Pilot Trial of an Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program for Older Adults
Phase: NA
Conditions: Mild Cognitive Impairment, Adherence, Patient, Ketosis
Sponsor: Florida State University

PROTOCOL TITLE: MI-CBT Adherence Program for Lifestyle Interventions in Older 
Adults
NCT: 04817176
Date: 8.24.22

Table of Contents
1.0
Study Summary ........................................................................................................3
2.0
Objectives* ...............................................................................................................4
3.0
Background*.............................................................................................................4
4.0
Study Endpoints*......................................................................................................4
5.0
Study Intervention/Investigational Agent.................................................................4
6.0
Procedures Involved* ...............................................................................................5
7.0
Data and Specimen Banking*...................................................................................5
8.0
Sharing of Results with Subjects* ............................................................................6
9.0
Study Timelines*......................................................................................................6
10.0
Inclusion and Exclusion Criteria* ............................................................................6
11.0
Vulnerable Populations*...........................................................................................6
12.0
Local Number of Subjects ........................................................................................7
13.0
Recruitment Methods................................................................................................7
14.0
Withdrawal of Subjects*...........................................................................................7
15.0
Risks to Subjects*.....................................................................................................7
16.0
Potential Benefits to Subjects* .................................................................................8
17.0
Data Management* and Confidentiality...................................................................8
18.0
Provisions to Monitor the Data to Ensure the Safety of Subjects*...........................8
19.0
Provisions to Protect the Privacy Interests of Subjects ............................................9
20.0
Compensation for Research-Related Injury..............................................................9
21.0
Economic Burden to Subjects...................................................................................9
22.0
Consent Process........................................................................................................9
23.0
Process to Document Consent in Writing...............................................................12
24.0
Setting.....................................................................................................................13
25.0
Resources Available ...............................................................................................13
26.0
Multi-Site Research* ..............................................................................................13
MOD00002647
FSU IRB Approved
24 August 2022

1.0
Study Summary
Study Title
Pilot Trial of a Motivational Interviewing and Cognitive 
Behavioral Therapy (MI-CBT) Ketogenic Nutrition 
Adherence Program for Older Adults
Study Design
Block Randomized Pilot Pragmatic Clinical trial completed 
virtually through HIPAA Compliant Zoom
Primary Objective
Assess feasibility and acceptability of all protocol 
components of a pilot pseudo-pragmatic trial testing a 6-
week telehealth KNA program compared to a KN 
information only group for older adults with MCI in the FSU 
SeniorHealth clinic to prepare for a full-scale trial.
Secondary 
Objective(s)
Assess signal of initial effect of the KNA program on 
important clinical outcomes and adherence relative to a KN 
information-only condition.
Research 
Intervention(s)/ 
Investigational 
Agent(s) 
Using a centralized telehealth approach, the KNA program 
will consist of 6 weekly group meetings, which will take 
place via HIPAA-compliant Zoom. The group will be co-led 
by a clinical psychologist and a nurse practitioner with 
expertise in nutrition. Approximately half of each session 
will be devoted to providing nutrition information and half 
devoted to psychoeducation, MI activities, and CBT skills. 
Participants assigned to the KN-only group will also attend 
weekly group meetings with information about how to 
adhere to KN and how to track macronutrients, food intake, 
and ketone levels. Participants will be provided with the 
same participant binder as the KNA group with 
informational handouts and KN recipes, but without the MI-
CBT handouts. Participants will be asked to track their food 
intake and daily ketone levels, and will be provided with the 
option of attending a weekly Zoom meeting where they may 
ask questions about KN and receive additional nutrition 
information as needed. These optional meetings will be 
offered for 6 weeks.
IND/IDE # 
Study Population
Older adults 60+
Sample Size
N = 60
Study Duration for 
individual 
participants
1 year, including pre/post assessments; intervention is 6 
weeks.
Study Specific 
Abbreviations/ 
Definitions 
KN = ketogenic nutrition; KNA = ketogenic nutrition 
adherence; MCI = Mild Cognitive Impairment; PCT = 
Pragmatic clinical trial
MOD00002647
FSU IRB Approved
24 August 2022

2.0
Objectives*

Objective 1:  
Assess feasibility and acceptability of all protocol components of a pilot pragmatic trial 
testing a 6-week telehealth KNA program compared to a KN information only group for 
older adults with possible or pre-MCI in the community and at a senior health clinic to 
prepare for a full-scale trial.  
Specifically, we will examine the feasibility of the recruitment, retention, assessment, 
electronic health record (EHR) downloads, and intervention delivery methods through the 
FSU SeniorHealthTM clinic. If we determine it is not feasible to recruit the full sample 
through this clinic, we will expand recruitment to the community.
We hypothesize that
o
The study protocol (MI-CBT KNA program) will result in high patient 
retention (90%) and patient attendance of intervention sessions (80%), and 
o
A centralized MI-CBT telehealth delivery approach will be associated with 
high intervention acceptability ratings from patients and key stakeholders. 
o
MI-CBT KNA program will result in higher adherence to KN compared to the 
KN information-only group as evidenced by higher levels of ketones at week 6 
of the intervention using at-home ketone urinalysis test strips.
To test these hypotheses, we will use a mixed methods approach using qualitative 
interviews, quantitative measures of patient satisfaction with the intervention (using the 
Client Satisfaction Questionnaire) and provider perception of the overall fit of the 
intervention in the clinic, and of patient intervention attendance and study attrition. 
Qualitative data from providers and patients will be thematically coded to further examine 
acceptability and barriers to implementation.  

Objective 2: 
Assess signal of initial effect of the KNA program on important clinical outcomes and 
adherence relative to a KN information-only condition. 
We hypothesize that patients in the KNA condition, relative to the KN-only condition, will 
show 1) higher rates of clinically significant improvements on the RBANS total scale 
scores, improvements in daily functioning (FSQ), decreases in patient CAIDE risk score, 
improvements in HBA1C levels and comprehensive metabolic panels, and improvements 
in self-reported pain using the Rolland-Morris Pain scale, and 2) improved adherence to 
KN, as evidenced by higher levels of measurable urine ketones in the KNA condition 
compared to the KN-only condition.
We will also examine the feasibility of using electronic health record (EHR) data as an 
additional measure of health, pain, and cognitive outcomes.   
To visually examine these hypotheses (as significance testing is not appropriate for a pilot 
study), we will extract data on clinical outcomes from the EHR to examine patient 
outcomes before and after engaging in the intervention and to compare group differences. 
MOD00002647
FSU IRB Approved
24 August 2022

We expect that patients in the KNA condition will have higher rates of transferring to 
MCI or normal range on the RBANS and improvements in functional status on the FSQ. 
Participants in the KNA condition will have reductions in self-reported pain and greater 
improvements on other health indices.  Additionally, we expect higher rates of measurable 
ketones (trace or higher) in the KNA program compared to KN-only based on daily, at-
home urinalysis test strips. Combined, these data will provide important information about 
the clinical effects of the programs and feasibility of the proposed study components for 
a larger ePCT. 
3.0
Background*
Alzheimer’s disease (AD) is the fifth leading cause of death in the United States, and 
despite decades of research, there are still no effective treatments or preventive 
interventions. One promising intervention has been nutrition that mimics calorie 
restriction, such as ketogenic nutrition (KN).  Ketogenesis appears to be one of the 
primary pathways through which calorie restriction provides benefit. Thus, nutritionally 
dense KN provides many of the physiological benefits of calorie restriction while 
providing sufficient satiation and nutrition. Specifically, KN may directly target 
neurobiological mechanisms associated with the development of AD, such as defects in 
mitochondrial function, cerebrospinal fluid biomarkers, and dysfunctional glucose and 
lipid metabolism.
Recent feasibility trials of KN in older adults demonstrate substantial improvements in 
cognitive scores and mood, suggesting that KN is a promising therapeutic for targeting 
multiple disease markers associated with AD. Ketogenic nutrition (KN) is also a 
promising intervention that may directly target mechanisms associated with pain in older 
adults. In fact, in addition to targeting mechanisms associated with chronic pain,1 KN is 
associated with a range of benefits across multiple chronic conditions often associated 
with pain. Despite being a promising intervention, there are significant barriers to testing 
and implementing nutritional interventions to prevent AD in real-world settings. One of 
the most challenging barriers is the difficulty of adhering to long-term diet modification, 
which may be especially challenging to implement in older adults with mild cognitive 
impairment (MCI). 
Clinical psychology offers multiple empirically supported techniques for changing 
behavior and thinking and maintaining change. Cognitive behavior therapy (CBT), 
specifically, has documented success in application to adherence to weight loss and 
diabetes prevention and treatment programs and can be combined with motivational 
interviewing (MI) strategies to enhance motivation and adherence to lifestyle change 
programs. MI-CBT skills can be used in a group setting to improve the scale-up of 
interventions while providing social support and accountability. 
Thus, group-based MI-CBT may be key to pragmatically increasing patient adherence to 
ketogenic nutrition long-term.  In sum, the scientific premise is that adherence to 
nutritionally dense KN may be a powerful therapeutic for older adults with cognitive 
impairment; however, there remain significant challenges to testing and disseminating a 
KN intervention on a larger scale. The proposed project will address these challenges by 
pragmatically assessing the effectiveness of a telehealth KN adherence (KNA) program 
embedded in a community clinic, FSU SeniorHealthTM, on cognitive and health outcomes. 
MOD00002647
FSU IRB Approved
24 August 2022

My project will build on basic science and existing feasibility trials to assess whether a 
KNA program increases adherence and retention in KN intervention studies, while 
influencing important clinical and patient-oriented outcomes. Further, we will pilot an 
embedded pragmatic clinical trial (PCT) approach in order to prepare for a full-scale PCT. 
Key innovations include: 

Testing the application of MI-CBT behavioral techniques to address major challenges 
of promising nutrition interventions in older adults with MCI. The MI-CBT skills 
portion is designed to enhance motivation and remove personal barriers to eating 
healthy, while reducing conflicts at home and providing a supportive environment.

Applying a centralized telehealth delivery model in the context of the community and 
a senior health clinic to assess the feasibility of delivering this type of health-behavior 
intervention. We will use a centralized delivery model to increase the scalability and 
fidelity of the intervention and to reduce clinician burden. This pilot will provide data 
on the feasibility of using an embedded PCT approach to translate our KNA program 
directly to the community. 

Utilizing existing, embedded clinic data from EHRs to improve the scalability, reduce 
costs, and reduce the burden on clinicians and patients for completing clinical 
research. Through the examination of existing data in EHRs, we will be able to reduce 
study costs for assessment appointments, measures, and researcher and clinician time.
4.0
Study Endpoints*
This study will focus on assessing the feasibility and acceptability of all protocol 
components of a pilot pragmatic trial, testing a 6-week telehealth KNA program compared 
to a KN information only group for older adults with possible MCI in the community and 
at a senior health clinic to prepare for a full-scale trial. We will use a mixed methods 
approach using qualitative interviews, quantitative measures of provider’s perception of 
the overall fit of the intervention in the clinic, and of patient intervention attendance and 
study attrition. Qualitative data from providers and patients will be thematically coded to 
further examine acceptability and barriers to implementation.
We will also focus on assessing signal of initial effect of the KNA program on important 
clinical outcomes and adherence relative to a KN information-only condition. Data on 
clinical outcomes will be extracted or requested from patient health records before and 
after engaging in the intervention and to compare group differences. Patient participants 
will also complete assessments in-person, following appropriate COVID-19 precautions, 
pre- and post-intervention. 
We expect that patients in the KNA condition will have higher rates of transferring to the 
normal range on the RBANS, greater improvements in functional status on the FSQ, and 
greater improvements in self-reported pain and other health indices. Additionally, we 
expect higher rates of measurable ketones (trace or higher) in the KNA program compared 
to KN-only based on daily, at-home urinalysis test strips. Combined, these data will 
provide important information about the clinical effects of the programs and feasibility of 
the proposed study components for a larger PCT. 
5.0
Study Intervention/Investigational Agent
MOD00002647
FSU IRB Approved
24 August 2022

Using a centralized telehealth approach, the KNA program will consist of 7 weekly group 
meetings across 6 weeks, which will take place via HIPAA-compliant Zoom. The MI-
CBT KNA group will be co-led by a clinical psychologist and a nurse practitioner with 
expertise in nutrition, and the KN information-only group will be led by a nurse 
practitioner only. Approximately half of each session will be devoted to providing 
nutrition information and half devoted to psychoeducation, MI activities, and CBT skills. 
Each group session will be recorded and rated by a trained clinician using a modified MI 
Coach Rating Scale to measure fidelity to MI-CBT strategies and reviewed with Dr. Naar, 
a recognized expert on MI and CBT.  These recordings will be stored on a secure College 
of Medicine network drive and will only be used for the duration of the project and 
reviewed by the study team for quality control and intervention consistency. Any 
information from these recordings used for research purposes will be fully de-identified, 
with qualitative information transcribed and coded by the research team. Participants will 
be compensated $20 each week for their time in the study and completion of weekly 
“homework” (i.e., food logs, ketone logging, and online survey (MSQ, PHQ-9, pain scale, 
self-reported weight, daily ketone level, self-reported adherence to KN, self-reported 
barriers and facilitators to adherence, GAS, group cohesion scale, social support scale, 
and perceived stress scale.))
KNA Week 1
The first group meeting will consist of a 1.5 hour informational and psychoeducational 
session to introduce participants to the purpose of the group, the ketogenic nutrition goals, 
and to the MI-CBT model of behavior change in relation to nutrition. Participants will be 
given a binder that includes weekly goals, handouts on how to maintain KN, including 
daily recipes and food lists, as well as MI-CBT handouts and worksheets. Participants will 
be asked to slowly begin reducing their daily net carbohydrate intake to 125g over the 
first week. 
We will provide individualized recommendations for macronutrient intake based on the 
net carbohydrate weekly goal and participant health information (e.g., sex, weight, height, 
activity level). Participants will log macronutrient intake in their food logs in order to 
ensure that approximately 60% of their diet involves healthy fats (e.g., fish, avocado, olive 
oils), and to begin learning the general macronutrient content of foods they consume. 
Participants will have the option of completing these food longs online or using paper 
copies at home. The focus of these first meetings will be on nutritional education and 
helping participants identify relevant values, goals, and reasons for committing to make 
healthy changes.
KNA Weeks 2-4
In 1-hour weekly meetings, participants will learn about the CBT model and relevant 
skills, with assigned homework. Based on feedback from the feasibility trial, the program 
will emphasize cognitive restructuring and problem-solving as primary skills, while 
handouts on additional techniques (e.g., distress tolerance, behavioral activation, 
mindfulness) will be provided as optional. 
These skills will help participants identify health goals, manage triggers for unhealthy 
eating behaviors, and overcome external obstacles to healthy eating. MI will be employed 
throughout these sessions, through worksheets as well as reflective listening, 
MOD00002647
FSU IRB Approved
24 August 2022

summarizing, affirming, and open-ended questions from the group leaders. Participants 
will be instructed to gradually reduce their net carbohydrate intake across the first 3 weeks 
of the program in a step-wise fashion (i.e., 125g in week 1, 75g in week 2, 50g or less in 
week 3) in order to reduce possible adverse responses to the diet (e.g., GI distress, fatigue). 
Healthy fat intake is a core component of this program, and participants will be provided 
with ample instruction on ways to increase healthy fat intake while maintaining a healthy 
balance of macronutrients (e.g., 60% fat, 30% protein, 10% carbohydrates).
KNA Weeks 5-6
In the final two sessions, the focus will shift to emphasize CBT skills practice, 
maintenance of goals, sustainment of progress, and social support. Participants will make 
maintenance plans, learn to manage slips, and continue practicing cognitive restructuring 
skills. The recommended net carbohydrate intake will be reduced to 20g or less these 
weeks, depending on individual ketone level and macronutrients.   
KN-Only (Condition 2)
Participants assigned to the KN-only group will attend a 1.5-hour informational session 
as a group, which will provide comprehensive information about how to adhere to KN 
and how to track macronutrients, food intake, and ketone levels. Participants will be 
provided with the same participant binder as the KNA group with informational handouts 
and KN recipes, but without the MI-CBT handouts. 
Participants will be asked to track their food intake and daily ketone levels, and will be  
asked to attend a weekly Zoom meeting where they may ask questions about KN and 
receive additional nutrition information as needed. These optional meetings will be 
offered for 6 weeks. The structure of this control condition will allow us to examine of 
the benefits that an MI-CBT group approach provides for increasing adherence to KN and 
retention in a KN program, compared to KN education only.
6.0
Procedures Involved*
Design Overview
Preparation. During the first 6 months of the study, my team will work closely with key 
stakeholders (i.e., clinic director, practice manager, and nurse practitioner) in the FSU 
SeniorHealthTM clinic to coordinate initial contact with patients about the study. Initial 
contact will include posting flyers in the SeniorHealth clinic, handing out flyers during 
appointments, and emailing flyers or calling patients who have consented to be contacted 
about FSU research studies (a consent process, which is completed as part of the normal 
SeniorHealth intake packet), posting flyers in the Westminster Oaks monthly newsletter, 
and patients will be able to fill out a contact card with their name, phone number, and email 
that will be placed in a locked “drop box” in the SeniorHealth clinic. A study team member 
will collect these cards weekly to enter into a secure screening waitlist. Patients may also 
discuss interest with their provider or contact the study team directly using the information 
on the study flyer. If we are unable to recruit the full sample through FSU SeniorHealth, 
we will expand recruitment to community older adults more broadly, including individuals 
from the Institute for Successful Longevity participant registry. Community participants 
will be recruited through flyers, e-mails, and phone calls. Potential participants will only 
be contacted through e-mail or phone calls if they have previously provided consent to be 
MOD00002647
FSU IRB Approved
24 August 2022

contacted for research purposes.  Potential participants will be added to a secure screening 
waitlist, which will include only their name and phone number. This screening waitlist 
containing potential participant contact information will be stored in a password protected 
document. Contact information for potential participants will be destroyed for any 
participant who does not qualify and consent to remain in the study.   
Screening phone call. After confirming interest in being contacted about the study, 
participants will be contacted by a member of the research team and screened for eligibility. 
This screening will include a telephone MoCA,  sections 1 and 4 from the Functional Status 
Questionnaire, a brief memory complaint scale, a brief self-rated pain during the past week 
(0-10), and self-reported height, weight, and age. Participants will also be asked to report 
any restrictive dietary or medical conditions that may make them unable to change their 
nutrition. Participants will be compensated with a $5 e-gift card for completing the 
screening and will be asked to provide their full name and email address to receive the gift 
card. This contact information will not be retained for future research purposes unless 
participants consent to be contacted for future studies. All screened participants will be 
provided with a handout on healthy living designed in collaboration with the SeniorHealth 
physicians. If participants are eligible, then they will be sent an online consent form via 
REDCap, which they will read and review using HIPPA-compliant Zoom with a member 
of the research team before signing. The study team will then complete a final eligibility 
check of the patient’s EHR, self-reported health conditions, or provided health records and 
review with a SeniorHealth physician to confirm eligibility and ensure participant’s safety. 
The SeniorHealth physician will be blinded to participant identify of non-clinic 
participants. Participants who are eligible and consent to participate will have screening 
data linked with other study data, in order to reduce redundancy in assessment measures. 
Pre-intervention EHR data download & collection of Health Records(Time 0). FSU 
SeniorHealth patients will be asked to provide our team access to relevant EHR data. 
Participants who are not patients at FSU SeniorHealth will be asked to provide the same 
records if possible, but self-reported health conditions and medications will be accepted. 
Our team will extract and clean relevant EHR/health data on participants who consent to 
participate in the study. Data from EHR/health records will be used to conduct a secondary 
eligibility screening to determine if there are any other major health conditions that will 
exclude participants from the study. Data requested will only include the minimum PHI 
necessary to complete the proposed study. Data from the EHR or requested health records 
will include the following information only from appointments pertinent to the study: 
patients’ problem/diagnostic list, medication list, patient vitals, metabolic panels, HbA1C, 
potassium, CRP, scores on recent cognitive and psychological assessments (i.e., MoCA, 
depression inventories), and relevant provider notes about a patient’s cognitive functioning 
and pain.  Data from the EHR/health records will be used to calculate a CAIDE dementia 
risk score (Exalto et al., 2014), which includes age, education, sex, cholesterol, BMI, and 
systolic blood pressure (See Figure 1). The FSU SeniorHealth EHR is maintained on 
Athena and thus all the information will be accessed from Athena by the study PI, who is 
a licensed clinician who has completed the required HIPAA and Privacy trainings required 
to access this information. These data will include the participants MoCA scores, GDS, 
and FSQ scores or relevant qualitative data about their activities of daily living, and 
demographic characteristics. We will also include laboratory results that may be relevant 
to cognitive outcomes for secondary data analyses, including: HbA1c, glucose, potassium, 
MOD00002647
FSU IRB Approved
24 August 2022

blood pressure, and cholesterol. Laboratory data that is pulled from the EHR, will be used 
as a comparison to metabolic and HbA1c data obtained from a blood draw during two in-
person assessments. 
Baseline Assessment (Time 1). In addition to embedded EHR and other health record data, 
we are collecting additional data to evaluate the personal impacts of the intervention. This 
in-person assessment will include: the Repeatable Battery of Neuropsychological Status 
(RBANS update – form A), GAS, PHQ-9, FSQ, ISEL, MSQ, CAIDE risk score, OPQOL, 
GSE, PSQI, SCOFF, social support, self-efficacy, a verbal pain descriptor scale, the Brief 
Pain Inventory, The WOMAC-Pain scale, the PANAS, PSS, the WHY-MPI, and the 
Roland-Morris Pain and Pain-related Disability scale, a fasting blood draw for a 
comprehensive metabolic panel and HbA1C (completed by a certified medical assistant), 
a weight and body composition assessment, and basic vitals (blood pressure and heart rate). 
Participants will be scheduled in the morning for these assessments in order to allow 
approximately 10-hour fasting for the blood draw. This assessment will be completed in-
person following COVID-19 precautions (described in section 14), and patient participants 
will be compensated $30 for their time. 
Post-intervention Assessment (Time 2). Participants will complete this assessment in the 
final weeks of the program, in order to assess participants when they are in ketosis. 
Participants will be asked to return their ketone logs either electronically, reported over the 
phone, or via mail to the study PI. The research team will complete qualitative interviews 
with participants to collect information about barriers and facilitators to completing the 
program and adhering to KN. Participants will complete the RBANS update – Form B, the 
PHQ-9, FSQ, MSQ, GAS, CAIDE risk score, OPQOL, PSS, PSQI, social support (ISEL), 
self-efficacy (GSE), group cohesion, a verbal pain descriptor scale, the Brief Pain 
Inventory, The WOMAC-Pain scale, the PANAS, the Roland-Morris Pain and Pain-related 
Disability scale, the WHY-MPI, and participants’ global impression of change, a second 
fasting blood draw for comprehensive panels (completed by a certified medical assistant), 
a weight and body composition assessment, and basic vitals (blood pressure and heart rate). 
Participants will be scheduled in the morning for these assessments in order to allow 
approximately 10-hour fasting for the blood draw. This assessment will be completed in-
person following COVID-19 precautions, and patient participants will be compensated $30 
for their time. 
Post-intervention Assessment (Time 3). Patient participants will complete this assessment 
approximately 3 months after completing the intervention program, in order to assess long-
term maintenance. The research team will complete qualitative interviews with participants 
to collect information about barriers and facilitators to adhering to KN long-term. 
Participants will complete the RBANS Update – form C, the PHQ-9, FSQ, MSQ, GAS, 
CAIDE Risk score, OPQOL, PSQI, social support (ISEL), self-efficacy (GSE), a verbal 
pain descriptor scale, the Brief Pain Inventory, The WOMAC-Pain scale, the PANAS, PSS, 
the WHY-MPI, the Roland-Morris Pain and Pain-related Disability scale, the Client 
Satisfaction Questionnaire (8-item), and participants’ global impression of change in pain. 
This assessment will be completed in-person following COVID-19 precautions and patient 
participants will be compensated $30 for their time.
Participants who express barriers to completing the 3-month post-intervention 
assessment in person will have the option to complete this assessment remotely if they 
MOD00002647
FSU IRB Approved
24 August 2022

choose to. In the even that a participant chooses to complete the Time 3 assessment 
remotely, the following procedures will be conducted: a research assistant will 
schedule a phone call with the participant at a time that is convenient to them to 
complete the qualitative interviews with participants and collect self-reported height, 
weight, and ketone test (if available); participants will be asked to complete 
questionnaires via REDCap by following a link to the survey that will be emailed to 
them by a team member; lastly, due to the nature of the RBANS, participants who 
choose to complete the Time 3 assessment remotely will not be asked to complete the 
RBANS Update – form C. Participants will receive the same amount of compensation, 
$30, for their time upon completing the assessment procedures. 
Post-intervention EHR data download and Provider Assessment (Time 4). Approximately 
six months post-intervention, we will complete a final data extraction from the EHR for 
SeniorHealth patients, which will include the same data as Time 0. We will also request 
updated health records from non-FSU SeniorHealth clinic participants. Additionally, we 
will complete semi-structed interviews with the clinic providers to assess implementation 
barriers and facilitators. Providers will also complete quantitative measures on 
implementation acceptability (i.e., Modified version of the Assessment of Fit Scale for 
outpatient clinics). Provider participants will be compensated with a $25 gift card for their 
time. 
Weekly Assessments. Throughout the active intervention phase, participants will also 
complete a weekly online survey to assess information about their weight, health symptoms 
(MSQ), mood (PHQ-9), anxiety (GAS), stress (perceived stress scale), daily ketone levels, 
response to adherence and barriers to KN, pain, group cohesion, and social support. 
Participants will be asked to mail or email their food diaries to the study team each week 
to assist in monitoring nutritional adherence and safety.  
Sources of Materials
Data 
will 
be 
obtained 
directly 
from 
participants, 
including: 
survey 
data, 
neuropsychological data, and health information. Data will also be collected from FSU 
SeniorHealth EHRs, but will only include the minimum PHI necessary to complete the 
proposed study. Data from the EHR will include the following information only from 
appointments pertinent to the study: patients’ problem/diagnostic list, medication list, 
patient vitals, potassium levels, metabolic panels, HbA1C, CRP, scores on recent cognitive 
and psychological assessments (i.e., MoCA, depression inventories), and relevant provider 
notes about a patient’s cognitive functioning.  Finally, we will complete semi-structed 
interviews with the clinic providers and patient participants to assess implementation 
barriers and facilitators. Provider participants will also complete quantitative measures on 
implementation acceptability (i.e., Modified version of the Assessment of Fit Scale for 
outpatient clinics). Only Dr. Sheffler and key study personnel will have access to 
individually identifiable private information (e.g., names, dates of birth, etc.) outside of 
clinic staff. Staff responses will not be shared with other providers at the clinic. All the 
information extracted from EHR will be save on FSU’s W drive until it is deidentified. 
Deidentified information will be stored in locked file cabinets, within a locked suite, and 
transferred to a password protected computer once coded.
MOD00002647
FSU IRB Approved
24 August 2022

7.0
Data and Specimen Banking*
Blood samples will be collected by a certified medial assistant in a phlebotomy lab at the 
Center for Translational Behavioral Science. Samples will be labeled and identified only 
by an ID number. These samples will be used to assess comprehensive metabolic profiles 
(CMPs) and HbA1c of participants. Samples will be stored temporarily in a -80 F freezer 
in the phlebotomy lab. HbA1C will be extracted through point-of-care and analyzed 
immediately. CMPs will be analyzed using a Piccolo Xpress Chemistry analyzer in the 
College of Human Sciences with the assistance of Dr. Bahram Arjmandi and Neda 
Akhavan. Samples will be transported in a medical transport cooler by trained research 
personnel. Once results of the CMPs are returned, these will be coded and stored with 
other participant data (described below). Biological samples will be disposed of after 
analysis as biowaste.  
Data for Future Use
Participants consent to these procedures as part of the consent process.
Data collected during this research study may be used for future research purposes. The 
data stored will be de-identified. De-identified Data that cannot be linked to participants 
will be kept indefinitely; this data will be saved for future use and may be shared with 
other researchers. This data may be used for secondary data analysis to inform future 
publications examining late-life health and cognition, as well as preliminary data for 
future grant applications.
At the end of the study data collected may be made available, in accordance with the NIH 
Data Sharing Policy (http://grants.nih.gov/grants/policy/data_sharing). This data will be 
saved for future use and may be shared with other researchers. By participating in this 
study, participants are agreeing to allow us to save and share their data anonymously for 
research purposes.
We will ask consented participants if they wish to be contacted for future research 
opportunities.  On the Study consent form, we ask participants if they wish to be contacted 
about future research opportunities in which they might be eligible. For this study, 
information retained for individuals that give permission to keep their contact information 
for future research opportunities will include: Names, Email addresses and Working 
phone number. This information will be collected using a secure REDCap form, only 
accessible by the study team. Contact information will be stored and maintained in a 
password protected excel file, and will be kept separate from individual study related 
information. Access to this information will be limited to only designated study team 
members throughout the duration of the study. 
After consenting to participate in this study, individuals interested in being contacted for 
future studies will be directed to a secure REDCap form to provide their permission to be 
contacted, contact information (email and phone) and age.  The statement on the Consent 
form is as follows:
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All screened individuals will be asked if they are interested in being contacted about future 
research studies. Only by answering “Yes” to interested in future research studies, they will 
be asked by the study team member conducting the screener to provide their contact 
information (email and phone) and age. The statement on the Study Screener form is as 
follows: “Would you like to be contacted for future studies?"
The study team will carefully review and document which participants granted permission for 
the study team to retain their information. Participants who say "yes" will have their 
information stored in a password-protected file, separate from the study data, and accessible 
to only trained members of the study team. Participants may request to be removed from the 
mailing list at any time, in which case a note will be made for data cleaning to remove that 
individual when data is cleaned.
Sharing of Results with Subjects*
Participants will not receive diagnostic feedback about their performance on the phone 
cognitive assessments or results of any biological or emotional testing. Participants may of 
course request to view their own medical records through the FSU SeniorHealth Clinic as 
part of their usual care; however, the study team will not release individual results of testing 
to participants through the study. 
8.0
Study Timelines*
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See table below.
9.0
Inclusion and Exclusion Criteria*
Study Population
Older adults, between the ages of 60-85, and with possible or pre-mild cognitive impairment 
(MCI) were chosen in order to specifically assess the effect of the intervention on individuals 
at higher risk for converting to AD. These individuals may observe the greatest cognitive 
benefits from the intervention, while not requiring a caregiver or significant other to provide 
assistance or consent. The ages 60-85 were chosen, as this age range is often where early signs 
of dementia begin to emerge on neuropsychological testing.
Inclusion Criteria
To meet eligibility for inclusion in the intervention, participants must be 60-85, meet criteria 
for possible mild cognitive impairment, have a Telephone MoCA score >12, be English 
speaking, and have internet access with video conferencing, and report interest in participating 
in a nutrition intervention. In addition to the criteria above, a subsample of 20 participants 
will be selected based on self-reported pain on the Rolland-Morris pain scale (A1) of 3 or 
greater during the past week.
Exclusion Criteria
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Participants will be excluded if they report any exclusionary health or major psychiatric 
conditions as determined by their physician at the FSU SeniorHealth clinic (e.g., Type 1 
diabetes, schizophrenia etc.), are under-weight based on BMI, have a diagnosable major 
neurocognitive disorder, or if they report use of prescriptions that may interact with their 
ability to adhere to the diet (e.g., insulin, MAOIs, immunosuppressant etc.).  Those deemed 
unable to provide informed consent based on the telephone cognitive screener (MoCA<12) 
will be excluded.
10.0
Vulnerable Populations*
Participants, age 60-85, years may enroll in the proposed study. We will not include any 
participants who are unable to provide consent. Of note, a mild neurocognitive disorder 
(MNCD) also known as MCI is characterized by slight decline in cognitive functioning, 
which require compensatory strategies to retain independence. Individuals with MNCD are 
able to live and function independently and are able to provide consent to participate. The PI 
is a licensed clinical psychologist with a specialty in geropsychology and will rule out 
individuals who do not have capacity to consent via a telephone cognitive screener. 
Potential harms from participating in this study are not greater than those encountered in 
everyday life, standard medical care, or during the performance of routine physical or 
psychological evaluations. Participants will be assured that their information will be kept 
confidential to the best of the study team’s ability, and the responses they provide will have 
no impact on their relationship with any academic or health institution. The study team will 
screen potential participants for possible dementia in order to ensure participants have the 
cognitive capacity to provide consent to participate. 
11.0
Local Number of Subjects
We are seeking to enroll a maximum of 60 participants and a minimum of 40 
participants. 
12.0
Recruitment Methods
Recruitment methods will be employed to engage up to 60 participants (aged 60–85), to 
participate in this study. Recruitment materials include a study informational flyer (see 
attached), which will be posted throughout the community at locations that provide 
permission to post the flyer. The flyer may also be handed out directly to interested 
individuals. The flyer will contain information about the nutrition program, research, and 
study team contact information. The research team is available to answer questions about the 
study including participant responsibilities, benefits, risks, and alternatives.
We will work with our stakeholders/partners at FSU SeniorHealthTM clinic to increase 
awareness regarding the study. They will receive a study packet, including study summary, a 
participant study information sheet, and study team contact information. We will ask them to 
refer the participants to the study and to distribute study information to interested participants. 
Interested participants will receive a study information sheet and study team contact 
information which will include a website link to the primary study screener for eligibility 
determination and subsequent enrollment. They will also be asked to share a link on their 
website regarding our study.
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Additionally, the PI and trained study team members on the project may hand out flyers and 
collect contact information from interested individuals during community events and 
community talks. With participants’ permission, any contact information collected will be 
added to a protected online document for participants interested in being contacted about 
potential research participation and physical copies will be destroyed.
Preliminary screen. After confirming interest in being contacted about the study, participants 
will be contacted by a member of the research team and screened for eligibility. This screening 
will include a telephone MoCA,  sections 1 and 4 from the Functional Status Questionnaire, 
a brief memory complaint scale, self-rated pain during the past week (0-10), and self-reported 
height, weight, and age. Participants will also be asked to report any restrictive dietary or 
medical conditions that may make them unable to change their nutrition. Participants will be 
compensated with a $5 e-gift card for completing the screening and will be asked to provide 
their full name and email address to receive the gift card. This contact information will not be 
retained for future research purposes. All screened participants will be provided with a 
handout on healthy living designed in collaboration with the SeniorHealth physicians. If 
participants are eligible, then they will be sent an online consent form, which they will read 
and review using HIPPA-compliant Zoom with a member of the research team before signing. 
For participants who are patients at FSU SeniorHealth, the study team will then complete a 
final eligibility check of the patient’s EHR and review with the physician to confirm eligibility 
and ensure participant safety. For participants who are not patients at FSU SeniorHealth, we 
will request patients provide a copy of their most recent medical records, including health 
conditions, medications, and recent lab work – this step will be optional. The study team will 
determine final eligibility of these patients based on self-reported health conditions or review 
of the records they provide. Participants who are eligible and consent to participate will have 
screening data linked with other study data, in order to reduce redundancy in assessment 
measures.  Patients and participants who have previously provided consent to be contacted 
for research may be called or emailed to assess interest in the study if they are not screened 
during their normal clinic visits. From this sample, we will recruit up to 60 patients who meet 
criteria for possible MCI (e.g., MoCA score of 18-25 and some self- or other-reported changes 
in daily living due to cognition). 20 participants will be selected based on self-reported pain 
of moderate intensity or greater in addition to the other inclusion criteria. There will be two 
intervention conditions: 30 patients will be randomly assigned to the 6-week KNA group 
program and 30 to the KN-only condition. All patients will be given the option of signing up 
for one of three start dates for the programs, with 10 patients maximum in each group. These 
conditions are designed to determine whether MI- CBT strategies improve adherence to KN, 
thereby enhancing the benefits compared to providing KN information alone. Key 
stakeholders in the clinic will be engaged early in the project to increase buy-in to the 
intervention and to introduce staff to the project. 
Recruitment call. The group leaders and study coordinators will call potential participants to 
provide more information about the respective programs and to determine the patients’ 
interest and availability to participate. A log will be maintained that will track the calls made 
by the group leaders to provide information regarding the study to prospective participants. 
The log will include the number of times they were contacted, date they were contacted on, 
name of the person contacted or spoken to and their initial and final response. Individuals who 
indicate that they would like to join the study will be provided with detailed study information; 
additionally, SeniorHealth patients will be asked to provide verbal and electronic written 
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consent and signed HIPAA authorization. After a final eligibility review of the EHR (for 
SeniorHealth patients) and self-reported health conditions, participants will then be randomly 
assigned to a condition.
13.0
Withdrawal of Subjects*
A participant meets the criteria for “premature discontinuation” if they withdraw from the 
study before completion. Premature discontinuation would include participants who decide 
to voluntarily end their participation early for any reason, as well as participants who may be 
withdrawn from the study based on an adverse response to the intervention and consultation 
with the MD, Dr. Paul Katz. Participants may choose not to attend some sessions or complete 
all assessments, but they will not be compensated for assessments they do not complete. 
Participants will not be involuntarily removed from the study for missing sessions or 
assessments if they indicate that they would like to remain in the study. If a participant fails 
to attend 2 consecutive appointments and assessments without notifying the study team, we 
will reach out to them up to 3 times via phone and/or email to assess their interest in 
continuing in the study. No response from the participant will be considered a premature 
discontinuation, and they will be withdrawn from the study. Completion represents 
completing the assessments in addition to the intervention. There are no alternative treatments 
or procedures for participants that choose to withdraw from the study, other than care as usual. 
Participants will be reminded that their participation is voluntary and they may choose to end 
participation in the study at any time.
14.0
Risks to Subjects*
We are only recruiting individuals without unstable chronic medical conditions for this 
nutrition intervention (e.g., significant gallbladder problems, cancer, Type 1 diabetes). 
Further, participants who are underweight based on BMI will be excluded (BMI<19). 
Individuals with these conditions will be screened out in the initial call prior to completing 
the consent process. 
Thus, primary risks associated with changing diet may include, gastrointestinal upset (i.e., 
bloating, diarrhea, gas, and constipation), change in weight, headache, and fatigue. 
Participants will be closely monitored by the study team on a weekly basis to assess any 
adverse response to the diet. If a significant adverse response is reported or identified, the 
team will consult the MD consultant on the team, Dr. Paul Katz, for a clinical decision. 
Participants will be asked to provide two fasting blood samples for assessment of metabolic 
panels and HbA1c. There may be slight discomfort when inserting the needle. Even with 
precautions, minor bruising and swelling around the puncture site can occur. Because every 
person’s veins are different, and veins move frequently, bruising can occur even with the most 
experienced phlebotomists. Participants will be required to fast for 8-12 hours prior to the 
blood draw. The primary risks associated with fasting may include lightheadedness. Thus, we 
will provide snacks for participants after the blood draw is complete. 
Other risks include mental fatigue from completing some potentially challenging cognitive 
tasks. 
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Protection against Risk
Participants will be given the option to end participation at any time with no penalty for doing 
so. Participants may take breaks from testing as requested or choose not to answer sensitive 
questions. 
For the intervention portion, participants will be closely monitored by the group leaders on a 
weekly basis to assess any adverse response to the diet. If a significant adverse response is 
reported or identified, the team will consult the MD and nurse practitioner on the team for a 
clinical decision.  
Physical copies of all tests and measures will be stored in locked cabinets in a secured suite 
in Research Building B at Innovation Park or maintained in the SeniorHealth clinic (for 
SeniorHealth patients only). Data from these physical copies will be coded and transferred to 
electronic spreadsheets, which will be password protected and stored in encrypted locations. 
All identifiable participant data will be stored separately in a password protected document. 
Data will be connected to an ID number rather than participant information.
Prior to the blood draw CMAs will wash and sanitize hands then don gloves. Gloves will stay 
on for the duration of the blood draw. Once the blood draw is complete the needed will be 
capped and disposed on in the appropriate sharps container. CMAs will keep gloves on until 
the draw area is sanitized and disinfected. After the area has been cleaned appropriately, 
CMAs will doff gloves, dispose of them in a biohazard bag and wash hands.  Biological 
samples will be stored in a -80 F freezer in a locked phlebotomy lab at the Center for 
Translational Behavioral Sciences. Only the study PI and CMAs on the team will have access 
to this laboratory. Samples will be disposed of as biowaste after analysis.  
Participants are permitted to participate in in-person study activities if they have completed a 
full COVID-19 vaccination series. At screening, participants may share information with the 
research team regarding their COVID-19 vaccination status; however, based on IRB guidance 
this is their decision and is not a requirement. If participants choose to disclose their COVID-
19 vaccination information the study team will make note of it in the study records.  If 
participants indicate that they are not vaccinated or will not be vaccinated by the start of the 
study and fall within a “high-risk” category, they will be deemed ineligible to participate in 
the in-person portions of the study. To maximize participant safety to protect against COVID-
19 or Coronavirus, COVID-19 precautions will still be implemented for fully vaccinated 
participants. These precautions include, wearing a mask at all times, maintaining social 
distancing when possible, having hand washing and sanitizing stations readily available, and 
cleaning and disinfecting frequently touched surfaces and objects. Participants and members 
of the research team will be told to stay home if they are feeling sick. Participants and study 
team members will wear masks (over nose and mouth) for the duration of all in-person 
contact, and extra masks will be made available to participants if needed. All frequently 
touched surfaces (doorknobs, tables, handles, light switches etc.) will be cleaned and 
disinfected before and after participant contact. Gloves will be worn while surfaces are being 
disinfected and hand will be washed for at least 20 seconds when cleaning is finished and 
gloves have been removed.  All research personnel with participant contact will have 
completed a full COVID-19 vaccination series. 
15.0
Potential Benefits to Subjects*
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A goal of the current study is to assess whether ketogenic nutrition may be beneficial for 
memory and pain severity in older adults and whether the use of an MI-CBT group approach 
may improve adherence to this type of nutrition. Previous research has demonstrated that a 
low-carbohydrate diet has multiple benefits on cognitive functioning, pain, and other health 
factors in older individuals. Thus, participants will be provided with a supportive environment 
for making this diet change as well as empirically validated cognitive behavioral skills for 
behavior change in general. 
During the proof-of-concept preliminary trial, participants reported improvements in energy 
stability, alertness, blood glucose levels, and mood. Participants may experience 
improvements in their cognitive status and will be closely monitored by health professionals.
16.0
Data Management* and Confidentiality
Data acquired from this study will consist of qualitative and quantitative data gathered from 
the 3 assessments and EHR stored on Athena only, as well as data collected from clinic staff 
about their experience being involved with the intervention from a clinical standpoint. Data 
will only include the minimum PHI necessary to complete the proposed study. Data from the 
EHR will include the following information only from appointments pertinent to the study: 
patients’ problem/diagnostic list, medication list, patient vitals, metabolic panels, HbA1C, 
CRP, potassium levels, scores on recent cognitive and psychological assessments (i.e., MoCA, 
depression inventories), and relevant provider notes about a patient’s cognitive functioning.   
All reports, and other study related material will be identified by a coded number only, to 
maintain participant confidentiality. All records with personally-identifying information will 
be kept on FSU’s W Drive and once it has been deidentified, it will be transferred in a locked, 
limited access area (such as a locked file cabinet). Forms containing data/information, will be 
coded by a unique number and stored on a password protected computer and College of 
Medicine server. The encrypted REDCap database used to collect data will be collected and 
stored digitally on a password protected computer and College of Medicine server. Participant 
identity will be kept confidential in presentations or publications of the results of this study.
Data will be collected using FSU REDCap platform or via telephone and will be stored using 
unique ID numbers which will be kept separate from contact information and other study data. 
They will be saved in separate locked or password protected files. Data will undergo initial 
coding to understand reoccurring themes and ideas by exploring word frequencies and 
definition of concepts. This data will be exported into SPSS for quantitative data analysis. 
Results from the quantitative data analysis will be integrated with that of the qualitative data 
analysis to generate the final product. Data from completed study assessments will be linked 
using a coded participant number. Data collected from patient EHR or provided health records 
will be stored on a separate HIPAA Compliant server (W Drive) at the FSU College of 
Medicine. Data will only be moved from this server if all personal identifying information 
has been removed and coded. Once PHI has been removed and data is coded, it may be stored 
with other coded data on a separate, secure College of Medicine server. Only study team key 
personnel will have access to the data. 
All computer entry and networking programs will be done with coded numbers only. Data 
collected for this study is coded and confidential where only the study team will be able to 
link the participant data to identifying information. However, research information that 
identifies the participant may be shared with the FSU Institutional Review Board (IRB) and 
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others who are responsible for ensuring compliance with laws and regulations related to 
research, including people on behalf of the National Institutes of Health (NIH) and the Office 
for Human Research Protections (OHRP).
Information will be kept confidential – we will only use this information to contact participant 
for the purposes of this study. After the conclusion of the study and related data analysis, data 
will be de-identified. Data that cannot be linked to an individual (i.e., de-identified data) will 
be kept indefinitely; this data will be saved for future use and may be shared with other 
researchers. 
17.0
Provisions to Monitor the Data to Ensure the Safety of Subjects*
The data and safety monitoring plan will involve routine (i.e., quarterly) monitoring by the 
research team of:

Removal of direct identifiers from information gathered;

Documentation of access to data;

Security of the database with participant identifiers and the documentation of 
investigator access to this database; 

Any conditions that may negatively impact the confidentiality of information.  
Data collected from the EHR will only include the minimum PHI necessary to complete the 
proposed study. 
18.0
Provisions to Protect the Privacy Interests of Subjects
Given the nature of the intervention as a group intervention run through the participants’ 
health clinic, complete privacy cannot be guaranteed, as both providers and other intervention 
participants will interact with the participants.  Participants will be made aware of these 
limitations to privacy during the initial consent process. Outside of the participants clinical 
provider and intervention group, only individuals on the study team will have access to 
identifiable information. 
Data collected from the EHR will only include the minimum PHI necessary to complete the 
proposed study. 
During phone assessments, every effort will be made to ensure that the participant is in a quiet 
room, free of distraction or individuals not involved in the study. Participants may be 
contacted via phone or email during their engagement in the study, and they will be made 
aware of the limitations to privacy and confidentiality posed by these forms of communication 
during the consent process.
Participants will be identified by a unique study ID. All study information will be kept 
confidential and only accessible by the study team. All electronic documents will be password 
protected and maintained by key study personnel. The file linking the participant ID with 
identifiable information will be kept until that participant has completed data collection and 
then deleted. The full dataset, without identifying information, will be kept for 10 years on a 
password-protected computer.
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The Zoom group sessions recordings will not be used for research purposes. These will only 
be stored for the duration of the project and then deleted. These will only be used for PI 
training in Motivational interviewing skills in supervision with Dr. Sylvie Naar, a co-
investigator and mentor on the training grant that funds this project.  Zoom sessions will be 
recorded using FSU HIPAA compliant zoom and the recordings will be automatically stored 
locally on the PI’s college of medicine laptop and then moved to the secure FSU W drive. 
The recordings of the Zoom group sessions will be deleted after each supervision session is 
complete. 
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PROTOCOL TITLE: KNA Pilot Trial
Page 22 of 24
Revised: December 1, 2018
19.0
Compensation for Research-Related Injury
Participants will not be compensated for research-related injury, and this will be clearly 
indicated on the consent form. 
Data collected from the EHR will only include the minimum PHI necessary to complete the 
proposed study. 
20.0
Economic Burden to Subjects
N/A
21.0
Consent Process
Consent will be obtained following the “SOP: Informed Consent Process for 
Research (HRP-090).” Given that the study is a telehealth intervention, consent 
will be obtained in two ways. First, participants will be sent a link to an FSU 
REDCap form that will include the complete consent document and a text box for 
an electronic signature. Additionally, participants will be mailed or emailed a 
copy of the consent form for their records. Participants will review this consent 
document on the phone or via video call through HIPAA Compliant Zoom with a 
research team member prior to providing an electronic signature. The research 
team member will ask basic questions about the study to ensure that the 
participant understands their role and the extent of the study before providing 
consent. Please see attached consent document for more details. 
22.0
Process to Document Consent in Writing
Our consent process will follow the “SOP: Written Documentation of Consent 
(HRP-091).” However, all consent processes will be documented electronically, 
rather than using a physical copy. The full consent form (see attached) will be 
reviewed with the participant telephonically or via HIPAA Compliant Zoom by a 
trained research team member. Participants will be asked to electronically sign 
and date the consent form only after they have reviewed the form with the 
researcher, have demonstrated their understanding of the research procedures, and 
have had an opportunity to ask questions about the study. Documentation of 
consent will be stored electronically using the FSU REDCap platform. During the 
consent process, participants will be asked if they are interested in being 
contacted for future studies, and their contact information will be stored in a 
password protected file.  
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PROTOCOL TITLE: KNA Pilot Trial
Page 23 of 24
Revised: December 1, 2018
23.0
Setting
All intervention and assessments will be completed either telephonically or virtually using 
HIPAA Compliant Zoom.
All data will be gathered and analyzed by faculty and staff at Florida State University’s 
Center for Translational Behavioral Science at 2010 Levy Ave Building B, Suite B0266, 
Tallahassee, FL 32310 and FSU SeniorHealthTM clinic at 4449 Meandering Way, 
Tallahassee, FL 32308.
24.0
Resources Available
Center for Translational Behavioral Science (CTBScience) is a university center, affiliated 
with the FSU College of Medicine. This facility provides 6 faculty offices, 4 research core 
offices, a program manager office, two shared postdoc offices, offices for a research 
coordinator and research assistants, and a shared space for students and staff working with 
faculty. The center also houses 4 multifunctional participant spaces, 2 of which can 
function as working sleep laboratories equipped with state-of-the-art sleep diagnostic 
equipment, video monitoring / recording capability and 2 of which have the ability to be 
used as both assessment rooms and therapy rooms. Further, the center houses a conference 
room with video conferencing capabilities and a community space that functions as a group 
meeting room and/or classroom. 
Within its three cores (Management Core, Methods Core, and Tech Core), the Center has 
a dedicated clinical trials coordinator, administrative coordinator, grants contracts 
administrator, data manager, biostatisticians, and a communications expert as well as 
access to FSU’s IT, library, and other administrative resources. CTBScience also hosts the 
Adolescent Trials Network (ATN) Scale It Up Center’s Analytic Core, Implementation 
Science Core, and Management Core, with dedicated faculty members assisting with 
protocol development, recruitment and retention, sustainment, study management, data 
management and analysis, and dissemination.  There is a Youth Community Advisory 
Board (YCAB) nation-wide for the ATN, and an ATN Bioethics Working Group, which is 
made up of a team of national ethics experts.  
The Management core, along with the study team will maintain responsibility for the 
overall conduct and implementation of the study.  The study team is responsible for data 
management, analysis and reporting. The Protocol Leads are responsible for scientific 
leadership and dissemination. Moreover, Dropbox is utilized to facilitate the storage and 
sharing of study-related documents, which further informs protocol personnel about any 
updates to research procedures.
The SeniorHealth clinic will not provide physical resources, other than provider 
participation in giving patients study handouts to assess interest. The FSU SeniorHealth 
clinic is partially virtually and partially in-person, which partners with patients’ primary 
care physician to optimize the patient’s health and wellness. These geriatric physicians 
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PROTOCOL TITLE: KNA Pilot Trial
Page 24 of 24
Revised: December 1, 2018
provide health assessment and management for older adult patients. All study sessions, and 
assessments will be completed virtually, and all records will be accessed through a secure 
portal. 
25.0
Multi-Site Research*
N/A 
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