A Physical Activity Program to Disrupt Sedentary Time in Older Latinos
Phase: NA
Conditions: Sedentary Behavior, Cognitive Impairment
Sponsor: University of Illinois at Chicago

 
 
 
 
A Physical Activity Program to Disrupt Sedentary Time in Older Latinos (PAIS) 
 
NCT04507464 
 
8/10/2021 

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A Physical Activity Program to Disrupt Sedentary Time in Older Latinos (PAIS) 
 
 
 
Principal Investigator: 
[Ulf G. Bronas, PhD, ATC, ATR, FSVM, FAHA, Associate Professor 
University of Illinois at Chicago College of Nursing, Department of Biobehavioral Health 
Science 
845 S. Damen Avenue, Chicago, IL 60612 
Telephone: 312-325-5886 
bronas@uic.edu 
Co-Investigators: 
David Marquez, PhD Professor David X. Marquez, PhD, FACSM, FGSA, FSBM, 
University of Illinois at Chicago Department of Kinesiology and Nutrition, 1919 W. Taylor 
Street, Room 625, MC 994, Chicago, Illinois 60612, marquezd@uic.edu 
Cynthia Fritschi, PhD, RN, Associate Professor, University of Illinois at Chicago College 
of Nursing, Department of Biobehavioral Health Science, 845 S. Damen Avenue, 
Chicago, IL 60612 fritschi@uic.edu 
Susan Dunn, PhD, RN, Associate Professor, University of Illinois at Chicago College of 
Nursing, Department of Biobehavioral Health Science, 845 S. Damen Avenue, Chicago, 
IL 60612 sdunn01@uic.edu 
Spyros Kitsiou, PhD, Assistant Professor, Biomedical and health information science. 
205 AHSB, M/C: 530, University of Illinois at Chicago, skitsiou@uic.edu 
Olu Ajilore, PhD, MD Associate Professor, University of Illinois Center for Depression 
and Resilience (UI CDR) Professor of Psychiatry, Director, Mood and Anxiety Disorders 
Program, Director, Clinical Research Core/Center for Clinical and Translational Science, 
Associate Director, Residency Training and Education, Department of Psychiatry, 
University of Illinois-Chicago oajilore@uic.edu 
Amparo Castillo, PhD, MD, Interim Director, Midwest Latino Health Research, Training 
and Policy Center, UIC - College of Social Work, Community Engagement and 
Collaboration Core, UIC - Center for Clinical and Translational Sciences, 1640 West 
Roosevelt Road - Suite 605, Chicago, IL 60608, amparo@uic.edu 
Alana Steffen, PhD, Research Assistant Professor, University of Illinois at Chicago 
College of Nursing, Department of Health System Science, 845 S. Damen Avenue, 
Chicago, IL 60612 steffena@uic.edu 
 

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Study Location(s): The University of Illinois at Chicago, College of Nursing, Room 
229 
845 S. Damen Avenue, Chicago, IL 60612 
 
Sponsor: Midwest Roybal Center for Health Promotion and Translation 
 
Version: 10.0 
Date:  8-10-2021 

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Table of Contents 
Page 
TABLE OF CONTENTS 
4 
LIST OF ABBREVIATIONS 
5 
1.0 
PROJECT SUMMARY/ABSTRACT 
6 
2.0 
BACKGROUND/SCIENTIFIC RATIONALE 
7 
3.0 
OBJECTIVES/AIMS 
7 
4.0 
ELIGIBILITY 7 
4.1 INCLUSION CRITERIA 
7 
4.2 EXCLUSION CRITERIA 
7 
4.3 EXCLUDED OR VULNERABLE POPULATIONS 8 
5.0 
SUBJECT ENROLLMENT 8 
6.0 
STUDY DESIGN AND PROCEDURES 8 
7.0 
EXPECTED RISKS/BENEFITS 10 
8.0 
DATA COLLECTION AND MANAGEMENT PROCEDURES 10 
9.0 
DATA ANALYSIS 15 
10.0 QUALITY CONTROL AND QUALITY ASSURANCE 15 
11.0 DATA AND SAFETY MONITORING 
15 
12.0 STATISTICAL CONSIDERATIONS 
20 
13.0 REGULATORY REQUIREMENTS 
20 
13.1 INFORMED CONSENT 
20 
13.2 SUBJECT CONFIDENTIALITY 21 
13.3 UNANTICIPATED PROBLEMS 22 
14.0 REFERENCES 
20 
APPENDICES 
23 

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LIST OF ABBREVIATIONS 
 
COI 
 
 
Conflict of Interest 
DHHS  
 
Department of Health and Human Services 
DMC  
 
Data Monitoring Committee 
DSMB  
 
Data and Safety Monitoring Board 
DSMP  
 
Data and Safety Monitoring Plan 
FERPA 
 
Family Educational Rights and Privacy Act 
FDA  
 
Food and Drug Administration 
GCP  
 
Good Clinical Practice 
HIPAA 
 
Health Insurance Portability and Accountability Act 
IBC 
 
 
Institutional Biosafety Committee 
ICD 
 
 
Informed Consent Document 
ICH 
 
 
International Conference of Harmonization 
IDE 
 
 
Investigational Device Exemption 
IDS 
 
 
Investigational Drug Service 
IND 
 
 
Investigational New Drug  
IRB 
 
 
Institutional Review Board 
LAR  
 
Legally Authorized Representative 
OHRP  
 
Office of Human Research Protections 
OPRS  
 
Office for the Protection of Research Subjects 
PHI 
 
 
Protected Health Information 
PI 
 
 
Principal Investigator 
PPRA  
 
Protection of Pupil Rights Amendment 
QA/QI  
 
Quality Assurance/Quality Improvement 
SAE  
 
Serious Adverse Event 
SOP  
 
Standard Operating Procedure 
 
 

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1.0 
Project Summary/Abstract 
This study has been revised to allow for maximal social distancing in order to expedite 
the study time line, minimize risk of COVID19 exposure, and ensure participant safety.  
  
The Latino population over age 65 will reach 18% of the total U.S. population by 2050. 
Currently, over 12% of older adult Latinos have been diagnosed with Alzheimer’s 
disease and related dementias (ADRD). Even more striking, the number of Latinos with 
ADRD is expected to increase 9-fold over the next 3 decades, representing an epidemic 
increase of ADRD.2 The high incidence of ADRD in conjunction with physical function 
limitations place older Latinos at a high risk for loss of independence and significant 
caregiver burden. Sedentary time (defined as sitting) has been shown to be associated 
with reduced cognitive function in healthy older Latinos. Studies are clearly needed to 
investigate the benefits on cognition and brain connectivity of breaking up and replacing 
sedentary time with physical activity (PA) in older Latinos. However, in order to develop 
and deliver a successful intervention we need to understand how to best conduct a 
lifestyle intervention in the Latino community. Our current understanding is rooted in a 
Eurocentric view that assumes that interventions that work in one community will work 
the same way in a different community. This assumption is likely incorrect and 
represents a significant gap in our ability to develop a successful intervention at the 
multiple l levels that are required across the socio-ecological model (SEM) to be 
successful. We propose to investigate the interactive effects of behavior determination 
to increase PA levels in older Latinos.  This study will examine factors that facilitate 
initiation of and adherence to behavioral change at the individual level using the social 
cognitive theory, and ecological momentary assessment in an inner-city Chicago Latino 
Senior community. Our objectives are: 1) to discern the individual characteristics and 
the social networks within the community that influence behavior change to increase PA 
levels in the Latino community. 2) To assess the feasibility and acceptability of our PA 
measures. 3) To test the feasibility and initial impact of an intervention program 
designed to replace sedentary time with PA that has been designed specifically for older 
Latinos and delivered at home, to improve cognitive function and brain connectivity. We 
will achieve these objectives by using phone interviews, ecological momentary 
assessment, and an ecological momentary intervention within an inner city Chicago 
Latino senior community. Findings will directly facilitate the development and 
progression of culturally appropriate intervention(s) that will lead to rapidly translatable 
programs for older adults at risk for cognitive and physical decline. This proposal is 
very relevant to ADRD and aging research and addresses several areas of focus. 1). 
Physical Activity promotion, creation, modification and pilot testing of a principle-based 
intervention to reduce sedentary behavior and increase physical activity. 2). Pilot testing 
an intervention to enhance mobility in older adults to improve cognitive and physical 
functioning to prevent or forestall loss of independence. 3). We are harnessing 
technology to promote and sustain a behavioral intervention to achieve healthy aging in 
older adults.  
 

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2.0 
Background/Scientific Rationale  
The Latino population over age 65 will comprise 18% of the total U.S. population by 
2050. Currently, over 12% of older adult Latinos have been diagnosed with Alzheimer’s 
disease and related dementias (ADRD). Even more striking, the number of Latinos with 
ADRD is expected to increase 9-fold over the next 3 decades, representing an epidemic 
rate of increase. The high incidence of ADRD in conjunction with physical function 
limitations place older Latinos at a high risk for loss of independence and significant 
caregiver burden. Sedentary time (defined as sitting) is a known risk factor for reduced 
cognitive function in healthy older Latinos. Studies are clearly needed to investigate the 
benefits on cognition and brain connectivity of breaking up and replacing sedentary time 
with physical activity (PA) in this population. However, in order to develop and deliver a 
successful intervention we need to understand how to best conduct a lifestyle 
intervention in the Latino community. We propose to investigate the interactive effects of 
behavior determination to increase PA levels in this population.  This study will examine 
factors that facilitate initiation of and adherence to behavioral change at the individual 
level using social cognitive theory, and ecological momentary assessment in an inner-
city Chicago Latino Senior community.  
 
3.0 
Objectives/Aims 
 
Successful lifestyle interventions must act on multiple levels across the SEM in order to 
in order to increase daily physical activity. The SEM underscores the importance of 
understanding how the individual and the individual’s interpersonal community affect 
behavior change. Our long-term goal is to develop an intervention that is specifically 
tailored to older Latinos to prevent or forestall cognitive and physical function decline. 
Specifically, we propose to investigate the interactive effects of behavior determination 
to increase physical activity (PA) levels in older Latinos. Our objectives are  
 
1) to discern the individual characteristics and the social network within the community that 
influence behavior change to increase PA levels in an inner city Chicago Latino 
community.  
2) To assess the feasibility and acceptability of our PA measures. 
3) To test the feasibility of an intervention designed to replace sedentary time with 
PA that has been designed specifically for older Latinos and delivered in their homes to 
improve cognitive function. 
 
• Aim 1 (stage 1A): Conduct individual phone interviews to determine the individual 
characteristics and the social networks that influence behavior change to reduce and 
replace sedentary time with PA within an older adult Chicago Latino community. The 
focus groups will be 50% male and 50% female to enable comparisons of possible 
gender-differences.   
• Aim 2 (stage 1A): Assess the feasibility and acceptability of our PA measures and 
ecological momentary assessment (EMA) in this community. 

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• Aim 3 (stage 1B): Determine the feasibility and acceptability of an ecological 
momentary intervention (EMI) program designed to reduce and replace sedentary time 
with PA in older Latinos, delivered in the home-setting over 6 weeks, compared to 
participants randomized to receive physical activity guidelines in Spanish. 
• Exploratory aims (stage 1B): To explore the feasibility and preliminary effect of the 
EMI intervention on cognitive function in older Latinos, compared to participants 
randomized to guidelines.  
 
Study Duration: This is a feasibility pilot randomized, controlled trial of a 6-week 
intervention. Outcome measures will be obtained at baseline and at 6-weeks. Behavior 
choices and preference data will be continuously captured during the intervention. 
 
4.0 
Eligibility 
We will randomize 80 older Latinos from a Chicago Latino community center to either 
the EMI intervention (n=40) or to physical activity guidelines (n=40.  
 
Dr. Ulf Bronas or study designee will assess and determine the subject eligibility. An 
eligibility checklist will be completed prior to any study participant randomization. 
Eligibility criteria will be continuously monitored by the PI/RA and document via an 
eligibility checklist at the baseline and follow-up.  
 
4.1 Inclusion Criteria 
• Men and women >55-89 years of age, no history of major head trauma, ownership of a 
working smartphone, and ability to use video calls. 
 
4.2 Exclusion Criteria 
• No ability to use video technology 
• Wheelchair dependent 
• Diagnosed dementia,  
o Participating in a supervised exercise program with intent to increase fitness levels 3 
days/week, 
• Contraindications to PA per ACSM  
▪ Requires assistive ambulation;  
▪ Unstable angina,  
▪ Claudication 
▪ severe arthritis,  
▪ extreme dyspnea on exertion,  
▪ Class III-IV heart failure;  
▪ Current uncontrolled sustained arrhythmias,  
▪ severe/symptomatic aortic or mitral stenosis, 
▪  hypertrophic obstructive cardiomyopathy,  
▪ severe pulmonary hypertension,  
▪ active myocarditis/pericarditis,  
▪ thrombophlebitis,  
▪ recent systemic/pulmonary embolus (within 3 months);  
▪ Revascularization procedures within the previous 6 months;  

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▪ Pregnancy 
 
4.3 Excluded or Vulnerable Populations 
Vulnerable populations are not included in this study.   
The following populations are excluded from this study: 1. Pregnant women: Pregnant 
women are excluded to limit any potential influence on measures.   
Non-English speaking population:  Non-English speaking population other than Spanish 
will be excluded from the study.  
Spanish speaking population will be included once IRB approval has been obtained for 
the Spanish translated versions of the consent, phone app, and study documents. 
   
5.0 
Subject Enrollment 
 
Participants are community dwelling adults without dementia. We have established 
strong relationship with this organization and key stakeholders. Participants will be 
recruited through a flyer with information about the study posted on organization’s 
website and by word of mouth. We have developed a media recruitment script that will 
be used as the script for a video presentation that will be posted on a website, TV add, 
Facebook, and read as a radio add. We will send a notice via the CCTS research match 
and the TNN Match service using the form titled “research match”.   
• Participants that contact the study team will be sent the consent form and given as 
much time as they feel necessary to decide if they would like to participate.  Participants 
will be encouraged to ask any questions at any time throughout the course of the study.  
Research personnel will be available to answer these questions. Subjects will be 
informed that participating in this research is voluntary. Subjects will be informed that 
they may withdraw from the research at any time without penalty. Patient providers are 
not part of the study team.  
 
6.0 
Study Design and Procedures 
 
This research will be performed via telephone/video conference to maximize social 
distancing and participant safety. The intervention will be performed by the participants 
at home.  
 
This is a pilot randomized, controlled trial of a 6-week intervention for feasibility. 
Outcome measures will be obtained at baseline and at 6-weeks. Behavior choices and 
preference data will be continuously captured during the intervention. We will randomize 
80 older Latinos from the Chicago Latino community to either an ecological momentary 
intervention using fitbits (n=40) or to physical activity guidelines (n=40).  
 
Study interaction 1-baseline test (Approximately 2 hours). Participants will be screened 
for inclusion/exclusion criteria. If criteria for inclusion in the study are met participants 
will undergo informed consent process. Following informed e-consent conducted via 
zoom video/telephone participants will asked about their demographics (demographic 

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form), and contact information (Face sheet), and then they will be asked about their 
medical history. Following the medical history we will fill out the Charlson co-morbidity 
questionnaire, and conduct the following cognitive function measures as approved by 
the NIH for use via video call: a. Picture vocabulary test, b. Picture sequence test, c. List 
sorting test, d. Oral reading recognition test, e. Auditory verbal learning test, and the 
Trail Making test A and B. Following the cognitive function testing, we will conduct a 
phone/video interview. The interview will be recorded, analyzed and used to develop the 
intervention.  
 
Following the interview we will conclude the phone call and send the participants an 
activity monitor to be worn on the waist for 8 days to measure sedentary time: The 
participants will mail the monitor back to us after 8 days. Once we have received the 
physical activity monitor we will randomize the participant to intervention or control.  
 
Optional in-person visit (approximately 1 hour) If the participant is willing and 
able to undergo an MRI scan. No contrast will be used.  
• The MRI Visit will take place about one-week after the initial phone call.  
Participants will come to the Magnetic Resonance Imaging Center, 3T 
research center 2242 W. Harrison St. Chicago IL 60612and return the 
actigraph to us.  We will ask participants to do the following: 
•  Have an MRI to take pictures of the brain at a scanning facility. Scanning 
will last approximately 1 hour during. 
• Before entering the MRI room, participants will be asked to remove from all 
metal objects, including jewelry, watches, hair holders, or eyeglasses; and 
asked to empty pockets of all materials, including keys, wallets, and 
magnetic cards such as ATM and credit cards. In addition, if the clothing 
has more than a minimal amount of metal content, they may be asked to 
change into a hospital gown or other suitable garment. Finally, they may be 
asked to remove any eye shadow you may be wearing, because eye 
shadow sometimes contains metallic substances. 
• Because the MRI machine makes loud noises while it scans, a researcher 
or technician will provide participants with earplugs to reduce the noise 
level.  
• All of the procedures described above will be performed by qualified, 
licensed personnel and arranged at the participant’s convenience. We will 
inform participants of any abnormalities found in the tests; however, the 
information obtained from the MRI and cognitive testing is experimental in 
nature and does not allow for clinical interpretation. We will, however, 
contact participants if the MRI or cognitive test results warrant a formal 
clinical follow-up and discuss this with their medical provider (e.g., General 

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Practitioner). Ultimately, however, it is up to the participant to follow-up 
with a doctor for a clinical evaluation 
 
Following the MRI, we will assess cognitive and basic motor function using the 
NIH toolbox the NIH Toolbox measures for Cognitive function will completed 
using the standard NIH Ipad (see administration manual): 
• C.2.2 NIH Toolbox Flanker Inhibitory Control and Attention Test page 67  
• C.2.4 NIH Toolbox Dimensional Change Card Sort Test (DCCS) page 98  
• C.2.5 NIH Toolbox Pattern Comparison Processing Speed Test page 124  
• C.2.7 NIH Toolbox Oral Reading Recognition Test page 151  
• C.2.8 Oral Symbol Digit Test page 154 
 
Following the NIH Toolbox measures for Cognitive function, the NIH toolbox motor 
measures will completed using the standard NIH Ipad (see administration manual): 
• Pegboard dexterity test (172) 
• Balance measures with the addition of iPod app for assessment of sway 
(179). 
• Two-minute walk (198) 
• Grip strength (using handheld dynamometer, 176) 
• 4 meter walk (195) 
 
Study interaction 2 (Approximately 1 hour): Participants will be notified via telephone 
which group that were randomized to.  
 
Participants randomized to the intervention group will be sent a fitbit that has been set 
up to deliver the intervention as described below. We will schedule a telephone call or 
zoom video call (whichever the participant prefers) to set up the HIPPA compliant EMA 
system and to provide education about the fitbit and the intervention to disrupt 
sedentary time.  
 
Intervention (home-setting): We will deliver content in real-time, and in the real-world 
environment using a wearable sensor, an activity tracker and the Illumivu mEMA smart 
phone app, which will enable real-time delivery of behavior options and real-time 
feedback on the effectiveness of behavior choices. Although the intervention will be 
guided by the interview findings, in general, participants will wear a Fitbit that has been 
programmed to deliver a notification (a buzz) when activity has ceased for more than 10 
minutes. They will receive suggestions on their smartphone app on how to replace 
sitting time with PA such as standing up 5 times or taking 20 steps, or even performing 
a short (20 seconds) preferred dance routine. We will capture Fitbit data in a real-time 
platform (ICardia). Participants will receive reminders from their smartphones to enter 

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real-time feedback on activity options selected and how successful they were in 
adopting the option. These data will allow us to track underlying preferences for 
behaviors and tailor the program accordingly. Participants will receive a message 
immediately with positive choices for behavioral action. Resulting actions and delivery of 
the intervention will be automatically captured and downloaded in real time. We will 
teach them how to use these devices once they are assigned to the intervention group. 
The sensor and activity tracker will record their everyday physical activity level. When 
participant stays sedentary too long during a day, the smartphone app will send a real-
time reminder with some physical activity options for participant to choose designed 
based on their preferences and focus group discussions (e.g., standing up 5 times, 
taking 20 steps, or performing a short dance routine). Resulting actions and delivery of 
the intervention will be automatically captured and downloaded into the devices in real 
time. 
 
Participants randomized to the control group will be sent general guidelines for 
disruption of sedentary time.  
 
Study interaction 3-Follow-up (Approximately 1 hour): At the completion of the 6-week 
intervention period all participants will be sent an activity monitor to be worn on the 
waist for 8 days to measure sedentary time: The participants will mail the monitor back 
to us after 8 days. Once we have received the physical activity monitor we will schedule 
a phone interview with the participants to understand where they had difficulty and what 
did or did not work for them. We will then repeat the cognitive function tests and the 
optional MRI scan.  
 
7.0 
Expected Risks/Benefits 
Risk associated with the medical history assessment 
Discomfort could be felt by participants when answering questions about their medical 
history. 
Risk associated with the cognitive function questionnaires.  
There is a slight risk that participants will feel uncomfortable with filling out the 
questionnaires. Participants could find answering the questions boring and/or tiring. We 
will monitor the progress and allow participants to take breaks as needed. If they 
become upset or uncomfortable, they may skip a given question. 
 
Optional MRI scans:  
The MRI scans are performed with a powerful magnet without using x-ray radiation or 
radioactive material. The magnetism of the machine attracts certain metals, which could 
put a participant at risk. Therefore, people with pacemakers, infusion pumps, metal 

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prostheses, metallic-backed transdermal patches or metallic shrapnel will be excluded 
from the study.  A checklist will be completed that addresses issues of MRI safety. 
Some people may feel somewhat closed-in (claustrophobic) during the MRI procedure. 
The MRI scans can get quite noisy and this may cause some discomfort. We will 
provide padding, a blanket as well as ear plugs to ensure comfort. Participants will stay 
in contact with study staff during the entire MRI procedure and can request to stop at 
any time 
 
Risk associated with the intervention. 
There are no known risks associated with activities to break up sedentary time as they 
are considered usual activities of daily living.  
 
8.0 
Data Collection and Management Procedures 
• 
We will use EMI designed to deliver content in real-time, and in the real-world 
environment. EMI, using a wearable sensor, an activity tracker and the Illumivu mEMA 
smart phone app, will enable real-time delivery of behavior options and real-time 
feedback on the effectiveness of behavior choices. This methodology will enable us to 
create a culturally appropriate intervention that is based on preferences of individuals 
within their community networks.  Although the intervention will be guided by the focus 
group findings, in general, we expect that participants will wear a Fitbit that has been 
programmed to deliver a notification (a buzz) when activity has ceased for more than 10 
minutes. They will receive a notification on their smartphone app with a suggestion on 
how to replace sitting time with PA such as standing up 5 times or taking 20 steps, or 
even performing a short preferred dance routine. We will capture Fitbit data in a real-
time platform (ICardia). Participants will receive reminders from their smartphones to 
enter real-time feedback on the PA options selected and how successful they were in 
adopting the option. These data will allow us to track underlying preferences for 
behaviors and tailor the program accordingly. Participants will receive a message 
immediately with positive choices for behavioral action. Resulting actions and delivery of 
the intervention will be automatically captured and downloaded in real time.  
 
• 
Outcomes: Sedentary time will be measured using the Actigraph, a validated tool for 
measuring sedentary time in older adults following standard procedures over 7 days at 
baseline and at follow up. Sedentary behavior will be defined as: 1) waking activity with 
an energy expenditure ≤ 1.5 metabolic equivalents occurring in a sitting or reclining 
posture; 2) vector magnitude counts are <70 counts/15-s and vertical axis counts are 
<10 counts/15-s. Sedentary interruption will be defined as counts >100/minute. Non-
wear time will be considered to be 60 minutes of zero-activity counts. Any counts over 
15,000 will be considered erroneous. A valid day will consist of 10 waking hours. At 
least 5 complete days of data must be available to be included in the analysis.  
 
• 
Cognitive and Physical Function Measures will be assessed using the NIH Toolbox 
measures.  
 

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• 
Image acquisition will be performed on GE 3T MRI research dedicated scanner (MR 
750) pre- and post-intervention. After a brief scout image for localization, we will acquire 
whole brain images using diffusion tensor imaging (DTI); and high-resolution 3D T1-
weighted imaging. We will determine and quantify white matter integrity (DTI-FA/MD); 
and hippocampal volume (T1). These are indices of alterations of brain inter-
connections, structure, and function, which are associated with cognitive functioning 
(details, table 2).  
 
Table 2. Imaging Parameters 
Technique 
Purpose 
Parameters (TE=echo time; TR=repetition time; 
BW=bandwidth; FOV=field of view; TI=inversion time) 
DTI 
White matter 
integrity 
(FA/MD) 
quantification 
single-shot EPI & parallel imaging using the same 32-
channel phased-array head coil; TE/TR~70/5525ms, b-
values 0,1000s/mm2, 33 directions, FOV=20cm2, matrix 
160x160, NEX 2, parallel imaging acceleration factor 2; 
6 B0 images, Slice thickness 3 mm 
T1/BRAVO Hippocampal 
Volume 
Quantification 
Coronal; TI=4.5, Flip=13º, 1.5mm slice thickness, no 
gap, BW=±25kHz, FOV=22cm2 
T2-FLAIR 
White matter 
hyperintensity 
quantification  
Coronal; TE/TR=104.5/9500ms, TI=2.5sec, FOV 22cm2 
ASL 
Cerebrovascular 
perfusion 
Cerebral blood 
flow 
axial; Spiral-FSE acquisition; post-label delay time = 1.8 
sec, TE/TR=minimum, flip angle=90°, slice thickness = 
3-5 mm, matrix size = 128x128, FOV 22cm2 
Resting-
state fMRI 
Resting state 
networks 
Subjects will be instructed to keep their eyes open, 
focus on a fixation point, and “not think of anything in 
particular”. Resting-state data will be acquired: total 
scan time = 8 minutes.  
 
• 
Image Analyses DTI: FSL with TBSS, we will quantify FA and MD from whole brain 
and tract specific white matter. T1/FSPGR: Using FreeSurfer, we will extract 
hippocampal volumes (right and left) as well as sub-fields of the hippocampas adjusted 
for intracranial volume.T2-FLAIR: Using standard software, we will quantify white matter 
hyperintensity volumes across the entire brain white matter.  We will use a seed-based 
approach to measure resting state networks of interest. Functional connectivity 
networks: Functional brain networks will be generated using the resting-state fMRI 
toolbox, CONN (http://www.nitrc.org/projects/conn; (Whitfield-Gabrieli and Nieto-
Castanon, 2012)). In brief, raw EPI images are realigned, co-registered, normalized, 
and smoothed before analysis.  Any confound effects from motion artifact, white matter, 
and CSF are regressed out of the signal. Using the same label maps as the structural 
brain networks, functional brain networks will derived using pairwise BOLD signal 
correlations. 
 

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• 
Feasibility and acceptability: We will conduct formative assessments at the 
completion of the intervention at week 6. We will derive the number of times the phone 
app was accessed and the number and types of behavior choices that were made. We 
will review these data with participants in order to understand where they had difficulty 
and what did or did not work for them.  
 
9.0 
Data Analysis 
• 
We will conduct a thematic analysis to explore themes from individual phone interviews. 
Feasibility and acceptability will be assessed using descriptive and non-parametric 
statistics. Exploratory analyses will be conducted to assess for trends and effect sizes. 
Dr. Alana Steffen of the College of Nursing statistician will conduct all analyses. The 
apriori stated analysis is listed below. 
This is a pilot study for feasibility. For these pilot data we will emphasize descriptive 
statistics such as means, standard deviations, effect sizes, medians, interquartile 
ranges, frequencies, and percentages to demonstrate the feasibility of recruitment, 
adherence, and retention, treatment effects over time, and proof of concept.  Our 
statistical approach for a full trial of these hypotheses will be Generalized Linear Mixed 
Models (GLMM) with an identity link function for a continuous outcome or a logit link 
function for a binary outcome.  Conceptually, GLMM is a more advanced version of 
repeated measures ANOVA that can account for potential correlation among multiple 
measurements over time while having flexibility in fitting outcomes with different 
distributions (such as normal, binomial or Poisson, etc.). One advantage of this 
approach over repeated measures ANOVA is that there is no assumption that 
participants are measured at every, or even the same, time points. Therefore, these 
models are very flexible at handling missing data. Participants who have a missing 
observation are not excluded, thus, this produces the intention to treat (ITT) full 
information maximum likelihood (FIML) model.  Conducting these models on pilot data 
help with sample size calculations for a future R01 submission. 
• 
 
 
10.0 Quality Control and Quality Assurance 
Data will be continuously evaluated for protocol adherence during weekly meetings with 
the PIs and the study staff. Dr. Bronas will evaluate all data for quality during weekly 
study meetings. Biweekly visits will be conducted by the PI to ensure that data collection 
is carried out according to the protocol. 
 
11.0 Data and Safety Monitoring 
Serious adverse events will be monitored and tracked at each follow-up period.  
Patients will be queried at the phone call and at 6 weeks if they have had any visits to 
the emergency department or hospitalizations (see attached checklist).  We will also ask 
if they have had any symptoms of cardiac-related problems such as chest, arm or jaw 
pain while exercising or not exercising. Data will be recorded on an excel spreadsheet 
and reviewed by the PI at weekly study meetings.  Any unanticipated adverse events or 
problems will be reported to the IRB within 7 days on notification.  The PI will monitor 
safety data.  Subjects are free to withdraw from the study at any time.  If a subject 
withdraws from the study we will ask the subject (only once) if they are willing to come 

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back for the follow-up tests.  If the subject does not want to complete the study, no 
further contact attempts will be conducted and the subject will be discontinued from the 
study (this will be reported at the annual continuing review).  
 
Adverse Event and Serious Adverse Event Collection and Reporting 
Adverse events will be tracked on an ongoing basis for the full sample using an adapted 
version of the NIA Adverse Event Form (https://www.nia.nih.gov/research/dgcg/clinical-
research-study-investigators-toolbox/adverse-events) and serious adverse events will 
be tracked using the NIH Serious Adverse Event Form 
(https://www.nia.nih.gov/research/dgcg/clinical-research-study-investigators-
toolbox/adverse-events). Adverse events will be reviewed during semi-annual meetings 
of the Data Safety Monitoring Committee (see 3.0 below for details). The PI will be 
informed of serious adverse events as soon as they occur and will notify the Safety 
Officer (Chair of the Committee) within 24 hours of notification. In addition, adverse 
events and serious adverse events will be reported to the UIC IRB and NIA consistent 
with their established protocols and will use the NIA AE/SAE Flow Process to guide this 
process and timeline (https://www.nia.nih.gov/research/dgcg/clinical-research-study-
investigators-toolbox/adverse-events). 
AEs will be defined as any health-related event that occurs within the intervention or 
assessment measure sessions. Expected AEs may include strained or sore muscles 
and fatigue. AE severity will be classified as:  
• Mild - if the symptoms are tolerated and do not interfere with the participant’s 
daily life. 
• Moderate – if the symptoms cause some concern or some disruption to the 
participant’s daily life, but can be alleviated through rest or relatively simple non-
medical intervention. 
• Severe – if the symptoms cause a major disruption in their daily life and require 
medical intervention or drug therapy. 
All AEs will be documented using the Adverse Event Form by the PI. The PI will assess 
the relatedness of the AE to the study intervention and the expectedness of the AE. The 
PI will follow the Adverse Event flow chart to determine routing and reporting of the AE. 
All AEs will be reported to the DSMC and IRB in accordance with reporting guidelines. 
SAEs are not expected to occur within this intervention. However, potential SAEs could 
be a serious injury related to the intervention, a cardiac event resulting from physical 
activity, and death. All SAEs will be documented in the Serious Adverse Event form and 
reported to the NIA program officer and Safety Officer within 48 hours. All participant 
deaths will be reported to the NIA program officer and Safety Officer within 24 hours. All 
SAEs will be reported to the DSMC and IRB in accordance with reporting guidelines. 
 
In addition to holding semi-annual DSMC meetings, all AE and SAE data will be 
reported quarterly by the pilot PI to the NIA project officer and Safety Officer. 
 
1.3 Protection Against Study Risks. 
Informed Consent Process.  Potential participants will be provided with a copy of the 
consent form approved by the UIC IRB to follow during the verbal description and also 
to read on their own. A member of the research team will fully describe the study to the 

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potential participant(s) verbally, covering all of the content in the consent form, including 
potential risks and benefits. Potential participants will be given time to read the consent 
form and invited to ask any questions they may have about the study.  Questions will be 
answered and any identified misunderstandings about the study will be clarified. 
Individuals interested in participating at this point will be asked to sign the e-consent 
and will be provided with one copy for their use. The standard consent form template 
used by the UIC IRB includes all of the basic sections identified in the NIA Informed 
Consent Checklist (https://www.nia.nih.gov/research/dgcg/clinical-research-study-
investigators-toolbox/informed-consent). 
 
Protections Against Study Risk. We believe that the potential risks to participants in this 
study are minimal and are risks that anyone disrupting sedentary time is likely to 
experience. There may be a small risk of muscle soreness associated with increased 
physical activity. Participants will be encouraged to (a) consult their health care provider 
before initiating any new physical activity; and (b) perform physical activities at a pace 
that is comfortable for them and in a way that is consistent with any recommendations 
from their medical provider.  
Special care will be taken to ensure confidentiality of all data as described above. All 
project staff will be required to be current in training in Human Research Subjects 
protection sponsored by the University of Illinois at Chicago. The staff will also receive 
additional training on confidentiality by the principal investigator.  
 
We do not anticipate any serious adverse events or distress as a result of participating 
in the proposed research. Any concerns will be immediately reported the principal 
investigator.  
 
Interim Analysis will not be performed. The pilot intervention will last 6 weeks. The 
assessments will occur on two occasions (i.e., baseline; immediately post-intervention), 
so there will not be an opportunity to do an interim analysis during this short term pilot 
study. 
 
Data and Safety monitoring. 
 
The pilot Principal Investigator (PI) will be responsible for ensuring participants' safety 
on a daily basis. The pilot will be monitored by a local Data Safety Monitoring 
Committee and Safety Officer that will not require approval by the NIA. The Safety 
Officer in conjunction with a Data Safety Monitoring Roybal Center Committee will act in 
an advisory capacity to the NIA Director to monitor participant safety, evaluate the 
progress of the study, to review procedures for monitoring the confidentiality of the data, 
the quality of data collection matter, management, and analyses. 
 
Frequency of Data and Safety Monitoring/ Safety Officer (SO) Reports. 
The pilot PI will meet semi-annually with the DSM Committee, either in-person or by 
teleconference call, to review study progress, data quality, and participants’ safety. 
Written summary reports will be submitted twice a year and will include a detailed 
analysis of study progress, data and safety issues. Margaret (Peg) Baumann, MD will 

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serve as chair of the committee, and as SO for any adverse event reports. Other 
members will include Susan Hughes, PhD (Roybal PI, SPH); Karen Peters, PhD (SPH); 
and Eileen Collins, PhD (Nursing). 
The PI will be informed of serious adverse events as soon as they occur and will notify 
the SO within 48 hours. In addition, serious adverse events will be reported to the UIC 
IRB and NIA consistent with their established protocols. 
In addition to semi-annual DSMC meetings, all AEs and SAEs will be reported quarterly 
to the Safety Officer and NIA project officer. 
 
Data Analysis and Coordination 
Since this is a single site pilot with a small sample (n=80) with a brief intervention and 
follow-up period (6 weeks), the pilot PI will coordinate data analysis and will not be 
blinded to the outcome data or data identifying the pilot participants.  
 
Content of Data and Safety Monitoring Report/ SO Reports. 
 
The content of the SO report will include study status/quality, participant descriptive 
information, adverse events, and dropout rates/reasons. 
 
DSM Committee/ SO Membership and Affiliation. 
The following individuals have accepted positions as part of the DSM Committee. Given 
the safe guards in place and the relatively low-risk to subjects within this pilot, we are 
using a local DSM Committee and not requesting review and approval by the NIA. 
 
Susan Hughes, PhD 
Professor, School of Public Health and Director, Center for Research on Health 
and Aging, University of Illinois at Chicago 
Dr. Hughes is the Roybal Center PI and will be a DSMC member. 
 
 
Karen Peters, PhD 
Clinical Assistant Professor, School of Public Health, University of Illinois at 
Chicago 
Dr. Peters has a broad background in community-based participatory research and 
evaluation, with specific training and research experience in community-engaged or -
partnered research in both urban and rural areas. She is experienced in the design and 
conduct of evaluation studies, including data collection, synthesis, production and 
dissemination of evaluation results to community members that are tailored to their 
specific needs and interests. 
 
Eileen Collins, PhD 
Associate Dean for Research, Office of Research Facilitation and Professor, 
College of Nursing, University of Illinois at Chicago 
Her research focuses on improving physical function and quality of life through 
cardiovascular and pulmonary rehabilitation interventions. She has been continually 

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funded for over 20 years by organizations such as NIH, VA and various foundations. Dr. 
Collins has published over 80 papers in peer-reviewed publications. 
 
Margaret (Peg) Baumann, MD 
Geriatric Medicine Physician, Jesse Brown Veterans Administration Medical 
Center 
Dr. Baumann has accepted the position as the local Safety Officer and will work with the 
study PI and the DSM Committee to review pilot study data and safety monitoring.  
 
Conflict of Interest for SO. 
 
The SO will adhere to the Conflict of Interest Policy and procedures of the University of 
Illinois.  
 
Protection of Confidentiality. 
 
Data will be presented to the SO and the DSM Committee in a blinded manner during 
meetings and in written reports. The content of the SO reports and discussions will be 
treated as confidential. Participant identities will not be known to the SO. 
 
SO Responsibilities.  
 
The responsibilities of the local DSM Committee and the SO include: 
 
• Review the research protocol, informed consent documents and plans for 
data safety and monitoring; 
• Recommend subject recruitment be initiated after receipt of a satisfactory 
protocol; 
• Evaluate the progress of the trial, including periodic assessments of data 
quality and timeliness, recruitment, accrual and retention, participant risk 
versus benefit, performance of the trial sites, and other factors that can affect 
study outcome; 
• Consider factors external to the study when relevant information becomes 
available, such as scientific or therapeutic developments that may have an 
impact on the safety of the participants or the ethics of the trial; 
• Review study performance, make recommendations and assist in the 
resolution of problems reported by the Principal Investigator; 
• Protect the safety of the study participants;  
• Report to NIA on the safety and progress of the trial; 
• Make recommendations to the NIA and the Principal Investigator concerning 
continuation, termination or other modifications of the trial based on the 
observed beneficial or adverse effects of the treatment under study; 
• Ensure the confidentiality of the study data and the results of monitoring; and, 
• Assist the NIA by commenting on any problems with study conduct, 
enrollment, sample size, and/or data collection. 
•  

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12.0 Statistical Considerations 
We will conduct a thematic analysis to explore themes from interviews and focus groups. 
Feasibility and acceptability will be assessed using descriptive and non-parametric 
statistics. Exploratory analyses will be conducted to assess for trends and effect sizes. 
Dr. Alana Steffen of the College of Nursing statistician will conduct all analyses. The 
apriori stated analysis is listed below. 
This is a pilot study for feasibility. For these pilot data we will emphasize descriptive 
statistics such as means, standard deviations, effect sizes, medians, interquartile 
ranges, frequencies, and percentages to demonstrate the feasibility of recruitment, 
adherence, and retention, treatment effects over time, and proof of concept.  Our 
statistical approach for a full trial of these hypotheses will be Generalized Linear Mixed 
Models (GLMM) with an identity link function for a continuous outcome or a logit link 
function for a binary outcome.  Conceptually, GLMM is a more advanced version of 
repeated measures ANOVA that can account for potential correlation among multiple 
measurements over time while having flexibility in fitting outcomes with different 
distributions (such as normal, binomial or Poisson, etc.). One advantage of this 
approach over repeated measures ANOVA is that there is no assumption that 
participants are measured at every, or even the same, time points. Therefore, these 
models are very flexible at handling missing data. Participants who have a missing 
observation are not excluded, thus, this produces the intention to treat (ITT) full 
information maximum likelihood (FIML) model.  Conducting these models on pilot data 
help with sample size calculations for a future R01 submission. 
 
13.0 Regulatory Requirements 
13.1 Informed Consent  
Participants are community dwelling adults without dementia, but with concern or that 
have family members with dementia. We have established strong relationship with key 
stakeholders. Participants will be recruited through a flyer with information about the 
study posted on organization’s website and by word of mouth. We have developed a 
media recruitment script that will be used as the script for a video presentation that will 
be posted on a website, TV add, Facebook, and read as a radio add. We will send a 
notice via the CCTS research match and the TNN Match service using the form titled 
“research match”.   
• Participants that contact the study team will be sent the consent form and given as 
much time as they feel necessary to decide if they would like to participate.  Each 
interested subject will be mailed a copy of the consent form 1 week prior to scheduling 
the initial consent phone visit.  This will be done to allow potential subjects sufficient 
time to consider participation. Participants will be encouraged to ask any questions at 
any time throughout the course of the study.  Research personnel will be available to 
answer these questions. Subjects will be informed that participating in this research is 
voluntary. Subjects will be informed that they may withdraw from the research at any 

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time without penalty. Patient providers are not part of the study team. Informed consent 
will be obtained using procedures and documents understandable to the subject.  
Individuals who are unable to give informed consent will be excluded from participation 
in this research.  All study personnel will have received the required UIC CITI and 
HIPAA training prior to initiation of the study.  The PI (Ulf Bronas), and the study 
manager will obtain consent.  Informed consent documents will be kept in a locked file 
cabinet in a locked office separate from other study documents.  Only the PI (Ulf 
Bronas) will have access to these files. 
• During the e-consent process, the study will be thoroughly explained and all questions 
will be answered. Comprehension of all study procedures will be ascertained by non-
leading open-ended questions. If participants express an understanding of the study 
and study procedures and would like to participate in the study, informed e-consent will 
be obtained. Participants will be able to continue to refer the information or contact the 
investigator if they have questions. 
13.2 Subject Confidentiality  
• 
Precautions to protect subject privacy will be taken throughout the course of the 
study.  All telephone conversations with potential subjects will be conducted in a private 
setting.  No face to face conversations will take place. Strict procedures will be put in 
place to minimize the risk of breach of confidentiality.  All subjects will be assigned a 
study code.  The master list of the subject’s name and the linked code will be kept by 
the study manager in a locked file cabinet in a locked office.  All information provided by 
subjects will kept strictly confidential and will not be reported on an individual basis.  
None of the information provided by subjects will become part of the medical record.  
Hard copy data will be stored in a locked office, and electronic data will be stored on a 
password-protected computer.  Hard copy and electronic data will be coded, with the 
master list kept separately in a secure file in the principal investigator’s office.  Subjects 
who refuse to agree to the HIPAA authorization and consent form will not be able to 
participate in this study. Study data will be coded in numerical order (e.g. PAIS001, 
PAIS002 etc.). The link to the code will be maintained by the project manager and will 
be kept in a locked file cabinet in a locked office separate from study data.  An 
electronic copy of the masterfile will be kept in a folder, separate from the data and 
study forms, on a UIC secured drive. The project manager and PIs will have access to 
the code.   The link to identifiers will be destroyed after 6 years.  The study statistician 
will have access to the de-identified database for analysis purposes.   
• 
Internet-based application/package –Specify: iCardia: Remote collection of Fitbit 
data and delivery of text-messages will be done via iCardia, a secure, password-
protected, internet-based application that has been developed at UIC and is currently 
hosted in a HIPAA-compliant server at the ACCC Secure Research Environment. Text-
messages will be programmed in the iCardia system by the RAs and the PI, based on 
each person’s responses to the interview at baseline and will be sent to study 
participants based on their preferences captured at baseline. Participants will be able to 
change their preferred days/hours by responding to the text-messages sent. 
Participants who no longer wish to receive reminders or text-messages may reply with 
“STOP.” iCardia automatically will stop sending messages if this is received; thus, 
messages will be immediately discontinued without requiring contact with research 

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team. iCardia is password protected and will only be accessed by the PI and key 
research personnel at UIC through an encrypted, Secure Sockets Layer/VPN 
connection. iCardia will be used in this study for two purposes: (1) to send motivational 
text-messages about breaking up sedentary time to study participants in the intervention 
group; and (2) to remotely collect Fitbit data pertaining to participants’ physical activity 
(steps, minutes of activity, intensity of activity, sedentary minutes, etc.). Storing and 
exportation of Fitbit data from iCardia is done using Subject ID codes only.  Text-
messages send from iCardia will not contain patient health information or any other 
sensitive data.  
• 
Ilumivu EMA app for recording of behavior options: All data collected from the mobile 
app are encrypted before being pushed to the cloud-based storage database. No data 
are ever stored on the server's file server but always in the database. Access to the 
database is gated so entry is only permitted to users entering through the approved 
route (i.e. you can't hack your way into the database by guessing at the URL). llumivu's 
main servers are located in the USA.  Data are made accessible to the researchers only 
by directly accessing the secure site with their verified login credentials and 
downloading the dataset as a CSV file. Datasets will never be transmitted by email. The 
mEMA platform does not require any Personally Identifying Information (PlI) from 
participants. The mEMA platform automatically generates a unique identifying code that 
you give to the user to enter into their mobile app. They key linking this code to any PII 
is stored outside the mEMA system by the investigators. All the PlI data is encrypted 
and stored in a database separate from the data entered into assessments by your 
respondent. When the research team downloads the aggregated dataset it will contain 
no PII. When respondents are completing assessments via the mobile apps then they 
will never be able to access the web-platform. Designated portions of an ilumivu-based 
site may only be accessed after supplying a verified user ID and password. Data can be 
stored either in an encrypted manner or in clear-text. All data are encrypted in 
transmission 
• 
PI will share data through sharing requests and also work with the Program Officer 
to identify relevant NIH-recommended data repositories for the pilot data. PI will make 
the data available for sharing by the time of the online publication of the pilot’s main 
findings. All data will be properly de-identified before sharing. 
13.3 Unanticipated Problems 
• All study-related, serious, unanticipated adverse events will be reported to the IRB 
within 48 hours of discovery.  Other unanticipated events will be reported to the IRB at 
the time of continuing review.  We will comply with university policies and procedures 
regarding any unforeseen identifiable data loss. 

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14.0 
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Appendices 
Eligibility Checklist 
Demographic 
Face sheet 
Charlson Comorbidities  
Medical history questionnaire 
Telephone script 
Interview guide 
Participant satisfaction survey