedentary break goal will be set as 3 minutes of standing/walking every 1 
hour and then increasing its duration to 5 minutes and its frequency to every 30 
minutes. 
These goals were feasible in stroke patients and T2D patients.(16, 33) The participant will 
enter the goal into the Fitbit for self-monitoring and fill out the first worksheet in the 
Ten Top Tips (TTT). The TTT is a booklet developed from the Habit Formation Theory 
and includes 10 tips to add SB breaks into their daily routine.(34) The ten tips are 
modified to eight in our study. See Appendix for the TTT and worksheet. This goal 
session will last approximately 1 hour. 
 
5.3.2 Fitbit 
Intervention group participants’ Fitbits will be programmed to provide the ‘Reminder to 
Move’ or ‘Move Alert’. The move alert is a notification that cues the participant to walk 
at least 250 steps per hour. The Fitbit will vibrate when they have been sitting for 60 
minutes. Participants can select the days and the time ranges to receive the move alerts. 
Patients will be encouraged to review their daily summary before they go to bed. 
 
5.3.3 Smart Water Bottle 
We will provide a HidrateSpark water bottle, and the study team member will assist 
participants in downloading the app and creating an account. The study team member 
will instruct participants on how to use the bottle, with the official user manual. The 
device alerts participants with a color change and message on the Fitbit to keep them 
hydrated. The device provides the daily water intake summary in the Fitbit app. We will 
advise participants to drink 4.5 – 6 bottles (500ml/bottle) of water per day based on 
current recommendations by the U.S. National Academies of Medicine.(35) The 
HidrateSpark accounts require a unique email address for each user and the same email 
which is used to Fitbit account will be used to the HidrateSpark app. The same rules will 
be applied to the HidrateSpark account, and the account information will be stored in 
protected PI’s computer within encrypted documents. Once the intervention is 
concluded, HidrateSpark data will not be collected. Also, the HidrateSpark bottle and the 
app will be reset for the participant to keep using the bottle. 
 
5.3.4 Text Messages 

Date: May 15th, 2024 
 
 
 
Text messages will be provided to support and enhance the habit formation process. 
Text messaging has shown effectiveness in many exercise studies.(36-38) There are three 
weekly default text messages which will be sent. Participants will also receive up to one 
text message per day providing a daily tip, which will be tailored to participants based 
on preferred message frequency and activity choices. In addition, the interventionist will 
offer weekly personalized feedback on the participant’s progress towards goal 
achievement and helpful tips. The first default text message will be sent on Thursday to 
provide feedback on their progress for the week. The second default text message will 
be sent on Saturday morning to encourage them to sync their Fitbit to the Fitbit app. 
 
The third text message will be sent on Monday morning to prompt participants to 
report their weekly activity. Participants will be instructed to open their Fitbit app, tap 
on ‘Hourly Activity’, and navigate to their data from the previous week. They will then 
respond to the survey text message with their average daily active hours from the 
previous week. Based on the participants’ responses, the interventionist will propose an 
adjustment to the goal, either by suggesting a new lower goal or recommending the 
same goal. Participants will then respond to either accept the proposal or reject it.  They 
will also get an introductory video explaining Fitbit app navigation. 
 
When participants take an SMS survey, questions are asked one at a time as an SMS text 
message conversation/thread. We will ask three questions (three SMS text messages). 
Participants may respond with any kind of alpha-numeric text for SMS survey. Only 
REDCap administrators are allowed to enable the Twilio option to initiate a survey as an 
SMS conversation. All messages and Fitbit data will be managed in REDCap. After week 
6, participants will set a new goal with the interventionist as part of the mid-program 
counseling session (described below, in 5.3.5 Mid-Program Counseling Session). 
 
Below is the process of developing and providing text messages: 
1. Creation of weekly text message template: Dr. Mulvaney (Co-I), an expert in 
effective health communication, and the PI co-created the weekly message 
template with Dr. Mulvaney. 
2. Fitbit data transfer: We will transfer the Fitbit data from the participants’ Fitbit 
accounts to REDCap by developing our own data collection interface using 
Fitbit’s Web Application Programming Interface (API). This platform provides 

Date: May 15th, 2024 
 
 
 
secure data acquisition and management tools that facilitate remote data 
collection from Fitbit without the need for study participants to return the devices 
to researchers for data extraction. 
3. Integration of Fitbit data into the text message template. The collected Fitbit data 
from REDCap will be integrated into our weekly text message template. 
4. Send text messages using Twilio and Redcap. The customized text message will 
be sent using the Twilio plug-in for REDCap. Twilio module enables our study to 
make and receive SMS text messages, both to and from study participants. A 
REDCap and Twilio account are linked together. When a user indicates that an 
SMS (text) or a call should be sent to a cell phone, REDCap requests that action 
through Twilio. When a user responds, Twilio relays that information back to 
REDCap. The data is stored in the REDCap database. Twilio does not store any 
data, nor does it keep a log of its actions. 
 
5.3.5 Mid-Program Counseling Session 
At the halfway point of the intervention (after week 4), a focused counseling session will 
be conducted to re-evaluate and adjust the participants' activity patterns and sedentary 
break schedules. This interventionist-assisted session represents a critical touchpoint in 
the intervention, offering participants an opportunity to recalibrate their targets and 
enhance the positive behavioral changes initiated in the program. The session is 
outlined as follows: 
1. Prior to the scheduled Zoom meeting, study participants will be mailed an 
activPAL device to their home address. Instructions will be provided to 
participants to ensure correct usage of the activPAL device, which they will wear 
for a period of one week. Participants will be informed of the procedures for 
returning the device using a prepaid express mail envelope for overnight 
shipping. 
2. Upon receipt of the returned activPAL devices, the study team will promptly 
download and analyze the collected data. The interventionist will then utilize the 
data from the activPAL to assess the participant's activity patterns during the 
mid-program review. 
3. During the Zoom meeting, the interventionist and participant will review the 
activity data together. The interventionist will facilitate a discussion to reflect on 
the participant's progress and challenges encountered in meeting the established 
goals. Personalized feedback will be provided, and the sedentary break schedules 

Date: May 15th, 2024 
 
 
 
will be adjusted based on the insights from the activPAL data. Goals and 
expectations for the remainder of the program will be discussed, reset, and 
agreed upon, ensuring they are realistic and achievable for the participant. 
Participants will be encouraged to incorporate the revised goals into their daily 
routine using their Fitbit for self-monitoring. 
4. The audio will be recorded to guarantee consistent adherence to the protocol 
and to maintain inter-rater reliability among the interventionists. The audio 
recorded files and transcripts will be saved in the secured computer at a locked 
office. 
 
5.3.6 Control Group 
The control group will receive the American Heart Association’s Healthy Living booklet. 
Control group participants will receive all study assessment but will not be instructed to 
monitor sitting time. The Fitbit move alert setting will be disabled for the control group. 
 
5.4 Post-Intervention Visit 
After 8 weeks, all participants will be invited to an in-person visit (post-intervention 
visit). During the visit, all the above parameters will be re-measured by the same trained 
research staff. The visit will take about 1 hour including the completion of a series of 
questionnaires (which participants may complete beforehand) and biometric 
assessments. All participants will wear the activPAL3 and the CGM for 7 days to examine 
their post-intervention activity and glycemic control. They will return the devices via pre- 
paid mail. All participants will receive $50 for the post intervention visit, and an 
additional $50 for mailing back the devices to the study team. 
Therefore, total compensation would be $150 for each participant. Also, all participants 
will be informed of their 24-hour glucose results and activity patterns retrieved from the 
activPAL device. 
1. Questionnaires 
Participants will answer the same questions about their demographics, 
socioeconomic characteristics, medical history and current medication, health 
behaviors, and patient-centered outcomes (e.g., confidence in reducing SB and 
increasing PA, habit strength for SB, quality of life, and diabetes self- 
management). Participants will have a choice to complete these questionnaires 
during the post-intervention visit in person or to receive paper copies of the 
questionnaires by mail. Printed copies will be identified by the participant’s 

Date: May 15th, 2024 
 
 
 
REDCap record ID number; there will be no additional identifying information on 
the printed questionnaires. If a participant chooses to receive the questionnaires 
by mail, he or she will be asked to complete them using a blue or black ink pen 
no sooner than 2 days prior to their scheduled post-intervention visit and will 
bring the completed surveys to their post-intervention visit. After the post- 
intervention visit is completed, the study team will enter their responses manually 
into REDCap and upload a scanned PDF version of the paper questionnaires to 
their REDCap record. Paper copies of the surveys will be kept in a locked cabinet 
in the study team’s office at the Vanderbilt School of Nursing. Alternatively, 
participants may opt to receive an email invitation that contains a unique link to a 
REDCap survey. REDCap ensures that all data transmitted during the survey 
completion process is secure and that participant privacy is maintained. The 
system is compliant with standards for sensitive data, such as HIPAA in the United 
States. In addition, participants will answer questions (Table 2) about feasibility 
and acceptability of the intervention. Level of satisfaction with the intervention 
will be assessed by using 23 items from the questionnaire developed by Lyons, 
Swartz, Lewis, Martinez and Jennings(39) and Burner, Zhang, Terp, Bench, Lee, Lam, 
Torres, Menchine and Arora(40). We will also use the 10-item System Usability 
Scale(41) to assess usability. The scale is considered as “industry standard” and 
provides a global measure of satisfaction(42). 
2. Biometric Assessment 
Participants will undergo the same physical examination (e.g., height, weight, 
blood pressure, hip circumference, waist circumference). The same protocol and 
instruments will be used. 
3. activPAL data download 
The 7 days of activPAL data will be downloaded and stored in the PI’s computer. 
 
6.0 Reporting of Adverse Events or Unanticipated Problems involving Risk to 
Participants or Others 
 
Consent 
For the pre-screening activity, potential participants recruited from the email 
distribution list will sign an e-consent in REDCap. Participants will be given information 
about what questions we will ask. There are no benefits or side effects related to this 
prescreening activity. Once they meet all the eligibility criteria, they will be invited for 

Date: May 15th, 2024 
 
 
 
the in-person baseline visit. At the visit, participants are given as much time as they 
would like to consider participation from the initial invitation to participate until they 
sign the “main” consent form. Participants are encouraged to ask as many questions as 
possible and reminded that participation is completely voluntary and will not affect their 
medical rights. They are also told that they have the option to discontinue participation 
at any time for any reason. 
 
Finger Prick Random Blood Glucose Test 
Risks associated with the finger prick include temporary discomfort from the needle 
prick, bruising, and rarely (<1%) infection. These risks will be minimized by using a 
sterile technique and applying sustained pressure to the site. 
 
activPAL 
The activPAL activity tracker is a safe, non-invasive method to capture information about 
activity cycles. Participation in this study requires that participants wear an activPAL 
tracker adhered (using Tegaderm adhesive dressing) to the front of the right thigh 
during waking hours for a minimum of 7 consecutive days (baseline and follow-up). The 
Tegaderm adhesive dressing used to apply the activPAL devices is hypoallergenic and 
consists of a dual layer hydrogel that does not pull at the skin or hair. There are few risks 
associated with wearing the activPAL device and include slight discomfort, such as light 
pressure from the activPAL or irritation from the waterproof dressing. 
 
Continuous Glucose Monitor 
The FreeStyle Libre Pro Flash Glucose Monitoring System is an FDA-approved, 
professional continuous glucose monitoring device indicated for detecting trends and 
tracking patterns in persons (age 18 and older) with diabetes. After application of the 
sensor, only a thin, flexible filament will remain under the skin and the sensor is held in 
place by an adhesive. The following are possible adverse effects of inserting a sensor 
and wearing the adhesive patch: local erythema (redness), local infection, inflammation, 
pain or discomfort, bleeding at the glucose sensor insertion site, bruising, itching, 
scarring or skin discoloration, and adhesive irritation. There is a remote risk of sensor or 
needle fracture during insertion, wear or removal, with fragments retained under the 
skin. 
 
Fitbit 

Date: May 15th, 2024 
 
 
 
Participants will wear an additional wrist-worn activity tracker for 8 weeks during 
waking hours. There are few risks associated with wearing the device and include slight 
discomfort, such as light pressure from the wristband or irritation from wearing a damp 
band after showering or swimming. There is a possible risk of confidentiality loss. To 
reduce the risk, we will create an anonymous email account for the Fitbit app. All 
identifiable data will be kept on password-protected computer systems in a locked 
office. 
 
Smart Water bottle 
Participants will use the smart water bottle to increase the frequency of standing and 
moving by frequently going to the restroom and kitchen for refills. There is no risk 
associated with using the smart water bottle. To reduce the possible risk of 
confidentiality loss, we will create an anonymous email account for the HidrateSpark 
app. All identifiable data will be kept on password-protected computer systems in a 
locked office. 
 
8-Week Sedentary Behavior Intervention 
Participants will gradually decrease their sedentary behavior and replace the sedentary 
behavior with a short period of light intensity physical activity such as 2 to 3 minutes of 
standing or walking over 8 weeks. While participating in this intervention, there is a 
potential risk of experiencing physical discomfort or symptoms that may include back 
pain, muscle ache, knee pain, and other discomforts arising from increased activity 
levels. Additionally, participants may also experience annoyance or inconvenience 
associated with receiving the tailored text messages. These symptoms or discomforts 
may occur during the course of the study, but the study team will take measures to 
minimize any adverse effects and ensure participants' safety and well-being throughout 
the research process. The level of risk associated with these symptoms or the risk of 
falling or injury is similar to the risks associated with day-to-day activity. Trained 
research staff members will instruct participants to make sure there are no hazards 
within the walking path and surrounding area. 
 
Suicidal ideation or severe distress 
Research has confirmed that simply asking a participant about whether they have 
thoughts of suicide is not a likely trigger of such an event(43). It is usually only when the 

Date: May 15th, 2024 
 
 
 
person reports ideation as well as an intent, plan, and/or means to commit suicide that 
risk for immediate suicide is considered to be more acute. 
 
If a participant reports severe distress or suicidal ideation during the survey 
administration (Baseline visit 2 or Post-intervention visit), the research staff will 
immediately notify the PI. The PI will provide the participant with help to get treatment. 
This may include: 
• working with the participant to contact his/her doctor, 
• contacting a trusted family member, or a therapist to discuss his/her thoughts, 
• or working with the participant on a plan that may include getting him/her to a 
hospital for safety. 
 
7.0 Study Withdrawal/Discontinuation 
 
Taking part in this study is voluntary, and the participant has the right to refuse to take 
part in the study. The participant can withdraw from the study at any period and should 
notify the PI or a study staff member. The decision to withdraw will not affect the 
participant’s ability to get healthcare at the institution, or their enrollment in any health 
plans or benefits. The investigator may decide to discontinue a participant’s participation 
without permission because she may decide that staying in the study will be harmful for 
the participant, or the sponsor may stop the study. A participant's decision to withdraw 
from this study will not be retroactive. For example, if a participant provides consent and 
completes the baseline visit but then decides to withdraw from the study at the post- 
intervention visit, the data collected from the baseline visit, which was collected in good 
faith, will not be destroyed. 
 
Criteria for Discontinuation of Individual Participants 
Subjects can decide to discontinue entirely from the study at any time for any reason. 
Subjects can also be discontinued from the study or discontinued from the study 
treatment due to Investigator decision as detailed below. 
1. Withdrawal of consent. 
2. At the Investigator’s discretion in certain situations such as lack of compliance or 
serious adverse event. 
3. One DKA event or one episode of hyperglycemic, hyperosmolar nonketotic 
syndrome (HHNS) 

Date: May 15th, 2024 
 
 
 
4. Dangerous hypoglycemia (glucose <54mg/dl after three treatments or unable to 
function due to low blood glucose during study visits) 
5. Continuous hyperglycemia (random blood glucose >300mg/dl two times in a row 
during study visits) 
 
Protocol for hypoglycemia 
During any study visits, if the study participant develops any of the symptoms below, 
the study team member will check glucose levels immediately. The symptoms are 
• Weakness and tiredness 
• Sweating 
• Fast breathing 
• Shakiness, nervousness, and or anxiety 
• Nausea 
• Confusion and problems communicating 
• Light-headedness, dizziness 
 
If the glucose level is below 70mg/dl, one of the following options will be administered. 
1. 2 oz (60ml) juice 
2. 15mg of glucose tables 
 
After 15 minutes, the study team member will re-check glucose level. If the glucose level 
is still below 70mg/dl, the treatment will be repeated up to 2 times. 
 
If the participant’s glucose level is still below 70mg/dl after three treatments, the study 
team member will notify the PI and ask participants to call healthcare provider. If the 
participant’s glucose level is still below 54mg/dl or the participant is unable to function 
because of mental or physical changes due to low blood glucose, call 911 immediately 
and notify the PI. 
 
Protocol for hyperglycemia 
During the first visit, the finger prick random glucose level of potential participants is 
300 mg/dl or higher two times in a row, the RA will notify PI immediately. The potential 
participants will be informed of their glucose levels and asked to contact their 
healthcare provider immediately. The PI will withdraw the study participant to prevent 
severe hyperglycemic events and/or DKA. 

Date: May 15th, 2024 
 
 
 
 
Adverse events (AEs) will be reported according to IRB policies. Any adverse event 
requiring reporting will be reported no later than 10 working days to the IRB using the 
IRB form “Report of Unanticipated Problem Involving Risk to Participants or Others” (IRB 
Form #1105). Reporting will depend on adverse event severity: 
Grading of Severity 
0: No AE or within normal limits. 
1: Mild AE. 
2: Moderate AE. 
3: Severe AE resulting in inpatient hospitalization, or a persistent or significant 
disability/incapacity. 
4: Life-threatening or disabling AE. 
5: Fatal AE. 
 
8.0 Statistical Considerations 
 
Based on Sit Less V1’s (IRB #221566) effect size of 0.71 for reducing sitting time, we 
estimated a minimum sample size of 66. To assess the scalability of Sit Less V2, we aim 
to recruit 80 patients. Eligible participants will include T2D patients from VUMC who 
report sitting for over 10 hours daily, own a smartphone, and do not currently use an 
activity tracker. We will screen potential participants using VUMC’s electronic health 
records (EHR) and send recruitment messages via the My Health at Vanderbilt app. 
According to our EHR search, we have 2,125 eligible patients, and with a 4% recruitment 
rate — as seen with enrolling 7 participants monthly from Sit Less V1 — reaching a 
target of 80 participants within 12 months is achievable. 
 
Analysis Strategies 
Aim 1: Acceptability outcomes will be reported as percentages or averages. 
Aims 2 & 3: Descriptive analyses are planned to characterize the study sample on all 
measures including baseline demographics and covariates. For this pilot study, 
exploratory linear mixed modeling will be used to provide descriptive statistics relative 
to treatment effects, both within- and between-groups effects on the primary and 
secondary outcomes over time. We will also estimate effect sizes for those outcomes. 
 
9.0 Privacy/Confidentiality Issues 

Date: May 15th, 2024 
 
 
 
 
All Personal Health Information (PHI) and Personal Identifying Information (PII) will be 
kept confidential, unless release is required by law. Release of PHI/PII information will 
only be allowed if it is legally required by law. The PI and staff have been trained in 
confidentiality and HIPAA requirements and will conduct the study using Good Clinical 
Practice guidelines. 
Upon enrollment, participants will be assigned a unique study ID number and 
anonymous email account that will be used to label all research data including Fitbit 
data, CGM data, questionnaires, and activPAL data. The study ID and the anonymous 
email will serve as the only identifier used on all study-related documents. Informed 
consent will occur at the time of recruitment once eligibility verification is completed. 
The participant identifiers will be stored in the Master List, which will include full name 
and contact information (e.g., phone number, email address) and will be used for 
administrative purposes only. The Master List will be maintained by study staff and 
stored in a file separate from the coded study dataset on a password-protected 
computer. Only individuals directly involved with the study (e.g., PI or her staff) will have 
access to this file. 
 
This individualized email address will then be linked to a Fitbit account in which personal 
identifiers should not be used. Importantly, research staff and participants will be 
advised that the email and Fitbit accounts should be used strictly for the study’s 
purpose. Moreover, account information will be stored in protected PI’s computer within 
encrypted documents. 
 
All the Fitbit data will be extracted from the Fitbit account to Redcap using the Fitbit 
web API developed by VU School of Nursing IT team. Fitbit data will be stored on a 
secure computer at University School of Nursing server and password-protected, only 
accessible by the PI and/or the IT team. The Fitbit data will be uploaded into REDCap. 
 
To send weekly text messages from REDCap, we will utilize the third-party 
service Twilio.com which means that all voice calls and SMS messages will be routed 
through Twilio's servers. However, REDCap goes to great lengths to ensure that voice 
call records and SMS transcriptions do not stay in Twilio's logs but are removed shortly 
after being completed. This is done for security and privacy concerns (e.g., HIPAA), in 
which our survey participants' phone numbers and their survey responses do not get 

Date: May 15th, 2024 
 
 
 
permanently logged on Twilio's servers but instead remain securely and separately in 
REDCap. Twilio uses two-factor authentication to access the application administratively. 
The integrated module can only be turned on by a REDCap Administrator. Twilio 
configuration is managed by a REDCap administrator. The integration requires 
‘inspectors’ be turned off at the Twilio level to ensure no logging data is retained. 
 
However, this method is limited to two-way interaction, which means that Twilio and 
REDCap system do not allow research participants to text back to the study team. To 
facilitate two-way communications, we will have a wireless cell phone and answer any 
questions if the participants have any. 
 
All hard copy documents (e.g., sleep diary or wear log) will be stored in a locked filing 
cabinet and office. All electronic records, including the Master List and voice recordings, 
will be stored on a secure computer at Vanderbilt University School of Nursing and 
password-protected, only accessible by the PI and/or her staff. No identifiable 
information will be stored on any mobile devices (laptops, USB keys, CDs, DVDs, etc.). 
Research files will be kept for 7 years after the study is completed. Data entry will be 
completed in REDCap by the PI and/or her staff and will be imported to SPSS file format 
for analysis. Only de-identified data will be used for analysis. 
 
10.0 Follow-up and Record Retention 
 
Raw hard copy research data will be kept in locked file cabinets in a locked office. All 
electronic records, including the Master List and voice recordings, will be stored on a 
secure internal Vanderbilt University School of Nursing server and password-protected, 
only accessible by the PI and/or her staff. After a period of seven years from the end 
date of the study, all identifying information, including signed consent forms and the 
Master List, will be destroyed. Anonymous raw data and electronic data will be 
maintained indefinitely. 
 
 
References 

Date: May 15th, 2024 
 
 
 
1. 
Bellettiere J, LaMonte MJ, Evenson KR, Rillamas-Sun E, Kerr J, Lee I-M, et al. 
Sedentary Behavior and Cardiovascular Disease in Older Women. Circulation. 
2019;139(8):1036-46. 
2. 
Young DR, Hivert M-F, Alhassan S, Camhi SM, Ferguson JF, Katzmarzyk PT, et al. 
Sedentary behavior and cardiovascular morbidity and mortality: a science advisory from 
the American Heart Association. Circulation. 2016;134(13):e262-e79. 
3. 
Rezende LFMd, Rodrigues Lopes M, Rey-López JP, Matsudo VKR, Luiz OdC. 
Sedentary behavior and health outcomes: an overview of systematic reviews. PloS one. 
2014;9(8):e105620. 
4. 
Bergouignan A, Latouche C, Heywood S, Grace MS, Reddy-Luthmoodoo M, Natoli AK, 
et al. Frequent interruptions of sedentary time modulates contraction-and insulin- 
stimulated glucose uptake pathways in muscle: ancillary analysis from randomized clinical 
trials. Scientific reports. 2016;6(1):1-13. 
5. 
Hamer M, Hackett RA, Bostock S, Lazzarino AI, Carvalho LA, Steptoe A. Objectively 
assessed physical activity, adiposity, and inflammatory markers in people with type 2 
diabetes. BMJ Open Diabetes Research and Care. 2014;2(1):e000030. 
6. 
Cichosz SL, Fleischer J, Hoeyem P, Laugesen E, Poulsen P, Christiansen J, et al. 
Objective measurements of activity patterns in people with newly diagnosed Type 2 
diabetes demonstrate a sedentary lifestyle. Diabetic medicine. 2013;30(9):1063-6. 
7. 
Loprinzi PD. Accelerometer-determined sedentary and physical activity estimates 
among older adults with diabetes: considerations by demographic and comorbidity 
characteristics. Journal of aging and physical activity. 2014;22(3):432-40. 
8. 
Van der Berg JD, Stehouwer CDA, Bosma H, van der Velde JHPM, Willems PJB, 
Savelberg HHCM, et al. Associations of total amount and patterns of sedentary behaviour 
with type 2 diabetes and the metabolic syndrome: The Maastricht Study. Diabetologia. 
2016;59(4):709-18. 
9. 
Ekelund U, Steene-Johannessen J, Brown WJ, Fagerland MW, Owen N, Powell KE, et 
al. Does physical activity attenuate, or even eliminate, the detrimental association of sitting 
time with mortality? A harmonised meta-analysis of data from more than 1 million men 
and women. Lancet. 2016;388(10051):1302-10. 
10. 
Boulé NG, Kenny GP, Haddad E, Wells GA, Sigal RJ. Meta-analysis of the effect of 
structured exercise training on cardiorespiratory fitness in Type 2 diabetes mellitus. 
Diabetologia. 2003;46(8):1071-81. 
11. 
Kennerly A-M, Kirk A. Physical activity and sedentary behaviour of adults with type 
2 diabetes: a systematic review. Practical Diabetes. 2018;35(3):86-9g. 
12. 
Bouchard C, Blair SN, Katzmarzyk PT. Less Sitting, More Physical Activity, or Higher 
Fitness? Mayo Clin Proc. 2015;90(11):1533-40. 
13. 
Chastin SFM, Egerton T, Leask C, Stamatakis E. Meta-analysis of the relationship 
between breaks in sedentary behavior and cardiometabolic health. Obesity. 
2015;23(9):1800-10. 
14. 
Dempsey PC, Larsen RN, Dunstan DW, Owen N, Kingwell BA. Sitting Less and Moving 
More: Implications for Hypertension. Hypertension. 2018;72(5):1037-46. 
15. 
Dunstan DW, Kingwell BA, Larsen R, Healy GN, Cerin E, Hamilton MT, et al. Breaking 
up prolonged sitting reduces postprandial glucose and insulin responses. Diabetes care. 
2012;35(5):976-83. 

Date: May 15th, 2024 
 
 
 
16. 
Ezeugwu VE, Manns PJ. The Feasibility and Longitudinal Effects of a Home-Based 
Sedentary Behavior Change Intervention After Stroke. Archives of Physical Medicine and 
Rehabilitation. 2018;99(12):2540-7. 
17. 
Henson J, Davies MJ, Bodicoat DH, Edwardson CL, Gill JMR, Stensel DJ, et al. Breaking 
Up Prolonged Sitting With Standing or Walking Attenuates the Postprandial Metabolic 
Response in Postmenopausal Women: A Randomized Acute Study. Diabetes Care. 
2016;39(1):130. 
18. 
Lynch BM, Nguyen NH, Moore MM, Reeves MM, Rosenberg DE, Boyle T, et al. A 
randomized controlled trial of a wearable technology-based intervention for increasing 
moderate to vigorous physical activity and reducing sedentary behavior in breast cancer 
survivors: The ACTIVATE Trial. Cancer. 2019;125(16):2846-55. 
19. 
Freene N, van Berlo S, McManus M, Mair T, Davey R. A Behavioral Change 
Smartphone App and Program (ToDo-CR) to Decrease Sedentary Behavior in Cardiac 
Rehabilitation Participants: Prospective Feasibility Cohort Study. JMIR Form Res. 
2020;4(11):e17359. 
20. 
Patterson K, Davey R, Keegan R, Niyonsenga T, Mohanty I, van Berlo S, et al. A 
smartphone app for sedentary behaviour change in cardiac rehabilitation and the effect on 
hospital admissions: the ToDo-CR randomised controlled trial study protocol. BMJ Open. 
2020;10(12):e040479-e. 
21. 
Frese EM, Fick A, Sadowsky HS. Blood pressure measurement guidelines for 
physical therapists. Cardiopulm Phys Ther J. 2011;22(2):5-12. 
22. 
Craig CL, Marshall Al Fau - Sjöström M, Sjöström M Fau - Bauman AE, Bauman Ae 
Fau - Booth ML, Booth Ml Fau - Ainsworth BE, Ainsworth Be Fau - Pratt M, et al. 
International physical activity questionnaire: 12-country reliability and validity. (0195- 
9131 (Print)). 
23. 
Segal-Isaacson CJ, Wylie-Rosett J, Gans KM. Validation of a Short Dietary Assessment 
Questionnaire: The Rapid Eating and Activity Assessment for Participants Short Version 
(REAP-S). The Diabetes Educator. 2004;30(5):774-81. 
24. 
Buysse DJ, Reynolds CF, 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep 
Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 
1989;28(2):193-213. 
25. 
Adams MM. On our feet: Feasibility trial of an intervention to reduce sedentary 
behavior and increase physical activity [Ph.D.]. Ann Arbor: The University of North Carolina 
at Greensboro; 2012. 
26. 
Verplanken B, Orbell S. Reflections on past behavior: a self-report index of habit 
strength 1. Journal of applied social psychology. 2003;33(6):1313-30. 
27. 
Hays RD, Bjorner Jb Fau - Revicki DA, Revicki Da Fau - Spritzer KL, Spritzer Kl Fau - 
Cella D, Cella D. Development of physical and mental health summary scores from the 
patient-reported outcomes measurement information system (PROMIS) global items. 
(1573-2649 (Electronic)). 
28. 
Sangha O, Stucki G Fau - Liang MH, Liang Mh Fau - Fossel AH, Fossel Ah Fau - Katz 
JN, Katz JN. The Self-Administered Comorbidity Questionnaire: a new method to assess 
comorbidity for clinical and health services research. (0004-3591 (Print)). 
29. 
Schmitt A, Gahr A Fau - Hermanns N, Hermanns N Fau - Kulzer B, Kulzer B Fau - 
Huber J, Huber J Fau - Haak T, Haak T. The Diabetes Self-Management Questionnaire 

Date: May 15th, 2024 
 
 
 
(DSMQ): development and evaluation of an instrument to assess diabetes self-care 
activities associated with glycaemic control. (1477-7525 (Electronic)). 
30. 
Polonsky WH, Fisher L Fau - Earles J, Earles J Fau - Dudl RJ, Dudl Rj Fau - Lees J, Lees 
J Fau - Mullan J, Mullan J Fau - Jackson RA, et al. Assessing psychosocial distress in diabetes: 
development of the diabetes distress scale. (0149-5992 (Print)). 
31. 
Dubé MC, Valois P Fau - Prud'homme D, Prud'homme D Fau - Weisnagel SJ, 
Weisnagel Sj Fau - Lavoie C, Lavoie C. Physical activity barriers in diabetes: development 
and validation of a new scale. (0168-8227 (Print)). 
32. 
Mitchell T, Borner K, Finch J, Kerr J, Carlson JA. Using Activity Monitors to Measure 
Sit-to-Stand Transitions in Overweight/Obese Youth. Med Sci Sports Exerc. 
2017;49(8):1592-8. 
33. 
Wadden TA, West DS, Neiberg RH, Wing RR, Ryan DH, Johnson KC, et al. One-year 
weight losses in the Look AHEAD study: factors associated with success. Obesity. 
2009;17(4):713-22. 
34. 
White I, Smith L, Aggio D, Shankar S, Begum S, Matei R, et al. On Your Feet to Earn 
Your Seat: pilot RCT of a theory-based sedentary behaviour reduction intervention for 
older adults. Pilot and Feasibility Studies. 2017;3(1):23. 
35. 
Institute of Medicine. Dietary Reference Intakes for Water, Potassium, Sodium, 
Chloride, and Sulfate. Washington, DC: The National Academies Press; 2005. 638 p. 
36. 
Agboola S, Jethwani K, Lopez L, Searl M, O’Keefe S, Kvedar J. Text to move: a 
randomized controlled trial of a text-messaging program to improve physical activity 
behaviors in patients with type 2 diabetes mellitus. Journal of medical Internet research. 
2016;18(11):e6439. 
37. 
Pellegrini CA, Hoffman SA, Daly ER, Murillo M, Iakovlev G, Spring B. Acceptability of 
smartphone technology to interrupt sedentary time in adults with diabetes. Translational 
Behavioral Medicine. 2015;5(3):307-14. 
38. 
Block G, Azar KMJ, Romanelli RJ, Block TJ, Hopkins D, Carpenter HA, et al. Diabetes 
prevention and weight loss with a fully automated behavioral intervention by email, Web, 
and mobile phone: A randomized controlled trial among persons with prediabetes. Journal 
of Medical Internet Research. 2015;17(10):e240. 
39. 
Lyons EJ, Swartz MC, Lewis ZH, Martinez E, Jennings K. Feasibility and Acceptability 
of a Wearable Technology Physical Activity Intervention With Telephone Counseling for 
Mid-Aged and Older Adults: A Randomized Controlled Pilot Trial. JMIR Mhealth Uhealth. 
2017;5(3):e28. 
40. 
Burner E, Zhang M, Terp S, Bench KF, Lee J, Lam CN, et al. Feasibility and 
Acceptability of a Text Message–Based Intervention to Reduce Overuse of Alcohol in 
Emergency Department Patients: Controlled Proof-of-Concept Trial. JMIR mHealth and 
uHealth. 2020;8(6):e17557. 
41. 
Brooke J. SUS: A quick and dirty usability scale. Usability Eval Ind. 1995;189. 
42. 
Brooke J. SUS: a retrospective. Journal of usability studies. 2013;8(2):29-40. 
43. 
Gould MS, Marrocco FA, Kleinman M, Thomas JG, Mostkoff K, Cote J, et al. Evaluating 
iatrogenic risk of youth suicide screening programs: a randomized controlled trial. Jama. 
2005;293(13):1635-43.