Stress-reduction Wellness Program for Midlife Black Women (B-SWELL)
Phase: NA
Conditions: Cardiovascular Risk Factor, Stress, Self Efficacy, Depressive Symptoms, Health Behavior
Sponsor: University of Cincinnati

   Institutional Review Board
FWA #: 00003152
APPROVAL
February 11, 2022
Holly Jones
CON AD for Nursing Research
Dear Holly Jones,
Type of Submission:
Continuing Review
Title:
Improving Healthy Lifestyle Behaviors in Midlife Black 
Women to Lower Heart Disease Risk.
Investigator:
Holly Jones
IRB ID:
CR03_2019-0426
Funding:
Name: National Institutes of Health - NIH
IND, IDE, or HDE:
None
Study Risk Level:
No greater than minimal risk
Documents Reviewed:
DSMP report August 2021_2.docx
JONES_2021_Continuing Review_revised 2.5.2022.docx
On 1/28/2022, the IRB reviewed the above submission using an EXPEDITED review procedure in accordance 
with 45 CFR 46.110(b)(1) which was given approval pending the response to modifications required.
Response to the modifications required provided to the IRB were reviewed and approved on 2/9/2022 under 
the following category(ies):
• (4) Noninvasive procedures
• (7)(a) Behavioral research
• (7)(b) Social science methods
• (mm) Minor modification
CONTINUING REVIEW REQUIREMENT:
The IRB approved the protocol from 1/28/2022 to 1/27/2023. Thirty days before 1/27/2023, you are to submit 
a completed continuing review and required attachments to request continuing approval or closure.  You can 
submit a continuing review by navigation to the active study and clicking Create Modification/CR.  If continuing 
review approval is not granted before the expiration date of 1/27/2023, approval of this study expires on that 
date. 
PI NOTIFICATIONS:
This approval is through the IRB only. You may be responsible for reporting to other regulatory officials.  
Please check with your institution and department to ensure you have met all reporting requirements.

CR03_2019-0426
Continuing Review Approval
Page 2 of 2
WHERE CAN I FIND MY IRB APPROVED DOCUMENTS?
Approved and/or final versions of documents submitted to the IRB can be found under the documents tab of 
the study’s RAP submission. Watermarked (“stamped”) versions of the consent form will appear in the right-
side column as a pdf document. The approval or acknowledgement letter can be found in the top right section 
of the submission’s main study page under letter.
INTERNATIONAL CONFERENCE ON HARMONIZATION AND GOOD CLINICAL PRACTICES STATEMENT:
The Institutional Review Board is duly constituted (fulfilling FDA requirements for diversity), has written 
procedures for initial and continuing review of clinical trials: prepares written minutes of convened meetings 
and retains records pertaining to the review and approval process all in compliance with requirements defined 
in 21 CFR Parts 50, 56 and 312 Code of Federal Regulations. This institution is in compliance with the ICH GCP as 
adopted by FDA/DHHS.
Thank you for your cooperation during the review process.

 
Page 1 of 29 
Revised: January 11, 2019 
  
 
Research Protocol Template 
 
 
PROTOCOL TITLE: 
Improving Healthy Lifestyle Behaviors in Midlife Black Women to Lower Heart Disease Risk. 
 
PRINCIPAL INVESTIGATOR: 
Holly J. Jones 
College of Nursing 
513-558-5285 
joneshj@ucmail.uc.edu 
VERSION NUMBER/DATE: 
Version 6. November 25, 2020 
 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
5 
9/23/2020 
Changes to approach due to COVID 
Yes 
6 
12/4/2020 
Changes to title  to maintain blinding among 
participants. Increase value of gift provided at 
12 weeks. Clarify the purpose of audiotaping 
for the Zoom sessions. It is used for quality 
assurance. On page 22, found an area of 
inconsistency with prior approval of use of 
information sheet.  
Yes 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Page 2 of 29 
Revised: January 11, 2019 
 
 
 
 
Table of Contents 
1.0 
Study Summary ................................................................................................... 3 
2.0 
Objectives* .......................................................................................................... 4 
3.0 
Background* ........................................................................................................ 4 
4.0 
Study Endpoints* ................................................................................................. 8 
5.0 
Study Intervention/Investigational Agent ............................................................. 9 
6.0 
Procedures Involved* ........................................................................................... 9 
7.0 
Data and Specimen Banking*..............................................................................15 
8.0 
Sharing of Results with Subjects* .......................................................................15 
9.0 
Study Timelines* ................................................................................................15 
10.0 
Inclusion and Exclusion Criteria* ........................................................................16 
11.0 
Vulnerable Populations* .....................................................................................17 
12.0 
Local Number of Subjects ...................................................................................17 
13.0 
Recruitment Methods ..........................................................................................17 
14.0 
Withdrawal of Subjects* .....................................................................................17 
15.0 
Risks to Subjects* ...............................................................................................18 
16.0 
Potential Benefits to Subjects* ............................................................................18 
17.0 
Data Management* and Confidentiality ..............................................................19 
18.0 
Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................21 
19.0 
Provisions to Protect the Privacy Interests of Subjects .........................................21 
20.0 
Compensation for Research-Related Injury .........................................................22 
21.0 
Economic Burden to Subjects..............................................................................22 
22.0 
Consent Process ..................................................................................................22 
23.0 
Process to Document Consent in Writing ............................................................23 
24.0 
Setting ................................................................................................................23 
25.0 
Resources Available ............................................................................................25 
26.0 
HIPAA ................................................................................................................27 
27.0 
Other Reviews ....................................................................................................27 
28.0 
Multi-Site Research* ...........................................................................................28 
 
 
 

 
Page 3 of 29 
Revised: January 11, 2019 
 
1.0 
Study Summary 
 
Study Title 
Improving Healthy Lifestyle Behaviors in Midlife Black 
Women to Lower Heart Disease Risk. 
 
Study Design 
Developmental research study and pilot.  
Primary Objective 
The primary objective of this research is to develop a midlife 
Black women’s Stress-reduction WELLness 
intervention, B-SWELL, for midlife Black women based on 
the stressors and themes identified in the PI’s preliminary 
research. 
Secondary 
Objective(s) 
Determine the feasibility of the B-SWELL intervention with 
a trial of 50 midlife Black women randomized 
to the B-SWELL intervention (25) or to a wellness education 
(WE) control group (25): 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
8-week community-based, behavioral intervention 
IND/IDE #  
N/A 
Study Population 
Midlife Black women 
Sample Size 
50 
Study Duration for 
individual 
participants 
8 weeks 
Study Specific 
Abbreviations/ 
Definitions  
B-SWELL: Black women’s Stress-reduction WELLness 
Intervention 
WE: Wellness attention control group 
CBPR: Community-Based Participatory Research 
C-RAB: Community Research Advisory Board 
 
 

 
Page 4 of 29 
Revised: January 11, 2019 
2.0 
Objectives* 
2.1 Describe the purpose, specific aims, or objectives. 
Purpose: The purpose of this research is to develop a midlife Black women’s Stress-reduction WELLness 
intervention, B-SWELL, to promote healthy lifestyle behaviors based on the stressors and themes identified 
in the PI’s preliminary research and consistent with the American Heart Association’s Life Simple 7 Success 
Plan (LS7) behaviors. 
  
Aim 1: Develop the B-SWELL intervention for midlife Black women through the innovative leveraging 
of CBPR methodology and LS7 modifiable healthy lifestyle behaviors. 
a) To develop components of the B-SWELL intervention prototype for midlife Black women. 
b) Obtain ratings of the new components of the B-SWELL from an expert panel consisting of four   
    midlife Black women laypersons, three researchers and three integrative health care specialists for    
    degree of accuracy, relevance, and feasibility to inform further refinements. 
Aim 2: Determine the feasibility of the B-SWELL intervention with a trial of 50 midlife Black women 
randomized to the B-SWELL intervention (25) or to a wellness education (WE) control group (25): 
a) Obtain recruitment, retention, treatment fidelity ratings, and satisfaction ratings for the intervention  
                 procedures for both groups, including technology; 
b) Compare mediator measures (stress, self-efficacy) for participants in the B-SWELL intervention     
    group with those in the WE group at 8 and 12 weeks. 
c) Compare outcome measures (LS7 summary scores, unhealthy days, general health, depressive 
    symptoms) for participants in the B-SWELL intervention group with those in the WE attention 
    control group at 8 and 12 weeks. 
 
2.2 State the hypotheses to be tested. 
Our hypothesis proposes that B-SWELL (intervention) participants will show improved self-efficacy in 
managing life stress and adopting the LS7 behaviors, compared to an attention control group (WE group) 
receiving traditional wellness education. 
 
3.0 
Background* 
3.1 Describe the relevant prior experience and gaps in current knowledge. 
Cardiovascular disease (CVD) is the primary cause of death in all women, and as women transition 
through midlife, the prevalence of CVD exceeds that of men.(American Heart Association, 2016) Midlife Black 
women, defined as ages 40-64, unduly shoulder the burden of CVD (49%), hypertension (40%), and heart 
failure (50% greater risk).(Go et al., 2013; Gudmundsdottir, Hoieggen, Stenehjem, Waldum, & Os, 2012) 
Midlife Black women also report higher levels of chronic stress and greater numbers of stressful life events in 
comparison to midlife White women,(Schulz et al., 2000; Turner & Avison, 2003) putting them at greater risk 
for CVD. In addition to the physical impact, coping with chronic stress takes time and energy away from self-
care, functioning as a barrier to the adoption of healthy lifestyle behaviors.(Pedersen, von Kanel, Tully, & 
Denollet, 2017; Pogosova et al., 2015) Existent interventions do not fully address the unique factors 
contributing to the experience of stress, lifestyle behaviors, and CVD risk in midlife Black women.  
In the PI’s prior research, we identified the particularities of stress and how they manifest in the lives of 
midlife Black women. Key stressors included: workplace stress, parenting, finances, and media stress.(Jones, 
Sternberg, Janson, & Lee, 2016; H. J. Jones, Norwood, & Bankston, 2018) The theme, ‘Strong Black Woman’, 
was identified along with the subthemes of ‘gendered racism and discrimination’ and ‘life balance’.(H. J. Jones 
et al., 2018) The Strong Black Woman persona explains the elevated risk for morbidity and persistent chronic 
stress in Black women due to simultaneous exposures to racism and sexism and the gendered expectations of 
being the primary familial care-giver and supporter of others and the community alike.(Mullings, 2000; Woods-

 
Page 5 of 29 
Revised: January 11, 2019 
Giscombe, Lobel, Zimmer, Wiley Cene, & Corbie-Smith, 2015) This persona serves as a coping mechanism 
under extremely oppressive conditions, cultivating strength and resilience among Black women, but leads to a 
deterioration of health due to chronic active coping.(Geronimus, 2001; Lekan, 2009) 
Many Black women internalize characteristics of the ‘Strong Black Woman’ and while these 
characteristics are generally positive, it is easy to envision how a ‘Strong Black Woman’ can become stressed, 
overwhelmed, and isolated.(Beauboeuf-Lafontant, 2009) Much research has been done to provide a voice and 
understanding to the Black female experience in America however, none have used that voice to identify and 
target the unique perceived stressors that may serve as barriers to the adoption of healthy lifestyle behaviors. 
The purpose of this research proposal is to develop a midlife Black women’s Stress-reduction WELLness 
intervention, B-SWELL, to promote healthy lifestyle behaviors based on the stressors and themes identified in 
preliminary research.(Jones et al., 2016; H. J. Jones et al., 2018) Community-based participatory research 
(CBPR) methods will be used to engage the community and include midlife Black women in the development 
of the B-SWELL. We propose that the skills and knowledge gained through participation in the B-SWELL 
program will increase receptivity to the healthy lifestyle behaviors outlined in the American Heart Association’s 
Life Simple 7 Success Plan (LS7). The LS7 targets seven risk factors known to increase cardiovascular related 
health risk: cholesterol, fasting glucose, blood pressure, body mass index, physical activity, diet, and 
smoking.(Windham et al., 2017) By the age of 40, the prevalence of CVD is equal between men and women but 
by the age of 60, more women are affected.(Mozaffarian et al., 2016) This noted increased risk of CVD across 
midlife warrants the need for intervention. 
 
 
3.2 Describe any relevant preliminary data. 
 
Two preliminary studies conducted by the PI will inform this research.(Jones et al., 2016; H. J. Jones et 
al., 2018) These studies sought to understand the complexity of stress as a health indicator for midlife Black 
women. The first study used mixed methods to assess changes in perceived stress across midlife and identify 
significant life stressors.(Jones et al., 2016) The sample of 15 midlife Black women from the San Francisco Bay 
area (mean age 61years) had high-perceived stress scores that persisted across midlife. Although stress scores 
were consistent over time (between ages 40 and 60), the sources of stress changed. Significant life stressors 
included finances, caring for family members, relationships, personal health and aging, race and gender-based 
discrimination, and raising children.(Jones et al., 2016) 
“Race is the hidden in plain view stressor in USA life. I am Black and that has caused me stress working 
in a White world. Equal, or perhaps worse, is the fight to have my voice heard as a woman.” 
 
This sample of midlife Black women was part of a larger cohort of Black and White midlife women. In 
the cohort (N=39), midlife Black women had higher perceived stress scores, a greater number of depressive 
symptoms and, were more likely to be obese and have elevated blood pressures compared to White women of 
similar age and demographics.(Jones et al., 2016) Higher perceived stress scores correlated with older 
biological age, indicating a greater health risk profile;19 a finding that is consistent with the literature. 
The second study conducted by the PI(H. J. Jones et al., 2018) used community engagement and focus 
groups to identify stress-related themes in the lives of midlife Black women residing in the Greater Cincinnati 
area. Key stressors were identified within six major themes: workplace, parenting, finances, social media, 
gendered racism and discrimination, and life imbalance(H. J. Jones et al., 2018). The participants also identified 
stress-reduction strategies and barriers to adopting those strategies. The six themes highlighting key life 
stressors in this second study were similar to those reported by the PI in the first study.(Jones et al., 2016) Two 
new sources of stress also emerged: social media and life imbalance.(H. J. Jones et al., 2018) Stress-reduction 
strategies were also similar between the two studies and included exercise, prayer, hobbies and other self-care 
activities, and fellowship.(H. J. Jones et al., 2018) The ‘Strong Black Woman’ theme was prevalent in the 
Cincinnati cohort:  
 “...we fail to seek assistance...sometimes you have to step back and recognize you might be a little bit in 
over your head and you need some help” 

 
Page 6 of 29 
Revised: January 11, 2019 
 
The focus group discussions in this second study generated ideas for the content (i.e., finances, 
parenting) and delivery (i.e., lectures, demonstrations) of a culturally tailored stress reduction program. The 
women also recommended the use of technology (social media, websites) for continued access to information 
and support. A manuscript authored by the PI and her primary mentor that highlights the ideas for content and 
delivery of the B-SWELL intervention is under peer review. 
The findings for these preliminary studies are notable for their similarities. Midlife Black women in the 
San Francisco Bay area shared similar experiences with stress and sources of stress with midlife Black women 
from the Midwest.(Jones et al., 2016; H. J. Jones et al., 2018) Furthermore, the women reported similarities in 
preferred coping strategies.(Jones et al., 2016; H. J. Jones et al., 2018) The stress reduction strategies reported 
reflect culturally acceptable approaches for midlife Black women. This preliminary research underscores the 
importance of using the voices of midlife Black women to inform the design of interventions intended to 
improve behavior. CBPR methodology will facilitate the collaboration between the research team and the 
targeted population. This proposed research aims to fill that gap in the current intervention literature; themes 
identified in the PI’s preliminary research(Jones et al., 2016; H. J. Jones et al., 2018) will inform the 
development of a stress-reduction wellness program for midlife Black women, B-SWELL. This project has the 
potential to improve our knowledge about the complex relationship between stress and behavior while 
decreasing CVD risk in a high-risk population.  
The work of the mentoring team is essential to the success of this research. The primary mentor, Dr. 
Tamilyn Bakas, has a body of research that focuses on the care of the family caregiver. She developed the 
Telephone Assessment and Skill-building Kit (TASK) for stroke family caregivers through a K01 Award, then 
tested efficacy of this innovative program (TASK II) through an R01-funded randomized controlled clinical 
trial (RCT). (Bakas et al., 2015; Bakas et al., 2009) She has a currently funded R21 designed to optimize the 
TASK III program using technology (i.e., Task III website and eBook) and goal setting strategies to further 
improve caregiver health. Dr. Bakas has invited the PI to join her R21 research team where she will take an 
active role in helping to optimize the TASK III program. The PI will learn essential skills as a member of Dr. 
Bakas’ research team (i.e., intervention development, clinical trial management, use of technology for 
intervention delivery). Many midlife Black women serve in caregiving roles, making her involvement in Dr. 
Bakas’ research highly relevant to the current project.  
Dr. Butsch Kovacic has a body of research grounded in CBPR and the health of under-represented 
communities.64 She is the faculty liaison for the community research advisory board identified in this study and 
has a currently funded NIH R25 SEPA grant. Her expertise in epidemiology is an excellent complement to this 
research, as she understands the intersectionality of environment, person, and health; stress-related illness; and 
the challenges facing midlife Black women. The PI served as a co-investigator on Dr. Butsch Kovacic’s recent 
research that used recreational music making to decrease stress in midlife Black women.  
 
3.3 Provide the scientific or scholarly background for, rationale for, and significance of the 
research based on the existing literature and how will it add to existing knowledge. 
3.3.1. Cardiovascular Health Disparities for Midlife Black Women. 
Black women are projected to have the lowest life expectancy of all racial/ethnic groups in the U.S. by 
2060. This lower life expectancy projection is attributed to health problems that occur across the life span but 
in midlife Black women (ages 40-64), is commonly attributed to cardiovascular disease (CVD). It is estimated 
that 49% of adult black women have heart disease and over 40% have been diagnosed with hypertension.1 
African American women are more likely to be obese, increasing their risk for Type 2 diabetes, hypertension 
and CVD.29 Although CVD is the number one cause of death in all women, African American women over the 
age of 60 have the greatest incidence of heart failure30 and 64% of Black women do not know that heart 
disease is their greatest health risk.1 Despite these statistics, studies show that intervention in midlife 
can aide in the prevention of chronic conditions like CVD and increase life expectancy.31,32 
Midlife Black women are exposed to multiple and competing daily stressors resulting from role changes, 
major life events, and menopause, in addition to microaggressions and discriminatory acts related to their age, 

 
Page 7 of 29 
Revised: January 11, 2019 
gender, and ethnicity. The unique stressors experienced by midlife Black women contribute to the development 
of chronic conditions such as CVD because they tend to occur persistently and over prolonged periods of time. 
This chronic exposure has been associated with inflammation and plaque development in the vasculature 33. 
These stressors also function as barriers to the adoption of lifestyle behaviors that can prevent and even reverse 
these conditions 34. Coping with multiple stressors requires time that could otherwise be devoted to exercise, 
preparation of healthy foods, sleep, or fellowship; behaviors that have been shown to minimize, and possibly 
reverse, the effects of chronic stress 6,35. In fact, recent literature supports the need for tailored interventions 
for midlife Black women based upon observed health disparities and the strong relationship between health 
deterioration and chronic active coping 13,36  
 
 
 
3.3.2. Theoretical underpinnings 
In the effort to conceptualize and design a stress-reduction wellness intervention for midlife 
Black women, two theoretical frameworks will be used: Black Feminist Thought and Social Cognitive 
theory. Black Feminist Thought is a theoretical point of view that seeks to clarify the ideas and experiences of 
Black women from the perspective of Black women.37 Black Feminist Thought and its related constructs 
explain the elevated health risks and morbidity within the context of racism, sexism, and gendered 
expectations experienced by midlife Black women.10,11 The “Strong Black Woman” is a cultural construct 
arising from the Black Feminist perspective and was a major theme identified in the PI’s preliminary work.8,37 
The ‘Strong Black Woman’ persona, encapsulates a set of characteristics, beliefs, and behaviors that have 
been historically associated with the ‘Strong Black Woman’ (independence, resilience, perseverance) and 
deemed necessary for survival. This persona also contributes to a deterioration of health12 as women 
struggle to meet the expectations and needs of others with little regard for their own needs.29 
Bandura’s Social Cognitive Theory39 will guide the development of this intervention. Self-efficacy, a 
construct arising from Bandura’s theory, has been shown to influence the adoption of healthy lifestyle 
behaviors.40,41 Self-efficacy is defined as “an individual’s judgement of his or her capabilities to organize and 
execute courses of action.”42 Self-efficacy recognizes that the intersectionality between person, behavior, and 
environment is key to understanding the motivations, perceptions, and barriers that influence decisions and the 
adoption of healthy lifestyle behaviors.39,42 In understanding and recognizing the significant stressors in the 
lives of midlife Black women, we can make steps to change perceptions and behaviors For this research study, 
self-efficacy will be viewed as a mediator for the adoption of healthy lifestyle behaviors. 
 
3.3.3. Intervention Research Studies: 
Targeting Interventions to Black Women: In general, intervention studies designed to improve 
healthy lifestyle behaviors are not focused on Black women. However, recommendations on how to tailor and 
target this population exist.29,43 Interventions targeted to vulnerable populations such as midlife Black women 
are advised to incorporate theory and take into account cultural and social factors that influence the decision to 
adopt (or avoid) specific behaviors.44 Mwenda et al. used the ‘Transtheoretical Model’ stages of change to 
evaluate factors associated with increased physical activity in a sample of hypertensive Black women.45 In 
another study, researchers concluded that the inclusion of social networks and a variety of behavioral 
strategies is imperative when designing interventions intended to improve the adoption of healthy lifestyle 
behaviors in Black women.46 Social networks, in particular, are key cultural factors of importance to midlife 
Black women. Finally, a literature review of interventions to promote exercise in Black women recommended 
that intragroup differences and communal resources be assessed in the design and implementation of 
interventions.47 The results of these highlighted studies can be applied to future interventions. 
Interventions to Improve Health: Intervention studies focused on healthy lifestyle behaviors in Black 
women tend to target specific health behaviors such as cancer screening or exercise. Few target general 
health or well-being.50,51 Napholz developed a psychoeducational intervention for Black working women with 
the goal of reducing role conflict and improving well-being.50 This research focused solely on work role 
experiences for Black women. Napholz acknowledged the work role as a major life domain and discussed the 

 
Page 8 of 29 
Revised: January 11, 2019 
impact of prejudicial racial attitudes and other harmful stimuli encountered during daily work place 
interactions.50 She proposed that gender- and culture-appropriate content improved the receptivity of her 
intervention and she advocated for the use of tailoring to improve interventions. Work stress was a significant 
stressor in the preliminary research focus group study conducted by the PI. The proposed research 
will look beyond work stress to include the multiple, competing stressors experienced by midlife Black women. 
Gaston, Porter, & Thomas 52 created an intervention designed to improve knowledge about 
major illness and nutrition for midlife Black women. This intervention used a support group approach 
to increase awareness and engagement. In another study, civic engagement was used to promote 
participation in lifestyle behaviors that reduce CVD risk. The adapted intervention was conducted in 
churches and ‘change clubs’ were formed. The ‘change clubs’ created a social network and group 
dynamic centered on improving lifestyle behaviors. Both studies aimed to improve general health. 
Culturally relevant approaches were identified but specific risk factors (i.e. stress) were not addressed. 
Stress Interventions: Stress-reduction intervention studies aimed at Black women have targeted 
health problems such as pre-term labor, high blood pressure, and obesity. These health problems 
have demonstrated strong associations with stress and alarming disparities for Black women. In a 
study by Wesley,56 on-to-one sessions using deep breathing exercises or guided imagery were 
successful in decreasing perceived stress scores in pregnant Black women. Another study by Lechner 
and colleagues,57 used cognitive behavioral stress therapy to improve psychological adaptation in a sample of 
Black female breast cancer survivors. Alternatively, Cox and colleagues did not find significant success in their 
stress-augmented weight loss intervention program for adult Black women.55 Engagement was a key mediator 
related to lack of adherence to the intervention55 and is often proposed as a rationale for gender and cultural 
tailoring. These studies demonstrate a willingness of Black women to use a variety of stress-reduction 
strategies and highlights the importance of culture and inclusion when delivering interventions. No 
intervention studies were found that focus on the life stressors relevant to midlife Black women and the 
mechanisms through which these stressors serve as barriers to health lifestyle behavior.  
 
3.3.4. Technology Use During COVID-19 Pandemic.  
There has been a steady increase in the use of technology in behavioral interventions. The addition of 
technology has shown effectiveness in several areas that increase its popularity. Technology has potential to 
reach a wider scope of people, ease access to information, decrease barriers to participation, improve collection 
and retention of research data, and eliminate internal bias, among others. Technology used for information and 
communication in behavioral interventions has been shown to improve outcomes when combined with other 
methodologies such as face-to-face (Lau, Lau, Wong, & Ransdell, 2011). Several systematic reviews focus on 
the use of technology in interventions designed to assess the effectiveness of physical activity and/or dietary 
behavior change. In the majority of systematic reviews (Kroeze, Werkman, & Brug, 2006; Lau et al., 2011; van 
den Berg, Schoones, & Vliet Vlieland, 2007; Vandelanotte, Spathonis, Eakin, & Owen, 2007), positive effects 
were noted with the addition of technology while others reported mixed results (Norman et al., 2007). Due to 
the COVID-19 pandemic, the B-SWELL RCT will be conducted remotely online. The use of technology in this 
study has the potential to improve our knowledge about technology in behavioral research studies.  
 
4.0 
Study Endpoints* 
4.1 Describe the primary and secondary study endpoints. 
The primary endpoint is to develop the B-SWELL intervention for midlife Black women using theory-based 
research, community engagement, and CBPR methods.  
 
The secondary endpoint is to decrease stress and eliminate barriers to the adoption of healthy lifestyle behaviors 
in midlife Black women, ultimately reducing CVD risk in this vulnerable population. 
4.2 Describe any primary or secondary safety endpoints. 

 
Page 9 of 29 
Revised: January 11, 2019 
N/A 
 
5.0 
Study Intervention/Investigational Agent 
5.1 FDA-Related, Select Applicable: 
☐ 
Drugs or 
Biologics 
The proposed research involves the administration of an article (e.g. 
drug, biologic, herbal preparation, dietary supplement, etc.) to a 
human where the article is intended for use in the diagnosis, cure, 
mitigation, treatment, or prevention of disease or is intended to 
affect the structure or any function of the body. For both FDA and 
non-FDA approved article. 
☐ 
Devices 
Any research that involves the use of a device (medical or other 
devices, approved or investigational) to test the safety or 
effectiveness of the device or the device is the focus of the 
research. Note: This includes research that will use human samples 
to test the safety or effectiveness of a device. 
☐ 
Data 
Collection 
Any research that involves the collection of data or other results 
from individuals that will be submitted to, OR held for inspection 
by, the FDA. In general this would include research that involves 
any data that will be provided (in any form) to a pharmaceutical, 
medical device or biotech company. 
☐ 
Specimens 
Any research activity where specimens (of any type) from 
individuals, regardless of whether the specimens are identifiable, 
are used to test the safety or effectiveness of any device (medical or 
other devices, approved or investigational) and the information will 
be submitted to, or held for inspection by, the FDA. 
☒ 
None of 
the Above 
None of the above describes my research. 
1.1  
1.2 Describe the study intervention and/or investigational agent (e.g., drug, device) that is 
being evaluated. 
N/A 
5.2 Drug/Device Handling: If the research involves drugs or device, describe your plans to 
store, handle, and administer those drugs or devices so that they will be used only on 
subjects and be used only by authorized investigators. 
            N/A 
5.3 If the drug is investigational (has an IND) or the device has an IDE or a claim of 
abbreviated IDE (non-significant risk device), include the following information: 
            N/A 
 
6.0 
Procedures Involved* 
6.1 Describe and explain the study design. 
This is a development and feasibility study. It will take place in two parts as outlined in Aims 1 & 2. In 
accordance with Aim 1, we will develop a stress reduction wellness intervention for midlife Black 
women and rate its accuracy, relevance, and feasibility using an expert panel and a community research 

 
Page 10 of 29 
Revised: January 11, 2019 
advisory board. We will then pilot the intervention using a sample of 50 women randomized to either the 
B-SWELL group or the WE (attention control) group. Satisfaction ratings will be obtained from 
participants. The study findings will be used to determine feasibility of the intervention and support a 
larger trial.  
6.2 Provide a description of all research procedures being performed and when they are 
performed, including procedures being performed to monitor subjects for safety or 
minimize risks. 
 
6.2.1 Methods for Aim 1 
Aim 1: Develop the B-SWELL intervention for midlife Black women through the innovative leveraging of 
CBPR and LS7 modifiable healthy lifestyle behaviors. In Aim 1, the content for both the intervention (B-
SWELL) and control groups (WE) will be developed. The B-SWELL intervention is proposed as an 8-week 
community-based intervention, culturally tailored to decrease stress in midlife Black women while 
simultaneously addressing key risk factors associated with CVD (Figure 1). The B-SWELL program will 
address key stressors and cultural themes identified in the PI’s preliminary research 8,9 to provide a unique 
approach tailored to midlife Black women. Each module in the 8-week intervention will focus on the adverse 
effects of stress on health, in particular CVD, and the importance of minimizing these effects through healthy 
lifestyle behaviors (LS7). Links will be drawn between stress and CVD risk factors such as lack of exercise, 
poor diet, smoking, sleep deprivation, and non-adherence to treatment regimens. Stress reduction strategies 
included in the B-SWELL will be presented with emphasis on the needs and preferences of midlife Black 
women. For example, culturally relevant images will be used in guided imagery exercises. The tools learned in 
the B-SWELL will enable participants to be self-directed and create personalized plans to adopt healthy 
lifestyle behaviors. Content will be delivered by lecture, demonstration, and interactive exercises to increase 
engagement and promote inclusivity.  
Consider this scenario: a midlife Black woman desires to improve her health and lifestyle habits. 
Through the B-SWELL program, she gains an understanding of how personal beliefs, culture, and socialized 
expectations inform her lifestyle decisions and affect her risk factors for CVD. She learns strategies to address 
the key stressor in her life: poor life balance. She receives support and validation from other participants in the 
program and takes steps to adjust her schedule and make time for exercise. She joins a carpool at her daughter’s 
school that frees her up 2 times a week to participate in a morning walking group while also allowing her extra 
time in the afternoon to relax before her daughter and husband return home. Empowered by this positive 
change, she decides that she will next create a personalized plan to stop smoking. 
Collaboration with the West End C-RAB and other community partners is critical to Aims 1 & 2. 
In CBPR, the community is recognized as a vital stakeholder to be included at every stage of the 
research. The C-RAB’s participation will ensure that the B-SWELL reflects the needs of midlife Black 
women. The final intervention, including its materials and processes, will reflect knowledge gained from the 
PI’s training plan, input from community collaborators, and refinements dictated by the initial ratings. 
Data Collection Procedures: Aim 1. Data collection will occur during the development phase in 
Aim 1. Data will be collected using survey ratings about materials and components of the B-SWELL 
intervention from 10 identified experts. The expert panel will include four midlife Black women laypersons, 
three researchers (identified as experts by having a doctoral degree and strong record of publication), and three 
integrative health care specialists. Rating surveys will be similar to those used by Dr. Bakas in her feasibility 
study 22 to assess accuracy, relevance, and feasibility. Ratings will be averaged across the experts, with 
possible scores ranging from 1=strongly disagree to 5=strongly agree. 
Recruitment and Informed Consent. Following approval from the UC IRB, research activities will begin. 
In Aim 1, the intervention will be developed and expert raters will be recruited to assess and evaluate the 
intervention materials and content. Experts will be recruited by word of mouth and by special invitation from 
the researchers by email, mail, telephone, or flyers. They will receive a study information sheet explaining that 
participation is voluntary and that their decision will not affect their relationship with the University of 

 
Page 11 of 29 
Revised: January 11, 2019 
Cincinnati, their employer, or the researchers. Full information will be provided and questions answered prior to 
consent. Incentives will be provided to the experts for participation. 
 
 
 
6.2.2. Methods for Aim 2 
Aim 2: Determine the feasibility of the B-SWELL intervention with a trial of 50 midlife Black women 
randomized to the B-SWELL intervention (25) or to a general wellness education (WE) control group (25). Aim 
2 will focus on conducting a successful trial of the 8-week B-SWELL intervention for midlife Black women. 
The preliminary conceptual model in Figure 2 will guide this phase of the research. We anticipate that the 
model will be refined as we synthesize the new knowledge and feedback from the community (Aim 1). During 
Aim 2, community-based activities will focus on the recruitment, trial, data collection, and dissemination. 
Midlife Black women will be recruited and randomized into one of two groups: B-SWELL intervention group 
or a wellness education control group, WE group. Sessions will be held online using the Zoom online platform 
which has been approved and is supported by the university for research.  Participants will be asked not to share 
intervention materials or experiences with midlife Black women outside of their assigned group. Participants in 
both groups will be introduced to AHA’s LS7 behaviors, LS7 materials, and the LS7 website using B-SWELL 
tablets. Participants in the B-SWELL intervention group will also receive education about stress, with a focus 
on unique stressors experienced by midlife Black women. 
 
Program evaluation will be ongoing. Data collection telephone interviews will occur at three time 
points: baseline (pre-intervention), 8 weeks (completion of the study), and 12 weeks (4 weeks post intervention) 
for both the B-SWELL and WE groups. Outcome measures will include LS7 scores, number of unhealthy days, 
depressive symptoms, and perceived general health. Ratings will be obtained from community collaborators to 
evaluate recruitment, retention, and treatment fidelity for both groups. Qualitative feedback and satisfaction 
ratings for the B-SWELL groups, WE groups, and technology will be obtained from participants at completion.  
Recruitment and Eligibility: Aim 2: The sample of participants for Aim 2 will consist of 50 
Black or African-American women randomized to a B-SWELL group (n=25) or to a WE attention control 
group (n=25). Inclusion criteria include being Black or African-American, between the ages of 40 and 64, 
fluent in the English language, ability to hear and speak well enough to engage in everyday conversation, access 
to a telephone, access to WIFI and willingness to participate. Exclusion criteria include recent immigration to 
the U.S., prisoner or on house arrest, pregnant, terminal illness (i.e., late stage cancer, end-of-life condition, 
renal failure requiring dialysis), history of Alzheimer’s, dementia, or severe mental illness (i.e., suicidal 
tendencies, schizophrenia, or severe untreated depression), or any other major health conditions or disabilities 
(i.e. visual impairment, blindness, deafness) prohibiting safe or full participation in the program. Recruitment 
will involve use of fliers, referral, snowballing, and purposeful sampling in targeted communities. Fliers may be 
posted in businesses, on list serves, or group websites to increase distribution.  The 8-week trial will take place 
virtually using a Zoom account established through the UC CON for the PI. Dates and times of the online 
virtual sessions will be established based on availability of the participants following randomization.  
 
Interventions and Treatment Fidelity Methods: The B-SWELL intervention will follow procedures 
such as those proposed in Figure 1 and will be refined prior to trial based on feedback from the community 
collaborators and expert ratings (Aim1). Participants will be randomized to either the B-SWELL or WE groups. 
Both groups will be introduced to the LS7 materials. The B-SWELL will receive additional instruction about 
stress. B-SWELL and WE group sessions will occur on different dates and times and, participants will be asked 
not to share experiences with women outside of their assigned group. Participants will also be asked to secure  
private location when attending the virtual sessions to ensure privacy and confidentiality. Treatment fidelity of 
both groups will be monitored using Borrelli’s Treatment Fidelity Checklist (Design, Training, Delivery, 
Receipt, Enactment). Facilitators of the intervention and control groups will be trained prior to the start of the 
trials.. Zoom meetings will be audio taped for quality assurance. 
Data Collection Procedures: Aim 2. Data collection will occur at baseline, 8 weeks, and 12 weeks. 
Baseline data will be collected from B-SWELL and WE participants using telephone interviews conducted by 
trained, blinded research assistants. Data collection at 8 and 12 weeks may be collected via phone interview or 
through a REDCap link on the B-SWELL study tablets provided to B-SWELL and WE participant. Completion 

 
Page 12 of 29 
Revised: January 11, 2019 
of the surveys (interview or via REDCap link) is expected to last 30-45 minutes for each timepoint. Instruments 
are listed in Table 5. 3.4.d.  
Randomization Procedures: Following baseline data collection, participants will be randomized to 
either the B-SWELL or WE group using 1:1 block randomization to promote equal group sizes. The 
randomization allocation sequence will be blinded to data collectors to avoid bias during follow-up data 
collection telephone interviews. Following randomization, the PI or research assistant will notify the participant 
of their group assignment and upcoming group meetings. Treatment fidelity will be monitored using the 
Borrelli’s Treatment Fidelity Checklist (Design, Training, Delivery, Receipt, Enactment). 
Recruitment and Informed Consent. In Aim 2, trial of the intervention will be conducted. Participants for 
the trial of the intervention will be recruited using fliers, referral, snowballing, and purposeful sampling in 
targeted communities. Fliers may be posted on list serves or group websites to increase distribution.  A letter of 
introduction and study information sheet will be the first contact made for the study. A telephone number is 
provided for potential participants to call if they wish to participate. The PI or trained research staff will make 
the calls from a private location to protect confidentiality of the participant. If eligible and interested in 
participating, the person will be invited to participate and receive informed consent. All participants will be 
given full information about the nature, purpose, and possible risks and benefits of the study. Participants will 
be informed that participation in the study is voluntary, and they are free to discontinue participation at any 
time. Those who are eligible and who have signed the informed consent will be enrolled. The PI or research 
staff trained by the PI will obtain consent. Upon completion of the study, participants will receive a gift valued 
at $40 and keep all study materials. Study materials will consist of a study binder, AHA and LS7 informational 
materials, and a Fire 8 tablet.  
 
 
6.3 Describe: Procedures performed to lessen the probability or magnitude of risks. 
This study has minimal risk. Some survey items asked during the phone interviews may focus on negative 
emotions or experiences. There is a risk of loss of confidentiality for participants involved in the study given the 
online Zoom platform used for each session. Audiotapes of the Zoom sessions are for quality assurance. 
Transcriptions will be de-identified. There are no anticipated physical, social, legal, or other potential risks 
connected with the proposed procedures. The alternative to participating in the study is not to participate in the 
study. Participants and experts may withdraw at any time or may choose not to answer items during the 
interviews that make them uncomfortable. 
Protections against risk. Participants may choose not to answer items during interviews or participate in 
portions of the intervention program with which they are uncomfortable. In the unlikely event that a participant 
appears to be distressed, she will be referred to appropriate resources or be given the telephone number for the 
national Suicide Hotline (800-784-2433; 800-SUICIDE) if appropriate. The PI will inform the IRB of 
any adverse events and/or any amendments to the protocol. Training for data collectors also will include how to 
respond to any potential adverse events experienced by participants, such as suicidal tendencies or severe 
depression. Participants with these types of problems will be given information about how to seek help and will 
be encouraged to inquire whether medication and/or psychological counseling would be helpful. In the event of 
suicidal thoughts, the PI or research staff may contact a health care provider on the participant’s behalf so that 
they can contact the participant directly to determine if treatment is necessary. 
 
To avoid loss of confidentiality during the online Zoom sessions, participants will be asked to find a 
private location from which to attend the online Zoom sessions. Additionally, participants will be required to 
attend Zoom sessions with video and will be asked to keep session discussions and activities private. 
Only authorized study personnel will have access during the Zoom sessions, Zoom audiotapes or 
transcriptions, REDCap data, database, or contact information for study participants and expert panel members. 
For data analysis, study ID numbers will be generated to protect the identity of the participants in the final data 
set. Participants will not be identified in any way in reports or manuscripts from the study. Data from surveys 
will input directly into a REDCap database either manually or via the link on the study tablets. REDCap is 
backed up nightly by the university. Only authorized study personnel will have access to REDCap. Any calls to 
participants will be made to a telephone number provided by the participant at a time that is convenient for the 

 
Page 13 of 29 
Revised: January 11, 2019 
participant. Research staff will make calls from a private location in order to protect confidentiality. Informed 
consent forms and contact information from participants will be stored separately in a locked file cabinet to 
protect confidentiality. 
Tablets will be programmed with content and links relevant to the B-SWELL study and appropriate 
restrictions. Programming will be conducted by the B-SWELL research team under guidance of UC CATER 
staff. All study materials, including tablets, will be handled in accordance with UC COVID-19 protocols (i.e. 
gloves and masks).  
 
• 
All drugs and devices used in the research and the purpose of their use, and their 
regulatory approval status. 
N/A 
• 
The source records that will be used to collect data about subjects. (Attach all 
surveys, scripts, and data collection forms.) 
All study data and tracking will be entered into an electronic data system, REDCap (www.REDCap.org), a 
secure research electronic data management system with validated data entry, audit trails for tracking data 
manipulation, and export procedures. It is HIPAA complaint satisfying all local, state, and federal regulation for 
the capture and storage of private health information for research purposes. 
 
Zoom accounts have been purchased by the UC CON.  Zoom accounts will be supported by the UC 
CON CATER technology experts. Zoom links have been determined to be secure and appropriate for research 
by the UC depart of research. Members of the B-SWELL research team will be trained in the use and 
management of online Zoom group sessions, privacy, and technical issues.  
 
  
The surveys used to collect data are included in the chart below and attached.  
 

 
Page 14 of 29 
Revised: January 11, 2019 
 
 
 
6.4 What data will be collected during the study and how that data will be obtained? 
Rating surveys, self-report survey data, and satisfaction ratings will be gathered from the expert panel and 
participants (Aims 1 & 2) and entered directly into a REDCap database via laptop computer or REDCap survey 
link. Intake data will be labeled with study ID numbers and stored separately. Names, contact information, or 
any other identifiers will be stored separately from all data that is collected. Access to the database, contact 
information, or links between study ID numbers and participants enrolled in the study will be limited to the 
investigators. Participants will not be identified in reports or manuscripts from the study. All paper forms and 
study materials will be stored in locked file cabinets accessible only to authorized study personnel. All 
computers, servers, and electronic files used in the study will be password protected and accessible only to 
authorized study personnel. Authorized study personnel will include the investigators and research staff 
involved in the study.  
6.5 If there are plans for long-term follow-up, what data will be collected during this period.  
A third and final data collection time point will occur 4 weeks after the completion of the intervention 
(12 weeks).  
6.6 For Humanitarian Use Device (HUD) uses provide a description of the device, a summary 
of how you propose to use the device, including a description of any screening procedures, 
the HUD procedure, and any patient follow-up visits, tests or procedures. 
Construct  
 
Survey Tool 
Time  Baseline 
8wks  12wks  
Moderators 
Demographic data: income, marital status, children,  education, 
health problems, and community of residence (among others). 
5 
X 
 
 
Mediator  
Cohen’s Perceived Stress Scale (PSS-10): measures perception 
of general stress. Items are rated on a scale of 0–4 (Max score 
=40). 66,67  Higher stress levels correspond with higher scores. 
5 
X 
X 
X 
Mediator  
General Self-Efficacy Scale (GSE): 10-item psychometric scale 
that assesses optimistic self-beliefs to cope with life demands.68 
5 
X 
X 
X 
Primary 
Outcome  
AHA Life’s Simple 7 (LS7): developed to promote 
cardiovascular health in accordance with the organization’s 
2020 Impact Goals.69 Risk behaviors scored 0 to 2. Higher 
scores indicate trend towards optimal health behaviors and 
lower risk for CVD.  
5 
X 
X 
X 
Secondary 
Outcome  
Number of Unhealthy Days (UD): Number of days in past 
month participant felt physical/mental health was not good.70  
2 
X 
X 
X 
Secondary 
Outcome  
Perceived General Health: Uses the general health perception 
item from the Short Form Health Survey (SF36). Health rated 
as ‘excellent’, ‘very good’, ‘good’, ‘fair’ and ‘poor’.71  
2 
X 
X 
X 
Secondary 
Outcome  
Patient Health Questionnaire (PHQ-9): A diagnostic instrument 
for depressive symptoms. Scores each of the 9 DSM-IV criteria 
as ‘0' (not at all) to ‘3' (nearly every day).72  
5 
X 
X 
X 
Program 
Evaluation 
Satisfaction (Adapted from Satisfaction questionnaire): 
Measures usefulness, ease of use, and acceptability 
ratings.(Bakas et al., 2009) 
10 
 
 
X 
Technology 
Evaluation 
Satisfaction (Adapted from Satisfaction questionnaire): 
Measures usefulness, ease of use, and acceptability 
ratings.(Bakas et al., 2009) 
5 
 
 
X 
Total 
Minutes 
Total data collection minutes each visit 
40 
min 
30 min 
25 
min 
35 
min 

 
Page 15 of 29 
Revised: January 11, 2019 
N/A 
7.0 
Data and Specimen Banking* 
7.1 If data or specimens will be banked for future use, describe where the specimens will be 
stored, how long they will be stored, how the specimens will be accessed, and who will 
have access to the specimens. 
N/A 
7.2 List the data to be stored or associated with each specimen. 
N/A 
7.3 Describe the procedures to release data or specimens, including: the process to request a 
release, approvals required for release, who can obtain data or specimens, and the data to 
be provided with specimens. 
N/A 
8.0 
Sharing of Results with Subjects* 
8.1 Describe whether results will be shared with subjects or others and if so, describe how the 
results will be shared. 
We anticipate that there will be manuscripts, not only from the findings addressing Specific Aims 1 and 2, but 
also from secondary analyses from data generated from this study. We will disseminate results from Specific 
Aims 1 and 2, as well as results from secondary analyses, in peer-reviewed journals. We will also make the data 
available to others. Data will be shared with undergraduate honors students, MSN students, DNP students, PhD 
students, post-doctoral students, and interested faculty members at the University of Cincinnati, College of 
Nursing, and other institutions. Special measures will be taken to ensure that participants are not identifiable by 
any data that are shared. Close collaboration between the PI and her research team will be necessary for the use 
of shared data. 
 
This is a community-based participatory research plan and dissemination efforts will include community 
presentations to share the findings of the research and discuss its relevance and usefulness to the community. 
Measures will be taken to de-identify any data that is shared. Feedback and ideas from the community will be 
taken into consideration with future iterations of this research and larger clinical trials based upon the findings. 
This study will be registered and study results will be submitted to ClinicalTrials.gov in accordance with 
the NIH policy. Informed consent documents will include statements relating to the posting of clinical trial 
information at ClinicalTrials.gov.   
 
9.0 
Study Timelines* 
The duration for individual participation in the study is 12 weeks. The duration anticipated to enroll all 
study participants is 12 months. The estimated date for the investigators to complete primary analysis is 
April 2022. Please see the study timeline below: 
Grant Timeline 
Year 1 
Year 2  
Year 3 
Month 
3 
6 
9 
12 
15 
18 
21 
24 
27 
30 
33 
36 
Mentoring 
 
 
 
 
 
 
 
 
 
 
 
 
Didactic Coursework 
 
 
 
 
 
 
 
 
 
 
 
 
Workshops and conferences 
 
 
 
 
 
 
 
 
 
 
 
 
IRB approval process 
 
 
 
 
 
 
 
 
 
 
 
 

 
Page 16 of 29 
Revised: January 11, 2019 
 
 
 
 
 
 
 
 
 
 
10.0 Inclusion and Exclusion Criteria* 
10.1 Describe how individuals will be screened for eligibility. 
Recruitment will involve use of fliers, referral, snowballing, and purposeful sampling in targeted 
communities (Aim 1 & 2). Potential participants will express their interest by contacting the research 
team. Screenings will take place via phone. If a potential participant meets the study requirements, and 
agrees to the terms of the study, they will be randomized to either the intervention (B-SWELL) or 
control (WE) group (Aim 2).  
10.2 Describe the criteria that define who will be included or excluded in your final study 
sample. 
For Aim 2, inclusion criteria include self-identification as Black or African-American, between the ages of 40 
and 64, fluent in the English language, ability to hear and speak well enough to engage in everyday 
conversation, an email address, access to a telephone and WIFI, and willingness to participate. Exclusion 
criteria include recent immigration to the U.S., prisoner or on house arrest, pregnant, terminal illness (i.e., late 
stage cancer, end-of-life condition, renal failure requiring dialysis), history of Alzheimer’s, dementia, or severe 
mental illness (i.e., suicidal tendencies, schizophrenia, or severe untreated depression), or any other major 
health conditions or disabilities (i.e. visual impairment, blindness, deafness) prohibiting safe or full participation 
in the program.  
 
Indicate specifically whether you will include or exclude each of the following special populations:  
• 
Adults unable to consent 
Adults who are unable to consent will be excluded from this research study because this intervention 
focuses on increasing self-efficacy and one’s ability to make decisions about lifestyle changes to 
improve health. An inability to consent for one’s self speaks to agency. It is a contraindication for this 
study and implies that someone else may be deciding for the participant.  
• 
Individuals who are not yet adults (infants, children, teenagers) 
This research is targeted specifically to midlife Black women. Children and adolescents will not be 
recruited.  
 
Pregnant women are also excluded from this study. The study focuses on healthy lifestyle behavior and 
stress reduction; activities which should be beneficial to pregnant women. However, each pregnancy is 
unique and would require additional supervision. Safety measures for pregnant women are NOT 
included in the study procedures 
Advisory board meetings - 
quarterly 
 
 
 
 
 
 
 
 
 
 
 
 
Aim 1: Develop the B-
SWELL  components 
 
 
 
 
 
 
 
 
 
 
 
 
Aim 1: Obtain ratings of B-
SWELL components 
 
 
 
 
 
 
 
 
 
 
 
 
Aim 1: Data Analysis 
 
 
 
 
 
 
 
 
 
 
 
 
Aim 1: Refine B-SWELL 
components 
 
 
 
 
 
 
 
 
 
 
 
 
Aim 2: Recruitment 
 
 
 
 
 
 
 
 
 
 
 
 
Aim 2: Data collection 
 
 
 
 
 
 
 
 
 
 
 
 
Aim 2: Data analysis  
 
 
 
 
 
 
 
 
 
 
 
 
Aim 1&2: Dissemination 
 
 
 
 
 
 
 
 
 
 
 
 
R01 Grant writing 
 
 
 
 
 
 
 
 
 
 
 
 
K01 progress reports 
 
 
 
 
 
 
 
 
 
 
 
 

 
Page 17 of 29 
Revised: January 11, 2019 
• 
Prisoners 
Prisoners are excluded from this study as it is community-based research and requires participants to 
freely participate in virtual group activities, receive B-SWELL study documents in the mail, and have 
access to WIFI and a private location for group sessions.  
11.0 Vulnerable Populations* 
11.1 If the research involves individuals who are vulnerable to coercion or undue influence, 
describe additional safeguards included to protect their rights and welfare. 
N/A  
 
12.0 Local Number of Subjects 
12.1 Indicate the total number of subjects to be accrued locally. 
For Aim 1, ten (10) experts will be selected to review and rate the components developed for the B-SWELL 
intervention.  
For Aim 2, a total of fifty (50) midlife Black women will be recruited for participation in the pilot of the 
intervention.  
12.2 If applicable, distinguish between the number of subjects who are expected to be enrolled 
and screened, and the number of subjects needed to complete the research procedures. 
For Aim 2, statistical power is analyzed based upon assumptions that we have N=50 total or N=25/group 
complete all 3 data collection time points with complete observations. We will over sample participants 
at baseline to offset the predicted dropout rate and ensure the proposed sample size in the final visit. 
13.0 Recruitment Methods 
13.1 Describe when, where, and how potential subjects will be recruited. 
13.2 Describe the source of subjects. 
13.3 Describe the methods that will be used to identify potential subjects. 
13.4 Describe materials that will be used to recruit subjects.  
13.5 Describe the amount and timing of any payments to subjects. 
Recruitment will take place in Aim 1 and Aim 2 of this study. For Aim 1, an expert panel will be selected to 
rate the accuracy, relevance, and feasibility of the intervention. Purposeful recruitment methods will be used. 
For example, flyers will be placed in strategic locations. Referrals and recommendations will be accepted. The 
expert panel will include four midlife Black women laypersons, three researchers (identified as experts by 
having a doctoral degree and strong record of publication), and three integrative health care specialists. $100 is 
allocated for each reviewer for their time and effort (total $1000). 
 
Aim 2 will include CBPR techniques, such as community engagement, to assist in recruiting midlife Black 
women in the Greater Cincinnati area. Collaboration with an experienced community research advisory board 
will guide the recruitment efforts and selection of study sites. Recruitment will involve use of fliers, referral, 
snowballing, and purposeful sampling in targeted communities. Fliers may be posted in businesses, on list 
serves, or group websites to increase distribution.  All potential participants will be provided with written 
information about the nature, purpose, and possible risks and benefits of the study. Study participants will 
receive a $20 incentive per person at each data collection time point: baseline (before the start of the program), 
8 weeks (at completion of the study), and 12 weeks. For 50 participants with three data collection time points, 
the total is $3000. 
 
14.0 Withdrawal of Subjects* 

 
Page 18 of 29 
Revised: January 11, 2019 
14.1 Describe anticipated circumstances under which subjects will be withdrawn from the 
research without their consent. 
Participants may be withdrawn from the research without consent if they exhibit behaviors that disrupt 
the study activities, fail to adhere to online confidentiality guidelines, or are disrespectful and/or 
distressing to other participants in the study.  
14.2 Describe any procedures for orderly termination. 
The decision for termination will be made by the PI. Any and all communications regarding a termination and 
related procedures will be initiated by the PI. Only relevant research personnel will be advised and appropriate 
documentation will be placed in RedCap.  
14.3 Describe procedures that will be followed when subjects withdraw from the research, 
including partial withdrawal from procedures with continued data collection. 
When participants choose to withdraw from the research, all data collection and contact will cease.  
Upon withdrawal, the participant will be required to return the B-SWELL study tablet and materials.  
Documentation will be updated in RedCap to reflect the change. Only relevant research personnel will be  
Advised of the participant’s status.  
 
15.0 Risks to Subjects* 
15.1 List the reasonably foreseeable risks, discomforts, hazards, or inconveniences to the 
subjects related the subjects’ participation in the research.  
There is minimal risk in this study. Some items asked during the data collection phone calls or group 
(intervention or attention control) sessions may focus on negative emotions or experiences. There is also 
a risk of loss of confidentiality for participants and expert raters involved in the study due to the online 
Zoom platform used for group sessions. To avoid loss of confidentiality during the online Zoom 
sessions, participants will be asked to find a private location from which to attend the online Zoom 
sessions. Additionally, participants will be required to attend Zoom sessions with video and will be 
asked to keep session discussions and activities private 
There are no anticipated physical, social, legal, or other anticipated risks connected with the 
proposed procedures. There are no investigational drugs or devices associated with the study, and we do 
not anticipate any serious adverse events. Adverse events attributed to data collection or participation in 
the group (intervention or attention control) sessions are unlikely. Data collection will take place via 
phone for each of the third data collection time points (baseline, 8, and 12 weeks). The time estimated 
for data collection is 24 to 34 minutes. Data collection when be scheduled at the convenience of the 
participant.  
15.2 If applicable, indicate which procedures may have risks to the subjects that are currently 
unforeseeable. 
N/A 
15.3 If applicable, indicate which procedures may have risks to an embryo or fetus should the 
subject be or become pregnant. 
N/A 
15.4 If applicable, describe risks to others who are not subjects. 
N/A 
. 
16.0 Potential Benefits to Subjects* 

 
Page 19 of 29 
Revised: January 11, 2019 
16.1 Describe the potential benefits that individual subjects may experience from taking part in 
the research. 
Participants involved in the study may perceive benefit by knowing that they are assisting in the 
development of a novel intervention program tailored to midlife Black women and designed to decrease 
stress and CVD risk. Participants in this study will have improved knowledge about stress, stress 
reducing strategies, personal cardiovascular disease risk, and healthy lifestyle behaviors. Participants 
may also increase their social and support networks and awareness of resources within their 
communities. In addition, participants who engage in the program may improve their health through the 
adoption of healthy lifestyle behaviors and decrease their overall CVD risk. 
16.2 Indicate if there is no direct benefit. Do not include benefits to society or others. 
N/A 
17.0 Data Management* and Confidentiality 
17.1 Describe the data analysis plan, including any statistical procedures or power analysis. 
In Aim 1 and Aim 2a, numerical measures will be summarized using descriptive statistics (i.e., means, standard 
deviations, and frequencies) regarding expert ratings of degrees of accuracy, relevance and feasibility of new 
components of the B-SWELL program (Aim 1), and recruitment, retention, treatment fidelity ratings, and 
satisfaction ratings (Aim 2a). For Aims 2b and 2c, numerical dependent variables (stress, self-efficacy, LS7 
scores, unhealthy days, perceived general health, depressive symptoms) will be inspected of empirical 
distributions to ensure they meet conditions for parametric statistical models. Variable transformation will be 
used otherwise. All statistical tests will be performed using SPSS Version 25. Parameter estimates with P-
values less than .05 will be considered statistically significant. Assumptions related to each statistical test used 
will be checked using residual plots, qq-plots, and tests for homogeneity of variance/ covariance. In Aim 2b, 
continuous mediators (stress, self-efficacy) will be compared between groups (B-SWELL vs WE) using t-tests 
at each visit (baseline, 8 weeks, 12 weeks). 
 
In Aim 2c, using mixed effect models, primary (i.e., LS7 summary scores) and secondary outcome measures 
(i.e., unhealthy days, perceived general health, depressive symptoms) will be assessed for their associations 
with time (baseline, 8 weeks, 12 weeks), group (B-SWELL vs. WE), and interaction. In particular, each of the 
outcome measures will be treated as the dependent variable, and the time effect, group effect, and the 
interaction will be treated as independent variables or fixed effects of interest in the mixed effect model. 
Random effects will be used to account for within person correlation due to repeated measurements. Other 
covariates, such as demographics and attendance rate, will be controlled for by including them in the model and 
checking for their interaction with the intervention. Post hoc analysis of group means will be compared cross-
sectionally, as well as longitudinally between time points (such as week 8 or 12 vs. baseline). Considering the 
limited sample size for this pilot-type of study, statistical tests will not be adjusted for multiple comparisons in 
post hoc analyses. Significant findings will be considered preliminary in nature and inspire future research. 
 
Power. Statistical power is analyzed based upon assumptions that we have N=50 total or N=25/group complete 
all four data collection time points with complete observations. Should there be any concern of dropout from the 
study, we will over sample participants at baseline to offset the predicted dropout rate and ensure the proposed 
sample size in the final visit. The statistical tests are two sided with a targeted significance level of 0.05. In 
Aim2b and Aim2c post hoc analyses when we compare means using a two group t-test with equal variances 
assumption, we will reach 85% power to detect an effect size (i.e. difference of means/standard deviation of the 
difference) of 0.87.73 In Aim2c when we compare means using a paired t-test between visits in a group, we will 
reach the 85% power to detect an effect size of 0.63.73 If possible, and plausible, missing data could be 
included into analysis after multiple imputation, thus increasing the sample size and statistical power to detect 
differences. The main emphasis will be on exploring data trends to inform future work, rather than 

 
Page 20 of 29 
Revised: January 11, 2019 
significance, since this is a feasibility study. Significance will be emphasized when testing efficacy of the B-
SWELL intervention compared to the WE attention control group in a future, well-powered RCT. 
17.2 Describe the steps that will be taken to secure the data during storage, use, and 
transmission. 
All study data and tracking will be entered into an electronic data system, REDCap (www.REDCap.org), a 
secure research electronic data management system with validated data entry, audit trails for tracking data 
manipulation, and export procedures. It is HIPAA complaint satisfying all local, state, and federal regulation for 
the capture and storage of private health information for research purposes. The PI is familiar with 
RedCap through prior research projects. The PI is committed to compliance with HIPAA, data safety 
procedures, NIH recommendations, and CITI trainings. All research personnel will be trained in the use 
of secure data and RedCap prior to their participation in the study and any communication with 
participants.  
 
The Zoom platform has been approved by the UC Department of Research. Zoom provides 
advanced security and infrastructure to provide security during online activities. Administrators have the 
ability to perform secure log-ins, start a secured meetings with password, and schedule secured meetings 
with password. Secure meeting capabilities include the following: 
• Role-based user security (i.e. waiting room, lock a meeting, end a meeting, expel a 
participant) 
• Host and client authenticated meeting 
• Open or password protected meeting 
• Edit or delete meeting 
• Host controlled joining meeting 
• In-meeting security (i.e. all data is encoded) 
• Authentication 
The account administrator (study PI) will have the following security capabilities:  
• Secure login options using standard username and password or SAML SSO  
• Add user and admin to account  
• Delete user from account Security Guide Zoom Video Communications, Inc. July 2020 
• Manage account dashboard and cloud recordings 
 
17.3 Describe any procedures that will be used for quality control of collected data. 
For Aim 1, ratings will be obtained using survey tools adapted from a validated satisfaction questionnaire. 
For Aim 2, data will be collected using validated survey tools. In addition, data will be collected via phone to  
decrease the risk for missing data. Data collected via the B-SWELL study tablet will be linked directly to the 
REDCap. REDCap will be used to organize, store, and secure data. Only trained research personnel will handle 
the data and have access to REDCap.  
17.4 Describe how data or specimens will be handled study-wide: 
Rating surveys, self-report survey data, and satisfaction ratings will be gathered from the expert panel and 
participants (Aims 1 & 2) and entered directly into a REDCap database via laptop computer or REDCap survey 
link (for experts). Intake data will be labeled with study ID numbers and stored separately. Names, contact 
information, or any other identifiers will be stored separately from all data that is collected. Access to the 

 
Page 21 of 29 
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database, contact information, or linkages between study ID numbers and participants enrolled in the study will 
be limited to the investigators. Participants will not be identified in reports or manuscripts from the study. All 
paper forms and study materials will be stored in locked file cabinets accessible only to authorized study 
personnel. All computers, servers, and electronic files used in the study will be password protected and 
accessible only to authorized study personnel. Authorized study personnel will include the investigators and 
research staff involved in the study.  
 
Data will be handled by trained research personnel only. Trained research personnel will be responsible 
for collecting and logging data. Data will be stored for the duration of the study and for five years following the 
completion of the study.  
 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
This section is required when research involves more than Minimal Risk to subjects. 
N/A 
19.0 Provisions to Protect the Privacy Interests of Subjects 
19.1 Describe the steps that will be taken to protect subjects’ privacy interests. 
Participants may choose not to answer items during interviews or participate in portions of the 
intervention program with which they are uncomfortable. Participants will be informed that 
participation in the study is voluntary and that they are free to discontinue participation at any 
time. Participants will be informed of risks related to privacy using an online format (Zoom). 
19.2 Describe what steps you will take to make the subjects feel at ease with the research 
situation in terms of the questions being asked and the procedures being performed 
Recruitment and retention of Black women in research studies is a historic problem. Using community-
based participatory research (CBPR) methods, our team hopes to achieve optimal recruitment numbers 
and minimize attrition in this study. CBPR techniques, such as community engagement, will assist in 
targeting and tailoring the study procedures, thereby increasing its appeal to a large number of midlife 
Black women in the Greater Cincinnati area. Collaboration with an experienced community research 
advisory board will guide the recruitment efforts and selection of study sites. Recruitment activities will 
include the use of fliers and pamphlets, referral, snow balling, and/or remote community presentations. 
All potential participants will be provided with written information about the nature, purpose, and 
possible risks and benefits of the study.  
 
Transparency and full disclosure are necessary to improve retention. Participants will be informed that 
participation in the study is voluntary and that they are free to discontinue participation at any time. 
Research staff having contact with the participants in the study will be trained using this process in the 
event that at any time the participant has any questions or wishes to withdraw. To prevent attrition, 
duplicates will be built into the program when possible to accommodate participant’s schedules. Group 
session times will be selected based on availability of participants. In addition, phone or text messages 
will be sent to remind participants about the sessions and incentives will be offered after each of the four 
data collection time-points.  
 
19.3 Indicate how the research team is permitted to access any sources of information about the 
subjects. 
Participants may choose not to answer items during interviews or participate in portions of the 
intervention program with which they are uncomfortable.  

 
Page 22 of 29 
Revised: January 11, 2019 
Only authorized study personnel will have access to the database or contact information for study 
participants and expert panel members. For data analysis, study ID numbers will be generated to 
protect the identity of the participants in the final data set. Participants will not be identified in 
any way in reports or manuscripts from the study. Data from surveys will input directly into a 
REDCap database. REDCap is backed up nightly by the university. Only authorized study 
personnel will have access to REDCap. All calls to participants will be made to a telephone 
number provided by the participant at a time that is convenient for the participant. Research staff 
will make calls from a private location in order to protect confidentiality. Informed consent 
forms and contact information from participants will be stored separately in a locked file cabinet 
to protect confidentiality.  
 
20.0 Compensation for Research-Related Injury 
N/A 
21.0 Economic Burden to Subjects 
21.1 Describe any costs that subjects may be responsible for because of participation in the 
research. 
There is no cost to participate in this study.  
22.0 Consent Process 
22.1 Indicate whether you will you be obtaining consent, and if so describe: 
For Aim 1, experts will receive a study information sheet explaining that participation is voluntary 
and that their decision will not affect their relationship with the University of Cincinnati, their employer, 
or the researchers. Full information will be provided and questions answered prior to consent.  Consent 
will be obtained prior to the start of the study.  
 
For Aim 2, participants will receive full information about the nature, purpose, and possible risks 
and benefits of the study. Participants will be informed that participation in the study is voluntary, and 
they are free to discontinue participation at any time. Those who are eligible and who have signed the 
informed consent will be enrolled.  Eligibility will be determined via phone. Participants will receive an 
information sheet for their records following screening, receipt of study details, a question/answer 
period, and verbal consent.  Consent will take place prior to collection of baseline data. There may be a 
brief waiting period between notification of eligibility and consent. 
 
 
We will be following “SOP: Informed Consent Process for Research. 
 
Ongoing consent is not required. We are seeking consent for participation in the study for a 
duration of 12 weeks.          
Non-English Speaking Subjects 
        N/A 
Waiver or Alteration of Consent Process (consent will not be obtained, required 
information will not be disclosed, or the research involves deception) 
N/A 
Subjects who are not yet adults (infants, children, teenagers) 
N/A 

 
Page 23 of 29 
Revised: January 11, 2019 
Cognitively Impaired Adults 
   N/A 
Adults Unable to Consent 
   N/A 
Adults Unable to Consent 
N/A 
23.0 Process to Document Consent in Writing 
23.1 Describe whether you will be following “SOP: Written Documentation of Consent (HRP-
091).” If not, describe whether and how consent of the subject will be documented in 
writing. 
We will use the UC template for our consent documentation: HRP-502S University of Cincinnati Social, 
Behavioral, and Educational consent to participate in Aim 1 of this research study. The HRP-502I University of 
Cincinnati Information Sheet for Research Study will be used for Aim 2 of his study.   
23.2 If your research presents no more than minimal risk of harm to subjects and involves no 
procedures for which written documentation of consent is normally required outside of the 
research context, the IRB will generally waive the requirement to obtain written 
documentation of consent. 
This research presents no more than Minimal Risk of harm to subjects. The research involves no 
procedures for which written consent is normally required outside of the research context. The research 
is not FDA-regulated.  
The waiver of documentation of consent is required because the study sessions will be held 
online. Following screening, randomization, and baseline data collection, participants will receive a 
copy of the study information sheet for their records in the mail.  The written script of the information 
will be provided orally via phone. The information sheet will be provided or electronically displayed and 
include all required and appropriate additional elements of consent disclosure. 
23.3 (If you will document consent in writing, attach a consent document. If you will obtain 
consent, but not document consent in writing, attach a consent script. Review 
“CHECKLIST: Waiver of Written Documentation of Consent (HRP-411)” to ensure that 
you have provided sufficient information.  
See attached consent document. 
24.0 Setting 
24.1 Describe the sites or locations where your research team will conduct the research. 
For Aim 1, experts from the Greater Cincinnati Tri-State area will be recruited by word of mouth and by special 
invitation from the researchers by email, mail, telephone, or flyers. They will receive a study information sheet 
explaining that participation is voluntary and that their decision will not affect their relationship with the 
University of Cincinnati, their employer, or the researchers.  
 
For Aim 2, participants for the trial of the intervention will be recruited from the Greater Cincinnati Tri-State 
area using flyers ad pamphlets, community virtual presentations about the study, referral, and snow balling. A 
letter of introduction and study information sheet will be the first contact made for the study. A telephone 
number is provided for potential participants to call if they wish to participate. The PI or trained research staff 

 
Page 24 of 29 
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will make the calls from a private location to protect confidentiality of the participant. If eligible and interested 
in participating, the person will be invited to participate and receive informed consent. All participants will be 
given full information about the nature, purpose, and possible risks and benefits of the study. Participants will 
be informed that participation in the study is voluntary, and they are free to discontinue participation at any 
time. Those who are eligible and who have given consent will be enrolled. The PI or research staff trained by 
the PI will obtain consent.  
 
This is a single-site study with community partnership. All administrative activity, including grant 
administration, post award budget management, data management, and research and advisory team meetings 
will take place at UC and the UC College of Nursing. There are no separate lab or testing centers. The study 
intervention and control group sessions will take place virtually.  
 
This research study will use community-based participatory research methods (CBPR). In CBPR, the 
community is a vital stakeholder, to be included at every stage of the research. The West End Community 
Research Advisory Board (C-RAB), consisting of 20 active community residents, has been identified as a 
community partner. The C-RAB is associated with UC and the UC Center for Clinical & Translational Science 
& Training. Representatives from the C-RAB will serve as advisors on the PI’s advisory team and attend virtual 
quarterly meetings at the UC CON. The C-RAB’s participation will ensure that the B-SWELL intervention 
reflects the needs of midlife Black women in Cincinnati. The final intervention, including its materials and 
processes, will reflect knowledge gained from the C-RAB and other community collaborators.  
 
24.2 
Select all applicable UC/UC Health Affiliated Research Sites:  
☐ 
Barrett Cancer Center 
(Including IV Therapies & 
Pancreatic Disease Clinic 
☐ 
Medical Sciences Building 
☒ 
College of Nursing 
☐ 
Shriners Hospital 
☐ 
Crossroads Center 
☐ 
UC Gardner Neuroscience 
Institute 
☐ 
Drake Center 
☐ 
UCMC (Emergency 
Department, Inpatient, and 
Outpatient Units) 
☐ 
Genome Research Institute 
(Reading Campus) 
☐ 
UCMC (Emergency 
Department, Inpatient, and 
Outpatient Units) 
☐ 
Hoxworth: Inpatient Unit 
☐  
UCMC NICU 
☐ 
Hoxworth: Outpatient Clinics 
☐ 
University of Cincinnati Physicians 
(UCP) 
☐ 
Infectious Disease Clinic 
(Holmes-UC Health) 
☐ 
University Pointe Surgical Hospital 
☐ 
Infectious Disease Clinical Trial 
Unit (Holmes-UC) 
☐ 
VA-Cincinnati Medical 
Center 
☐ 
Kettering Laboratory 
☐ 
West Chester Hospital 
☐ 
Linder Center of Hope 
☐ 
Other UC Health Affiliated 
Clinic 
☐ 
Liver Transplant Clinic (Medical Arts Building) 
 

 
Page 25 of 29 
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25.0 Resources Available 
25.1 Describe the resources available to conduct the research: For example, as appropriate: 
Recruitment Justification: 
Recruiting the required number of suitable participants (N=50) to meet the objectives in Aim 2 within the 
agreed recruitment period is highly feasible. Statistical power is analyzed based upon assumptions that we have 
N=50 total or N=25/group complete all four data collection time points with complete observations. We will 
over sample participants at baseline to offset the predicted dropout rate and ensure the proposed sample size in 
the final visit. 
Recruitment will be facilitated through the use of CBPR methods. Interest in the PI’s prior research was 
great and the high level of interest is anticipated to continue. Use of community resources to assist in 
recruitment will be beneficial.  
 
Time devoted to research: 
This research project will be funded through a NIH K01 (NHLBI) career development award that allows the PI 
to spend 75% of her time on research.  
 
Facilities: 
College of Nursing Physical Facilities: The CON is housed in Procter Hall on the UC Academic Health Center 
campus which includes the Colleges of Allied Health Sciences, Medicine, and Pharmacy, University of 
Cincinnati Medical Center, Cincinnati Children’s Hospital, and the Cincinnati Veteran’s Administration 
Hospital. The CON has 110 offices for faculty and administration. Lounges for faculty/staff and students, 
offices for graduate assistants, administrative offices, and storage space are also located in the CON. The 
Institute for Nursing Research and Scholarship (INRS) is also housed in the CON (see description below).  
Office Space and Computer Needs: The PI has a private office at the CON with a telephone for 
participant enrollment and laptop computers using Microsoft Office Software and SPSS statistical software. The 
laptop is connected to the UC Academic Health Center Server and is Internet accessible. The PI has access to a 
secure computer research server for data storage at the CON. There is convenient access to facsimile 
transmission, email, and photocopying equipment. Administrative assistance is also available. 
Center for Academic Technologies & Educational Resources (CATER): The College of Nursing is 
committed to providing quality information technology (IT) support for students, faculty and staff to facilitate 
success. For this reason, the college established the Office of Technology-Enhanced Learning which includes 
the Center for Academic Technologies and Educational Resources (CATER). CATER includes a staff of 10 full-
time individuals (instructional designers and information technology specialists) led by the Assistant Dean for 
Technology. CATER provides services including but not limited to desktop support, help desk support, server 
administration, eLearning, instructional design, classroom technology, web design/administration, group and 
one-to-one training, technology seminars and workshops, and continuing education training. The CON has 
made data storage a priority and houses a separate, secured research server for storage of all research data which 
is administered by CATER according to University policies and procedures. In addition, CATER is well versed 
on approved university servers for data storage such as ‘box’ and ‘Redcap’. 
 Institute for Nursing Research and Scholarship (INRS): The Institute for Nursing Research and 
Scholarship (INRS) provides the infrastructure to facilitate the scholarly activities of faculty members in the 
CON. The INRS is directed by the Associate Dean for Research and Translation. Staff members in the INRS 
include a Statistician, a Program Coordinator, two grant administrators, an accountant and eleven graduate 
student assistants. The INRS promotes scholarly excellence through research interest groups, a writing support 
group, a Statistical Consultation Lab, and regularly scheduled INRS educational forums. The INRS staff 
members offer administrative support, pre-grant and post-award budget management, data entry/management, 
and grant writing/editing support to principal investigators. Other services include literature reviews, copying 
and office space for project directors, research assistants, and graduate assistants assigned to funded research 
projects. The INRS is a locked and secure environment with desks, computers with statistical analysis 

 
Page 26 of 29 
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capabilities, and qualitative analysis software capabilities, file storage space with locks for confidential research 
participant data files. 
 Center for Clinical & Translational Science & Training (CCTST): The CCTST has been funded by the 
National Center for Advancing Translational Sciences (NCATS) (1UL1TR001425-01). Investigators request 
services through the CCTST’s online “Research Central” portal at http://cctst.uc.edu. The CCTST Center for 
Improvement Science (CIS) provides an infrastructure to support interprofessional team focused learning and 
promotes utilizing the principles of team science for translational research. The CCTST has promoted multi-
disciplinary collaboration through Integration Committee consultations and topic-based studios to help define 
solutions for problems encountered during the course of faculty research. The Biostatistics, Epidemiology and 
Research Design (BERD) program provides all investigators ready access to experts in research 
methods. Individualized services include review of IRB protocols; advice on study designs, including project 
implementation and data collection methods; guidance on appropriate statistical methods; development of data 
safety and monitoring plans; and consultation on clinical research ethics. The Biomedical Informatics (BMI) 
core serves as the hub for research informatics that provides services that include development of databases and 
surveys using REDCap (Research Electronic Data Capture), a software toolset and workflow methodology. The 
Community Engagement core is broadening and strengthening collaborations between the Academic Health 
Center and community, and has ties with the West End Community Research Advisory Board (C-RAB) for 
underserved populations.  
University of Cincinnati Libraries: The University of Cincinnati library system of eleven libraries 
houses 3.6 million books and serials, 19,500 journal subscriptions, and 141,000 audio-visual pieces. Access to a 
larger core collection of books and journal titles is available through University of Cincinnati Libraries 
Information Database (UCLID), an online public access catalog supporting all University of Cincinnati 
Libraries. The UC Libraries are a founding member of OhioLINK which provides access to 48 million books, 
12,000 electronic journals, 140 online databases, and over 55,000 electronic books. The Donald C. Harrison 
Health Sciences Library (HSL) is within easy walking distance of the College. The HSL has assigned a librarian 
to be the primary liaison to the CON. 
 
University of Cincinnati Medical Center (UC Health): The University of Cincinnati Medical Center, 
University Health, is an urban medical center that serves the Greater Cincinnati Tri-State area and is considered 
one of the region’s top medical facilities. UC Health houses the region’s largest group of board-certified 
physicians that include psychiatrists.  
 
Medical and Psychiatric Resources:  
In the unlikely event that a participant appears to be distressed, she will be referred to appropriate resources or 
be given the telephone number for the national Suicide Hotline (800-784-2433; 800-SUICIDE) if appropriate. 
The PI will inform the IRB of any adverse events and/or any amendments to the protocol. Training for data 
collectors also will include how to respond to any potential adverse events experienced by participants, such as 
suicidal tendencies or severe depression. Participants with these types of problems will be given information 
about how to seek help and will be encouraged to inquire whether medication and/or psychological counseling 
would be helpful. In the event of suicidal thoughts, the PI or research staff may contact a health care provider on 
the participant’s behalf so that they can contact the participant directly to determine if treatment is necessary. 
Alternatively, the participant may be referred to UC Health for immediate evaluation and/or treatment if 
deemed necessary. 
 
Information Processes: 
Training team members in research ethics. All of the research team members have completed their CITI 
training for the protection of human subjects. The PI will remind the research team of the expected research 
conduct and required adherence to UC IRB and research sponsored program policies and procedures when 
conducting the initial research project orientation, and during ongoing research team meetings. 
Training team members in research activities. Research assistants will be trained to provide overall 
study support including clerical activities, participant screening, data collection, preparation of training 
manuals, coordination of research team meetings, scheduling, monitoring adherence to protocol, and other 

 
Page 27 of 29 
Revised: January 11, 2019 
study-related tasks as assigned. Team members will be trained through a one day training workshop provided 
by the PI and co-investigators. Those having direct contact with research participants will be trained in the 
informed consent process and the IRB approved protocol for the study, with emphasis on the protection of 
human subjects.  
Verification. The PI and Co-investigators will review procedures monthly and complete adherence to 
protocol checklists on all staff with retraining as necessary. Weekly team meetings will be conducted to verify 
procedures and to address issues as they arise. IRB approved documentation will be available to all research 
staff and will be included as an essential part of all training sessions. Audiotapes of Zoom sessions will be 
reviewed by facilitators and the PI at random for self-evaluation and quality assurance. 
 
26.0 HIPAA 
☒ 
Not using HIPAA-protected information for any research activities. 
☐ 
Through a HIPAA Authorization signed by the participant (or their legally authorized 
representative). 
☐ 
Requesting that the IRB approve a waiver of authorization in this application. SUBMIT 
HIPAA WAIVER REQUEST FORM. 
☐ 
As a limited data set under a data use agreement. 
 
27.0 Other Reviews 
19.1 Select applicable: 
☐ 
Radiation Safety: The proposed research involves the research participants being 
exposed to radiation for research purposes. Note: This includes an increase of frequency 
of radiological imaging procedure and/or increase duration of clinically indicated 
radiological imaging procedures. 
☐ 
Institutional Biosafety Committee: IBC Approval is required for research that will 
utilize any of the following: infectious agents, select agents (See “Selected Agents for 
IBC Review”), recombinant DNA or viral gene transfer vectors, select agents or toxins 
for human gene transfer or an agent (virus, bacteria, etc.) that has been genetically 
modified. Information regarding submission to the University of Cincinnati IBC can be 
found at: Institutional Biosafety Committee. The IRB must receive a copy of IBC 
approval prior to issuing final IRB approval. 
☐ 
Infectious Agent: The proposed research involves an infectious agent that is 
administered to a human subject, or that involves a risk of accidental exposure to a 
member of the research team, other hospital staff or other patients in the hospital. 
 
 
19.2 CT.Gov Registration 
 
 
☒ 
The PI is responsible for registration of this study on www.clinicaltrials.gov (If yes, 
contact the IND-IDE Assistance Program at (513) 558-0453). 
 
19.3 Identify where funds are being held:  
 
 
☒ 
Funds held in Sponsored Research Services for a Grant or Contract (funds are held 
internally at UC) 

 
Page 28 of 29 
Revised: January 11, 2019 
This research will be funded by the NIH National Heart, Lung, and Blood Institute 
through a K01 career development award. Funds will be held by the UC College of 
Nursing and dispersed/managed according to federal, state, and institution 
regulations. 
☐ 
Funds are from a UC department account (held internally at UC) 
☐ 
Funds held in a Corporate account from a Contract (funds held externally at UC) 
 
28.0 Multi-Site Research* (Please complete if you are the lead PI for multi-site research) 
N/A 
 
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(2015). Telephone Assessment and Skill-Building Kit for Stroke Caregivers: A Randomized Controlled 
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Beauboeuf-Lafontant, T. (2009). Behind the Mask of the Strong Black Woman: Voice and the Embodiment of a 
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Geronimus, A. T. (2001). Understanding and eliminating racial inequalities in women's health in the United 
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William B., . . . Turner, Melanie B. (2013). Heart Disease and Stroke Statistics—2013 Update. A Report 
From the American Heart Association, 127(1), e6-e245. doi:10.1161/CIR.0b013e31828124ad 
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findings and clinical implications. Ther Adv Chronic Dis, 3(3), 137-146. 
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Jones, Sternberg, Janson, & Lee. (2016). A Qualitative Understanding of Midlife Sources of Stress and Support 
in African-American Women. J Natl Black Nurses Assoc, 27(1), 24-30.  
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