The HARMONY Study: A Culturally-relevant, Randomized-controlled, Stress Management Intervention to Reduce Cardiometabolic Risk in African American Women
Phase: NA
Conditions: Heart Diseases, Stroke, Pre-diabetes, Hypertension, Obesity, Overweight, Stress
Sponsor: University of North Carolina, Chapel Hill

 
 
The HARMONY Study- A Culturally Relevant, 
Randomized-Controlled, Stress Management 
Intervention to Reduce Cardiometabolic Risk in African 
American Women 
 
 
 
NCT number NCT04705779 
Document Date 05/27/2022 

ii 
 
 
CONFIDENTIALITY STATEMENT 
This document is confidential communication. Acceptance of this document constitutes agreement by the 
recipient that no unpublished information contained herein will be published or disclosed without prior 
approval of the Principal Investigators or other participating study leadership and as consistent with the 
NIH terms of award.  
 

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Table of Contents 
1 
STATEMENT OF COMPLIANCE ................................................................................................................ 1 
1 
PROTOCOL SUMMARY ............................................................................................................................... 2 
1.1 
Synopsis ................................................................................................................................................ 2 
1.2 
Schedule of Activities .......................................................................................................................... 2 
2 
INTRODUCTION ............................................................................................................................................ 4 
2.1 
Study Rationale .................................................................................................................................... 5 
2.2 
Background ........................................................................................................................................... 6 
3 
OBJECTIVES AND ENDPOINTS ................................................................................................................ 8 
4 
STUDY DESIGN ........................................................................................................................................... 17 
4.1 
Overall Design .................................................................................................................................... 17 
4.2 
Scientific Rationale for Study Design .............................................................................................. 18 
4.3 
End-of-Study Definition ..................................................................................................................... 18 
5 
STUDY POPULATION ................................................................................................................................ 18 
5.1 
Inclusion Criteria ................................................................................................................................ 18 
5.2 
Exclusion Criteria ............................................................................................................................... 19 
5.3 
Lifestyle Considerations .................................................................................................................... 19 
5.4 
Screen Failures .................................................................................................................................. 19 
5.5 
Strategies for Recruitment and Retention ...................................................................................... 19 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ............................................ 20 
6.1 
Study Intervention(s) or Experimental Manipulation(s) Administration ...................................... 20 
6.1.1 
Study Intervention or Experimental Manipulation Description ................................. 20 
6.1.2 
Administration ................................................................................................................. 21 
6.2 
Fidelity ................................................................................................................................................. 21 
6.2.1 
Interventionist Training and Tracking .......................................................................... 21 
6.3 
Measures to Minimize Bias: Randomization and Blinding ........................................................... 21 
6.4 
Study Intervention/Experimental Manipulation Adherence .......................................................... 22 
6.5 
Concomitant Therapy ........................................................................................................................ 22 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL ......................................................................................... 22 
7.1 
Discontinuation of Study Intervention/Experimental Manipulation ............................................. 22 
7.2 
Participant Discontinuation/Withdrawal from the Study ............................................................... 23 
7.3 
Lost to Follow-Up ............................................................................................................................... 23 
8 
STUDY ASSESSMENTS AND PROCEDURES ...................................................................................... 24 
8.1 
Endpoint and Other Assessments ................................................................................................... 24 
8.2 
Adverse Events and Serious Adverse Events ............................................................................... 32 
8.2.1 
Definition of Adverse Events ........................................................................................ 32 
8.2.2 
Definition of Serious Adverse Events .......................................................................... 32 
8.2.3 
Classification of an Adverse Event .............................................................................. 33 
8.2.4 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 34 
8.2.5 
Adverse Event Reporting .............................................................................................. 35 
8.2.6 
Serious Adverse Event Reporting ............................................................................... 35 
8.3 
Unanticipated Problems .................................................................................................................... 35 
8.3.1 
Definition of Unanticipated Problems .......................................................................... 35 
8.3.2 
Unanticipated Problems Reporting .............................................................................. 36 
9 
STATISTICAL CONSIDERATIONS .......................................................................................................... 36 
9.1 
Statistical Hypotheses ....................................................................................................................... 36 

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9.2 
Sample Size Determination .............................................................................................................. 37 
9.3 
Populations for Analyses .................................................................................................................. 38 
9.4 
Statistical Analyses ............................................................................................................................ 38 
9.4.1 
General Approach .......................................................................................................... 38 
9.4.2 
Analysis of the Primary Endpoint(s) ............................................................................ 38 
9.4.3 
Analysis of the Secondary Endpoint(s) ....................................................................... 38 
9.4.4 
Baseline Descriptive Statistics ..................................................................................... 39 
9.4.5 
Planned Interim Analyses ............................................................................................. 39 
9.4.6 
Sub-Group Analyses ..................................................................................................... 39 
9.4.7 
Tabulation of Individual Participant Data .................................................................... 39 
9.4.8 
Exploratory Analyses ..................................................................................................... 39 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 40 
10.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 40 
10.1.1 
Informed Consent Process ........................................................................................... 40 
10.1.2 
Study Discontinuation and Closure ............................................................................. 40 
10.1.3 
Confidentiality and Privacy ........................................................................................... 41 
10.1.4 
Future Use of Stored Specimens and Data ............................................................... 42 
10.1.5 
Key Roles and Study Governance .............................................................................. 43 
10.1.6 
Safety Oversight ............................................................................................................. 43 
10.1.7 
Data Handling and Record Keeping ............................................................................ 44 
10.1.8 
Protocol Deviations ........................................................................................................ 44 
10.1.9 
Publication and Data Sharing Policy ........................................................................... 45 
10.1.10 
Conflict of Interest Policy .............................................................................................. 45 
10.2 
Additional Considerations ................................................................................................................. 46 
10.3 
Abbreviations and Special Terms ................................................................................................... 46 
10.4 
Protocol Amendment History ........................................................................................................... 48 
11 
REFERENCES ............................................................................................................................................. 49 
 
 
 
 
 
 
 
 
 
 
 

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1 
STATEMENT OF COMPLIANCE 
 
The trial will be carried out in accordance with International Council on Harmonisation Good Clinical 
Practice (ICH GCP) and the following:  
 
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 
46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812).  
 
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are responsible for 
the conduct, management, or oversight of NIH-funded clinical trials have completed Human Subjects 
Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be 
submitted to the IRB for review and approval. Approval of both the protocol and the consent form(s) must 
be obtained before any participant is consented. Any amendment to the protocol will require review and 
approval by the IRB before the changes are implemented to the study. All changes to the consent form(s) 
will be IRB approved; a determination will be made regarding whether a new consent needs to be 
obtained from participants who provided consent, using a previously approved consent form.] 
 
 

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1 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
 
Title: 
The HARMONY Study- A Culturally Relevant, Randomized-Control, 
Stress Management Intervention to Reduce Cardiometabolic Risk In 
African American Women 
Grant Number: 
1 R01 MD015388-01A1 
Study Description: 
The HARMONY study is a randomized controlled trial (RCT) to test a 
culturally-tailored mindfulness-based stress management intervention. 
This RCT is designed to help African American Women (AAW) build 
on their strengths to promote stress management and improved 
cardiometabolic (CM) health by enhancing positive reappraisal, self-
regulation, and self-efficacy, all of which are cognitive-behavioral 
facilitators of self-management and positively impacted by mindfulness 
training. This 2- arm CM-risk reduction RCT with 200 AAW ≥ 18 years 
old with CM risk, will be powered to detect group differences in 
exercise and healthy eating behavior. 
 
Objectives*: 
 
Primary Objective: The primary objectives are listed in section 3. 
Secondary Objectives: The secondary objectives are listed in section 3. 
Endpoints*: 
Primary Endpoint: The primary endpoints are listed in section 3. 
Secondary Endpoints: The secondary endpoints are listed in section 3. 
Study Population: 
200 African American or Black women who are greater than 18 years 
old will be enrolled in the study. Participants must have at least one 
cardiometabolic risk factor.  
Phase* or Stage: 
Phase II 
 
Description of 
Sites/Facilities Enrolling 
Participants: 
All participants will be enrolled by study personnel at UNC Chapel Hill. 
Description of Study 
Intervention/Experimental 
Manipulation: 
The HARMONY intervention is a combination of a culturally tailored 
mindfulness program with a culturally tailored exercise and nutrition 
education CM risk-reduction program.  
Study Duration*: 
3.5 years 
 
Participant Duration: 
Approximately 13 months 
1.2 
SCHEDULE OF ACTIVITIES  
 
Schedule of Activities: Outcome Visits: 
 
 
Screening 
(by telephone) 
 
Pre-Baseline 
Period 
Baseline 
 
Randomization 
(when groups 
fill) 
Week 16 
(+/- 14 Days) 
Week 32 
(+/- 14 Days) 
Week 48 
(+/- 14 Days) 
Informed consent 
(telephone) 
X 
 
 
 
 
 
 

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Screening 
(by telephone) 
 
Pre-Baseline 
Period 
Baseline 
 
Randomization 
(when groups 
fill) 
Week 16 
(+/- 14 Days) 
Week 32 
(+/- 14 Days) 
Week 48 
(+/- 14 Days) 
Informed consent (in-person) 
 
 
X 
 
 
 
 
Inclusion/exclusion criteria 
review 
 
X 
 
X 
 
 
 
 
CM Risk Questionnaire 
X 
 
 
 
 
 
 
Physical Activity Readiness 
Questionnaire (PAR-Q) 
X 
 
 
 
 
 
 
Superwoman Schema 
Questionnaire (SWS) 
X 
 
 
 
X 
X 
X 
Perceived Stress Scale (PSS-
14) 
X 
 
 
 
X 
X 
X 
General Stress Assessment 
X 
 
 
 
X 
X 
X 
Demographics Questionnaire 
X 
 
 
 
 
 
 
Health History Questionnaire 
 
 
X 
 
 
 
 
University of RI Change 
Assessment Scale 
 
 
X 
 
 
 
 
Provide ActiGraph Activity 
Monitor (with mailer for 
participant to mail back) 
 
 
X 
 
X 
X 
X 
Provide Fitbit device 
 
 
X 
 
 
 
 
Dietary Risk Assessment  
 
 
X 
 
X 
X 
X 
Veggie Meter Procedure 
 
 
X 
 
X 
X 
X 
Weight/Height (Height only 
required at baseline) 
 
 
X 
 
X 
X 
X 
Hip circumference 
 
 
X 
 
X 
X 
X 
Waist circumference 
 
 
X 
 
X 
X 
X 
Blood draw 
 
 
X 
 
X 
X 
X 
Fingerstick 
 
 
X 
 
X 
X 
X 
Blood Pressure 
 
 
X 
 
X 
X 
X 
Five Facet Mindfulness Scale 
 
 
X 
 
X 
X 
X 
Contextualized Stress Scale 
 
 
X 
 
X 
X 
X 
Network Stress 
 
X 
 
 
X 
X 
X 
Mindful Eating Questionnaire  
 
X 
 
 
X 
X 
X 
Mindful Self-Care Scale  
 
 
X 
 
X 
X 
X 
Cognitive Emotion 
Regulation Questionnaire  
 
X 
 
 
X 
X 
X 
PROMIS Self-Efficacy for 
Managing Emotions 
 
X 
 
 
X 
X 
X 
PROMIS emotional distress-
depression scale 
 
X 
 
 
X 
X 
X 
Connor-Davidson Resilience 
Scale 
 
X 
 
 
X 
X 
X 

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Schedule of Activities: Group Sessions: 
 
 
2 
 
INTRODUCTION 
 
 
Screening 
(by telephone) 
 
Pre-Baseline 
Period 
Baseline 
 
Randomization 
(when groups 
fill) 
Week 16 
(+/- 14 Days) 
Week 32 
(+/- 14 Days) 
Week 48 
(+/- 14 Days) 
Self-Efficacy for Exercise 
Scale 
 
 
X 
 
X 
X 
X 
Diet Self-Efficacy Scale 
 
 
X 
 
X 
X 
X 
Buddy System Assessment 
 
 
 
 
X 
X 
X 
Mindfulness Practice 
Assessment (HARMONY 
group only) 
 
 
 
 
X 
X 
X 
Interview 
 
 
 
 
X 
 
X 
Randomization 
 
 
 
X 
 
 
 
Adverse Event Check 
 
 
X 
 
X 
X 
X 
 
Session 1 
Session 2 
Session 3 
Session 4 
Session 5 
Half-Day 
Retreat 
Session 6 
Session 7 
Session 8 
Booster Session 
1 
Booster Session 
2 
Booster Session 
3 
Booster Session 
4 
Booster Session 
5 
Booster Session 
6 
University of RI 
Change Assessment 
Scale  
X 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
Group Cohesion 
Questionnaire 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
 
 
Credibility Scale 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
 
 
Nutrition Survey 
X 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
Mindfulness Practice 
Assessment 
(HARMONY group 
only) 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Buddy System 
Assessment  
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
HARMONY/NEEW 
Session 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse Event Check 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 

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2.1 
STUDY RATIONALE  
African American Women (AAW) are at high risk for illness and death from serious cardiometabolic (CM) 
conditions – cardiovascular disease (CVD), diabetes, stroke and other health sequelae of constant, 
ongoing exposure to excessive stress, a top 10 determinant of health disparities.1-3 Health statistics for 
AAW are alarming: 50% of adult AAW have CVD, of which 50,000 die annually. AAW’s rate of stroke is 
double that of White women. Approximately 80% are overweight or obese.2 Of AAW > 55 years old, 25% 
have diabetes, and they have higher complication rates from poorer glucose control.2, 4-5 Preventive 
efforts are critical: heart disease, cerebrovascular disease, and diabetes are leading causes of death and 
disability in the US, with yearly direct (medical) and indirect (disability, work loss, premature death) 
costs estimated at $561 billion.1, 2  
AAW experience unique, chronic stress phenomena that occur at the intersection of race and gender, 
such as overt discrimination and micro-aggressions6, 7 Stress phenomena include, but are not limited to, 
two specific types. First,  contextualized stress (CS) is the exposure to pervasive, negative race- and 
gender-based sociocultural constraints experienced by AAW.8 Second, network stress (NS) is the 
vicarious experience of stresses encountered by family and close others, which to some AAW are as 
distressing as their own problems.9 In response to these two stress phenomena, AAW may feel obliged 
to present an image of strength, suppress emotions, resist dependence on others, succeed despite 
limited resources, and prioritize care of family and community over care of self. 10-17 Known as 
Superwoman Schema (SWS), these stress responses have paradoxical features: SWS may increase life 
stress, depression, emotional eating, self-sacrifice, delayed health promoting behaviors, and 
burdensome allostatic (“wear and tear”) load,18-20  while also promoting survival and adaptation in 
context of disproportionately high rates of exposure to toxic stress and trauma.10,11 Survey research and 
media profiles of SWS indicate its broad relevance to the stress and coping experiences of AAW in the 
US. A recent Al Jazeera media report on SWS in AAW had >4.8 million views, 2,500 comments, and 
57,000 shares, demonstrating its salience and importance to the health of AAW.21 A significant feature 
of our study, thus, is that we address SWS, contextualized stress and network stress.  The prevailing 
paradigm of intervention research related to CM risk reduction inadequately addresses stress as a 
barrier to adherence to healthy exercise and eating goals.22  
Physiological responses to stress, particularly hypothalamic-pituitary-adrenal (HPA)-axis activation and 
dysregulation, may affect CM risk directly. Constant, excessive demands on regulatory systems 
compromise cardiovascular, autonomic, metabolic, and neuro-endocrine activity, leading to illnesses 
such as diabetes.8, 23 Furthermore, allostatic load24-25 and the related concept of weathering may explain 
stress-related physiologic responses as the impact of cumulative risk from chronic exposure to life 
challenges and stress. As Geronimus noted “the cumulative impact of repeated experience with social, 
economic, or political exclusion” 26,p.133 among AAW is a stressor responsible for current health 
disparities.  African Americans may cope with chronic stress by engaging in unhealthy behaviors rather 
than making recommended lifestyle changes, a perspective supported by research.27 Because stress 
typically cannot  be eliminated, this intervention will be tested to manage (rather than control) chronic 
stress exposure, which may alter the stress response and in turn decrease CM risk.28-31 Interventions 
addressing adherence to healthy eating and exercise goals should target motivation and address self-
efficacy and self-regulation.  In the landmark 2017 Stress and Health Disparities Report, the American 
Psychological Association (APA) noted that interventions with elements to manage stress show promise 
to produce greater success in improving health equity for AAW and other populations.6 
Mindfulness-based stress reduction (MBSR) is an evidence-based approach to manage stress and 
improve self-efficacy, positive reappraisal, and self-regulation, through which cognitive-emotional and 
physiological effects of stress are improved 32-37 MBSR involves training persons in intentional self-
regulation of attention by learning to place awareness on present-moment experiences and to let go of 
fixation on thoughts of past and future.12 Tested in RCTs, mindfulness training is an effective 
intervention for reducing stress and increasing well-being in a variety of healthy and clinical 

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populations,18,38 including those at risk for cardiometabolic conditions.39-48 Mindfulness also moderates 
intrinsic motivation and physical activity, and is associated with success in fulfilling intentions49-50. 
Research suggests that mindfulness training may be a culturally relevant intervention for stress-related 
conditions in African Americans; 50 a growing body of research demonstrates the potential for effective 
use of mindfulness for stress-related conditions in AAW.52-53  Researchers have found that mindfulness is 
effective for improving perceived stress, addiction severity, anxiety, blood pressure, depressive 
symptoms, self-acceptance, and growth in samples that include AAW54-57.  Two studies have been 
successful in incorporating informal mind-body and other stress reduction techniques into lifestyle 
programs to promote weight loss by AAW.58-59 Despite demonstrated effectiveness of prevention 
strategies to delay onset or reduce development of CM conditions, AAW have been the least successful 
at reaching behavioral lifestyle change goals compared with women and men of other racial/ethnic 
groups.60-63 These findings strongly suggest the need for enhanced evidence-based interventions to 
overcome barriers to lifestyle changes among AAW.1, 64-73 This study proposes that a culturally–tailored 
mindfulness intervention addressing AAW’s distinct, unique experiences of stress and coping holds 
potential to increase engagement in healthy behaviors critical for preventing CM conditions. Through a 
culturally-tailored74 mindfulness training program, informed by awareness of the SWS, AAW will be 
encouraged to reconceptualize strategies such as self-care, aerobic and weight training exercise, and 
healthy eating as means to promote self-management. In contrast to a focus solely on weight loss, these 
strategies provide resilience, strength and fuel to meet life demands. This mindfulness intervention will 
be implemented at both individual and community levels, thus meeting NIH recommendations to 
address social-ecological factors influencing health disparities.75 
 
2.2 
BACKGROUND  
 
The HARMONY intervention shifts the prevailing paradigm, from a focus on encouraging diet and 
exercise in isolation of the influence of stress and other contextual factors that affect AAW’s ability to 
adhere to such recommendations, to an improved model in which AAW learn effective management of 
stressors through a culturally–tailored mindfulness intervention that raises awareness of AAW’s 
potential strengths and that emphasizes the importance of self-care and being healthy for improving 
coping and stress management. Through culturally-relevant mindfulness training, exercise, and nutrition 
education, AAW will benefit from stress management and improved self-regulation and adherence to 
mindfulness practice recommendations, exercise and diet, thus reducing CM risk.75, 22 HARMONY builds 
on findings from studies conducted by Drs. Giscombe, Gaylord and collaborators.9,10,12,18,20 33, 36,38,51, 52,76, 77 
Overall, research has demonstrated feasibility and acceptability of conducting a RCT to reduce 
cardiometabolic risk in African Americans using a mindfulness-based healthy lifestyle intervention 
(NIH/R21 We Can Prevent Diabetes Study).77,52 Importantly, the control condition was a culturally-
tailored exercise and healthy eating intervention.  HARMONY extends the impact of the exercise and 
nutrition education intervention with a culturally-tailored mindfulness stress management intervention, 
by enhancing stress management and self-regulation facilitating adherence to exercise and diet lifestyle 
changes.  The mindfulness stress management training in HARMONY is designed to raise awareness of 
how culturally-prevalent stress-related phenomena such as SWS can be transformed from being barriers 
to being facilitators of health. This transformation occurs through improvements in mindfulness, 
positive reappraisal, self-regulation, and self-efficacy; these efforts can sustain improvements in exercise 
and healthy eating behaviors and reduce risk for chronic cardiometabolic illnesses compared to those 
who do not receive the HARMONY program. 
The previous studies that provide the foundation for this clinical trial are as follows: 
Study 1: The African American Women’s Well-Being Study, with 189 AAW from diverse socioeconomic 

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backgrounds. This cross-sectional study demonstrated the importance of incorporating 
multidimensional and culturally relevant factors (e.g., gender- and race-related stress) into research on 
health disparities in AAW7 and showed significant, positive associations among culturally relevant stress, 
stress-related eating, and obesity.12 In a follow-up study with African American college women, 
Giscombe et al. found associations between stress, contextualized stress, eating behaviors, and BMI.97  
Another study demonstrated that AAW experienced a higher number of NS events than self-stress 
events; AAW perceived NS occurrences as bothersome as self-stress and both were significantly and 
positively associated with psychological distress symptoms.98 
Study 2: The SWS conceptual framework and the SWS Questionnaire was developed.10,19, 20,38 AAW focus 
group participants (n=48) described the experience of SWS, the associated resilience, and risk factors 
including stress and delayed health-promoting behaviors. The five SWS characteristics were identified: 
obligation to project an image of strength, obligation to suppress emotions, resistance to admitting 
vulnerability or accepting help from others, motivation to succeed despite limited resources, and 
prioritization of caregiving over self-care.10 Subsequently, using structural equation modeling in a 
secondary data analysis, it was demonstrated that significant positive relationships among race, gender, 
generic stressors, SWS, and obesity.12 
Study 3: Semi-structured interviews were conducted with 15 AA adults with experience in mindfulness 
meditation50 to examine cultural relevance of mindfulness. Participants reported that mindfulness could 
help AAs enhance stress management, reduce depressive symptoms, reduce blood pressure and rates of 
diabetes, and increase self-awareness and purposefulness. Participants recommended that mindfulness 
for AAs be adapted to enhance cultural relevance and therapeutic value. Suggested adaptations 
included emphasizing health benefits, connecting it to culturally specific practices and values in the AA 
community, and implementing a “buddy system” to sustain mindfulness practice.  
Study 4: 68 AA adults were enrolled to compare a mindfulness-based pre-diabetes (MPD) prevention 
program to a conventional diabetes prevention program for AA adults (>80% AAW) with pre-diabetes 
(Grant # R21 AT004276-03),76,51 using a mixed-methods, two-arm RCT. Participants reported acceptability, 
credibility, and cultural-relevance of the intervention. Enrollment of eligible participants (79%), session 
attendance (76.5%), retention (90%), and attendance at three post-intervention data collection sessions 
(83%, 82%, and 78%, respectively) demonstrated feasibility.  MPD resulted in reductions in perceived 
stress and BMI, reduced calorie, fat, and carbohydrate intake, and improved quality of life. Both groups 
reported increased knowledge about strategies to improve diet and exercise. MDP participants reported 
using mindfulness, breathing techniques, and conscious eating behaviors, and were more aware of 
stress. Participants recommended improvements that form the basis for this proposal:  1) explicit 
discussion of the potential impact of culturally-relevant, contextualized stressors for AAW; 2) 
incorporation of strategies in the mindfulness sessions for overcoming guilt and resistance to self-
sacrifice by enhancing self-compassion; and 3) incorporating strategies to help AAW overcome physical 
and psychological barriers to home-based mindfulness practice, exercise, and healthy eating (e.g., 
accountability partners). 
Study 5: The SWS Questionnaire was evaluated in a mixed-methods study in three samples of 
demographically diverse AAW across the US. (n=48; n=561; n=130)20 . A a five-factor structure was 
confirmed consistent with the SWS conceptual framework (see above in Study 2) and strong 
psychometric properties20,38 The majority of participants endorsed SWS. Significant, positive associations 
between SWS and use of food to cope with stress, poor sleep, and physical inactivity, among others 
were found– all factors associated with increased CM risk.20,38 Participants were also engaged in 
identifying strategies to improve feasibility and engagement of MPD. AAW wanted more mindfulness, 
diet and fitness education, more classes, and support for new habit development followed by 
maintenance support. Participants suggested increased motivational support, fun physical activities as 
exercise, and a “buddy system.”  Participants discussed culturally-relevant stress (i.e., SWS, NS) and 
desires to balance caregiving responsibilities with stress reduction and better health. We integrated all 
suggestions into the proposed intervention and are using the SWS conceptual framework and 

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questionnaire.38 
 
 
 
 
3 
OUTCOMES AND ENDPOINTS  
 
OUTCOMES 
ENDPOINTS 
Primary 
 
1.1 Change in amount of moderate to vigorous 
physical activity from baseline to 48 weeks 
after first group session 
The participant’s moderate to vigorous physical activity will 
be measured by triaxial accelerometry. Results will be 
reported in minutes, with higher numbers indicating a 
higher amount of moderate to vigorous physical activity. 
1.2 Change in the dietary risk assessment 
score from baseline to 48 weeks after first 
group session 
The participant’s dietary intake will be assessed using the 
dietary risk assessment, which includes 54 items. The 
dietary risk assessment measures the healthiness of a 
participant’s eating habits. Score ranges from 0 to 108, with 
higher scores associated with less healthy dietary intake.  
1.3 Change in veggie meter score from 
baseline to 48 weeks after first group session 
The participant’s nutrition will be assessed using the veggie 
meter, which uses light reflectance spectroscopy to provide 
an estimate skin carotenoid composite score. Score ranges 
from 0 to 800, with higher scores associated with greater 
fruit and vegetable intake.  
Secondary 
 
2.1 Change in BMI from baseline to 48 weeks 
after first group session 
The participant’s BMI is calculated as weight (kg) divided by 
height (cm). 
2.2 Change in weight from baseline to 48 
weeks after first group session 
The participant’s weight will be measured using a digital 
scale. 
2.3 Change in waist-to-hip ratio from baseline 
to 48 weeks after first group session 
The participant’s waist to hip ratio is calculated by using the 
mean of two waist circumference measurements divided by 
mean of two hip circumference measurements. Waist 
circumference will be measured at the midpoint between 
the upper iliac crest and lower costal margin in the 
midaxillary line. Hip circumference will be measured at the 
maximum width of the buttocks or gluteo-femoral fold.  
2.4 Change in percent body fat from baseline 
to 48 weeks after first group session 
The participant’s percent body fat is measured using lange 
skinfold calipers. The final measurement will be the mean 
of three measurements on the right side of the body. 
2.5 Change in in blood pressure (systolic blood 
pressure/diastolic blood pressure) from 
baseline to 48 weeks after first group session 
The participant’s blood pressure is measured using an 
electronic sphygmomanometer. The final measurement will 
be the mean of three measurements. 
2.6 Change in high sensitivity C-reactive 
protein amount from baseline to 48 weeks 
after first group session 
The participant’s high sensitivity C-reactive protein levels 
will be obtained via phlebotomy. 

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OUTCOMES 
ENDPOINTS 
2.7 Change in IL-6 amount from baseline to 48 
weeks after first group session 
The participant’s IL-6 levels will be obtained via 
phlebotomy. 
2.8 Change in glycosylated hemoglobin 
amount from baseline to 48 weeks after first 
group session 
The participant’s glycosylated hemoglobin levels will be 
obtained via phlebotomy. 
Tertiary/Exploratory 
 
3.1 Change in Five Facet Mindfulness Scale 
from baseline to 16 weeks after first group 
session 
The participant’s level of mindfulness will be measured 
using the Five Facet Mindfulness Scale, which includes 39 
items on a 5-point scale. The Five Facet Mindfulness Scale 
measures observing, the ability to verbally express one’s 
experience, acting with awareness, nonjudging of inner 
experience, and non-reacting to one’s inner experience. 
Score ranges from 1-5, with higher scores associated with a 
higher level of mindfulness.  
3.2 Change in Five Facet Mindfulness Scale 
from baseline to 32 weeks after first group 
session 
The participant’s level of mindfulness will be measured 
using the Five Facet Mindfulness Scale, which includes 39 
items on a 5-point scale. The Five Facet Mindfulness Scale 
measures observing, the ability to verbally express one’s 
experience, acting with awareness, nonjudging of inner 
experience, and non-reacting to one’s inner experience. 
Score ranges from 1-5, with higher scores associated with a 
higher level of mindfulness. 
3.3 Change in Five Facet Mindfulness Scale 
from baseline to 48 weeks after first group 
session 
The participant’s level of mindfulness will be measured 
using the Five Facet Mindfulness Scale, which includes 39 
items on a 5-point scale. The Five Facet Mindfulness Scale 
measures observing, the ability to verbally express one’s 
experience, acting with awareness, nonjudging of inner 
experience, and non-reacting to one’s inner experience. 
Score ranges from 1-5, with higher scores associated with a 
higher level of mindfulness. 
3.4 Change in Perceived Stress Scale from 
baseline to 16 weeks after first group session 
The participant’s general stress will be measured using the 
PSS-14, which includes 14 items on a 5-point scale. Scores 
range 0-56, with higher scores indicating greater perceived 
stress. 
3.5 Change in Perceived Stress Scale from 
baseline to 32 weeks after first group session 
The participant’s general stress will be measured using the 
PSS-14, which includes 14 items on a 5-point scale. Scores 
range 0-56, with higher scores indicating greater perceived 
stress. 
3.6 Change in Perceived Stress Scale from 
baseline to 48 weeks after first group session 
The participant’s general stress will be measured using the 
PSS-14, which includes 14 items on a 5-point scale. Scores 
range 0-56, with higher scores indicating greater perceived 
stress. 
3.7 Change in Network Stress Scale from 
baseline to 16 weeks after first group session 
The participant’s indirect and self-stress will be measured 
using the Network Stress Scale, which includes 10 items on 
a 4-point scale. The Network Stress scale assesses both 
exposure and appraisal of events that happened to both 

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self and close family members and friends. Higher scores 
represent higher exposure and appraisal. Score ranges from 
0, with 10 scores associated with a higher amount of 
indirect and self-stress. 
3.8 Change in Network Stress Scale from 
baseline to 32 weeks after first group session 
The participant’s indirect and self-stress will be measured 
using the Network Stress Scale, which includes 10 items on 
a 4-point scale. The Network Stress scale assesses both 
exposure and appraisal of events that happened to both 
self and close family members and friends. Higher scores 
represent higher exposure and appraisal. Score ranges from 
0, with 10 scores associated with a higher amount of 
indirect and self-stress. 
3.9 Change in Network Stress Scale from 
baseline to 48 weeks after first group session 
The participant’s indirect and self-stress will be measured 
using the Network Stress Scale, which includes 10 items on 
a 4-point scale. The Network Stress scale assesses both 
exposure and appraisal of events that happened to both 
self and close family members and friends. Higher scores 
represent higher exposure and appraisal. core ranges from 
0, with 10 scores associated with a higher amount of 
indirect and self-stress. 
3.10 Change in Giscombe Superwoman 
Schema Questionnaire from baseline to 16 
weeks after first group session 
The participant’s endorsement of Superwoman Schema will 
be measured using the Giscombe Superwoman Schema 
Questionnaire, which includes 35 items, divided in 5 
subscales, on a 4-point scale, ranging from 0 to 3. The 
Giscombe Superwoman Schema Questionnaire measures 
obligation to present an image of strength, obligation to 
suppress emotions, resistance to vulnerability, intense 
motivation to succeed, obligation to help others. There are 
5 different subscales for the superwoman schema, so 
participants will report 5 different scores. Score ranges for 
each subscale are 0-18 (strength), 0-21 (suppress 
emotions), 0-21 (resistance to vulnerability), 0-18 
(motivation to succeed), 0-27 (obligation to help others), 
with higher scores associated with a greater endorsement 
of the selected superwoman schema scale characteristic. 
3.11 Change in Superwoman Schema 
Questionnaire from baseline to 32 weeks after 
first group session 
The participant’s endorsement of Superwoman Schema will 
be measured using the Giscombe Superwoman Schema 
Questionnaire, which includes 35 items, divided in 5 
subscales, on a 4-point scale, ranging from 0 to 3. The 
Giscombe Superwoman Schema Questionnaire measures 
obligation to present an image of strength, obligation to 
suppress emotions, resistance to vulnerability, intense 
motivation to succeed, obligation to help others. There are 
5 different subscales for the superwoman schema, so 
participants will report 5 different scores. Score ranges for 
each subscale are 0-18 (strength), 0-21 (suppress 

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emotions), 0-21 (resistance to vulnerability), 0-18 
(motivation to succeed), 0-27 (obligation to help others), 
with higher scores associated with a greater endorsement 
of the selected superwoman schema scale characteristic. 
3.12 Change in Superwoman Schema 
Questionnaire from baseline to 48 weeks after 
first group session 
The participant’s endorsement of Superwoman Schema will 
be measured using the Giscombe Superwoman Schema 
Questionnaire, which includes 35 items, divided in 5 
subscales, on a 4-point scale, ranging from 0 to 3. The 
Giscombe Superwoman Schema Questionnaire measures 
obligation to present an image of strength, obligation to 
suppress emotions, resistance to vulnerability, intense 
motivation to succeed, obligation to help others. There are 
5 different subscales for the superwoman schema, so 
participants will report 5 different scores. Score ranges for 
each subscale are 0-18 (strength), 0-21 (suppress 
emotions), 0-21 (resistance to vulnerability), 0-18 
(motivation to succeed), 0-27 (obligation to help others), 
with higher scores associated with a greater endorsement 
of the selected superwoman schema scale characteristic. 
3.13 Change in the Mindful Eating 
Questionnaire from baseline to 16 weeks after 
first group session 
The participant’s mindful eating will be measured using the 
Mindful Eating Questionnaire, which includes 28 items on a 
4-point scale. Score ranges from 1 to 4, with higher scores 
associated with more mindful eating. 
3.14 Change in the Mindful Eating 
Questionnaire from baseline to 32 weeks after 
first group session 
The participant’s mindful eating will be measured using the 
Mindful Eating Questionnaire, which includes 28 items on a 
4-point scale. Score ranges from 1 to 4, with higher scores 
associated with more mindful eating. 
3.15 Change in the Mindful Eating 
Questionnaire from baseline to 48 weeks after 
first group session 
The participant’s mindful eating will be measured using the 
Mindful Eating Questionnaire, which includes 28 items on a 
4-point scale. Score ranges from 1 to 4, with higher scores 
associated with more mindful eating. 
3.16 Change in the Mindful Self-Care Scale 
from baseline to 16 weeks after first group 
session 
The participant’s self-care will be measured using the 
Mindful Self-Care scale, which includes 42 items on a 5-
point scale. The Mindful Self-Care scale assesses 6 domains 
of self-care: physical care, supportive relationships, mindful 
awareness, self-compassion and purpose, mindful 
relaxation, and supportive structure. Score ranges from 1 to 
5, with higher scores higher associated with more self-care. 
3.17 Change in the Mindful Self-Care Scale 
from baseline to 32 weeks after first group 
session 
The participant’s self-care will be measured using the 
Mindful Self-Care scale, which includes 42 items on a 5-
point scale. The Mindful Self-Care scale assesses 6 domains 
of self-care: physical care, supportive relationships, mindful 
awareness, self-compassion and purpose, mindful 
relaxation, and supportive structure. Score ranges from 1 to 
5, with higher scores associated with more self-care. 

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3.18 Change in the Mindful Self-Care Scale 
from baseline to 48 weeks after first group 
session  
The participant’s self-care will be measured using the 
Mindful Self-Care scale, which includes 42 items on a 5-
point scale. The Mindful Self-Care scale assesses 6 domains 
of self-care: physical care, supportive relationships, mindful 
awareness, self-compassion and purpose, mindful 
relaxation, and supportive structure. Score ranges from 1 to 
5, with higher scores associated with more self-care. 
3.19 Change in the Cognitive Emotion 
Regulation Questionnaire from baseline to 16 
weeks after first group session 
The participant’s cognitive emotion regulation strategies 
will be measured using the Cognitive Emotion Regulation 
questionnaire, which includes 20 items on a 5-point scale. 
The Cognitive Emotion Regulation Questionnaire assesses 
the sub-scales of self-blame, other-blame, rumination, 
catastrophizing, positive refocusing, planning, positive 
reappraisal, putting into perspective and acceptance. 
Scores for each sub-scale ranges from 2 to 10, with higher 
scores associated with an increased usage of a specific 
cognitive strategy.  
3.20 Change in the Cognitive Emotion 
Regulation Questionnaire from baseline to 32 
weeks after first group session 
The participant’s cognitive emotion regulation strategies 
will be measured using the Cognitive Emotion Regulation 
questionnaire, which includes 20 items on a 5-point scale. 
The Cognitive Emotion Regulation Questionnaire assesses 
the sub-scales of self-blame, other-blame, rumination, 
catastrophizing, positive refocusing, planning, positive 
reappraisal, putting into perspective and acceptance. 
Scores for each sub-scale ranges from 2 to 10, with higher 
scores associated with an increased usage of a specific 
cognitive strategy. 
3.21 Change in the Cognitive Emotion 
Regulation Questionnaire from baseline to 48 
weeks after first group session 
The participant’s cognitive emotion regulation strategies 
will be measured using the Cognitive Emotion Regulation 
questionnaire, which includes 20 items on a 5-point scale. 
The Cognitive Emotion Regulation Questionnaire assesses 
the sub-scales of self-blame, other-blame, rumination, 
catastrophizing, positive refocusing, planning, positive 
reappraisal, putting into perspective and acceptance. 
Scores for each sub-scale ranges from 2 to 10, with higher 
scores associated with an increased usage of a specific 
cognitive strategy.  
3.22 Change in the PROMIS Self-Efficacy for 
Managing Emotions- Short Form from baseline 
to 16 weeks after first group session 
The participant’s management of emotions will be 
measured using the PROMIS Self-Efficacy for Managing 
Emotions, which includes 4 items on a 5-point scale. The 
PROMIS Self-Efficacy for Managing Emotions assesses the 
participant’s confidence to manage and control symptoms 
stress, discouragement, disappointment, and negative 
feelings. Score ranges from 5 to 20, with higher scores 
associated with a higher confidence level in managing 
symptoms. 

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3.23 Change in the PROMIS Self-Efficacy for 
Managing Emotions- Short Form from baseline 
to 32 weeks after first group session 
The participant’s management of emotions will be 
measured using the PROMIS Self-Efficacy for Managing 
Emotions, which includes 4 items on a 5-point scale. The 
PROMIS Self-Efficacy for Managing Emotions assesses the 
participant’s confidence to manage and control symptoms 
stress, discouragement, disappointment, and negative 
feelings. Score ranges from 5 to 20, with higher scores 
associated with a higher confidence level in managing 
symptoms. 
3.24 Change in the PROMIS Self-Efficacy for 
Managing Emotions- Short Form from baseline 
to 48 weeks after first group session 
The participant’s management of emotions will be 
measured using the PROMIS Self-Efficacy for Managing 
Emotions, which includes 4 items on a 5-point scale. The 
PROMIS Self-Efficacy for Managing Emotions assesses the 
participant’s confidence to manage and control symptoms 
stress, discouragement, disappointment, and negative 
feelings. Score ranges from 5 to 20, with higher scores 
associated with a higher confidence level in managing 
symptoms. 
3.25 Change in the PROMIS Emotional 
Distress- Depression Short Form 4a from 
baseline to 16 weeks after first group session 
The participant’s depressive symptoms will be assessed 
using the PROMIS Emotional Distress- Depression Scale, 
which includes 4 items on a 5-point scale. The PROMIS 
Emotional Distress-Depression Scale assesses self-reported 
negative mood, views of self, social cognition, and 
decreased positive affect and engagement. Scores range 
from 5 to 20, with higher scores associated with a higher 
degree of depressive symptoms. 
3.26 Change in the PROMIS Emotional 
Distress- Depression Short Form 4a from 
baseline to 32 weeks after first group session 
The participant’s depressive symptoms will be assessed 
using the PROMIS Emotional Distress- Depression Scale, 
which includes 4 items on a 5-point scale. The PROMIS 
Emotional Distress-Depression Scale assesses self-reported 
negative mood, views of self, social cognition, and 
decreased positive affect and engagement. Scores range 
from 5 to 20, with higher scores associated with a higher 
degree of depressive symptoms. 
3.27 Change in the PROMIS Emotional 
Distress- Depression Short Form 4a from 
baseline to 48 weeks after first group session 
The participant’s depressive symptoms will be assessed 
using the PROMIS Emotional Distress- Depression Scale, 
which includes 4 items on a 5-point scale. The PROMIS 
Emotional Distress-Depression Scale assesses self-reported 
negative mood, views of self, social cognition, and 
decreased positive affect and engagement. Scores range 
from 5 to 20, with higher scores associated with a higher 
degree of depressive symptoms. 
3.28 Change in the Connor-Davidson 
Resilience Scale from baseline to 16 weeks 
after first group session 
The participant’s resilience will be measured using the 
Connor-Davidson Resilience Scale, which includes 10 items 
on a 4-point scale. The Connor-Davidson Resilience Scale 
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despite obstacles, and how participants handle strong 
feelings. Score ranges from 0 to 40, with higher scores 
associated with increased resiliency. 
3.29 Change in the Connor-Davidson 
Resilience Scale from baseline to 32 weeks 
after first group session 
The participant’s resilience will be measured using the 
Connor-Davidson Resilience Scale, which includes 10 items 
on a 4-point scale. The Connor-Davidson Resilience Scale 
assesses ability to adapt to change, achievement of goals 
despite obstacles, and how participants handle strong 
feelings. Score ranges from 0 to 40, with higher scores 
associated with increased resiliency. 
3.30 Change in the Connor-Davidson 
Resilience Scale from baseline to 48 weeks 
after first group session 
The participant’s resilience will be measured using the 
Connor-Davidson Resilience Scale, which includes 10 items 
on a 4-point scale. The Connor-Davidson Resilience Scale 
assesses ability to adapt to change, achievement of goals 
despite obstacles, and how participants handle strong 
feelings. Score ranges from 0 to 40, with higher scores 
associated with increased resiliency. 
3.31 Change in the Contextualized Stress 
Measure from baseline to 16 weeks after first 
group session 
The participant’s racial and gendered stress exposure will 
be measured using the Contextualized Stress Measure, 
which includes 69 items on a 5-point scale. The 
Contextualized Stress Measure is divided into six subscales, 
including race/racism, burden, personal history, workplace, 
coping and support, and stress states. Score ranges from 0 
to 345, with higher scores associated with increased stress 
exposure. 
3.32 Change in the Contextualized Stress 
Measure from baseline to 32 weeks after first 
group session 
The participant’s racial and gendered stress exposure will 
be measured using the Contextualized Stress Measure, 
which includes 69 items on a 5-point scale. The 
Contextualized Stress Measure is divided into six subscales, 
including race/racism, burden, personal history, workplace, 
coping and support, and stress states. Score ranges from 0 
to 345, with higher scores associated with increased stress 
exposure. 
3.33 Change in the Contextualized Stress 
Measure from baseline to 48 weeks after first 
group session 
The participant’s racial and gendered stress exposure will 
be measured using the Contextualized Stress Measure, 
which includes 69 items on a 5-point scale. The 
Contextualized Stress Measure is divided into six subscales, 
including race/racism, burden, personal history, workplace, 
coping and support, and stress states. Score ranges from 0 
to 345, with higher scores associated with increased stress 
exposure. 
3.34 Change in the Diet Self Efficacy Scale 
from baseline to 16 weeks after first group 
session 
The participant’s perceived self-efficacy for healthy eating 
will be measured using the Diet Self-Efficacy scale, which 
includes 11 items on a 5-point scale. The Diet Self Efficacy 
Scale assesses high caloric food temptations, social and 
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impact eating behaviors. Scores range from 0 to 44, with 
higher perceived self-efficacy for healthy eating. 
3.35 Change in the Diet Self Efficacy Scale 
from baseline to 32 weeks after first group 
session 
The participant’s perceived self-efficacy for healthy eating 
will be measured using the Diet Self-Efficacy scale, which 
includes 11 items on a 5-point scale. The Diet Self Efficacy 
Scale assesses high caloric food temptations, social and 
internal factors, and negative emotional events which 
impact eating behaviors. Scores range from 0 to 44, with 
higher perceived self-efficacy for healthy eating. 
3.36 Change in the Diet Self Efficacy Scale 
from baseline to 48 weeks after first group 
session 
The participant’s perceived self-efficacy for healthy eating 
will be measured using the Diet Self-Efficacy scale, which 
includes 11 items on a 5-point scale. The Diet Self Efficacy 
Scale assesses high caloric food temptations, social and 
internal factors, and negative emotional events which 
impact eating behaviors. Scores range from 0 to 44, with 
higher perceived self-efficacy for healthy eating. 
3.37 Change in the Self Efficacy for Exercise 
Scale from baseline to 16 weeks after first 
group session 
The participant’s perceived self-efficacy for healthy exercise 
will be measured using the Self-Efficacy for Exercise Scale, 
which includes 9 items on a 11-point scale. Scores range 
from 0 to 90, with higher scores associated with higher self-
efficacy for exercise. 
3.38 Change in the Self Efficacy for Exercise 
Scale from baseline to 32 weeks after first 
group session 
The participant’s perceived self-efficacy for healthy exercise 
will be measured using the Self-Efficacy for Exercise Scale, 
which includes 9 items on a 11-point scale. Scores range 
from 0 to 90, with higher scores associated with higher self-
efficacy for exercise. 
3.39 Change in the Self Efficacy for Exercise 
Scale from baseline to 48 weeks after first 
group session 
The participant’s perceived self-efficacy for healthy exercise 
will be measured using the Self-Efficacy for Exercise Scale, 
which includes 9 items on a 11-point scale. Scores range 
from 0 to 90, with higher scores associated with higher self-
efficacy for exercise. 
3.40 Change in amount of moderate to 
vigorous physical activity from baseline to 16 
weeks after first group session 
The participant’s moderate to vigorous physical activity will 
be measured by triaxial accelerometry. Results will be 
reported in minutes, with higher numbers indicating a 
higher amount of moderate to vigorous physical activity. 
3.41 Change in amount of moderate to 
vigorous physical activity from baseline to 32 
weeks after first group session 
The participant’s moderate to vigorous physical activity will 
be measured by triaxial accelerometry. Results will be 
reported in minutes, with higher numbers indicating a 
higher amount of moderate to vigorous physical activity. 
3.42 Change in the dietary risk assessment 
score from baseline to 16 weeks after first 
group session 
The participant’s dietary intake will be assessed using the 
dietary risk assessment, which includes 54 items. The 
dietary risk assessment measures the healthiness of a 
participant’s eating habits. Score ranges from 0 to 108, with 
higher scores associated with less healthy dietary intake.  

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3.43 Change in the dietary risk assessment 
score from baseline to 32 weeks after first 
group session 
The participant’s dietary intake will be assessed using the 
dietary risk assessment, which includes 54 items. The 
dietary risk assessment measures the healthiness of a 
participant’s eating habits. Score ranges from 0 to 108, with 
higher scores associated with less healthy dietary intake.  
3.44 Change in veggie meter score from 
baseline to 16 weeks after first group session 
The participant’s nutrition will be assessed using the veggie 
meter, which uses light reflectance spectroscopy to provide 
an estimate skin carotenoid composite score. Score ranges 
from 0 to 800, with higher scores associated with greater 
fruit and vegetable intake.  
3.45 Change in veggie meter score from 
baseline to 32 weeks after first group session 
The participant’s nutrition will be assessed using the veggie 
meter, which uses light reflectance spectroscopy to provide 
an estimate skin carotenoid composite score. Score ranges 
from 0 to 800 with higher scores associated with greater 
fruit and vegetable intake. 
3.46 Change in BMI from baseline to 16 weeks 
after first group session 
The participant’s BMI is calculated as weight (kg) divided by 
height (cm). 
3.47 Change in BMI from baseline to 32 weeks 
after first group session 
The participant’s BMI is calculated as weight (kg) divided by 
height (cm).  
3.48 Change in weight from baseline to 16 
weeks after first group session 
The participants weight will be measured using a digital 
scale. 
3.49 Change in weight from baseline to 32 
weeks after first group session 
The participant’s weight will be measured using a digital 
scale. 
3.50 Change in waist-to-hip ratio from 
baseline to 16 weeks after first group session 
The participant’s waist to hip ratio is calculated by using the 
mean of two waist circumference measurements divided by 
mean of two hip circumference measurements. Waist 
circumference will be measured at the midpoint between 
the upper iliac crest and lower costal margin in the 
midaxillary line. Hip circumference will be measured at the 
maximum width of the buttocks or gluteo-femoral fold.  
3.51 Change in waist-to-hip ratio from 
baseline to 32 weeks after first group session 
The participant’s waist to hip ratio is calculated by using the 
mean of two waist circumference measurements divided by 
mean of two hip circumference measurements. Waist 
circumference will be measured at the midpoint between 
the upper iliac crest and lower costal margin in the 
midaxillary line. Hip circumference will be measured at the 
maximum width of the buttocks or gluteo-femoral fold.   
3.52 Change in blood pressure (systolic blood 
pressure/diastolic blood pressure) from 
baseline to 16 weeks after first group session 
The participant’s blood pressure is measured using an 
electronic sphygmomanometer. The final measurement will 
be the mean of three measurements. 
3.53 Change in in blood pressure (systolic 
blood pressure/diastolic blood pressure) from 
baseline to 32 weeks after first group session 
The participant’s blood pressure is measured using an 
electronic sphygmomanometer. The final measurement will 
be the mean of three measurements. 
3.54 Change in high sensitivity C-reactive 
protein amount from baseline to 16 weeks 
after first group session 
The participant’s high sensitivity C-reactive protein levels 
will be obtained via phlebotomy. 

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3.55 Change in high sensitivity C-reactive 
protein amount from baseline to 32 weeks 
after first group session 
The participant’s high sensitivity C-reactive protein levels 
will be obtained via phlebotomy. 
3.56 Change in IL-6 amount from baseline to 
16 weeks after first group session 
The participant’s IL-6 levels will be obtained via 
phlebotomy. 
3.57 Change in IL-6 amount from baseline to 
32 weeks after first group session 
The participant’s IL-6 levels will be obtained via 
phlebotomy. 
3.58 Change in glycosylated hemoglobin 
amount from baseline to 16 weeks after first 
group session 
The participant’s glycosylated hemoglobin levels will be 
obtained via phlebotomy. 
3.59 Change in glycosylated hemoglobin 
amount from baseline to 32 weeks after first 
group session 
The participant’s glycosylated hemoglobin levels will be 
obtained via phlebotomy. 
 
4 
STUDY DESIGN 
 
4.1 
OVERALL DESIGN 
 
The HARMONY study is a two-arm, randomized control, single site trial to test the HARMONY 
experimental group against an attention control group (Nutrition and Exercise Education Workgroup; 
NEEW). The study will be conducted in 8 cohorts of 25 participants, group sizes of 12-13 randomly 
assigned to HARMONY and 12-13 to NEEW. The allocation sequence will be generated using permuted 
blocks (2,4,6). Participants will be told after baseline assessment to anticipate a brief wait (~4 weeks) 
until 25 participants are accrued in the cohort, at which time participants will be randomized.77  
 
The main study hypothesis is that the HARMONY intervention will promote and sustain improvements in 
health behaviors that lower CM risk factors in AAW through improved management of stress. 
 
HARMONY is an intervention to help AAW manage chronic stress and develop and sustainable new 
healthy habits for exercise and eating as a means of self-care, despite pervasive environmental and 
sociocultural challenges and caregiving demands. A 16-week program using an approach based on 
mindfulness, HARMONY is designed to be scaled and translated for use in community settings serving 
AAW. Unique in length and focus on managing culturally-relevant stressors specific to AAW, who face 
high CM risk, HARMONY – unlike nutrition and exercise-only active control interventions – focuses 
specifically on mindful self-management of negative emotions and behaviors that may impact 
adherence to sufficient self-care engagement, adequate exercise, and/or healthy eating habits.50,78, 79,  
The goal of HARMONY is to provide AAW with strategies to address stress cognitively and emotionally in 
a way that simultaneously honors their desire to care for their families and communities while 
harmoniously and successfully integrating sustained engagement in exercise and healthy eating through 
improvements in mindfulness, positive reappraisal, self-regulation, and self-efficacy. Accordingly, AAW 
will have reduced psychological distress and improved resilience to stress,80-82 address barriers to 
sustaining their healthy lifestyle changes.  
 

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The NEEW group includes only the culturally tailored nutrition education and exercise program, which 
does not address mindfulness, positive reappraisal, self-regulation, and self-efficacy, stress 
management, or SWS. 
Participants will be engaged for approximately 13 months, which includes the following: 
• 
Screening telephone call 
• 
Pre-baseline period 
• 
Baseline visit 
• 
8 biweekly HARMONY/NEEW sessions over a 16-week period (e.g., weeks 1, 3, 5, 7, 9, 11, 13, 
15),  
• 
6 monthly booster sessions.  
• 
Follow-up assessments at 16, 32, and 48 weeks post first group session 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
The HARMONY study’s cohort group sizes (12-13) is consistent with prior mindfulness research yielding 
moderately high group cohesion, intervention credibility, and information uptake. 
 
To facilitate the attention control design, NEEW participants will have the same amount of contact with 
interventionist and encouragement to engage in intervention components and at-home activities. 
 
4.3 
END-OF-STUDY DEFINITION 
 
A participant is considered to have completed the study if she has completed the 48-week follow-up 
assessments.  
 
The end of the study is defined as completion of the 48-week follow-up assessments shown in the 
Schedule of Activities (SoA), Section 1.3 for all subjects. 
 
5 
STUDY POPULATION 
 
5.1 
INCLUSION CRITERIA 
 
To be eligible to participate in this study, an individual must meet all the following criteria: 
1. Self-reported African American or Black woman 
2. BMI= 25-39 kg/m2 (confirmed at baseline assessment) 
3. At least one cardiometabolic risk factor: 
a. < 150 minutes of self-reported moderate to vigorous exercise per week 
b. History of gestational diabetes 
c. Parent or sibling with prediabetes or diabetes 
d. Personal or family history of hypertension (≥130/80) 
e. Prediabetes or impaired glucose metabolism (HgbA1c=5.7-≤6.5) 
f. 
Personal or family history of abnormal cholesterol levels  
4. At least 18 years of age 
5. Able to read/speak English 

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6. Willing to attend scheduled classes, complete internet surveys and biomarker assessments 
7. Able/willing to engage in moderate to vigorous exercise 
8. Ambulatory 
9. Superwoman Schema Questionnaire score indicating at least moderate endorsement of one or 
more subscales (strength: 7; emotional suppression: 7; resistance of vulnerability: 8; motivation 
to succeed: 7; or helping others: 10) or a total score of 20 or greater. 
10. A Perceived Stress Scale-14 score of >5 or self-report at least “some” general stress. 
11. Willing to agree to be randomized between the two culturally-tailor programs. 
12. Willing to not share group assignment for the study. 
5.2 
EXCLUSION CRITERIA 
 
An individual who meets any of the following criteria will be excluded from participation in this study: 
 
1. Pregnant/anticipated pregnancy  
2. Substance use, mental health or medical condition that will prevent your ability to participate in 
the intervention  
3. Use of weight loss medication 
4. Current or recent (<6 months prior to enrollment) engagement in another weight loss or 
meditation program 
5. Impaired cognition (inability to follow and respond appropriately during screening) 
6. Diabetes diagnosis 
7. Lives in the same household as someone who is currently in the study or was previously in the 
study. 
 
5.3 
LIFESTYLE CONSIDERATIONS 
 
During this study, participants are asked to: 
 
• 
Refrain from starting weight loss medications/nutritional supplements taken for weight loss   
• 
Refrain from starting any weight loss or meditation program 
 
5.4 
SCREEN FAILURES 
 
Screen failures are defined as participants who consent to participate in this study but are not 
subsequently assigned to the study intervention or control group. Individuals who do not meet the criteria 
for participation in this trial (screen failure) because of meeting one or more exclusion criteria that are 
likely to change over time may be rescreened. Examples include a new diagnosis or new family history.  
 
5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
 
Please refer section B.1 of the UNC IRB application for the recruitment plan. 
 

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6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
 
6.1 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION 
 
6.1.1 STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION 
 
HARMONY INTERVENTION: 
 
The HARMONY intervention is the experimental intervention for this trial.  The HARMONY intervention 
will also be referred to as the “purple group”. 
 
The HARMONY intervention uses three strategies:  
 
• 
Mindfulness, with enhanced content on stressors unique to AAW, mindful self-compassion and 
mindful loving-kindness (LKM), specifically targeting caregiving, self-sacrifice, guilt related to self-
care engagement; 83-86 
• 
Mindfulness-based positive reappraisal, self-regulation, and self-efficacy strategies to resolve 
barriers to mindfulness-based positive reappraisal, self-regulation, and self-efficacy strategies to 
resolve barriers to engagement in mindful self-care practices in context of culturally-relevant 
stress and/or caregiving obligations; and 
• 
 Strategies to address cognitive-emotional barriers to self-care (e.g., guilt related to engaging in 
self-care)33-37,86-90  by developing new health-promoting cognitive and behavioral strategies.  
 
The HARMONY intervention will be delivered over 8 every-other-week sessions and 6 booster sessions by 
trained study interventionists. Each class will have three components: 
 
• 
Exercise sampler (e.g., Zumba®, African dance, weightlifting)92-94 
• 
Mindfulness cool down 
• 
Tailored education on CM condition prevention and risk reduction 
 
NEEW INTERVENTION: 
 
The control intervention is referred to as the NEEW (Nutrition and Exercise Education Workgroup) 
intervention.  The control intervention will be referred to as the “gold group”. 

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The NEEW group includes only culturally tailored nutrition and exercise, and does not address 
mindfulness, positive reappraisal, self-regulation, self-efficacy, stress management, or SWS. 
 
The NEEW intervention will be delivered over 8 every-other-week sessions and 6 booster sessions by 
trained study interventionists. Each class will have three components: 
 
• 
Exercise sampler (e.g., Zumba®, African dance, weightlifting)92-94 
• 
Stretching/cool down 
• 
Tailored education on CM condition prevention and risk reduction. 
6.1.2 ADMINISTRATION 
 
The HARMONY and NEEW interventions will be delivered over 8 every-other-week sessions and 6 booster 
sessions. All intervention sessions will be led by various interventionists: 
 
• 
A personal trainer to facilitate the exercise portion of the session; 
• 
A health educator (not trained in mindfulness) who will deliver the CM prevention and risk-
reduction education; and 
• 
A mindfulness instructor who will deliver the mindfulness cool down (for HARMONY group only). 
 
The personal trainer and health educator will lead both the HARMONY and NEEW groups, however they 
will be instructed to not speak about the other group to ensure blinding.  
 
Participants will interact with others in their group during the study but will not have contact with 
participants outside of their group. A “buddy system” will also be implemented where participants will be 
encouraged to communicate with their buddy to enhance accountability. 
 
All intervention sessions will be delivered over secure teleconferencing platforms (e.g. Zoom) due to the 
COVID-19 pandemic.  
6.2 
FIDELITY 
6.2.1 INTERVENTIONIST TRAINING AND TRACKING 
 
All intervention (NEEW and HARMONY) sessions will be audio-recorded for fidelity purposes. The fidelity 
lead will listen to or observe these sessions and will report blinded findings to the PIs. If necessary, the PIs 
will review findings with the interventionists and address barriers to adherence. 
 
Interventionists will review all session outlines and complete mock Zoom sessions with the study team 
prior to the first group session. Further details about the interventionist training are in the interventionist 
training plan.  
 
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
 
The study statistician will generate the allocation sequence using permuted blocks (2, 4, 6).  

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The study PIs, statisticians, and participants will be blinded to intervention assignment. The blind may be 
intentionally broken in case of an unexpected SAE or for other safety reasons. If the blind is broken 
intentionally, it will be recorded in the report of the event that caused the broken blind. The blind may 
also be broken intentionally for participants at the end of their participation by providing them with a 
debriefing statement to explain the two interventions. If the blind is broken unintentionally (e.g. an 
interventionist accidentally revealing a study group assignment to a PI), this will be reported to the 
appropriate regulatory authorities if applicable.   
 
To keep participants blinded, participants will be told during the recruitment and consenting process that 
they will be placed into one of two culturally tailored nutrition and exercise groups. The participants will 
be provided a debriefing statement at the end of their participation to explain the difference between the 
two groups, and to ask them not to disclose information to others about the different assignments. 
 
To prevent accidental unblinding, it will be very clear who is blinded to all members of the study team. 
The study team will be encouraged to take all questions and comments to an unblinded study team 
member prior to presenting them to blinded study team members, to ensure that the content of the 
question or comment would not inadvertently unblind them. In addition, documents that list intervention 
assignments will be limited and labeled appropriately to ensure blinded team members do not 
accidentally review them. Appropriate study team personnel will be trained to ensure the integrity of the 
study blind. 
 
6.4 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
 
Participants’ adherence to study procedures will be tracked in the following ways: 
 
• 
Documenting attendance at all sessions 
• 
Documenting attendance at data collection visits (4, 8, 12 months post first session) 
• 
Review of data in the Fitabase system 
 
6.5 
CONCOMITANT THERAPY 
 
During their participation in the study, subjects will be asked to refrain from taking any weight loss 
medication or supplements or enrolling in weight loss or meditation programs. 
 
 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
 
7.1 
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
 
When a subject discontinues from HARMONY/NEEW but not from the study, remaining study procedures 
will be completed as indicated by the study protocol.  If a clinically significant finding is identified 

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(including, but not limited to changes from baseline) after enrollment, the investigator or qualified 
designee will determine if any change in participant management is needed. Any new clinically relevant 
finding will be reported as an adverse event (AE). 
 
The data to be collected at the time of study intervention discontinuation will include the reason(s) for 
discontinuing the participant from the intervention.  
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
 
Participants are free to withdraw from participation in the study at any time upon request. 
An investigator may discontinue a participant from the study for the following reasons: 
 
• 
Significant study intervention non-compliance 
• 
If the participant does not complete their pre-baseline assessments in a timely manner (per 
investigator judgement) 
• 
Lost-to-follow up; unable to contact subject (see Section 7.3, Lost to Follow-Up) 
• 
Any event, medical condition or situation that occurs such that continued collection of follow-up  
study data would not be in the best interest of the participant or might require an additional 
treatment that would confound the interpretation of the study 
• 
The participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation 
 
The reason for participant discontinuation or withdrawal from the study will be recorded. Subjects who 
sign the informed consent form and are randomized but do not receive the study intervention may be 
replaced.  Subjects who sign the informed consent form, are randomized, receive the study intervention, 
and subsequently withdraw, or are discontinued from the study, will not be replaced. 
 
If a participant becomes pregnant during the study, they will temporarily stop all study procedures. Both 
the study investigator and the patient’s maternity care provider will be consulted to determine if the 
participant should continue with the study. If those parties agree that it is safe and appropriate, the 
participant will be allowed to continue with the study if they are willing. If the participant is either 
unwilling to continue or if the investigator or maternity care provider deem it unsafe for the participant 
to continue, they will be withdrawn from the study. 
7.3 
LOST TO FOLLOW-UP 
 
A participant will be considered lost to follow-up if she fails to return for 2 scheduled intervention sessions, 
or 1 data collection session and study staff are unable to contact the participant after at least 3 attempts.  
 
The following actions must be taken if a participant fails to attend a data collection visit or intervention 
session (unless there is a documented reason why they were absent): 
 

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• 
The study team will attempt to contact the participant, reschedule the missed visit, counsel the 
participant on the importance of maintaining the assigned visit schedule and ascertain if the 
participant wishes to and/or should continue in the study 
• 
Before a participant is deemed lost to follow-up, the investigator or designee will make every 
effort to regain contact with the participant (where possible, 3 telephone calls and, if necessary, 
a certified letter to the participant’s last known mailing address or local equivalent methods). 
These contact attempts will be documented in the participant’s study file.  
• 
Should the participant continue to be unreachable, she will be considered to have withdrawn 
from the study with a primary reason of lost to follow-up. 
 
 
 
8 
STUDY ASSESSMENTS AND PROCEDURES 
 
8.1 
ENDPOINT AND OTHER ASSESSMENTS 
 
The procedures and assessments described in this section will be performed at the time points described 
in the schedule of activities in section 1.3. 
 
Endpoint Assessments 
 
Superwoman Schema Questionnaire 
 
The participant’s endorsement of Superwoman Schema will be measured using the Giscombe 
Superwoman Schema Questionnaire, which includes 35 items, divided in 5 subscales, on a 4-point scale, 
ranging from 0 to 3. The Giscombe Superwoman Schema Questionnaire measures obligation to present 
an image of strength, obligation to suppress emotions, resistance to vulnerability, intense motivation to 
succeed, obligation to help others. There are 5 different subscales for the superwoman schema, so 
participants will report 5 different scores. Score ranges for each subscale are 0-18 (strength), 0-21 
(suppress emotions), 0-21 (resistance to vulnerability), 0-18 (motivation to succeed), 0-27 (obligation to 
help others), with higher scores associated with a greater endorsement of the selected superwoman 
schema scale characteristic. 
 
This questionnaire will be performed at telephone screening and 16, 32, and 48 weeks post first group 
session. The data will be entered electronically by the patient through REDCap survey; however, paper 
copies of the questionnaire may be used if necessary. 
 
Perceived Stress Scale 
 
The participant’s general stress will be measured using the PSS-14, which includes 14 items on a 5-point 
scale. Scores range 0-56, with higher scores indicating greater perceived stress. 

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This questionnaire will be performed at telephone screening and 16, 32, and 48 weeks post first group 
session. The data will be entered electronically by the patient through REDCap survey; however, paper 
copies of the questionnaire may be used if necessary. 
 
Actigraphy 
 
Participants will be given a triaxial ActiGraph Activity Monitor at baseline and 16, 32, and 48 weeks post 
first group session. Participants will be instructed to wear the ActiGraph Activity Monitor for 7 consecutive 
days. Participants will be instructed how to wear the ActiGraph Activity Monitor and special instructions 
for care by study personnel.  
 
For the purposes of this study, the participant’s moderate to vigorous physical activity will be measured. 
Moderate to vigorous physical activity is defined as activities that are strenuous enough to burn off three 
to six times as much energy per minutes as one does when sitting quietly, or exercises that clock in at 3 
to 6 METs. 
 
Dietary Risk Assessment 
 
The participant’s dietary intake will be assessed using the dietary risk assessment, which includes 54 items. 
The dietary risk assessment measures the healthiness of a participant’s eating habits. Score ranges from 
0 to 108, with higher scores associated with less healthy dietary intake. 
 
This questionnaire will be performed at baseline and 16, 32, and 48 weeks post first group session. The 
data will be entered electronically by the patient through REDCap survey; however, paper copies of the 
questionnaire may be used if necessary. 
 
Veggie Meter 
 
The participant’s fruit and vegetable intake will be measured by the participant’s skin carotenoids. The 
Veggie Meter uses a pressure-mediated reflection spectroscopy device to measure these carotenoids. 
Study personnel will calibrate the Veggie Meter as needed, and then ask the participant to wash their 
hands with soap and water.  The participant will then place their finger in the cradle of the meter, and will 
hold it there until the scan is complete. 
 
The Veggie Meter procedure will be performed at baseline and 16, 32, and 48 weeks post first group 
session. 
 
Weight and Height 
 

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The participant’s weight will be measured using an electronic scale. Weight will be converted to kilograms 
to calculate participant BMI.  The participant’s height will be measured to the nearest centimeter to 
calculate participant BMI.  
 
Weight will be performed at baseline and 16, 32, and 48 weeks post first group session. Height will be 
performed at baseline, and is optional to perform at 16, 32, and 48 weeks post first group session. 
 
Hip Circumference 
 
Hip circumference will be measured at the maximum width of the buttocks or gluteo-femoral fold. Two 
measurements will be recorded by study personnel. The mean of these measurements will be used for 
the waist-to-hip ratio. 
 
Hip circumference will be measured at baseline and 16, 32, and 48 weeks post first group session. 
 
Waist Circumference 
 
Waist circumference will be measured at the midpoint between the upper iliac crest and lower costal 
margin in the midaxillary line. Study personnel will record two waist circumference measurements. The 
mean of these measurements will be used for the waist-to-hip ratio. 
 
Waist circumference will be measured at baseline and 16, 32, and 48 weeks post first group session. 
 
Il-6 and CRP 
 
Specimens for the measurement of IL-6 and CRP will be collected using standard venipuncture.  
 
The phlebotomy procedure to obtain the IL-6 and CRP measurements will be completed at baseline and 
16, 32, and 48 weeks post first group session. 
 
HgbA1C 
 
HgbA1C will be assessed using a fingerstick procedure at baseline and 16, 32, and 48 weeks post first 
group session. 
 
Blood Pressure 
 
Blood pressure will be collected by an electronic sphygmomanometer after a five-minute rest in the sitting 
position. Study personnel will record three blood pressure measurements, and the average value will be 
used for analysis.  
 
Blood pressure will be measured at baseline and 16, 32, and 48 weeks post first group session. 

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Contextualized Stress Scale 
 
The participant’s racial and gendered stress exposure will be measured using the Contextualized Stress 
Measure, which includes 69 items on a 5-point scale. The Contextualized Stress Measure is divided into 
six subscales, including race/racism, burden, personal history, workplace, coping and support, and stress 
states. Score ranges from 0 to 345, with higher scores associated with increased stress exposure. 
 
This questionnaire will be performed at baseline and 16, 32, and 48 weeks post first group session. The 
data will be entered electronically by the patient through REDCap survey; however, paper copies of the 
questionnaire may be used if necessary. 
 
Network Stress Scale 
 
The participant’s indirect and self-stress will be measured using the Network Stress Scale, which includes 
10 items on a 4-point scale. The Network Stress scale assesses both exposure and appraisal of events that 
happened to both self and close family members and friends. Higher scores represent higher exposure 
and appraisal. Score ranges from 0, with 10 scores associated with a higher amount of indirect and self-
stress. 
 
This questionnaire will be performed during the pre-baseline period and 16, 32, and 48 weeks post first 
group session. The data will be entered electronically by the patient through REDCap survey; however, 
paper copies of the questionnaire may be used if necessary. 
 
Mindful Eating Questionnaire 
 
The participant’s mindful eating will be measured using the Mindful Eating Questionnaire, which includes 
28 items on a 4-point scale. Score ranges from 1 to 4, with higher scores associated with more mindful 
eating. 
 
This questionnaire will be performed during the pre-baseline period and 16, 32, and 48 weeks post first 
group session. The data will be entered electronically by the patient through REDCap survey; however, 
paper copies of the questionnaire may be used if necessary. 
 
Mindful Self-Care Scale 
The participant’s self-care will be measured using the Mindful Self-Care scale, which includes 42 items on 
a 5-point scale. The Mindful Self-Care scale assesses 6 domains of self-care: physical care, supportive 
relationships, mindful awareness, self-compassion and purpose, mindful relaxation, and supportive 
structure. Score ranges from 1 to 5, with higher scores higher associated with more self-care. 

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This questionnaire will be performed at performed at baseline and 16, 32, and 48 weeks post first group 
session. The data will be entered electronically by the patient through REDCap survey; however, paper 
copies of the questionnaire may be used if necessary. 
 
Cognitive Emotion Regulation Questionnaire 
The participant’s cognitive emotion regulation strategies will be measured using the Cognitive Emotion 
Regulation questionnaire, which includes 20 items on a 5-point scale. The Cognitive Emotion Regulation 
Questionnaire assesses the sub-scales of self-blame, other-blame, rumination, catastrophizing, positive 
refocusing, planning, positive reappraisal, putting into perspective and acceptance. Scores for each sub-
scale ranges from 2 to 10, with higher scores associated with an increased usage of a specific cognitive 
strategy.  
This questionnaire will be performed at performed during the pre-baseline period and 16, 32, and 48 
weeks post first group session. The data will be entered electronically by the patient through REDCap 
survey; however, paper copies of the questionnaire may be used if necessary. 
 
PROMIS Self-Efficacy for Managing Emotions 
The participant’s management of emotions will be measured using the PROMIS Self-Efficacy for Managing 
Emotions, which includes 4 items on a 5-point scale. The PROMIS Self-Efficacy for Managing Emotions 
assesses the participant’s confidence to manage and control symptoms stress, discouragement, 
disappointment, and negative feelings. Score ranges from 5 to 20, with higher scores associated with a 
higher confidence level in managing symptoms. 
This questionnaire will be performed during the pre-baseline period and 16, 32, and 48 weeks post first 
group session. The data will be entered electronically by the patient through REDCap survey; however, 
paper copies of the questionnaire may be used if necessary. 
 
PROMIS Emotional Distress-Depression Scale 
 
The participant’s depressive symptoms will be assessed using the PROMIS Emotional Distress- Depression 
Scale, which includes 4 items on a 5-point scale. The PROMIS Emotional Distress-Depression Scale assesses 
self-reported negative mood, views of self, social cognition, and decreased positive affect and 
engagement. Scores range from 5 to 20, with higher scores associated with a higher degree of depressive 
symptoms. 
 
This questionnaire will be performed during the pre-baseline period and 16, 32, and 48 weeks post first 
group session. The data will be entered electronically by the patient through REDCap survey; however, 
paper copies of the questionnaire may be used if necessary. 
 
Connor-Davidson Resilience Scale 

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The participant’s resilience will be measured using the Connor-Davidson Resilience Scale, which includes 
10 items on a 4-point scale. The Connor-Davidson Resilience Scale assesses ability to adapt to change, 
achievement of goals despite obstacles, and how participants handle strong feelings. Score ranges from 0 
to 40, with higher scores associated with increased resiliency. 
This questionnaire will be performed during the pre-baseline period and 16, 32, and 48 weeks post first 
group session. The data will be entered electronically by the patient through REDCap survey; however, 
paper copies of the questionnaire may be used if necessary. 
 
 
Self-Efficacy for Exercise Scale 
 
The participant’s perceived self-efficacy for healthy exercise will be measured using the Self-Efficacy for 
Exercise Scale, which includes 9 items on a 11-point scale. Scores range from 0 to 90, with higher scores 
associated with higher self-efficacy for exercise. 
 
This questionnaire will be performed at baseline and 16, 32, and 48 weeks post first group session. The 
data will be entered electronically by the patient through REDCap survey; however, paper copies of the 
questionnaire may be used if necessary. 
 
Diet Self Efficacy Scale 
 
The participant’s perceived self-efficacy for healthy eating will be measured using the Diet Self-Efficacy 
scale, which includes 11 items on a 5-point scale. The Diet Self Efficacy Scale assesses high caloric food 
temptations, social and internal factors, and negative emotional events which impact eating behaviors. 
Scores range from 0 to 44, with higher perceived self-efficacy for healthy eating. 
 
This questionnaire will be performed at baseline and 16, 32, and 48 weeks post first group session. The 
data will be entered electronically by the patient through REDCap survey; however, paper copies of the 
questionnaire may be used if necessary. 
 
Five Facet Mindfulness Scale 
 
The participant’s level of mindfulness will be measured using the Five Facet Mindfulness Scale, which 
includes 39 items on a 5-point scale. The Five Facet Mindfulness Scale measures observing, the ability to 
verbally express one’s experience, acting with awareness, nonjudging of inner experience, and non-
reacting to one’s inner experience. Score ranges from 1-5, with higher scores associated with a higher 
level of mindfulness. 
 
This questionnaire will be performed at baseline and 16, 32, and 48 weeks post first group session. The 
data will be entered electronically by the patient through REDCap survey; however, paper copies of the 
questionnaire may be used if necessary. 

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Other Assessments 
 
Cardiometabolic Risk Questionnaire 
 
The cardiometabolic risk questionnaire will be performed during the screening period to assess for BMI, 
exercise frequency, family history, and cardiometabolic medical history.  
 
The data will be entered electronically by the patient through REDCap survey; however, paper copies of 
the questionnaire may be used if necessary. 
 
Physical Activity Readiness Questionnaire 
 
The physical activity readiness questionnaire will be performed during the screening period to assess if 
the participant is able to exercise.  
 
The data will be entered electronically by the patient through REDCap survey; however, paper copies of 
the questionnaire may be used if necessary. 
 
Demographics Questionnaire 
 
The demographics questionnaire will be administered during the screening period to collect information 
regarding the participant’s age, race, socioeconomic class, and other elements. 
 
The data will be entered electronically by the patient through REDCap survey; however, paper copies of 
the questionnaire may be used if necessary. 
 
Health History Questionnaire 
 
The health history questionnaire will be administered during the screening period to obtain information 
about the participant’s medical history and medication usage.  
 
The data will be entered electronically by the patient through REDCap survey; however, paper copies of 
the questionnaire may be used if necessary. 
 
University of Rhode Island Change Assessment Scale 
 
The University of Rhode Island Change Assessment Scale assesses the participant’s readiness for change. 
Scores range from +2 to +14.   
 

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This questionnaire will be performed during the first group session and at the half-day retreat. The data 
will be entered electronically by the patient through REDCap survey; however, paper copies of the 
questionnaire may be used if necessary. 
 
Fitbit Measurements 
 
Fitbit devices will be provided to each participant at the baseline visit. The participant will be instructed 
to wear the Fitbit consistently for the duration of the study.  
 
A research staff member will create a email and password for each participant to connect the Fitbit 
device to the Fitabase platform.  
 
Group Cohesion Questionnaire 
 
The Group Cohesion Questionnaire assesses the participant’s perception of group cohesion, which 
includes 12 items on a 7-point scale. Scores range from 12 to 84, with higher scores associated with less 
group cohesion. 
 
This questionnaire will be performed at group sessions 2 and 7. The data will be entered electronically by 
the patient through REDCap survey; however, paper copies of the questionnaire may be used if necessary. 
 
 
 
Credibility Scale 
 
The credibility scale assesses the participant’s expectation of benefit once the intervention has been 
explained to them. It includes 5 items on a 10-point scale. Scores range from 0 to 45, with higher scores 
associated with higher expectation on benefit. 
 
This questionnaire will be performed at group sessions 2 and 7. The data will be entered electronically by 
the patient through REDCap survey; however, paper copies of the questionnaire may be used if necessary. 
 
Buddy System Assessment 
 
The buddy system assessment measures how often participants are communicating with their buddy, 
barriers to their participation in the buddy system, and other elements regarding the system. 
 
This questionnaire will be performed at all group sessions, and at 16, 32, and 48 weeks post first group 
session. The data will be entered electronically by the patient through REDCap survey; however, paper 
copies of the questionnaire may be used if necessary. 
 
Mindfulness Practice Assessment 
 
The mindfulness practice survey assesses how often the participants are practicing mindfulness. This 
questionnaire will only be given to participants in the HARMONY group.  
 

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This questionnaire will be performed at all group sessions, and at 16, 32, and 48 weeks post first group 
session. The data will be entered electronically by the patient through REDCap survey; however, paper 
copies of the questionnaire may be used if necessary. 
 
Nutritional Survey 
 
The nutritional survey assess the participants knowledge of nutrition, and also asks about current eating 
habits.  
 
This questionnaire will be performed prior to group session 1 and 8. The data will be entered 
electronically through REDCap survey; however, paper copies of the questionnaire may be used if 
necessary. 
 
General Stress Assessment 
 
The general stress assessment measures the participants overall stress levels. It is a one-question 
assessment, with answers ranging from 0 (no stress at all) to 3 (extreme stress).  
 
If the participant selects answer choices 1, 2, or 3, they are eligible for the study. 
 
Interview 
 
All participants will have an interview conducted at the 16- and 48-week post first group session 
timepoint. The interview will ask about participant opinion regarding the interventions, and the 
HARMONY group participants will be also asked about mindfulness and superwoman schema.  
 
8.2 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
 
8.2.1 DEFINITION OF ADVERSE EVENTS 
 
This protocol uses the definition of adverse event from the OHRP Guidance on Reviewing and Reporting 
Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events: “Any untoward or 
unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal 
physical exam or laboratory finding), symptom, or disease, temporarily associated with the subject’s 
participation in research, whether or not considered related to the subject’s participation in the research.” 
 
 
8.2.2 DEFINITION OF SERIOUS ADVERSE EVENTS 
 
This protocol uses the FDA’s definition of serious adverse event as defined in 21CFR312.32 (b): 
 
An adverse event is considered serious if, in the view of either the investigator or sponsor, it results in any 
of the following outcomes: 
 

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• 
Death; 
• 
A life-threatening adverse event; 
• 
Inpatient hospitalization or prolonging of existing hospitalization; 
• 
A persistent or significant incapacity or substantial disruption of the ability to conduct normal life 
functions; or 
• 
A congenital anomaly/birth defect. 
 
Important medical events that may not results in death, be life-threatening, or require hospitalization may 
be considered serious when, based upon appropriate medical judgement, they may jeopardize the patient 
or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this 
definition.  
8.2.3 CLASSIFICATION OF AN ADVERSE EVENT 
8.2.3.1 SEVERITY OF EVENT 
 
For adverse events (AEs), the following guidelines will be used to describe severity.  
 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities.  
• 
Moderate – Events result in a low level of inconvenience or concerns. Moderate events may cause 
some interference with functioning. 
• 
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug 
therapy or other treatment. Severe events are usually potentially life-threatening or 
incapacitating.  Of note, the term “severe” does not necessarily equate to “serious”. 
 
8.2.3.2 RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
 
All adverse events (AEs) will have their relationship to study procedures, including the intervention, 
assessed by the study PIs based on temporal relationship and her clinical judgment. The degree of 
certainty about causality will be graded using the categories below.  
 
 
• 
Definitely Related – There is clear evidence to suggest a causal relationship, and other possible 
contributing factors can be ruled out. The clinical event, including an abnormal laboratory test 
result, occurs in a plausible time relationship to study procedures administration and cannot be 
explained by concurrent disease or other drugs or chemicals. The response to withdrawal of the 
study procedures should be clinically plausible. The event must be pharmacologically or 
phenomenologically definitive. 
• 
Probably Related – There is evidence to suggest a causal relationship, and the influence of other 
factors is unlikely. The clinical event, including an abnormal laboratory test result, occurs within a 
reasonable time after administration of the study procedures, is unlikely to be attributed to 
concurrent disease or other drugs or chemicals, and follows a clinically reasonable response on 
withdrawal.  

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• 
Potentially Related – There is some evidence to suggest a causal relationship (e.g., the event 
occurred within a reasonable time after administration of study procedures). However, other 
factors may have contributed to the event (e.g., the participant’s clinical condition, other 
concomitant events). Although an AE may rate only as “possibly related” soon after discovery, it 
can be flagged as requiring more information and later be upgraded to “probably related” or 
“definitely related”, as appropriate. 
• 
Unlikely to be related – A clinical event, including an abnormal laboratory test result, whose 
temporal relationship to study procedures administration makes a causal relationship improbable 
(e.g., the event did not occur within a reasonable time after administration of the study 
procedures) and in which other drugs or chemicals or underlying disease provides plausible 
explanations (e.g., the participant’s clinical condition, other concomitant treatments). 
• 
Not Related – The AE is completely independent of study procedures administration, and/or 
evidence exists that the event is definitely related to another etiology. There must be an 
alternative, definitive etiology documented by the clinician.] 
 
8.2.3.3 EXPECTEDNESS  
 
The study PI will be responsible for determining whether an adverse event (AE) is expected or unexpected. 
An AE will be considered unexpected if the nature, severity, or frequency of the event is not consistent 
with the risk information previously described for the study procedures. 
 
 
 
 
 
8.2.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel during study visits, group sessions or other interactions with a study participant, or upon 
review by a study monitor. 
 
All AEs, not otherwise precluded per the protocol, will be captured on the appropriate case report form 
(CRF). Information to be collected includes event description, date of onset, PI’s assessment of severity, 
relationship to study procedures (assessed only by those with the training and authority to make a 
diagnosis), and date of resolution/stabilization of the event. All AEs occurring while on study will be 
documented appropriately regardless of relationship. All AEs will be followed to adequate resolution. 
 
Any medical or psychiatric condition that is present at the time that the participant is screened will be 
considered as baseline and not reported as an AE. However, if the study participant’s condition 
deteriorates at any time during the study, it will be recorded as an AE.  
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. Documentation of onset and duration of each episode will be 
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Study personnel will record events with start dates occurring any time after informed consent is obtained 
until the last day of study participation.  At each study visit, study personnel will inquire about the 
occurrence of AE/SAEs since the last visit.  Events will be followed for outcome information until resolution 
or stabilization. 
 
 
8.2.5 ADVERSE EVENT REPORTING  
 
Qualifying adverse events will be reported to the NIH funding institute. 
 
8.2.6 SERIOUS ADVERSE EVENT REPORTING  
 
The PIs will be responsible for conducting an evaluation of a serious adverse event. If the evaluation of 
the event determines that the event is related to the study, the study team shall report the results of such 
evaluation to the NIH and the reviewing Institutional Review Board (IRB) as soon as possible, but in no 
event later than 10 working days after the investigator first learns of the event. 
 
 
 
 
 
 
8.3 
UNANTICIPATED PROBLEMS 
 
8.3.1 DEFINITION OF UNANTICIPATED PROBLEMS 
 
This protocol uses the definition of Unanticipated Problems as defined by the Office for Human Research 
Protections (OHRP).  OHRP considers unanticipated problems involving risks to participants or others to 
include, in general, any incident, experience, or outcome that meets all of the following criteria: 
 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-
approved research protocol and informed consent document; and (b) the characteristics of the 
participant population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
• 
Suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized.] 
 

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8.3.2  UNANTICIPATED PROBLEMS REPORTING  
 
The investigator will report unanticipated problems (UPs) to the reviewing Institutional Review Board 
(IRB). The UP report will include the following information: 
 
• 
A detailed description of the event, incident, experience, or outcome  
• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP 
• 
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline:   
 
• 
UPs will be reported to the IRB a within 7 calendar days of the investigator becoming aware of 
the event   
 
 
 
 
 
 
 
 
9 
STATISTICAL CONSIDERATIONS  
9.1 
STATISTICAL HYPOTHESES 
 
Primary Endpoints: 
 
For each primary outcome (MVPA, dietary risk, and veggie meter), at each of 16, 32, and 48 weeks, the 
statistical hypotheses are: 
 
H0:  The change in the outcome does not differ between intervention and control groups. 
HA:  The change in the outcome does differ between intervention and control groups. 
 
Specifically, it is expected that AAW participating in an 8-session culturally relevant mindfulness 
intervention plus an exercise and nutrition education CM risk-reduction intervention will have greater 
sustained improvement in exercise and healthy eating behaviors at 16, 32, and 48 weeks post first 
intervention session, compared to AAW in an attention-control exercise and nutrition education CM risk-
reduction intervention without mindfulness. 
 
Secondary Endpoints: 
For each secondary outcome (CM risk biomarker), at each of 16, 32, and 48 weeks, the statistical 
hypotheses are: 
 
H0:  The change in the outcome does not differ between intervention and control groups. 

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HA:  The change in the outcome does differ between intervention and control groups. 
 
It is hypothesized that AAW participating in an 8-session culturally relevant mindfulness intervention plus 
an exercise and nutrition education CM risk-reduction intervention will have greater reduction in CM risk 
biomarkers at 16, 32, and 48 weeks post first intervention session, compared to AAW in an attention-
control exercise and nutrition education CM risk-reduction intervention without mindfulness. 
 
Tertiary Endpoints: 
 
Tertiary outcomes are self-reported mindfulness, stress management, positive reappraisal, self-
regulation, and self-efficacy mediate effects of the intervention on exercise and nutrition. 
 
For each tertiary outcome, at each of 16, 32, and 48 weeks, the statistical hypotheses are: 
 
H0:  The change in the outcome does not differ between intervention and control groups. 
HA: The change in the outcome does differ between intervention and control groups. 
9.2 
SAMPLE SIZE DETERMINATION 
 
200 participants will be enrolled (100 each in HARMONY and NEEW). Conservatively, based on prior 
research, comparisons of complete data on 80 participants per group are assumed, and also assume 20% 
attrition. Power calculations were performed with POWERLIB20 SAS/IML modules that incorporate 
methods to calculate power for the general linear multivariate model, which includes repeated measures 
data structures. Based on pilot study data, power analysis focuses on a group of representative variables 
addressed in the primary and secondary endpoints for CM risk factors. For primary and secondary 
endpoints, power is based on a separate multivariate model for these outcomes, incorporating measures 
from all timepoints. It is hypothesized that through improvements in self-management, women in 
HARMONY (experimental group) will show greater sustained improvements in exercise and healthy eating 
behaviors (primary endpoint) and greater reduction of CM risk biomarkers (secondary endpoint). Each 
hypothesis will be considered by specifying both a between-group contrast (HARMONY vs. NEEW) and the 
appropriate within-group contrast (three post-baseline timepoints versus baseline). This facilitates testing 
the null hypothesis that both groups have the same difference in population means for the change from 
baseline at a specific post-baseline time point against the alternative that the between-group difference 
of the change from baseline significantly differs from 0.  
 
The primary endpoint at 48 weeks post first group session is tested at a significance level of 0.05; 
the other two timepoints will be tested using a Bonferroni correction of a two-sided 0.025 (=0.05/2) 
significance level. A compound symmetry correlation structure is assumed across all timepoints in our 
calculations. Based on pilot data, correlation parameters are 0.35 for BMI, 0.11 for WHR and -0.45 for 
A1C. With 80 participants per group (total of 160), statistical power is 85% to detect an effect size of 0.56 
for BMI and exceeds 95% to detect an effect size of 0.45 for A1C and 0.59 for waist-hip ratio at each post-
baseline time point.76,94 In tertiary endpoints, it is hypothesized that mediation of the intervention effect 
on the primary outcomes (exercise and healthy eating) by the tertiary outcomes (improvements in self-
reported mindfulness, stress management, positive reappraisal, self-regulation, and self-efficacy).[In 
simulations of power for mediation tests, Fritz and Mackinnon95 found that when effect sizes 
(standardized regression coefficients) relating the intervention to the mediator and the mediator to the 
outcome are all ≥ 0.26 (small- medium, according to Cohen’s [1988] definition)96, the sample size (n=160) 

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is adequate for at least 80% power. If either effect size is much smaller (simulations used 0.14), the study 
will be underpowered. 
9.3 
POPULATIONS FOR ANALYSES 
 
Intent-to-treat analyses will be used and all participant’s data will be analyzed according to their random 
group assignment.  
 
9.4 
STATISTICAL ANALYSES 
 
9.4.1 GENERAL APPROACH 
All statistical tests, except for the exceptions noted here, will be conducted at an alpha level of 0.05.   
 
Exceptions: The 16-week and 32-week tests of intervention effect on the primary and secondary outcomes 
will be conducted using a Bonferroni-corrected alpha level of 0.025. 
For every primary endpoint, a linear mixed model will be built for the outcome at all three follow-up 
timepoints (16, 32, and 48 weeks) with the following fixed effects: intercept, value of the endpoint at 
baseline, timepoint (three parameters total, with baseline as the referent), intervention (control as the 
referent), and intervention by timepoint interaction (three parameters total, allows for a different 
intervention effect at each timepoint).  The test of the outcome at 48 weeks will be a test of the 
coefficient for the intervention effect at 48 weeks.   
A random intercept will be included to account for within-participant correlation. For the primary 
outcome, modeled at the three follow-up visits, the within-subject covariance matrix will be chosen based 
in the lowest AIC among unstructured, compound symmetric, and first-order autoregressive. To improve 
model fit, transformation of non-normal (i.e., highly skewed) endpoints will be considered.  If imbalance 
is detected among the randomized groups on one or more variables associated with the outcome 
(identified in section 9.4.4), these variables will also be included in the model. 
The fixed-effects can be interpreted like multiple regression parameters and provide basis for 
population regression lines. The random- effects component allows variation among participants. This 
plan accounts for within-subject correlations between measurements from the same individual across 
time.   
9.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
The primary endpoints of MVPA, dietary risk, and veggie meter will be assessed using the linear model 
described in 9.4.1.  A test of the appropriate interaction parameter at a significance level of 0∙05 will 
serve as the test of the intervention’s effect on each primary outcome. 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
 

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The secondary endpoints (BMI, % Body Fat, WHR, BP, and cytokines), dietary risk, and veggie meter will 
be assessed using the linear model described in 9.4.1.  A test of the appropriate interaction parameter at 
a significance level of 0∙05 will serve as the test the intervention’s effect on each primary outcome. 
 
The tertiary endpoints (mindfulness, stress management, positive reappraisal, self-regulation, and self-
efficacy dietary risk, and veggie meter will be assessed using the linear model described in 9.4.1.  A test 
of the appropriate interaction parameter at a significance level of 0∙05 will serve as the test the 
intervention’s effect on each primary outcome 
 
9.4.4 BASELINE DESCRIPTIVE STATISTICS 
 
Descriptive statistics will be presented for study demographics and endpoints, by intervention group, in 
the following manner: 
 
For continuous variables, means with standard deviations and range for variables with approximately 
normal distributions; median with IQR and range for variables that are not close to normally distributed. 
 
For categorical variables, sample size and percents will be presented for each category. 
 
Baseline comparison of participants randomized to HARMONY vs. NEEW will be conducted using t-tests 
(for approximately normal variables), Wilcoxon rank sum (for variables that are not approximately 
normal), and chi-square tests (for categorical or dichotomous variables; categories will be collapsed 
and/or Fisher’s Exact test will be used if the cell counts do not support the chi-square test).  These tests 
will each use an alpha level of 0.05. 
For each primary and secondary endpoint, we will use linear mixed models to assess whether 
HARMONY, compared to NEEW, will yield greater improvement on each outcome measure from 
baseline to post-baseline timepoints.  
 
9.4.5 PLANNED INTERIM ANALYSES  
 
N/A 
9.4.6 SUB-GROUP ANALYSES 
 
N/A 
9.4.7 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
 
For data sharing purposes, individual participant data will be listed by measure and timepoint. 
 
9.4.8 EXPLORATORY ANALYSES 
 
Other timepoints:  The intervention effect will be examined on the 16- and 32-week primary and 
secondary outcomes. Using the models described in 9.4.1, the intervention effect will be estimated at 16- 

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and 32-weeks using the appropriate interaction parameters.  These tests will be conducted at an alpha 
level of 0.025; this alpha level was selected using a Bonferroni correction because each outcome has two 
tests. 
 
Mediation: mediation of the intervention effect on the primary outcomes will be tested by each of the 
tertiary outcomes over 48 weeks. To account for temporal precedence, these analyses will use values for 
mediators measured at 32 weeks and primary outcome measured at the end of 48 weeks. Mediation will 
first be assessed using each of the three potential mediators one at a time and then in combination, to 
assess the possibility of multiple mediation.  
 
The indirect effect of the intervention will be estimated via the mediator(s), along with a 95% bias-
corrected bootstrapped confidence interval. This effect will be interpreted to the extent that it is in a 
direction consistent with the mediation hypothesis. It is important to estimate and test for mediation even 
if there is no evidence of an overall intervention effect. It is possible that the test of mediated effect has 
more statistical power, and mediation can be found in the absence of an overall effect. 
 
 
 
 
 
 
 
 
 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
10.1.1 INFORMED CONSENT PROCESS 
 
10.1.1.1 CONSENT/ASSENT 
AND 
OTHER 
INFORMATIONAL 
DOCUMENTS 
PROVIDED 
TO 
PARTICIPANTS 
 
Verbal consent will be obtained from the participant prior to any study procedures.  
 
Written consent will be obtained from the participant at their baseline visit. Consent forms describing in 
detail the study intervention, study procedures, and risks will be given to the participant at that visit and 
written documentation of informed consent will be completed prior to starting further study procedures.  
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
 
Verbal consent from the participant will be obtained via telephone during the telephone screening visit. 
The telephone consent form describes the study intervention, procedures, and risks. Documentation of 

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verbal consent will be kept by the study team in the participant’s file. Verbal consent will be obtained 
from the participant prior to sending their pre-baseline period questionnaires.  
 
Written consent will then be obtained from the participant at the beginning of their baseline visit, prior 
to conducting any further study procedures. 
 
For both verbal and written consent, the consent discussion will be led by study personnel delegated to 
conduct the consent process. Study personnel will explain the consent form to the subject, and the study 
subject will have the opportunity to ask any questions they may have regarding the consent before 
signing. The consent process will be documented in the participant’s study file. 
 
For written consent, a copy of the consent will be given to the patient for their records. 
10.1.2 STUDY DISCONTINUATION AND CLOSURE  
 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. If the study is prematurely terminated or suspended, the Principal Investigator (PI) will promptly 
inform study participants, the Institutional Review Board (IRB), and the NIH and will provide the reason(s) 
for the termination or suspension. Study participants will be contacted, as applicable, and be informed of 
changes to study visit schedule. 
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Demonstration of efficacy that would warrant stopping    
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination that the primary endpoint has been met 
• 
Determination of futility 
 
The study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the funding agency, IRB, or other relevant regulatory or oversight bodies. 
10.1.3 CONFIDENTIALITY AND PRIVACY  
 
Participant confidentiality and privacy is strictly held in trust by the study staff, the safety and oversight 
monitor(s), and the funding agency. This confidentiality is extended to the data being collected as part of 
this study. Data that could be used to identify a specific study participant will be held in strict confidence 
within the research team. No personally identifiable information from the study will be released to any 
unauthorized third party without prior written approval of the sponsor/funding agency.  
 
All research activities will be conducted in as private a setting as possible. However, due to the nature of 
the online group intervention, participants may talk about personal experiences in a group setting. 
Participants will be instructed to not reveal private information about other group members to others. In 
addition, participants will be asked to attend group sessions in a private area. 

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The study monitor, other authorized representatives of the sponsor or funding agency, representatives of 
the Institutional Review Board (IRB), or regulatory agencies may inspect all documents and records 
required to be maintained by the investigator, including but not limited to, study records for the 
participants in this study. The study site will permit access to such records. 
 
The study participant’s contact information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as 
long a period as dictated by the reviewing IRB, Institutional policies, or sponsor/funding agency 
requirements. 
 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will 
be and stored at UNC Chapel Hill. Individual participants and their research data will be identified by a 
unique study identification number. The study data entry and study management systems used by clinical 
sites and by research staff will be secured and password protected. At the end of the study, all study 
databases will be de-identified and archived at UNC Chapel Hill. 
 
Measures Taken to Ensure Confidentiality of Data Shared per the NIH Data Sharing Policies  
It is NIH policy that the results and accomplishments of the activities that it funds should be made available 
to the public (see https://grants.nih.gov/policy/sharing.htm). The PI will ensure all mechanisms used to 
share data will include proper plans and safeguards for the protection of privacy, confidentiality, and 
security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be 
traceable to a specific study participant). Plans for archiving and long-term preservation of the data will 
be implemented, as appropriate.  
 
Certificate of Confidentiality  
To further protect the privacy of study participants, the Secretary, Health and Human Services (HHS), has 
issued a Certificate of Confidentiality (CoC) to all researchers engaged in biomedical, behavioral, clinical 
or other human subjects research funded wholly or in part by the federal government.  Recipients of NIH 
funding for human subjects research are required to protect identifiable research information from forced 
disclosure per the terms of the NIH Policy (see https://humansubjects.nih.gov/coc/index). As set forth 
in 45 CFR Part 75.303(a) and NIHGPS Chapter 8.3, recipients conducting NIH-supported research covered 
by this Policy are required to establish and maintain effective internal controls (e.g., policies and 
procedures) that provide reasonable assurance that the award is managed in compliance with Federal 
statutes, regulations, and the terms and conditions of award. It is the NIH policy that investigators and 
others who have access to research records will not disclose identifying information except when the 
participant consents or in certain instances when federal, state, or local law or regulation requires 
disclosure. NIH expects investigators to inform research participants of the protections and the limits to 
protections provided by a Certificate issued by this Policy. 
 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  

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Data collected for this study will be analyzed and stored at UNC Chapel Hill. After the study is completed, 
the de-identified, archived data will be stored for use by other researchers including those outside of the 
study to comply with NIH guidelines for sharing of study data. This data sharing will ensure that 
confidential information is not disclosed, data are released in a form that does not endanger national 
security or compromise law enforcement activities, and that proprietary data are not released 
inadvertently. 
 
With the participant’s approval and as approved by local Institutional Review Boards (IRBs), de-identified 
biological samples will be stored at UNC Chapel Hill. These samples could be used to research the 
increased risk of cardiometabolic conditions in African American and Black women and to improve 
treatment. 
 
During the conduct of the study, an individual participant can choose to withdraw consent to have 
biological specimens stored for future research. However, withdrawal of consent with regard to 
biosample storage may not be possible after the study is completed.  
 
When the study is completed, access to study data and/or samples will be provided through UNC Chapel 
Hill. 
 
10.1.5 KEY ROLES AND STUDY GOVERNANCE 
 
Principal Investigator 
Safety Officer 
Dr. Cheryl Giscombe, Dr. Susan 
Gaylord 
 
UNC Chapel Hill  
 
4103 Carrington Hall, CB 7460 
Chapel Hill NC, 27599 
 
919-843-9491 
 
Cheryl.Giscombe@unc.edu, 
gaylords@med.unc.edu 
 
 
 
 
 
 
 
10.1.6 SAFETY OVERSIGHT 
 
Oversight for this study will be provided by the MPIs with delegation of responsibilities to designated 
study personnel. The Safety Officer will review the all reports of adverse events quarterly and when 

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necessary, make recommendations to the MPIs concerning continuation, termination or modification 
of any study protocol/ procedure based on observed beneficial or adverse effects.  
10.1.7 DATA HANDLING AND RECORD KEEPING  
 
10.1.7.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
 
Data collection will be the responsibility of the study staff under the supervision of the MPIs. The 
investigator will be responsible for ensuring the accuracy, completeness, legibility, and timeliness of the 
data reported. 
 
All source documents will be completed in a neat, legible manner to ensure accurate interpretation of 
data.   
 
Any hardcopies of the study visit worksheets will be provided for use as source document worksheets for 
recording data for each participant consented/enrolled in the study.  Data recorded in the electronic case 
report form (eCRF) derived from source documents will be consistent with the data recorded on the 
source documents. In many cases, the data will be entered directly into the eCRF, in those cases, the eCRF 
will be considered source. 
 
Data (including adverse events (AEs), concomitant medications, and expected adverse reactions data)  will 
be entered into REDCap. The data system includes password protection and quality features to identify 
data that appear inconsistent, incomplete, or inaccurate. Clinical data will be entered directly from the 
source documents. 
 
10.1.7.2 STUDY RECORDS RETENTION  
 
Study documents will be retained for a minimum of 3 years from the date of NIH Federal Financial Report 
submission. These documents should be retained for a longer period, however, if required by local 
regulations. No records will be destroyed without the written consent of the funding agency, if applicable. 
It is the responsibility of the funding agency to inform the investigator when these documents no longer 
need to be retained. 
 
10.1.8 PROTOCOL DEVIATIONS   
 
This protocol defines a protocol deviation as any noncompliance with the clinical trial protocol, or 
International Council on Harmonisation Good Clinical Practice (ICH GCP) requirements. The 
noncompliance may be either on the part of the participant, the MPIs, or the study site staff. As a result 
of deviations, corrective actions will be developed by the site and implemented promptly.  
 
These practices are consistent with ICH GCP:  

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• 
Section 4.5 Compliance with Protocol, subsections 4.5.1, 4.5.2, and 4.5.3  
• 
Section 5.1 Quality Assurance and Quality Control, subsection 5.1.1  
• 
Section 5.20 Noncompliance, subsections 5.20.1, and 5.20.2.  
 
It will be the responsibility of the MPIs to use continuous vigilance to identify and report applicable 
deviations. All deviations will be addressed in study source documents, reported to NIH Program Official 
and IRB if deemed necessary by their policies. The site investigator will be responsible for knowing and 
adhering to the reviewing IRB and NIH requirements.  
 
10.1.9 PUBLICATION AND DATA SHARING POLICY  
 
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
 
National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for 
publication. 
 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As 
such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be 
submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed 
journals.  Data from this study may be requested from other researchers after the completion of the 
primary endpoint by contacting UNC Chapel Hill.  Considerations for ensuring confidentiality of these 
shared data are described in Section 10.1.3. 
 
In addition, this study will comply with the NIH Genomic Data Sharing Policy, which applies to all NIH-
funded research that generates large-scale human or non-human genomic data, as well as the use of these 
data for subsequent research. Large-scale data include genome-wide association studies (GWAS), single 
nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, and gene 
expression data. 
 
10.1.10 
CONFLICT OF INTEREST POLICY 
 
The University of North Carolina at Chapel Hill's Policy on Conflicts of Interest and Commitment includes 
a rebuttable presumption that an investigator may not conduct human subjects’ research that is related 
to a financial interest of the investigator (or immediate family) except in compelling circumstances. 
Compelling circumstances are those facts that convince the reviewer that a covered individual who has a 
financial interest should be permitted to conduct human subjects’ research, taking into account the 
following factors: 
 

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• 
The nature of the research,  
• 
The nature and magnitude of the financial interest  
• 
How closely the financial interest is related to the research 
• 
The extent to which the interest may be affected by the research  
• 
The degree of risk to the human subjects involved that is inherent in the research protocol  
• 
The extent to which the investigator is uniquely qualified to perform a research study with 
important public benefit  
• 
The extent to which the interest is amenable to effective oversight and management.  
 
The applicable UNC-Chapel Hill COI Chair and/or Committee takes into these criteria into account when 
reviewing any disclosed conflict of interest in the context of the human study. 
 
The COI Chair or Committee considers the following factors into their review:  
 
• 
How the research is supported or financed, 
• 
The nature and extent of the conflict,  
• 
The role and responsibilities of the conflicted individual in the design, conduct, and reporting of 
the research, and  
• 
The ability of the conflicted individual to influence the outcome of the research. 
 
The IRB has final authority to determine whether the research, the COI, and the related management 
plan, if any, allow the research to be approved. 
 
10.2 ADDITIONAL CONSIDERATIONS 
 
NA 
10.3 ABBREVIATIONS AND SPECIAL TERMS 
 
AE 
Adverse Event 
ANCOVA 
Analysis of Covariance 
AAW 
African American Women 
CFR 
Code of Federal Regulations 
CLIA 
Clinical Laboratory Improvement Amendments 
CM 
Cardiometabolic 
CMP 
Clinical Monitoring Plan 
COC 
Certificate of Confidentiality 
CONSORT 
Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DSMB 
Data Safety Monitoring Board 
DRE 
Disease-Related Event 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Forms 
FDA 
Food and Drug Administration 

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FFR 
Federal Financial Report 
GCP 
Good Clinical Practice 
GWAS 
Genome-Wide Association Studies 
HIPAA 
Health Insurance Portability and Accountability Act  
ICH 
International Council on Harmonisation  
ICMJE 
International Committee of Medical Journal Editors 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
ITT 
Intention-To-Treat 
LSMEANS 
Least-squares Means 
MedDRA 
Medical Dictionary for Regulatory Activities 
MOP 
Manual of Procedures 
NCT 
National Clinical Trial 
NIH  
National Institutes of Health 
NIH IC 
NIH Institute or Center 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SMC 
Safety Monitoring Committee 
SOA 
Schedule of Activities 
SOP 
Standard Operating Procedure 
SWS 
Superwoman Schema 
UP 
Unanticipated Problem 
US 
United States 
 
 
 

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10.4 PROTOCOL AMENDMENT HISTORY.  
 
Version 
Date 
Description of Change  
Brief Rationale 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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11 REFERENCES  
1. Heart Disease and Stroke Statistics—2016 Update Dariush Mozaffarian, Emelia J. Benjamin, Alan S. Go, 
Donna K. Arnett, Michael J. Blaha, Mary Cushman, Sandeep R. Das, Sarah de Ferranti, Jean-Pierre Després, 
Heather J. Fullerton, Virginia J. Howard, Mark D. Huffman, Carmen R. Isasi, Monik C. Jiménez, Suzanne E. 
Judd, Brett M. Kissela, Judith H. Lichtman, Lynda D. Lisabeth, Simin Liu, Rachel H. Mackey, David J. Magid, 
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