Brain Connections, Self-care and Blood Pressure in Black and African Americans With Problems With Memory
Phase: NA
Conditions: Hypertension, Mild Cognitive Impairment
Sponsor: Ohio State University

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Official Title: Brain Connections and Blood Pressure 
NCT Number: NCT03736434 
Document Name: Protocol 
Document Date: 02.19.2019 
 
 
 

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I. 
Objectives 
The purpose of this pilot randomized controlled study is to adapt a previously tested intervention to 
improve resting state network and blood pressure in 120 (n=40 intervention; n=40 attention control; 
n = 40 control) Black and AA older adults with early Alzheimer’s disease and related dementia 
disorders and HTN. 
The study aims are to:  
 
A.1. Establish the feasibility and acceptability of the intervention in Black and AAs with Alzheimer’s 
disease and related dementia disorders and HTN.  
 
H1: The intervention will be feasible and acceptable to Black and AAs with Alzheimer’s disease and 
related dementia disorders. Feasibility will be measured by recruitment, attendance, and attrition.  
Acceptability will be measured by a garnering feedback in a debriefing after each session.   
 
A.2. Determine the effect size of the difference between the intervention, attention control, and 
control groups in resting state network connectivity and working memory and blood pressure to 
inform the sample size for the R01 trial.  
 
H2:  We hypothesize that compared to both control groups; the intervention group will have greater 
improvement in process measures of self-management mechanisms (self-efficacy, self-regulation, 
and emotion regulation), chronic stress, diet, and physical activity. The fMRIs and blood pressure 
will be obtained at baseline and 3 months. The intervention group (Mindfulness + DASH) will have 
improved resting state network connectivity and blood pressure as compared to the attention 
control (2-hour group social time and brief lecture on a non-diet/mindfulness topic such as personal 
safety, fire safety, and disaster preparedness) and the control group (care as usual with no 
intervention). The Center for Cognitive and Behavioral Brain Imaging, Arts & Sciences co-
investigators will analyze imaging data using their newly published statistical network model to 
quantify the subnetwork structures of the resting state network and evaluate changes of their 
topological properties. 
 
II. 
Background and Rationale 
African Americans (AA) are twice as likely to develop Alzheimer’s disease and related dementia 
disorders and develop hypertension (HTN) at an earlier age as compared to European-Americans 
(EA).1,2 The health behavior recommendations to improve cognition and decrease blood pressure 
share similar self-management strategies: healthy eating, physical activity and stress 
management.3,4 While other healthy diet and physical activity interventions (e.g., Dietary 
Approaches to Stop Hypertension[5] [DASH]) are delivered to self-manage blood pressure, we have 
not determined the effects of combining DASH with self-management interventions like mindfulness 
based stress reduction5 (Mindfulness) on brain functional connectivity and blood pressure in AA 
older adults.  
 
Functional connectivity is the statistical correlation between spatially remote sensory networks in 
the brain (e.g., ventral-medial prefrontal cortex and adjacent regions of sub-genual anterior 
cingulate and nucleus accumbens).6,7 The resting state network is part of the “emotional brain” and 
is the opposite of the analytic brain; as one activates, the other de-activates. Functional connectivity 
in the brain at rest, also known as the resting state network or empathy network, is responsible for 
retrieving memories, introspective thought and daydreaming.7 Dysregulation of the resting state 
network has been associated with Alzheimer’s disease.7 From our preliminary work, the ability to 
efficiently task differentiate between the emotional brain (the brain at rest) and analytic brain were 
associated with self-management mechanisms (self-efficacy, self-regulation, emotion regulation). 
Chronic stress, which is amenable to mindfulness interventions, acts to suppress cognitive 

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performance.8 Mindfulness training improves the resting state network function in older adults with 
cognitive impairment and depression.8 
 
In our initial work, our group tested a culturally informed intervention that combined mindfulness 
with DASH to improve blood pressure, diet and quality of life in prehypertensive AAs. This 8-week 
trial compared mindfulness + DASH and controls on blood pressure and resting state network 
function.10 The combined intervention group showed greater positive changes in diet, resting state 
network function and blood pressure as compared to controls.10 We will extend this work to those 
with Alzheimer’s disease and hypertension in AAs. To compensate for memory impairment, we will 
simplify diet education materials; incorporate repetition; use mnemonics; change the pace of the 
delivery; use easy to understand graphics; modify homework assignments; provide audio/video 
recordings for smartphone or CD player; and reminder calls between sessions to deliver the 
intervention in African American older adults with Alzheimer’s disease and related dementia 
disorders. Findings from this pilot RCT will inform an R01 parent application to the National 
Institutes on Aging for primary funding; the National Heart Lung and Blood and the National Institute 
of Nursing Research for secondary funding. 
 
RATIONALE. Interventions such as the DASH diet, lack cultural appropriateness (attention to the 
value of oneness in mind, body and spirit) and the appreciation of the social significance of food 
within the community and family unit.11-14 Therefore, they do not target the self-management of the 
mind and body in AAs with Alzheimer’s disease and HTN. In African Americans, socioeconomic 
disadvantage, such as low income, low education, and neighborhood safety, increases the 
cumulative stressors experienced and contributes to acute and chronic stress responses influence 
engagement in healthy self-management behaviors.15 The cognitive performance of older adults is 
impaired by stress so that learning new information is suppressed.15,16  Mindfulness is a mechanism 
by which older adults can regulate emotions that produce excess mental stress.17  Providing older 
adults with chronic conditions the opportunity to learn self-management skills in a group setting 
increases self-efficacy, self-regulation and emotion regulation resulting in the adoption of healthy 
behaviors.18Our rationale for combing two self-management interventions, mindfulness + DASH is 
to maximize the benefits of a simultaneously delivered intervention on neural network function. 
Alzheimer’s disease is a neural network connectivity disease.7  The scientific premise for 
mindfulness is that the practice of mindfulness increases attention and awareness by suppressing 
over activation of the resting state mode in the ventromedial prefrontal cortex and posterior 
cingulate cortex region of the brain.7 This in turn reduces distractive, ruminative thought and stress 
that impairs cognitive performance.7 Whereas practicing DASH recommendations (physical activity, 
stress management, low-fat, low sodium, and high in fish, fruits, fiber and vegetables) is proposed 
to prevent cognitive decline by decreasing glycemic spikes, triglycerides, cholesterol and 
neuroinflammation.19 Both interventions have been found to reduce blood pressure in older 
adults.19,20 In our preliminary study of prehypertensive AAs, suppression of the resting state network 
was observed in the intervention group. We are now translating what we learned to adapt the 
intervention to target resting state network function and blood pressure in AA older adults with 
Alzheimer’s disease and related dementia disorders. 
 
Separately, the use of mindfulness or DASH are not new. However, our project is unique in the 
combination of mindfulness + DASH and translation to community-dwelling AA older adults that are 
at risk of the deleterious effects of cognitive impairment and HTN on health outcomes. The 
proposed project is innovative in several ways. First, this study is unique because we implore a 
culturally informed intervention that is designed to affect two of the greatest threats to the health 
and well-being of older AAs: Alzheimer’s disease and related dementia disorders and hypertension 
related cardiovascular disease. Our study fills in the gaps in self-management research through the 
exploration of the effects of this mindfulness + DASH intervention to improve the resting state 
network and blood pressure in this vulnerable population. Moreover, a novel feature of this study is 
the use of the first ever approach to imaging analysis; the breakdown that reveal the subnetworks in 

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resting state. We use a novel statistical network model to capture topological and exogenous 
properties of the subnetworks in the brain. The benefit of using this method is that we can quantify, 
in a non-dichotomized threshold technique, the operating principles of the subnetworks associated  
with higher-order cognitive functions, including working memory, emotion and cognitive control. 
Findings of this study are expected to contribute to the dearth of science on neural network 
processing in Black and AA older adults.   
 
III. 
Procedures 
 
A. Research Design 
Approach. We will conduct a three-group RCT to describe the effect of the mindfulness + DASH 
diet on resting state network function (fMRI) and blood pressure (sphygmomanometer). The 
intervention involves eight weekly sessions for mindfulness +DASH education. The attention 
control group will participate in an 8-week social group on non-health related topics. The control 
group will not receive attention or intervention. Sample. A sample of 120 (n=40 mindfulness + 
DASH; n=40 attention control group, n=40 control group) community dwelling Black and African 
Americans adults aged 65 and older who meet study inclusion criteria will be recruited. Inclusion 
criteria are: (1) diagnosis of hypertension with or without medication use; (2) diagnosis of 
Alzheimer’s disease or related dementia disorders; (3) if no formal diagnosis of Alzheimer’s 
disease, then a SAGE score 17-10 or a MoCA 25-19.21,22 Rationale. These criteria were chosen 
to avoid persons with early-onset  Alzheimer’s disease; age ≤64.21 The cut point scores for the 
SAGE and MoCA are representative of persons with dementia and Alzheimer’s disease.21,22 
Exclusion criteria are: (1) unable to understand spoken English; (2) expect to move out of the 
area within six months (3) fMRI imaging contraindicated (history of shrapnel, metal in the body, 
heart pacemaker, heart defibrillator, metal in the eye, gunshot wound, or some types of metal 
elsewhere within the body such as certain surgical clips for aneurysms in the head, heart valve 
prostheses, electrodes, and some other implanted devices) or claustrophobia; (4) Visible signs 
of a previous, major stroke such as extreme weakness in one side of the body (5) <6 on the 
Brief Assessment of Understanding of the Study.23 Rationale. To avoid recruitment of persons 
that are unable to engage in the intervention.23  
 
B. Sample 
Community-dwelling African Americans aged 65 and older in Columbus and surrounding areas 
with hypertension and early-stage Alzheimer’s disease and related dementia disorders.  
 
C. Measurement / Instrumentation 
Table 1 displays all study measures. We have carefully chosen measures based on their 
appropriateness for this population, validity, reliability and level of burden. The study team has 
experience with all measures. Instruments either have been used by the study team in prior 
work or have been pilot tested for the purpose of the proposed application. In addition to the 
study visits for survey completion and fMRI, Most of the questionnaires use Likert-type scales 
and consist of 1-30 items averaging 10 items or less. Participant burden for participants was a 
major consideration in the selection of the study measures and thus, we chose measures used 
with older people that are short and easy to administer. Study staff offer breaks to participants to 
use facilities as needed. In our previous experiences, it takes no longer than 90 minutes to 
complete the visit. The fMRI lasts 30 minutes. From our experiences, it is best to do the fMRI at 
a separate visit to reduce participant burden. However, we will give participants the option to 
complete study visits one and two (fMRI) on the same day.  
 
Prescreen Measures 
 

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Brief Assessment of Understanding the Study23 has eight questions (3 open-ended and 5 
yes/no). The questions include describing the study and risks associated and benefits. The 
participant must get 6 out of 8 questions to provide consent.  
 
 
Table 1 
ITEMS 
MEASUREMENTS 
RATIONALE 
TIMEFRAME 
RELIABILITY / VALIDITY 
Informed consent  
Brief Assessment of 
Understanding of the Study 
Participant 
comprehension of study 
Baseline 
Rasch analysis and the 
inter-rater reliability (r =.81) 
Mental status screen  
Self-Administered Gerocognitive 
Examination (SAGE) and 
Montreal Cognitive Assessment 
Screen 
One self-administered 
(SAGE) 
One delivered by 
researcher 
Baseline, 3months  
SAGE-Spearman rank 
correlation between SAGE 
and neuropsychiatric 
battery =.84 
 
MoCA- dected 100% of 
Alzheimer’s dementia with 
a specificity of 87%. 
Demographic data and 
baseline functional status  
NINR Demographics 
Katz Activities of Daily Living  
Lawton Instrumental Activities of 
Daily Living  
Potential characteristics 
that could further 
describe feasibility 
Pre-rand 
Pre-rand, post-
intervention, 3mo 
Katz-Cronbach's α=0.838  
 
Lawton-Interrater 
reliability= .85  
Process measures 
 
 
 
 
Self-regulation 
Fleury survey 
Self-management 
mechanism 
Pre-rand, post-
intervention, 3mo 
Cronbach’s α= .87  
Self-efficacy 
Stanford Chronic Disease Self-
management Survey 
Self-management 
mechanism  
Pre-rand, post-
intervention, 3mo 
Internal consistency= .91 
Emotion-regulation 
Cognitive and affective 
mindfulness scale 
 
SF-36 QOL (mental composite 
score for emotions of anxiety and 
depression) 
 
PROMIS Anxiety and Depression 
Subscale 
Self-management 
mechanism and Potential 
characteristics that could 
further describe feasibility 
Pre-rand, post-
intervention, 3mo 
Cronbach's α =0.77 
 
 
 
Cronbach's α =0.72–0.94 
Chronic stress 
Perceived stress scale)  
Hair cortisol concentration 
analysis 
Everyday Discrimination Stress in 
the Healthcare Setting  
 
Self-report measure of 
stress 
Objective measure of 
long-term cortisol 
exposure as a proxy for 
chronic stress 
Pre-rand, post-
intervention, 3mo 
Pre rand and3 mo.  
Perceived stress scale-
Cronbach α = 0.83 
 
Hair cortisol- Within <3% 
and between (including 
extraction with each assay) 
<15% assays for pooled 
hair control. 
 
Everyday Discrimination 
Cronbach α = 0.83 
Healthy eating 
DASH diet survey  
Receipt of treatment 
Pre-rand, post-
intervention, 3mo 
Internal consistency (α = 
.77-.83). 
DASH questionnaire 
 
Twenty-one questions.  
 
Multiple choice and open-ended 
questions that are given to the 
mindfulness plus DASH 
intervention participants. The 
responses are reviewed as a 
group and it is used as a teaching 
tool.  
Receipt of treatment 
Investigator generated 
pre-post test questions to 
survey the intervention 
participant’s knowledge 
about the DASH eating 
plan and to also use a 
teaching tool. 
Mindfulness plus DASH 
participants only  
Session one and 
Session eight.  
Investigator generated 
used as a teaching tool.  
Mindfulness 
Cognitive and affective 
mindfulness scale 
Receipt of treatment 
 
Pre-rand, post-
intervention, 3mo 
Cronbach α=.77 
Physical activity 
Physical Activity Scale for the 
Elderly (PASE) 
Receipt of treatment 
Pre-rand, post-
intervention, 3mo 
Spearman correlation 
coefficient of 0.43 (p<0.01) 
between Actigraph data 
and total PASE score. 
Outcomes 
 
 
 
 
Resting state network 
fMRI scanner and investigator 
generated audiovisual delivered 
by EPrime.  
Primary outcome 
Pre-rand, post-
intervention, 3mo 
To be determined with 
preliminary data this pilot 
study 
Pain Scale 
Brief Pain Inventory Short Form 
(BPI-SF) 
A strong internal 
consistency reliability tool 
to measure clinical pain 
Pre-rand, post-
intervention, 3mo 
α =0.86-0.96  

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BP  
Omron HEM-907XL SBP333 and 
DBP  
Primary outcome 
Pre-rand, post-
intervention, 3mo 
ICC 0.94 and 0.92, SBP 
and DBP respectively  
Covariate 
 
 
 
 
AntiHTN medication use 
Medication labels on bottles 
Control for medication 
use 
Pre-rand, post-
intervention, 3mo 
Not available 
 
Mental and Functional Status and Demographic Data  
 
Self-Administered Gerocognitive Examination21 is a battery of 12 self-administered questions 
and drawings include naming pictures, similarities, calculation, memory, clock drawing and  
verbal fluency. Montreal Cognitive Assessment Screen22 is 13 questions that include 
visuospatial, memory, attention, abstraction and delayed recall.  National Institutes of Nursing 
Research common data elements demographic24 that includes gender, age, race, ethnicity, 
education, caregiver primary type, employment, marital status and number of household 
member and income in U.S. dollars per month. Katz Activities of Daily Living25 has six questions 
to function of basic activities such as bathing, dressing toileting, transferring, and continence 
and feeding. Instrumental activities of daily living26 are eight question that cover ability to use the 
phone, shopping, transportation, laundry food preparation, housing keeping and handling 
finances.  
 
Process Measures 
Self-regulation survey27 of nine questions on a Likert scale to determine health behavior 
practice.  Self-efficacy18 scale is for the participant to rates how confident they are in managing 
their chronic condition on a scale of 1-10 for each of the six questions.  SF-36 survey questions 
and PROMIS Anxiety and Depression Subscale that includes subscales for anxiety and 
depression symptoms.29 Perceived Stress Scale30 is a 10-item Likert scale questionnaire 
regarding stress over the past month. Every day Discrimination in the Healthcare Setting is 7 
questions on a Likert scale to measure the stress of discrimination in the healthcare setting as a 
result of age in ethnicity.37 The Brief Pain Scale will be administered prior to obtaining the 
imaging data since pain can contribute to chronic stress and difficulties regulation emotions.41,42  
Scalp hair cortisol31 is an emerging measure of chronic stress without the limitations of other 
biological specimens (saliva, urine, blood) used to assess cortisol regulation.30 Hair cortisol is a 
proxy measure to the total retrospective activity of stress exposure over the preceding 3 
months, much like hemoglobin A1c is a proxy measure of glucose control over the past three 
months. The reconstituted sample can be assayed immediately or frozen at -20 °C for later 
analysis. The lyophilized samples can also be stored frozen until reconstitution. Because 
cortisol ELISA kits are designed to measure cortisol values in liquid samples such as saliva or 
plasma, the output of the microplate reader software must be converted to amount of cortisol 
per unit weight of powdered hair. The following formula converts assay output in μg/dl to pg 
cortisol per mg hair: 
(A/B) * (C/D) * E * 10,000 = F where A = μg/dl from assay output; B = weight (in mg) of hair 
subjected to extraction; C = vol. (in ml) of methanol added to the powdered hair; D = vol. (in ml) 
of methanol recovered from the extract and subsequently dried down; E = vol. (in ml) of assay 
buffer used to reconstitute the dried extract; and F = final value of hair cortisol concentration in 
pg/mg. DASH Q32 is an 11-item self-report survey of foods recommended on the DASH diet 
(e.g., fruits, nuts, vegetable) that are eaten from 0-7 days in a week. Cognitive and affective 
mindfulness scale28,33 has 12 questions on a Likert scale regarding daily experiences such as “ I 
rush through activities without being really attentive to them. ”Physical Activity Scale for the 
Elderly (PASE)34 is a brief (5 minutes) and easily scored survey designed specifically to assess 
physical activity in epidemiological studies of persons age 65 years and older (10 questions). 
 

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DASH questionnaire. They will take an investigator-generated survey regarding their knowledge 
of the DASH diet during the first and last intervention, session eight.This will be used as a 
teaching tool to facilitate discussion and increase knowledge.  
 
 
Outcomes 
Resting state network.9,10 Prior to entering the scanner, participants will be scanned for metals in 
the body. Participants will be scanned using FDA approved Siemens 3T Wide Bore Scanner 
(60-70 cm diameter). A 2-minute structural run following by a 7 minute resting scan (no task) will 
be done. A 1-minute flare will be followed by a 6 minute DTI scan. Working memory. Working 
memory data will be obtained from the mental status examination (SAGE, MoCA).  
Systolic and diastolic blood pressure35 will be collected using an Omron automatic blood 
pressure machine. Small and large cuff sizes will be used.  
Covariate  
The diagnosis of hypertension duration and number of chronic conditions will be obtained by 
self-report. The number of chronic conditions will be limited to the 17 Medicare chronic 
conditions. Names of medications will be copied from prescription bottles or medication list36 
depending upon participant preference. 
 
D. Detailed study procedures 
 
Recruitment. We will recruit participants from area clinics and the local African American 
Churches, The Charitable Pharmacy of Central Ohio. Additionally, participants will be recruited 
from the CON Total Health and Wellness Center, local senior centers that service the African 
American community.  
 
Participant ID: Participant ID: Participants will be assigned a 5-digit ID number which will identify 
them at all data collection points.  
 
Retention Plans.  
In studies involving older adult (aged 65 and older), a threat to internal validity is selection bias 
or selection threat. This can occur due to study drop out. To decrease the risk of participants 
dropping out of the study, we have employed several strategies. 
1. Participant preferred location to collect baseline and3-month survey data. 
2. Participant may have significant other/family member/friend present throughout the process 
of enrollment an, study participation excluding entering the area where the MRI is housed. 
3. Holding intervention sessions and control session in a location with free parking. 
4. Providing cab transfers for participant to OSU and intervention/control sessions per 
participant’s preference. 
5. Frequent rest breaks and nutritious snacks during data collection and intervention/control 
sessions. 
6. Reminder calls to participants for study visits and sessions.  
7. In case we cannot contact a participant directly, we will also obtain contact information for 
family and friends who would know how to contact the participant. This frequent contact will 
also enable us to keep updated contact information for participants.  
8. For imaging data collection, the participant and the significant other/family member/friend 
that accompanies the participant for the  fMRI will receive an incentive for their time.  
9. Booster calls will be made to remind participants to practice what they’ve learned and to 
provide an opportunity to ask questions between sessions.  

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10. Participants will be remunerated for their assessment time according to the following 
schedule:  
 
Visit Type 
Remuneration 
Baseline surveys  
fMRI 
$30 
$75 participant and $30 for support person that accompanies participant  
If there is a gap of 4 or more months between the 
initial data collection and the start of the intervention, 
Baseline surveys will be recollected. 
 
If a participant refers a friend or family member 
$30 
 
 
 
$5  
3 Month surveys 
fMRI 
$30 
$75 participant and $30 for support person that accompanies participant 
 
The reason for any participant’s discontinuation and the date of withdrawal will be recorded in 
the participant’s case file. The participant’s case file, which will be completed up to the point of 
withdrawal, will be retained for three years. The study report will include reasons for participants’ 
withdrawals as well as details relevant to the Withdrawal. Each participant will be encouraged to 
complete the full course of the intervention assignment and study assessments.  However, it is 
understood that the participant may discontinue study participation at any time for any reason. 
The reason for early withdrawal must be documented in the participant’s case file and in the 
participant tracking document.     
Reasons for Withdrawal. Participants are free to withdraw from the study at any time for any 
reason. 
a. Participants should normally be withdrawn from the trial if a serious adverse event (SAE) 
occurs.   
b. Participants must be withdrawn from the trial if:  
c. They withdraw their consent; 
d. The investigator considers it in the best interest of the participant that he or she is withdrawn; 
e. participants’ withdrawals. Any participant withdrawn from the trial prior to completion will 
undergo all procedures indicated in this protocol as being scheduled to occur at discharge or 
upon early withdrawal.  The Principal Investigator or a monitor, and recommendation for follow 
up with health care provider will evaluate any participant withdrawn due to an adverse event 
(whether serious or non-serious).  
f. Relevant post-study procedures will be performed, wherever possible, on participants who 
elect to withdraw.   
 
Handling of withdrawal. If a participant is withdrawn from participation in the study at any time at 
his or her request, at the IRB or Principal Investigator’s discretion, the reason(s) for 
discontinuation shall be documented thoroughly in the source documents and participant’s case 
file. All participants who are withdrawn prematurely will undergo the procedures outlined in the 
Discharge visit 
 
Procedures overview. Using an IRB approved script, we will recruit, screen and enroll 
participants until we have 120 qualified participants. This script will include hypertension status, 
presence of metals in the body, and self-report of problems with memory. An initial visit will be 
scheduled to consent, screen, obtain baseline survey data (approximately 90 minutes), and 
complete the baseline fMRI (75 minutes, this includes getting the participant comfortable on the 
scanner table). If the participant expresses apprehension about entering the scanner, a mock 
scanner will be used to prepare the participant for study. Participants will be randomized by 
group after completion of baseline data collection (refer to table 1). If a gap of 4 or more months 
between the initial data collection and the start of the intervention exists, then data will be 

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recollected. A second visit will be done to collect post-intervention surveys and complete the 
final fMRI.  
 
Procedures. Potential participants will be pre-screened by phone or in person at a location that 
is convenient for the participant and in a private area using an IRB approved script. The IRB 
phone script will include a verbal consent so that we may ask pre-screening questions that 
include the following: self-reported diagnosis of hypertension; self-identified as having memory 
concerns. If the participant matches the inclusion criteria, then we will schedule a time and place 
that is convenient for the participant to complete the MoCA and SAGE. Potential convenient 
locations for the participant include, The OSU Department of Psychology, OSU East, home visit, 
or The Charitable Pharmacy Clinic.  
 
Informed consent. Consenting will occur in a quiet private area. It will be the participants’ choice 
to have family or significant other present during the consenting process and subsequent data 
collection. Participants will be given a copy of the consent form to follow along as the researcher 
reviews the consent form. Following the review of the consent form, the participant will be asked 
question from the Brief Assessment of Understanding of the Study.23 If the participant scores 
less than 6, we will thank the participant for their time and recommend that they contact their 
health provider if they have any questions or concerns.    
 
If the participant has a score 6 or greater on the Brief Assessment of Understanding of the 
Study and signs the consent form, we will begin with the SAGE and MOCA cognitive surveys. If 
the participant does not meet inclusion criteria based upon the results of the SAGE or MOCA, 
then we will thank the participant for their time. A copy of the consent form will be retained by 
the PI in a locked office in a locked file cabinet for 3 years.  
 
If the participant meets the inclusion criteria, the researcher will proceed with baseline blood 
pressure, surveys and hair collection. The first baseline visit should take approximately 90 
minutes and will be held at the location of the participant’s preference. The second baseline visit 
will be held in the OSU Department of Psychology to gather imaging data.   
 
The following will be collected during at baseline and 3 months (refer to table 1) at two separate 
visits:  
1. Brief Assessment of Understanding of the Study survey 
2. Self-Administered Gerocognitive Examination (SAGE) 
3. Montreal Cognitive Assessment Screen 
4. NINR Demographics form and self-reported list of chronic conditions  
5. Omron HEM-907XL SBP and DBP 
6. Katz Activities of Daily Living 
7. Medication labels on bottles 
8. Lawton Instrumental Activities of Daily Living 
9. Fleury of self-regulation  
10. Lorig Chronic Disease Self-Management Efficacy scale 
11. SF-36 QOL (mental composite score for emotions of anxiety and depression) 
12. PROMIS Anxiety and Depression Subscale 
13. Perceived stress scale  
14. Everyday Discrimination Scale in the Healthcare Setting 
15. Hair cortisol concentration analysis at baseline and 6 months  
16. DASH diet survey  

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17. Cognitive and Affective Mindfulness Scale 
18. Physical activity survey 
19. Scalp hair cortisol analysis is the HPA system’s response and responds to a variety of 
chronic stressors. 
20. Brief Pain Scale 
 
To promote participant comfort, frequent breaks for will be taken during data collection. Healthy 
snacks of water, fruit, and or granola bars will be available for participants. On hand will be an 
external assistive listening device should the participant request one for communication.  
 
We will begin with measuring blood pressure using an automatic blood pressure cuff (include 
brand). The left arm is preferred for blood pressure measurements.  We will collect 3 blood 
pressure readings. The arm will be raised passively for 15 seconds between measures.  
 
The questions to surveys will be read to the participant and answers recorded in RedCap under 
the participant’s study ID number. Response cards will be given to participants to follow along 
with the interviewer.  
 
Cortisol will be measured as from hair samples collected from the posterior vertex region of the 
scalp using thinning shears leaving no noticeable change in appearance. A 3 cm sample is 
taken from the posterior vertex of the scalp because this area has been shown to have less 
variation in cortisol levels than other areas of the scalp. The hair samples will be wrapped in 
aluminum foil, labeled with a coded participant identifier, and stored. Processing of hair samples 
will be completed in The Ohio State University College of Nursing Stress Lab.   
 
Randomization. Using a computer-generated random number sequence, we will randomly 
allocate the 120 recruited participants with a ratio of 1:1:1 to intervention (mindfulness + DASH) 
or attention control or control. For retention purposes, incentives are provided for completion of 
data collection. 
 
Intervention Protocol: PowerPoints and other computer aided strategies for delivery of the 
intervention. Repetition of key concepts will be embedded throughout the presentations and 
handouts. Changes will be made based upon their feedback. The mindfulness training will be 
delivered in the first hour and will include practice meditations, reflective thinking, and self-
monitoring of thoughts. Following a 10-minute break, the dietitian will deliver the 60-minute 
DASH intervention. Each will include didactic content, an experiential skills oriented portion 
(bringing in canned food, reading labels, and adapting favorite “soul food “recipe to low sodium 
guidelines), behavior change goal-setting and problem-solving. A time for review and homework 
will be provided at the end of each session (20-minutes).  
 
Mindfulness is the mental ability to enhance self-awareness of present internal and external 
experiences in a non-judgmental way. Mindfulness encourages a state of mind in which one 
distances from one’s own mental noise.5 It allows for a new awareness of mind that permits 
focused attention on releasing stressful constructions and a more relaxed moment-to-moment 
awareness and movement. MBSR is a participatory educational approach, exposing the power 
of internal resources in framing what a person experiences as stressful. Lifestyle change in 
MBSR refers to a change in one’s interior disposition toward awareness. The goal in MBSR is to 
habitually participate in meditation, without evaluating one’s meditation performance. In 2004, 
Bishop produced an operational definition of mindfulness for research investigations concerning 

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the mediating role and mechanism of the action of mindfulness.38. The two critical components 
were determined to be (1) self-regulation of attention and (2) the adoption of an orientation 
toward one’s experiences in the present moment. MIM was developed to retain the construct of 
mindfulness, as originally conceived and taught by Kabat-Zinn, while adapting it for working 
adults. Mindfulness in Motion (MIM) is comparable to traditional MBSR programs concerning the 
operational definition, differing only in the amount of time committed to the intervention. 
 
 
 
Summary of Intervention: 
•             Duration: 8 weeks 
•             Weekly group sessions of 1 hr. include a didactic presentation on stress and work-
related stress, theoretical material related to mindfulness, the somatic mind/body connection, 
relaxation, yoga, meditation, self-awareness, and bodily cues relating to emotional reactivity. 
Practices will include the body scan, gentle yoga movement, walking meditation, breathing, 
relaxation, and sitting meditation.  
•             Additionally, daily 20 min individual practices are done at least 5 times a week 
delivered via a CD or on a preloaded device. The 20 minute practices are an abbreviated 
version of the weekly hour instruction. Each participant is asked to track his/her daily meditation 
practice (adherence with the study protocol).  A diary for adherence records will be given to 
participants. 
•             MIM will be provided by Dr. Klatt or an MIM trained teacher who has Mindfulness 
training, and has been trained by Dr. Klatt in the adaptations necessary to successfully 
implement MIM.  
•             The location of the intervention will be in a room in the OSU East, allowing for a 
convenient, calm intervention environment. 
 
                The on-site MIM intervention sessions were designed by, and will be conducted or 
supervised by Maryanna Klatt, PhD.39,40 Each week, the group meeting consists of material 
related to mindfulness, e.g., the somatic mind/body connection, relaxation, yoga, meditation, 
self-awareness, and bodily cues relating to emotional reactivity. Group interaction centers on 
sharing ideas towards effective practice and practical daily challenges to being mindful. All 
instruction is conducted with the participants in chairs, or standing behind the chair. Loose fitting 
professional clothing is recommended to allow for movement. Each class begins with a prompt 
for contemplation during the next hour. The prompts directly relate to each weekly theme. 
Participants will receive a workbook, similar to the weekly handouts with space to reflect on 
these prompts, as the prompt serves as the focus of that week’s meditation. Participant’s 
response to the prompt is personal and silent. Some participants may then choose to share their 
thoughts, but there is no pressure to verbalize personal reflections. The workbook also provides 
assigned additional mindfulness exercises and brief readings. The participants will bring the 
workbook to each class.  
                Each weekly meeting employs the use of breathing techniques, progressive 
relaxation, body scans, pre-meditation movement, various yoga poses, and formal meditation 
practice. The intent of the didactic/experiential sessions is to encourage the explicitly defined 
objective of the study: stress reduction. The MBSR protocol calls for the MBSR curriculum to be 
employed in a way sensitive to the unique local conditions but the fundaments of MBSR are 
invariant.37 This program will be geared towards the local stresses commonly experienced by 
healthy working adults in SICU departments. The pre-meditation stretching brings the focus to 
the breath and body, enabling meditative awareness, while the background music is 

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standardized to be the background music in each session, and in the background of each 
meditation practice contained on the downloads. After introduction of the weekly theme/prompt 
the participants are led through a body scan, gentle stretching, yoga, progressive relaxation, 
and/or an eating meditation, and then into formal meditation. During the weekly session, 
participants can discuss if they wish thoughts and emotional responses experienced during 
meditation but this is not a requirement. 
 
The DASH3 eating plan is endorsed by the National Health, Lung, and Blood Institute and 
consists of a flexible and balanced eating plan. The emphasis of the DASH eating plan is on 
increasing intake of fruits and vegetables, eating fat-free or low-fat dairy products, whole grains, 
fish, poultry, beans, nuts, and vegetables oils. The DASH diet recommendations stress limiting 
sodium, sweets, sugary beverages, and red meats. Overall, the DASH diet is low in saturated 
and trans fats, and rich in potassium, calcium, magnesium, fiber, and protein. In addition, 
participants will be provided with ethnic recipes that are adapted to meet the DASH dietary 
guidelines. A combination of didactic, experiential, and “hands on” activities will be done to 
deliver the DASH diet guidelines. Participants will be encouraged to complete a weekly 
homework assignment to practice application of the DASH diet in daily life. They will received a 
plastic plate that displays serving sizes and food groups for a balance meal. (Figure 1) 
 
Figure 1. Nutrition Plate 
 
 
 
Reminders. A research assistant will contact participants prior to each session to answer 
questions and remind participants of the following session.  
 
The attention control group will attend eight, 2.5 hours sessions on non-health topics such as 
personal safety, fire prevention, cold weather protection, disaster preparation, internet safety, 
aging in place, how to know when it’s time to move and managing your money. The format will 
include lecture, break, educational video on the topic and question/answer time. The attention 
control and the mindfulness + DASH groups will have healthy snacks (i.e., fresh fruit, nuts, 
cheese, crackers, granola bars) and water during each meeting. Transportation will be provided 
or gas cards for those who drive/driven by others to the sessions. All sessions will be held at an 
easy to access location in the community with free parking (i.e., the CON Total Health and 
Wellness Clinic). Table of the lesson plan for the intervention and control groups can be found in 
attachments.  

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The control group, will not receive any form of intervention or attention. This will provide true 
and reliable insight of the impacts of mindfulness + DASH intervention on brain activity, in 
comparison to that of non-health related intervention given to the attention control group. The 
benefit of having a pure control group is that, the information collected can then be used to 
guide future comparison groups for the R01.  
 
 
 
Fidelity Monitoring. Each session of the Mindfulness + DASH will be audiotaped and an 
investigator generated fidelity check-list. The checklist is composed of the key elements needed 
to deliver Mindfulness and DASH education that was used in a previous study. Fidelity of the 
intervention “dose” will be monitored by tracking session attendance and time spent on each 
booster phone call. Interventionists will track the homework completion each week to assess 
treatment enactment fidelity.  
 
Incidental findings: Blood pressure. The following guidelines will be used to triage unanticipated 
blood pressure findings: If average systolic BP is >150 or diastolic BP is >110, we will instruct 
the participant to follow up with health provider or an urgent care center if the participant does 
not have a health provider. If blood pressure is 200/120 or greater refer to ED for immediate 
care.  
 
Incidental findings and interpretations of scans.  Under no circumstances may an investigator, 
research staff, or the imaging center staff interpret scans as normal or abnormal. All scans 
performed at the Center for Cognitive and Behavioral Brain Imaging are for research purposes 
only and are NOT intended for clinical diagnoses or therapeutic purposes. However, in 
recognition of the fact that, on occasion, incidental findings may need to be investigated 
medically, and in a best faith effort to inform research participants of that possibility, the policy of 
having all scans of normal research participants by a neroradiologist has been implemented. 
Every normal participant studied at the Center for Cognitive and Behavioral Brain Imaging will 
have, in addition to the structural MRI performed as part of the study, a brief T2 weighted 
sequence (2 minutes). This data will be sent for expert neuroradiological review, which will be 
provided, by contractual agreement between Center for Cognitive and Behavioral Brain Imaging 
and Nationwide Children’s Hospital at Columbus, Ohio, by neuroradiologists at Nationwide 
Children’s Hospital Columbus. This policy will be included in the Consent Form.  The language 
in the consent form allows the participant to choose if she/he wants the neuroradiologist to 
contact her/him or a physician of her/his choice in the event of an incidental finding. The scans 
will be provided to the neuroradiologists by Deborah Hardesty without identifying data. Scans 
will solely contain the CCBBI identifying number, gender and age of the participant. In the 
unlikely event that the team of neuroradiologists identifies an incidental finding, Deborah 
Hardesty will be asked to provide the participant’s name and contact, as well as his/her 
physician’s name and contact. The neuroradiologists will, at that time, inform us that the 
participant is not appropriate for research and will take it upon himself to contact the 
participant/physician and discuss the finding and any further action to be taken, if necessary. 
The Center for Cognitive and Behavioral Brain Imaging will not be involved in any medical 
interaction with the participant and will not be informed of any medical diagnosis. Deborah 
Hardesty will simply inform the respective PI/investigator identified on the forms signed prior to 
scanning, as soon as neuroradiologists report that a participant is not appropriate for research. 
There are two exceptions to the above mentioned policy: 
1. Participants who are part of repeated scanning for multiple studies, will have their scans 
reviewed after their first scanning session. If their participation continues for over one year, 

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the first scan performed one year after the previously reviewed scan will be sent for review. 
We need your cooperation in identifying such participants. 
 
2. Participants with known brain diseases who are part of structural/functional MR protocols will 
not have their scans sent to neuroradiologists for review and should therefore not sign the 
attached document. 
 
Per The Center for Cognitive and Behavioral Brain Imaging Investigators who will use brain 
damaged participants in research protocols should follow the policy of providing the structural 
scan to the participants’ physician. CDs with the structural images are offered to the participants 
so that, those who wish can consult directly with their own medical practitioner. 
 
 
Data Validity/Integrity   
It is the responsibility of the Principal Investigator to ensure that all team members handle data 
and related documentation appropriately. All participant information, including source 
documents must be reviewed by the PI and clinical team and entered into the RedCAP 
database.  To maintain up-to-date information, data will be entered directly into RedCap data 
entry forms. There will be ongoing processing of data and quality checks by the study 
statistician and or PI.  
 
Recruitment:  
Participant recruitment will be tracked and reviewed in the weekly meetings of the 
research team. In order to maintain confidentiality, the list, which includes the names of 
all potential participants, will be kept separately from the documentation and tracking 
spreadsheet in Redcap. Basic demographic information, as well as reasons for refusal 
will be noted for eligible individuals who decline participation. Tracking will be carried out 
to determine which and how many individuals are interested in study participation, are 
eligible for study participation, enroll in the study, and complete the first assessments.  
We will also track retention past random assignment. Enrolled participants will be given 
code numbers and their study participation will continue to be tracked via spreadsheet in 
Redcap, which will include documenting the occurrence and date of completion of data 
collection at each time point and their participation in the intervention and attention 
control sessions.  
 
 
Consistency of Data Collection:   
Data collection will follow study procedures. Data collection will be tracked as specified 
above and will be monitored in the bi-weekly meetings of key members of the research 
team. Any issues that arise can therefore be dealt with in a timely manner. Weekly 
meetings will also include review of upcoming data collection so questionnaires can be 
prepared in a timely manner.  
Imaging data will be uploaded to the PACS server automatically. 
To access the data, the PI will go to http://pacs.psy.ohio-state.edu/ from any computer. 
The  PI will have a user name and password to access the data.  
 
Quality Assurance:  
Dr. Wright will work closely with the statistician to design forms and a database that 
maximize accurate data entry using Redcap. To minimize data-entry error and data-
management miscoding, data will be either be entered directly into the study database in 
REDCap by the study staff or if collected via paper, will be will be double-entered by 
study staff into REDCap and verified by the PI. PI Wright will review the data collected 
and all related documentations monthly. Summary results will be entered into the larger 

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REDCap database. Source documents and electronic data will be checked for accuracy 
and adherence to study protocols. 
 
Data Storage: 
Consent forms and participant lists will be stored in locked file cabinets separate from 
participant data. The PI and designated study staff will have access to data.  All 
participant data will be labeled only with a code number. These coded data will be kept 
separate from the master list that links participants and their code numbers. Only the PI 
and research coordinator will have access to the master list. Research staff data 
collectors will have access to REDCap survey to collect participant data under their 
unique ID number.  
 
This study will utilize REDCap (Research Electronic Data Capture), a software toolset 
and workflow methodology for electronic collection and management of clinical and 
research data, to collect and store data. The OSU Center for Clinical and Translational 
Science (CCTS) Research Informatics Services will be used as a central location for 
data processing and management. REDCap provides a secure, web-based application 
that provides an intuitive data manipulation interface, custom reporting capabilities, audit 
trail functionality, real-time data monitoring/querying of participant records, and 
variations of data exporting/importing. REDCap is hosted by OSUWMC IT in the 
Ackerman Datacenter (640 Ackerman Road; Room 345) 
 
REDCap instance is located on internal OSUWMC network. Remote access to this 
network can be obtained over an encrypted VPN tunnel (AnyConnect) This VPN uses 
Protocol: DTLS and Cipher: RSA_AES_128_SHA1. Background checks are performed 
on all staff that are on the network or obtaining VPN access. 
 
Protocol Compliance:  
Mindfulness plus DASH diet education Intervention Integrity and Consistency. The 
interventionists (mindfulness trainer and dietitian) will follow the program outline. With 
permission, the sessions will be digitally recorded. To ensure fidelity, Dr. Kathy Wright 
will review and rate digital recordings for acceptable interventionist communication for 
checking-in regarding participant comfort, and skills training. Dr. Kathy Wright will 
communicate regularly with the interventionists on the project to provide feedback and 
continued training as necessary. Problems with implementation will be documented in 
writing and a plan developed to correct any discrepancies between the protocol and 
implementation practice. 
 
Termination for Significant Risk: 
Although the study is deemed low risk and adverse events are not anticipated, diligent 
monitoring will occur as specified above under Adverse Events Protocols. A participant 
that expresses concern about his or her participation or reports distress associated with 
receiving the mindfulness and DASH education or attention control group may be asked 
to discontinue participation in the study if there is concern about participant safety and 
wellbeing or about the safety and wellbeing of others. Likewise, if one of the research 
assistants, interventionists or supervising members of the Research Team expresses a 
concern about a participant’s safety or wellbeing, the Adverse Events Protocol would be 
used and it is possible that the participant could be asked to discontinue participation if 
there were concern about his or her, or others, safety and wellbeing. 
 
E. Internal Validity 

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To reduce the threats to internal validity we will do the following: data collectors will be blinded 
to the hypothesis of the study after randomization is completed; the PI will participate in baseline 
data collection only to train data collectors and we will use an intent to treat analysis.   
 
F. Data analysis 
We will use descriptive statistics to examine variable distribution, check for outliers and 
summarize sample characteristics. Bivariate tests (T-test and Chi-square) will be used to 
compare sample characteristics between the two study arms. Congruent with a RCT nature of 
the design, we will conduct intent-to-treat analysis.  
 
For Aim 1, we will use descriptive statistics to quantify the rates of recruitment, attendance, and 
attrition for feasibility. Using a semi-structured list of open-ended questions, we will elicit 
participant feedback regarding the acceptability of the intervention. A debriefing will be 
conducted following each session to identify any areas for improvements.   
 
For Aim 2, we will first use descriptive statistics and trend plots to examine the primary 
outcomes (resting state network connectivity and BP) and secondary outcomes (process 
measures, including self-management mechanisms [self-efficacy, self-regulation, and emotion 
regulation], diet, and physical activity) (see Table 1), among intervention, attention control 
group, control group over time (baseline and 3 months). Next, the mixed-effects linear modeling 
will be used to estimate the between-group difference in each outcome. From the mixed-effects 
modeling, we will 1) derive estimates of the between-group difference overall and at each time 
point, 2) adjust for within-participant clustering from repeated measures and 3) control for 
covariates (e.g., baseline measure, use of antihypertension medications).  Based on our 
previous study, we expect small-to-medium intervention effect on the primary outcomes (resting 
state network connectivity and BP). Sample size from this pilot study (40 per arm after 
accounting for 20% attrition) will not have sufficient power to detect small-to-medium effect sizes 
for between-group difference (e.g., 34% power to detect a Cohen’d of 0.5 with a two-sided 
significance level of 0.05). Therefore, we will not rely on statistical significance. Instead, we will 
estimate point estimates, 95% confidence intervals and effect sizes for between-group 
differences using mixed-effect linear modeling. These estimates along with clinical significance 
will guide our results interpretation and inform the sample size determination for a future R01 
full-scale trial.   
 
 
 
 
Table 2. Project timeline.  
Activity 
1-2 
months 
3-4 
months 
5-6 
months 
7-8 
months 
9-10  
months 
11-12 
months 
IRB application 
X 
X 
 
 
 
 
Recruitment and randomization 
 
X 
 
 
 
 
Adaptation of intervention for ADRD 
X 
 
 
 
 
 
Data collection (baseline and Time 1) 
 
X 
XT1 
 
XT2 
 
Delivery of Intervention  
 
X 
X 
 
 
 
Preliminary data analysis of baseline data for R01 
submission in June 2018 
 
X 
X 
 
 
 
Final data analysis 
 
 
 
 
X 
X 
Dissemination  
 
 
 
 
 
X 
 
 
  
 
 
 

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IV. 
Bibliography 
 
1. 
Mayeda, E.R., et al., Survival after dementia diagnosis in five racial/ethnic groups. Alzheimers Dement, 
2017. 13(7): p. 761-769. 
2. 
Mozaffarian, D., et al., Heart Disease and Stroke Statistics-2016 Update: A Report From the American 
Heart Association. Circulation, 2016. 133(4): p. e38-360. 
3. 
Tangney, C.C., DASH and Mediterranean-type Dietary Patterns to Maintain Cognitive Health. Curr Nutr 
Rep, 2014. 3(1): p. 51-61. 
4. 
Abate, G., et al., Nutrition and AGE-ing: Focusing on Alzheimer's Disease. Oxid Med Cell Longev, 
2017. 2017: p. 7039816. 
5. 
Kabat-Zinn, J., An outpatient program in behavioral medicine for chronic pain patients based on the 
practice of mindfulness meditation: theoretical considerations and preliminary results. Gen Hosp 
Psychiatry, 1982. 4(1): p. 33-47. 
6. 
Stillman, P.E., et al., Statistical Modeling of the Default Mode Brain Network Reveals a Segregated 
Highway Structure. Sci Rep, 2017. 7(1): p. 11694. 
7. 
van den Heuvel, M.P. and H.E. Hulshoff Pol, Exploring the brain network: a review on resting-state 
fMRI functional connectivity. Eur Neuropsychopharmacol, 2010. 20(8): p. 519-34. 
8. 
Fountain-Zaragoza, S. and R.S. Prakash, Mindfulness Training for Healthy Aging: Impact on Attention, 
Well-Being, and Inflammation. Front Aging Neurosci, 2017. 9: p. 11. 
9. 
Jack, A.I., et al., Visioning in the brain: an fMRI study of inspirational coaching and mentoring. Soc 
Neurosci, 2013. 8(4): p. 369-84. 
10. 
Wright KD, J.L., Fresco D, Wright JT,  Friedman, JP, Jack, AI,  Moore, SM. , Neuroprocessing and Self-
Management in Prehypertensive African Americans. 2016, Council for the Advancement of Nursing 
Science. 
11. 
Long, E., M. Ponder, and S. Bernard, Knowledge, attitudes, and beliefs related to hypertension and 
hyperlipidemia self-management among African-American men living in the southeastern United 
States. Patient Educ Couns, 2017. 100(5): p. 1000-1006. 
12. 
Klymko, K.W., et al., Self-care production experiences in elderly African Americans with hypertension 
and cognitive difficulty. J Am Acad Nurse Pract, 2011. 23(4): p. 200-8. 
13. 
Woods-Giscombe, C.L. and S.A. Gaylord, The Cultural Relevance of Mindfulness Meditation as a 
Health Intervention for African Americans: Implications for Reducing Stress-Related Health Disparities. 
J Holist Nurs, 2014. 32(3): p. 147-60. 
14. 
 Fleury, J., The index of self-regulation: development and psychometric analysis. J Nurs Meas, 1998. 
6(1): p. 3-17. 
15. 
Barnes, L.L. and D.A. Bennett, Alzheimer's disease in African Americans: risk factors and challenges 
for the future. Health Aff (Millwood), 2014. 33(4): p. 580-6. 
16. 
Steenland, K., et al., A Meta-Analysis of Alzheimer's Disease Incidence and Prevalence Comparing 
African-Americans and Caucasians. J Alzheimers Dis, 2016. 50(1): p. 71-6. 
17.      Prakash, R.S., et al., Mindfulness and the aging brain: a proposed paradigm shift. Front Aging Neurosci, 
2014. 6: p. 120. 
18. 
Lorig, K.R., et al., Chronic disease self-management program: 2-year health status and health care 
utilization outcomes. Med Care, 2001. 39(11): p. 1217-23..  

RESEARCH PROTOCOL: Brain connections, self-care and blood pressure in Black and African Americans 
with problems with memory Version: 02/19/2019 
 
19. 
Vauzour, D., et al., Nutrition for the ageing brain: Towards evidence for an optimal diet. Ageing Res 
Rev, 2017. 35: p. 222-240. 
20. 
Palta, P., et al., Evaluation of a mindfulness-based intervention program to decrease blood pressure in 
low-income African-American older adults. J Urban Health, 2012. 89(2): p. 308-16. 
21. 
Scharre, D.W., et al., Self-administered Gerocognitive Examination (SAGE): a brief cognitive 
assessment Instrument for mild cognitive impairment (MCI) and early dementia. Alzheimer Dis Assoc 
Disord, 2010. 24(1): p. 64-71. 
22. 
Freitas, S., et al., Montreal cognitive assessment: validation study for mild cognitive impairment and 
Alzheimer disease. Alzheimer Dis Assoc Disord, 2013. 27(1): p. 37-43. 
 
23. 
Resnick, B., et al., Reliability and validity of the evaluation to sign consent measure. Gerontologist, 
2007. 47(1): p. 69-77. 
24. 
Research, N.I.o.N., BRICS NINR Demographics. 2017. 
25. 
Katz, S., Assessing self-maintenance: activities of daily living, mobility, and instrumental activities of 
daily living. J Am Geriatr Soc, 1983. 31(12): p. 721-7. 
26. 
Hassani Mehraban, A., et al., Validity and reliability of the persian version of lawton instrumental 
activities of daily living scale in patients with dementia. Med J Islam Repub Iran, 2014. 28: p. 25. 
27. 
Fleury, J., The index of self-regulation: development and psychometric analysis. J Nurs Meas, 1998. 
6(1): p. 3-17. 
28. 
Feldman, G. C., Hayes, A. M., Kumar, S. M., Greeson, J. G., &Laurenceau, J. P. (2007). Mindfulness 
and emotion regulation: the development and initial validation of the Cognitive andAffective Mindfulness 
Scale-Revised (CAMS-R). Journal of Psychopathology and Behavioral Assessment, 29, 177–190 
29. 
Ware, J.E., Jr. and C.D. Sherbourne, The MOS 36-item short-form health survey (SF-36). I. Conceptual 
framework and item selection. Med Care, 1992. 30(6): p. 473-83. 
30. 
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. Journal of health and 
social behavior. Dec 1983;24(4):385-396.Cohen 
31. 
Wright KD, Hickman R, Laudenslager ML. Hair Cortisol Analysis: A Promising Biomarker of HPA 
Activation in Older Adults. The Gerontologist 2015;55 Suppl 1:S140-5. 
32. 
Warren-Findlow, J., C.L. Reeve, and E.F. Racine, Psychometric Validation of a Brief Self-report 
Measure of Diet Quality: The DASH-Q. J Nutr Educ Behav, 2017. 49(2): p. 92-99 e1. 
33. 
Bilevicius, E., S.D. Smith, and J. Kornelsen, Resting state network functional connectivity patterns 
associated with the Mindful Attention Awareness Scale. Brain Connect, 2017. 
34. 
Washburn RA, Smith KW, Jette AM, Janney CA. The physical activity scale for the elderly (PASE): 
Development and evaluation. Journal of Clinical Epidemiology. 1993 Feb 1;46(2):153–62 
35. 
Omboni, S., et al., Validation of the Omron M5-I, R5-I and HEM-907 automated blood pressure 
monitors in elderly individuals according to the International Protocol of the European Society of 
Hypertension. Blood Press Monit, 2007. 12(4): p. 233-42. 
36. 
Bromfield, S.G., et al., Blood Pressure, Antihypertensive Polypharmacy, Frailty, and Risk for Serious 
Fall Injuries Among Older Treated Adults With Hypertension. Hypertension, 2017. 70(2): p. 259-266. 
37. 
Peek, M.E., et al., Adapting the everyday discrimination scale to medical settings: reliability and validity 
testing in a sample of African American patients. Ethn Dis, 2011. 21(4): p. 502-9. 
38. Bishop et al., (2004). Mindfulness: A proposed operational definition. Clin Psychol Sci Practice, 11: 230-
241. doi:10.1093/clipsy/bph077 
39.  
Klatt, M., B. Steinberg, and A.M. Duchemin, Mindfulness in Motion (MIM): An Onsite Mindfulness 
Based Intervention (MBI) for Chronically High Stress Work Environments to Increase Resiliency and 
Work Engagement. J Vis Exp, 2015(101): p. e52359. 
40.. 
Gilbertson, R.M. and M.D. Klatt, Mindfulness in Motion for People with Multiple Sclerosis: A Feasibility 
Study. Int J MS Care, 2017. 19(5): p. 225-231. 
41.  
Mendoza T, Mayne T, Rublee D, Cleeland C. Reliability and validity of a modified Brief Pain Inventory 
short form in patients with osteoarthritis. Eur J Pain. 2006; 10(4):353-361.  

RESEARCH PROTOCOL: Brain connections, self-care and blood pressure in Black and African Americans 
with problems with memory Version: 02/19/2019 
 
42. Sorrell, J.M., Meditation for older adults: a new look at an ancient intervention for mental health. J 
Psychosoc Nurs Ment Health Serv, 2015. 53(5): p. 15-9.