Feasibility of a Yoga Intervention in Sedentary African-American Women
Phase: NA
Conditions: Sedentary Behavior
Sponsor: University of Minnesota

 
 
 
 
Study Protocol and Statistical Analysis Plan  
 
 
 
Official Title 
Feasibility of a Yoga Intervention in Sedentary African-American Women 
NCT Number 
NCT04710979 
Document Date 
November 19, 2022 

 
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Table of Contents 
 
1.0 Objectives ................................................................................................................................4 
2.0 Background ..............................................................................................................................4 
3.0 Study Endpoints/Events/Outcomes ..........................................................................................6 
4.0 Study Intervention(s)/Interaction(s) .........................................................................................7 
5.0 Procedures Involved.................................................................................................................9 
6.0 Data Banking .........................................................................................................................11 
7.0 Sharing of Results with Participants ......................................................................................11 
8.0 Study Duration .......................................................................................................................11 
9.0 Study Population ....................................................................................................................11 
11.0 Number of Participants ..........................................................................................................15 
12.0 Recruitment Methods .............................................................................................................15 
13.0 Withdrawal of Participants ....................................................................................................16 
14.0 Risks to Participants ...............................................................................................................17 
15.0 Incomplete Disclosure or Deception ......................................................................................17 
16.0 Potential Benefits to Participants ...........................................................................................17 
17.0 Statistical Considerations .......................................................................................................17 
18.0 Health Information and Privacy Compliance ........................................................................18 
19.0 Confidentiality .......................................................................................................................21 
20.0 Provisions to Monitor the Data to Ensure the Safety of Participants ....................................22 
21.0 Compensation for Research-Related Injury ...........................................................................23 
22.0 Consent Process .....................................................................................................................23 
23.0 Setting ....................................................................................................................................23 
24.0 Multi-Site Research ...............................................................................................................24 
25.0 Coordinating Center Research ...............................................................................................24 
26.0 Resources Available...............................................................................................................24 
27.0 References ..............................................................................................................................25 
 

 
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ABBREVIATIONS/DEFINITIONS 
● African-American (AfAm) 
● Data Safety and Monitoring Board (DSMB) 
● National Institutes of Health (NIH) 
● Physical Activity (PA) 
● Principal Investigator (PI) 
● Randomized Controlled Trial (RCT) 
 
 

 
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1.0 
Objectives 
1.1 Purpose:  
The primary objective of this study is to test the feasibility, acceptability, safety and targeted 
outcomes of a 3-month hatha and restorative yoga intervention to decrease sedentary 
behavior (primary outcome), stress and blood pressure in 60 sedentary (<30 minutes of 
moderate-to-vigorous PA per week) African-American women.  The proposed study has four 
aims:  
Aim 1: To refine a promising and innovative intervention to enhance its feasibility.  Based on 
our previously developed intervention, I HEART Yoga!, and subsequent experience, we will 
refine intervention strategies to incorporate findings from the pilot research and theoretically 
ground the intervention using an integrated model incorporating constructs from the Social 
Cognitive Theory and collectivism (i.e., social connectedness, sense of belonging, and 
community cohesion). We will conduct two focus groups of sedentary African-American women 
(n=16) to seek feedback on the intervention strategies (e.g., yoga sequences). 
Aim 2: Assess feasibility of a hatha and restorative yoga intervention (n=30) compared to a 
control group (n=30). We will examine feasibility of participant recruitment, retention and 
adherence; fidelity of intervention delivery; and intervention materials.  
Aim 3: Evaluate the acceptability and safety of a hatha and restorative yoga intervention (n=30) 
compared to a control group (n=30). We will examine the acceptability of intervention location 
and strategies, class format, enjoyment of sessions, and safety of the intervention.  
Aim 4: To test feasibility and appropriateness of the targeted outcomes (i.e., primary: sedentary 
behavior and secondary: blood pressure and stress) for subsequent trials. It is important to 
properly measure expected outcomes but not make comparisons between intervention and 
control groups. 
2.0 
Background 
2.1 Significance of Research Question/Purpose:  
A sedentary lifestyle is associated with chronic cardiovascular and physiological diseases and 
psychological disorders.1,2 Indeed, the 2018 Physical Activity Guidelines for Americans 
emphasize targeting sedentary time (i.e., waking behaviors in a seated or reclining posture at 
low energy expenditure8), independent of total activity.1,2 The Guidelines state: “Adults should 
move more and sit less throughout the day. Some physical activity is better than none.”2 The 
U.S. has now joined at least six other countries in adopting guidelines to reduce sedentary 
time.3-9 Persuasive evidence has emerged in the last 10 years: (a) adults spend inordinate time 
sedentary (~7.5 hr/day on average);10-16 (b) physiological mechanisms linking sedentary time to 
increased chronic disease risk are understood;17-19 and (c) excess mortality due to sedentary 
behavior is substantial.20,21 The current Guidelines are calling for evidence-based interventions 
to reduce sedentary time.2 For African-American women who disproportionately have 
sedentary lifestyles,22 a “move more and sit less” philosophy to target decreasing sedentary 
behavior is appropriate. Sedentary lifestyle has contributed to African-American women being 
80% more likely to be overweight or obesity compared to non-Hispanic white women,23 and 

 
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suffering from high rates of heart disease,24 hypertension,25,26 and other conditions. These 
statistics present a significant public health problem that must be addressed. Decreasing 
sedentary time has many mental, social, and psychological health benefits.25,27 Given the 
current state of health statistics among African-American women, it remains critical to find 
innovative ways to decrease sedentary time in this population. 
2.2 Preliminary Data: 
Co-PI Barr-Anderson conducted a 6-month, randomized controlled, pilot yoga intervention, I 
HEART Yoga!, with 59 overweight, sedentary African-American women.28 Thirty women were 
randomized to the intervention group and offered in-person and online yoga classes; the 29 
women in the usual care, control group received a 3-month membership at a local yoga studio 
after post-intervention data collection was completed. The aim of this pilot was to engage 
participants in yoga at least 3 times per week and to examine the effects on blood pressure, 
stress, and physical activity. A post-intervention focus group revealed that participants enjoyed 
the intervention and posted several affirmations on a private Facebook group page. Although the 
feedback was positive, there were several areas of I HEART Yoga! pilot study that participants 
recommended improving and enhancing, thus warranting the proposed YogaMoves feasibility 
study to test refined strategies.  
2.3 Existing Literature:  
Previous interventions to decrease sedentary behavior in African-American women. Previous 
interventions for African-American women to address sedentary lifestyles have mainly included 
traditional physical activity strategies such as walking, aerobics and dance.29-31 Walking programs, 
the most utilized of the interventions, are easy to implement, require minimum equipment, and 
usually are safe and acceptable for high-risk populations,32 such as sedentary adults carrying 
excess weight. However, focus groups with African-American women reported that the 
repetitiveness and monotony of traditional exercise interventions (i.e., walking and aerobics) 
may reduce motivation33 or cause musculoskeletal issues that may make typical, repetitive 
weight-bearing exercise uncomfortable or painful.34  
Increasing interest of yoga to address health outcomes. Yoga is a well-established Eastern 
practice that is promoted as a safe and effective way to encourage less sedentary behavior; 
improve strength, balance, and flexibility,35 and decrease depression and stress. Like walking, 
yoga is a minimal equipment activity, can be practiced almost anywhere at a variety of intensities, 
and can be used to decrease inactivity.36 However, yoga introduces not only physical movement, 
but also mindfulness and deep breathing that can lead to mental and psychological benefits,37 
and may be as effective as higher intensity activity for improving some health-related 
outcomes.38  
How can yoga decrease sedentary behavior? Preliminary research suggests that there are 
several mechanisms proposed for yoga to lead to better health outcomes. Biological mechanisms 
related to the autonomic nervous system have been connected to lowering blood pressure.39 
Stress has been positively impacted through a biological mechanism of improved circadian 
patterns in cortisol release,40 and through psychological mechanisms such as increased positive 
attitudes towards stress, self-awareness, coping mechanisms, appraisal of control, spirituality, 

 
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compassion, and mindfulness.39 Lastly, it is plausible for yoga to positively impact sedentary 
behavior as evidence supports that yoga aids in behavioral self-regulation.41 
Yoga as a potential intervention for African-American women. Much of the research on yoga 
has not focused on African-American populations despite the potential for suitability and 
effectiveness. Yoga research studies including African-Americans have primarily targeted those 
with breast cancer,42,43 heart failure,44,45 metabolic syndrome,46 arthritis,47 or low back pain.48-50 
These studies found yoga to be an effective strategy42-45,48,49 or acceptable form of activity.46,47 
Based on these previous studies and pilot work by our research team,28 yoga appears to be well-
suited to engage African-American women to have less sedentary lifestyles. 
In the U.S., yoga has become increasingly popular in recent years. From the 2017 National 
Health Interview Survey (NHIS) Adult Complementary and Alternative questionnaire, over 14 
million people stated they have practiced yoga in the past year.51 Although yoga has the 
reputation of attracting college-educated, white populations52 and is sometimes viewed as 
exclusionary to those outside that community, it has become increasingly popular among African-
Americans with the growth of Afrocentric yoga (i.e., focusing on Black or African culture),53 
establishment of Black yoga organizations,54 and expansion of social media presence of African-
American yoga practitioners.55,56 Furthermore, data from the NHIS questionnaire reported that 
almost 10% of African-Americans have practiced yoga in the past year compared to 13.5% of 
white Americans.51  
African-American women attend mainstream (i.e., majority white) yoga classes, but they 
do not always continue, partially due to unfamiliarity with various aspects of yoga.47 Chanting, 
use of Sanskrit instead of English to name poses, and “religious” sounding music can stimulate 
preconceived notions that yoga conflicts with religious beliefs.47 An additional barrier to adopting 
and sustaining a yoga practice is not feeling included due to the lack of representation of fuller-
body, African-American yoga practitioners.47 Previous yoga studies that targeted African-
Americans and modified classes to make it more culturally acceptable46,47 (i.e., no chanting, 
generic instrumental music, English names for poses, matching yoga instructors by race with 
participants), reported that participants found yoga to be more acceptable. One study even 
reported that 100% of the participants were still practicing yoga three months after the 
intervention.47 These culturally appropriate modifications have been critical in African-American 
women being open to practicing yoga and subsequently recognizing the health benefits.57 
In summary, the scientific premise of our proposed pilot study is that African-American 
women are highly affected by a sedentary lifestyle, and yoga is an engaging activity with 
biological and psychological mechanisms39-41 having promise to reduce sedentary behavior and 
improve health outcomes such as blood pressure and stress. The proposed study is highly 
significant given that it will address the need for innovative and culturally acceptable approaches 
to reduce sedentary time among those at elevated risk for chronic diseases. 
3.0 
Study Endpoints/Events/Outcomes 
3.1 Primary Endpoint/Event/Outcome:  
This is a feasibility study, therefore the primary endpoints of interests are related to feasibility 
and acceptability of the intervention. 

 
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• Feasibility: Recruitment of participants - 200 women recruited and screened; 76 women 
(16 for Aim 1 focus groups and 60 for pilot intervention) enrolled and consented 
• Feasibility: Retention and adherence - > 80% of intervention participants attend > 80% 
of  intervention sessions 
• Feasibility: Fidelity of intervention delivery - >90% of each videotaped session is 
delivered as planned based on training 
• Feasibility: Intervention materials and resources - 100% of intervention materials and 
resources are delivered as planned 
• Feasibility: Assessment measures - >80% intervention and control participants rate the 
assessments as not too burdensome; >90% intervention and control participants will 
complete baseline, post-intervention and 3-month follow-up assessments 
• Acceptability: Intervention location, in-person classes, instructors, home-based 
resources - >90% intervention participants rate the various intervention components as 
acceptable 
• Acceptability: Yoga intervention - >90% intervention participants rate intervention 
acceptable 
• Safety: Adverse events - Zero severe adverse events (causes major disruption to 
participant’s life, e.g., sprain, broken bone, CV event, death), zero moderate adverse 
events (causes minor inconvenience to participant, e.g., fainting spell, sore muscles for 
more than 3 days) and <10% of participants report mild  adverse events  (no major 
impact, e.g., headache, sore muscles for 2-3 days) 
3.2 Secondary Endpoint(s)/Event(s)/Outcome(s): 
• Sedentary behavior 
• Blood pressure 
• Stress 
4.0 
Study Intervention(s)/Interaction(s) 
4.1 Description: 
Formative assessment focus groups: After the research team revises the intervention 
strategies, the newly revised intervention strategies, including yoga sequence, will be presented 
and discussed during two focus groups of 6-8 sedentary African-American women. Please note 
that if the focus group participants propose intervention strategies different from what is 
expected by the MPIs, the MPIs will submit modifications to the IRB. Due to COVID-19 
restrictions, these focus groups will take place virtually approximately in April - June 2021. 
Yoga intervention: Please note that although we are anticipating conducting the yoga pilot 
intervention in-person, it is dependent on whether it is safe to have face-to-face contact due to 
COVID-19. If it is deemed unsafe to have face-to-face contact, the MPIs will submit a 
modification to IRB to reflect this change. Additionally, if it is safe to conduct the intervention 
face-to-face, the MPIs will submit the University-required “Sunrise Plan” outlining risk 
mitigation related to COVID-19.  

 
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Participants engaged in the formative assessment focus groups may be invited to  be a part of 
the pilot RCT. 60 participants will be randomly assigned to the yoga intervention (n=30) or 
control condition (n=30). It is anticipated that the yoga intervention will be a hybrid delivery 
(combination of in-person and virtual)  (June – August 2022) at two intervention locations, 612 
Jungle and The Zen Bin. There will be no contact with control participants during the 
implementation of the yoga intervention. The yoga intervention components are: 
• Hybrid, 60-minute yoga sessions will take place three times per week for 12 weeks to 
include a sharing circle at the end of each session. Participants will unite in a sharing 
circle to provide feedback as a group on how the practice felt and strategies for 
integration into ones’ daily life. Specifically, each session will include gentle hatha yoga 
which includes physical poses combined with stretching, breathing and some 
meditation. A proposed session would include: 
o Warm-Up: Controlled Breathing Meditation & Mindfulness (10 minutes): Mindful 
breathing (4-6 second inhales/exhales) through nose to increase focus on yoga 
practice and to build internal heat to better prepare the body for movement 
o Warm-Up: Gentle Movement (5 minutes): Child’s, Cat/cow, Thread the needle, 
Side puppy 
o Active Movement: Strength, Flexibility & Balance Poses (20 mins): 
o Cool Down: Stretching Poses (10 mins): Cobbler’s, Seated forward fold, Legs up 
the wall, Happy baby, Spinal twist 
o Cool Down: Resting Pose (5 mins): Final resting pose on back using props 
o Sharing Circle & Wrap-Up (10 mins): Group gathers in circle and share feedback 
about yoga session 
These classes will be held in-person, but there will be a synchronous option for participants 
to join virtually. Yoga sessions will be led by certified yoga instructors from the greater 
Twin Cities metro area. As preparation for the pilot RCT, they will participate in 
intervention-specific training developed by research staff regarding (1) instructing yoga 
as part of a scientific study, and (2) the practice of restorative yoga for race-based 
trauma. They will be provided yoga sequences outlined by research staff and quality 
control data will be collected as described in section 15.2.     
 
• A private Facebook group will be set up to keep participants connected to each other, 
thus further promoting collectivism, and for the research staff to maintain contact and 
share information with participants. Participants will be able to post freely to the 
Facebook page to stay connected, offer encouragement, and provide accountability to 
attend the weekly yoga sessions. Research assistants will keep track of the number of 
posts and “likes” each participant makes. Research staff will use Facebook to maintain 
contact and to share information with participants: 1) provide a weekly reminder for 
upcoming yoga sessions and workshops; 2) inform/remind participants of the biweekly 
themes of the sessions – there will be a new theme every other week (i.e., weeks 1, 3, 5, 
7, 9, 11); and 3) remain accessible to participants for assistance or requested 
information participants may need. This contact will be virtual.  

 
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• To align with and reinforce the biweekly themes established for the weekly yoga 
sessions (i.e., common yoga poses, the importance of breath, strengthening your core), 
biweekly, hybrid workshops will be offered. These workshops will take place during 
weeks 2, 4, 6, 8, 10, and 12 and will be specialty classes that allow participants 
additional exposure to meditation and breathing and longer class formats so they can 
delve deeper into yogic philosophy and practice. These workshops will be held in-
person, but there will be a synchronous option for participants to join virtually.  
Data collection: Yoga intervention and control participants (n=60) will complete baseline 
(March – May 2022), post-intervention (September – October 2022), and 3-month follow-up 
measures (January – February 2023) in-person at the University of Minnesota’s Epidemiology 
Clinical Research Center. 
Post-intervention focus groups: Four groups (high attendance and low attendance from each 
intervention location) of randomly chosen  intervention participants (anticipated n~20) will be 
invited to participate in a post-intervention focus group to assess intervention feasibility, 
acceptability, and safety with the overall program and specific components, and in order to 
inform program improvements. Focus groups will take place at the Epidemiology Clinical 
Research Center. 
5.0 
Procedures Involved 
5.1 Study Design: 
Our proposed feasibility study will be two-arm, RCT with 60 participants randomly assigned to 
either an intervention group (n=30) or control group (n=30). 
5.2 Study Procedures:  
Formative assessment focus groups will be conducted in April - June 2021. Data collected from 
these focus groups will be qualitative feedback on the proposed intervention strategies. The 
focus group guide is submitted with this IRB application. 
Data collected directly related to the pilot RCT yoga intervention will be: 
• Quality control data to make sure the yoga movements follow protocol and are safe for 
participants will be collected during the implementation of the yoga intervention. One 
yoga session will be randomly selected biweekly (during weeks 2, 4, 6, 8, 10, and 12) and 
videotaped so the content can be analyzed based on the established criteria related to 
poses, breathing and meditation. During these videotaped quality control sessions, 
participants will be asked to wear the activPAL to assess activity intensity. 
• Acceptability of yoga classes will be assessed during the yoga intervention via a short 
self-reported survey after each yoga session. The survey is included with this 
application. 
• Three, in-person data collection time points: baseline (March – May 2022), post-
intervention (September – October 2022), and 3-month follow-up measures (January – 
February 2023). Data to be collected during these time points are: 
o Sedentary behavior will be assessed with the activPAL3 micro accelerometer 
(PAL Technologies, Glasgow, United Kingdom) for seven consecutive days at 

 
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baseline before the start of the intervention, during three randomly selected 
weeks over the course of the 3-month intervention, and for one week at both 
the post-intervention and 3-month follow-up periods. The activPAL provides a 
valid and reliable measure of posture (sitting/lying vs. standing) for free-living 
settings58,59 and uses a transducer suitable for detecting lower intensity 
movements.60 The activPAL will be waterproofed using medical grade adhesive 
covering and attached to the midline of the thigh using a breathable, 
hypoallergenic tape. This method allows for the monitor to be worn 
continuously without removing for bathing or other water-based activities (a 
valuable feature that reduces missing data). 
o Blood pressure will be objectively measured using BpTRU BPM-200 (VSM 
MedTech Ltd, Coquitlam, Canada), an automated blood pressure recorder that 
has been validated against the mercury sphygmomanometer.61  Two blood 
pressures will be collected and averaged at each data collection time point 
following a five minute period of rest. 
o Stress will be measured in two different ways: biomarkers of physiological stress 
using cortisol saliva and perceived stress using questionnaires. Acute stress will 
be assessed using salivary cortisol levels taken at three different times (upon 
waking, 30 minutes after waking, and before going to bed) for 2 days at each 
data collection time point (assayed by UMN ARDL).62 Participants will be 
provided detailed instructions. Kits will be sent home with participants with clear 
instructions for capturing saliva samples in the morning and evening, and storing 
the date- and time-labeled plastic vials in their home freezer to be carried with 
them to their next clinic visit. Chronic stress will be assessed using common, valid 
self-report measures.63-65 
o Additional measures: Trained research staff will collect height, weight, and body 
fat % using a Shorr Height measuring board and Tanita BF-350 scale, 
respectively, to calculate BMI. Diet will be assessed using NCI’s web-based 
dietary recall, ASA-24, which has been validated in adults.66 A self-reported 
survey will be completed that inquiries on demographic characteristics (age, sex, 
marital status, education level, income), physical activity-related psychosocial 
variables (social support,67 self-efficacy,68 barriers,69 enjoyment70), eating-related 
behaviors (intuitive eating,71 eating as a coping mechanism72), and additional 
variables (collectivism,73 social connectedness,74 sense of belonging,75 
community cohesion76and embodiment77). The survey with the listed measures 
is included with this application. 
Post-intervention focus groups to assess intervention feasibility, acceptability, and safety with 
the overall program and specific components, and in order to inform program improvements 
will be completed September 2022. The focus group guide is submitted with this IRB 
application. 
5.3 Follow-Up: 
The data to be collected at follow-up are outlined in the previous section: sedentary behavior 
using activPAL, blood pressure using an automated blood pressure recorder, stress using 

 
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salivary cortisol samples and a survey, height, weight, and body fat % measured by trained 
research staff, and a survey of additional measures. 
5.4 
Individually Identifiable Health Information:  
PHI will not be collected from any participants.  
6.0 
Data Banking 
N/A 
7.0 
Sharing of Results with Participants 
7.1  
Formative assessment and post-intervention focus groups: After each set of focus groups, 
research staff will summarize the findings in a report that will be shared with respective focus 
group participants. This methodology is referred to as member checking and allows the focus 
group participants the opportunity to provide feedback on whether the content of the 
summary accurately depicts what they wanted to share with the research staff. 
Pilot RCT results: Findings from the pilot RCT will be shared with the participants through a 
presentation. Participants will have the opportunity to provide additional feedback and the 
research team will discuss plans for next steps. Additionally, the research team will utilize other 
online and media platforms, such as social media, infographics, videos, and podcasts, to 
disseminate our findings to a broader audience.  
 
8.0 
Study Duration 
8.1  
The duration anticipated for an individual participant’s participation in the study is: 
• Three months (April – June 2021) for 16 participants engaged in the formative 
assessment focus groups 
• One year (March 2022 – February  2023) for the 60 participants enrolled in the pilot RCT 
who will also participate in the post-intervention focus groups 
The duration anticipated to enroll all study participants is: 
• Two months (April – May 2021) for the 16 participants engaged in the formative 
assessment focus groups 
• Four months (February – May 2022) for the 60 participants enrolled in the pilot RCT who 
will also participate in the post-intervention focus groups 
The duration anticipated to complete all study procedures and data analysis: 
• Three years (November 2020 – October 2023) 
9.0 
Study Population 
9.1 Inclusion Criteria:  

 
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• Self-identified as an African-American woman at least 18 years old; 
• Engaging in less than 30 minutes/week of moderate-to-vigorous physical activity;  
• If employed, working in a sedentary occupation that requires primarily seated work;  
• If unemployed, typical day involves sedentary, primarily seated activities;  
• Able to exercise for 20 minutes continuously;  
• No pre-existing condition that limits physical activity;  
• Have access to a computer (or mobile device) and internet service; and 
• Vaccinated against COVID-19 or willing to provide proof of a negative test to attend any 
in-person components.  
9.2 Exclusion Criteria:  
• Diagnosed with heart disease, diabetes, cancer, kidney, liver disease, major depression 
or bipolar disease; 
• Take more than two daily medications for lipids or blood pressure; and  
• Current smoker. 
9.3 Screening: 
Participants will be initially screened via phone call for all participants (formative assessment 
focus group and pilot RCT participants). For pilot RCT participants only, eligibility will be verified 
during baseline data collection, which will take place at University of Minnesota’s Epidemiology 
Clinical Research Center. Verification is not occurring for the formative assessment focus group 
participants because their involvement is 100% virtual and not in-person. 
10.0 Vulnerable Populations 
10.1 
Vulnerable Populations:  
Population / Group 
Identify whether any of the 
following populations will be 
targeted, included (not necessarily 
targeted) or excluded from 
participation in the study.  
Children 
Excluded from Participation 
Pregnant women/fetuses/neonates 
Included/Allowed to Participate 
Prisoners 
Excluded from Participation 
Adults lacking capacity to consent 
and/or adults with diminished 
capacity to consent, including, but 
not limited to, those with acute 
Excluded from Participation 

 
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medical conditions, psychiatric 
disorders, neurologic disorders, 
developmental disorders, and 
behavioral disorders 
Non-English speakers 
Excluded from Participation 
Those unable to read (illiterate) 
Excluded from Participation 
Employees of the researcher 
Excluded from Participation 
Students of the researcher 
Excluded from Participation 
Undervalued or disenfranchised 
social group 
Targeted Population 
Active members of the military 
(service members), DoD personnel 
(including civilian employees) 
Excluded from Participation 
Individual or group that is 
approached for participation in 
research during a stressful situation 
such as emergency room setting, 
childbirth (labor), etc. 
Excluded from Participation 
Individual or group that is 
disadvantaged in the distribution of 
social goods and services such as 
income, housing, or healthcare. 
Excluded from Participation 
Individual or group with a serious 
health condition for which there are 
no satisfactory standard treatments. 
Excluded from Participation 
Individual or group with a fear of 
negative consequences for not 
participating in the research (e.g. 
institutionalization, deportation, 
disclosure of stigmatizing behavior). 
Excluded from Participation 

 
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Any other circumstance/dynamic 
that could increase vulnerability to 
coercion or exploitation that might 
influence consent to research or 
decision to continue in research. 
Excluded from Participation 
 
10.2 Additional Safeguards:  
By nature of the study, all participants will be minority women, specifically African-American 
women over the age of 18 years. African-American women are disproportionately affected with 
a sedentary lifestyle, excessive weight, hypertension, and stress. Over 60% of African-American 
women report being sedentary, and 80% are more likely to be at higher weight status (BMI>25 
kg/m2) compared to non-Hispanic white women. These statistics underscore that a significant 
public health problem, a sedentary lifestyle, coupled with overweight/obesity, is associated with 
chronic diseases (e.g., hypertension) and psychological disorders. Decreasing sedentary behavior 
has mental, social, and psychological health benefits in adults, independent of total physical 
activity. Given the current state of health statistics in African-American women, finding 
innovative ways to decrease sedentary time in this population are of particular interest. Inclusion 
of African-American women is essential to the success of this project.  
 
Pregnancy is an exclusion criterion at recruitment and during the intervention due to the possible 
risk of engaging in yoga if a participant is randomized to the yoga intervention group. However, 
if a participant becomes pregnant after the intervention has ended which overlaps with the post-
intervention and follow-up data collection periods, they will be retained and included in the 
study. Data collection at all time points include completing an electronic survey, wearing an 
activity monitor that tracks physical activity with the request for participants not to alter their 
usual behavior, and collecting salivary samples which entails collecting less than an ounce of 
saliva over two days. All of the data collection are of minimal risk to pregnant women.  
The potential adverse events anticipated in our pilot RCT would be injuries due to participation 
in yoga (e.g., muscle strain, fainting, falling) as well as other complications from comorbidities 
such as obesity, hypertension, diabetes and medication use. Participants will be instructed to 
call their healthcare provider and notify the research staff if they experience an injury or any 
adverse event. As a proactive measure, a detailed plan for monitoring risks, tracking and 
reporting adverse events will be established at the start of the study. Adverse events will be 
classified as severe (cause major disruption to participant’s life, e.g. sprain, broken bone, 
cardiovascular event, death), moderate (causes minor inconvenience to participant, e.g. 
fainting spell, sore muscles for >3 days), and mild (no major impact on participant, e.g. 
headache, sore muscles for 2-3 days). The PIs will implement the data collection form for 
monitoring side effects and adverse events on a routine basis.  The research assistants will 
administer this questionnaire weekly during the study to track any side effects or adverse 
events.   

 
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A Data Safety and Monitoring Board (DSMB) has been mandated by the funding agency, NIH. 
Members of the DSMC will be three senior PhD-level researchers including a biostatistician. The 
research staff will submit a written monitoring report to the DSMB twice a year (April and 
October).  
To further protect participants, participants will clearly know that they can end participation at 
any time, researchers will provide information to participants for UMN IRB advisors to report 
any activity that the find troublesome, and research staff will undergo cultural sensitivity 
training. 
 
11.0 Number of Participants 
11.1 Number of Participants to be Consented:  
For formative assessment focus groups, a maximum number of 16 (minimum of 12) participants 
will be enrolled for an average of 6-8 participants for each of the two focus groups.  
For the pilot RCT, a maximum number of 60 (minimum of 54) participants will be enrolled for an 
average of 27-30 participants for each of the intervention and control groups. Participants 
enrolled in the intervention condition will be consented to participate in the yoga intervention 
eligible and the post-intervention focus groups. 
12.0 Recruitment Methods 
12.1 Recruitment Process:  
Participants will be recruited using radio and print newspaper advertisements in media outlets 
with a predominantly African-American audience; social media (e.g., Facebook, Instagram, and 
Twitter) posts targeting local, African-American individuals, groups and organizations; email 
blasts distributed to local churches, community centers, libraries, and community organizations 
(particularly health organizations such as NorthPoint Health & Wellness Center, Smiley’s Clinic, 
Whittier Clinic) that serve African-Americans and/or women in the North Minneapolis area of 
Minnesota. All recruitment materials will have culturally appropriate representations of 
African-American women and examples are provided in this application. 
12.2 Source of Participants:  
Participants will be drawn from the greater Twin Cities, MN area. 
12.3 Identification of Potential Participants: 
All recruitment materials will have contact information (phone number and email address) that 
interested participants will use to express their desire to be involved in the study. All potential 
participants must self-identify as an African-American woman over the age of 18. 
Initial contact with prospective participants will be made by study team members listed on the 
IRB application; these research staff members will be trained by the PIs to properly screen 
participants.  
12.4 Recruitment Materials:  

 
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Materials that will be used to recruit participants and are included in this application are: 
• Flyer to be distributed via email and social media 
• Text for social media posts 
• Text for print newspaper posts 
• Transcript for recorded radio posts 
12.5 Payment:  
For the formative assessment focus groups, each participant will receive $25 as a thank you for 
their feedback and time. 
For each data collection timepoint, each participant will receive $50 for completing 
assessments, which includes wearing activPAL for 7 days; collecting two salivary samples; 
having blood pressure, height, weight, and body fat % measured by trained staff; and 
completing an electronic survey. After completing the in-person baseline assessment, each 
participant will receive $5 to complete an online survey. There are three data collection 
timepoints: baseline, post-intervention, and 3-month follow-up. Therefore, pilot RCT 
participants (both intervention and control participants) are able to receive up to $255 for 
completing measurements. 
Another incentive pilot RCT participants will receive yoga equipment that they will own. 
Participants assigned to the intervention group will receive a yoga mat, a yoga strap, a yoga 
bolster, a pair of yoga blocks, and a bag for carrying at the first in-person yoga session. 
Participants assigned to the control condition will receive their yoga equipment at the 3-month 
follow-up data collection as a thank you for participating in the study. Furthermore, since the 
control participants were not involved in the face-to-face yoga intervention, they will receive a 
three-month membership to a local yoga studio and a catalog of virtual yoga classes led by the 
intervention yoga instructors. The membership and catalog may assist the control participants 
in establishing a regular yoga practice. 
Additionally, intervention participants who engage in the post-intervention focus groups will 
receive a meal during the focus group and a $25 Tango Gift Card as a thank you for their 
feedback and time. 
13.0 Withdrawal of Participants 
13.1 
Withdrawal Circumstances: 
Because participants will be rigorously screened for participating, we will not withdraw any 
participants from the study. Only participants who are eligible and pass the screening will be 
recruited for the study. However, participants can assent or withdraw from the study at any 
given point, they will not be questioned nor will face penalty.  
13.2 
Withdrawal Procedures:  
This is a voluntary study, so participants can withdraw at any time during the study without any 
penalty or consequences. Once a participant withdraws from the study, there will be no 
attempt to collect additional data from them. 
13.3 
Termination Procedures: 

 
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It is highly unlikely that any one would be terminated from the study by the research staff, but 
participants may choose to withdraw and terminate their participation. In those cases, all 
available data may potentially still be used in data analysis.  
14.0 Risks to Participants 
14.1 Foreseeable Risks:  
Formative assessment and post-intervention focus groups: N/A 
Pilot intervention: The potential risks to participants assigned to the yoga intervention, 
including psychological, social, and legal, are considered minimal. The potential adverse events 
anticipated in our intervention would be injuries due to participation in yoga (e.g., muscle 
strain, fainting, falling) as well as other complications from comorbidities such as obesity, 
hypertension, diabetes and medication use. Participants will be instructed to call their 
healthcare provider and notify the research staff if they experience an injury or any adverse 
event. As a proactive measure, a detailed plan for monitoring risks, tracking and reporting 
adverse events will be established at the start of the study. Adverse events will be classified as 
severe (cause major disruption to participant’s life, e.g. sprain, broken bone, cardiovascular 
event, death), moderate (causes minor inconvenience to participant, e.g. fainting spell, sore 
muscles for >3 days), and mild (no major impact on participant, e.g. headache, sore muscles for 
2-3 days). Any adverse events will be reported to the DSMB and IRB. If an adverse event does 
occur, the only alternative to participation in the intervention is not to participate, which 
eligible participants are able to opt out.  
14.2 Reproduction Risks:  
N/A 
14.3 Risks to Others: 
N/A 
15.0 Incomplete Disclosure or Deception 
15.1 Incomplete Disclosure or Deception:  
There is no incomplete disclosure or deception to be utilized in this study. 
16.0 Potential Benefits to Participants 
16.1 Potential Benefits:  
Formative assessment focus groups: No direct benefits are expected.  
Pilot RCT: Participants enrolled in the yoga intervention will potentially receive the direct health 
benefits associated with regularly practicing yoga. 
17.0 Statistical Considerations 
17.1 Data Analysis Plan: 
Aims 1-3. Feasibility, acceptability, and safety.  Descriptive statistics of survey variables will be 
compared to the benchmarks in Table 6. For recruitment, we will record: a) the count of women 

 
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who express interest, b) weeks elapsed to screen 200 women, and c) number enrolled and 
consented as a % of the targets – 16 for focus groups and 60 for the pilot intervention. For 
retention and adherence, we will compute % of participants who attend > 80% of the yoga 
sessions by tracking attendance to all in-person sessions. For intervention fidelity, Dr. Barr-
Anderson will analyze the videotaped yoga sessions using established criteria to enumerate the 
number of planned specific yoga components that were completed as a percentage of the total. 
For feasibility we will compute the percentage of participants who: a) receive the materials and 
resources throughout the intervention, b) rate the assessments as ‘not too burdensome’ on a 
multiple choice question, and c) complete baseline, post-intervention, and follow-up 
assessments. For acceptability we will compute the percentage of participants who rate the 
various intervention components as acceptable. For safety we will track all adverse events 
experienced by participants, report them to the UMN IRB, and compare to the benchmarks. If 
benchmark goals are not met, we will explore why they were not met during the post-
intervention focus groups in hopes of gaining substantive information to address the missed 
benchmark goals in the future trial.  
Aim 4. Targeted Outcomes.  Per the NCCIH’s “Pilot Studies: Common Uses and Misuse”,77 the 
research team do not intend to evaluate the efficacy of the intervention. The behavioral and 
biological outcome data will be used to inform the design of the future trial by identifying 
feasibility/adherence problems with measures and suggesting effect size expectations.  Data 
will be cleaned for errors and outliers, checked for normality, and transformed if necessary. The 
primary behavioral outcome will be time spent sitting/lying down from the activPAL3 as the 
gold standard measure of sedentary time.  The research team will also analyze standing, 
stepping, sit-stand transitions, and moderate and vigorous physical activity data from the 
activPAL.  Blood pressure (systolic and diastolic average of three measurements), perceived 
stress, anthropometry and other exploratory measures will be analyzed similarly.  If missing 
data exceed 10% multiple imputation will be performed in addition to complete case analysis.  
For this pilot, we will report 95% confidence intervals. 
Proposed statistical analyses are outlined above.  
17.2 Data Integrity:  
There are two PIs for this study and the leadership plan helps to maintain the integrity of this 
study. Dr. Barr-Anderson will be responsible for overseeing intervention development, 
implementation, and qualitative evaluation and will not be involved with data collection and 
analyses. Dr. Pereira, along with our analyst and biostatistician, will lead quantitative data 
collection and analyses at baseline, post-intervention, and 3-month follow-up and will be 
blinded to the intervention conditions.  
18.0 Health Information and Privacy Compliance  
18.1 
Select which of the following is applicable to your research: 
☒ My research does not require access to individual health information and 
therefore assert HIPAA does not apply.   
☐ I am requesting that all research participants sign a HIPCO approved HIPAA 

 
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Disclosure Authorization to participate in the research (either the standalone 
form or the combined consent and HIPAA Authorization). 
☐ I am requesting the IRB to approve a Waiver or an alteration of research 
participant authorization to participate in the research. 
Appropriate Use for Research: N/A 
☐ An external IRB (e.g. Advarra) is reviewing and we are requesting use of the 
authorization language embedded in the template consent form in lieu of the 
U of M stand-alone HIPAA Authorization.  Note: External IRB must be serving 
as the privacy board for this option. 
18.2 
Identify the source of Private Health Information you will be using for your 
research (Check all that apply)   
☐ I will use the Informatics Consulting Services (ICS) available through CTSI (also 
referred to as the University's Information Exchange (IE) or data shelter) to 
pull records for me 
☒ I will collect information directly from research participants. 
☐ I will use University services to access and retrieve records from the Bone 
Marrow Transplant (BMPT) database, also known as the HSCT 
(Hematopoietic Stem Cell Transplant) database. 
☐ I will pull records directly from EPIC. 
☐ I will retrieve record directly from axiUm / MiPACS 
☐ I will receive data from the Center for Medicare/Medicaid Services  
☐ I will receive a limited data set from another institution  
☐ Other.  Describe: N/A 
18.3 
Explain how you will ensure that only records of patients who have agreed to 
have their information used for research will be reviewed. 
N/A 
18.4 
Approximate number of records required for review: 
N/A 
18.5 
Please describe how you will communicate with research participants during the 
course of this research.  Check all applicable boxes. 
N/A 
☐ This research involves record review only. There will be no communication 
with research participants. 

 
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☐ Communication with research participants will take place in the course of 
treatment, through MyChart, or other similar forms of communication used 
with patients receiving treatment.  
☐ Communication with research participants will take place outside of 
treatment settings. If this box is selected, please describe the type of 
communication and how it will be received by participants. 
18.6 
Access to participants 
N/A 
18.7 Location(s) of storage, sharing and analysis of research data, including any links to 
research data (check all that apply).   
☐ In the data shelter of the Information Exchange (IE)  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In the Bone Marrow Transplant (BMT) database, also known as the HSCT 
(Hematopoietic Stem Cell Transplant) Database  
 ☐ Store 
☐ Analyze 
☐ Share 
☒ In REDCap (recap.ahc.umn.edu)  
 ☒ Store 
☒ Analyze 
☐ Share 
☒ In Qualtrics (qualtrics.umn.edu) 
 ☒ Store 
☒ Analyze 
☐ Share 
☐ In OnCore (oncore.umn.edu)  
 ☐ Store 
☐ Analyze 
☐ Share 
☒ In the University’s Box Secure Storage (box.umn.edu) 
 ☒ Store 
☒ Analyze 
☒ Share 
☒ In an AHC-IS supported server. Provide folder path, location of server and IT 
Support Contact: Epidemiology & Community Health secured encrypted server 
managed by Jeff Johnson (johns260@umn.edu):  
\\files.epi.umn.edu\Pereira\YogaMoves 
 ☒ Store 
☒ Analyze 
☒ Share 
☐ In an AHC-IS supported desktop or laptop.  
Provide UMN device numbers of all devices: 
 ☐ Store 
☐ Analyze 
☐ Share 
☐ Other. 

 
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Indicate if  data will be collected, downloaded, accessed, shared or stored using a 
server, desktop, laptop, external drive or mobile device (including a tablet 
computer such as an iPad or a smartform (iPhone or Android devices) that you 
have not already identified in the preceding questions 
☐I will use a server not previously listed to collect/download research data 
☐I will use a desktop or laptop not previously listed 
☐I will use an external hard drive or USB drive (“flash” or “thumb” drives) not 
previously listed  
☐I will use a mobile device such as an tablet or smartphone not previously listed 
N/A 
18.8 Consultants. Vendors. Third Parties.  
N/A 
18.9 
Links to identifiable data:  
As participants are enrolled in the study, they will receive a unique identifier that will be 
attached to all of their research materials (i.e., data collection and assessments, intervention 
materials). A password-protected document will contain identifying information and will only 
be accessible by authorized research staff will have access to subject identities. In accordance 
with NIH guidelines (i.e., the funding agency), identifiable data will be destroyed 5 years after 
the conclusion of the study. 
18.10 Sharing of Data with Research Team Members.  
Electronic files will be stored in the University’s Box Secure Storage and only authorized 
research staff will have access to a given file (i.e., measurement staff, but not intervention staff, 
will be able to access baseline data files).  
 
18.11 Storage and Disposal of Paper Documents:  
We do not anticipate any paper documents as we will use electronic forms only. However, in 
the case that we have to use paper documents, we will keep all paper data collection forms in 
locked filing cabinets housed in the School of Kinesiology or Division of Epidemiology and 
Community Health and will destroy 5 years after the conclusion of the study. 
19.0 Confidentiality 
19.1 Data Security:  
All data collected, especially participant information, during the study will be treated with strict 
confidentiality. Information will be entered into our data files by coded numbers (without 
recording individual names), thus assuring anonymity. Only authorized research staff will have 
access to participant identities or condition allocation (i.e., Dr. Pereira and the measurement 
team will be blind to condition allocation). When the research team reports study results, 

 
22 of 29 
 
participants will not be named or identified in any way. All research team members have (or 
will) completed human subjects training. 
Yoga classes will be recorded as part of the intervention and will be stored on a password-
protected, view-only Google Drive. Videos will focus on instructors, with the goal of keeping 
participants out of the frame. Instructors will sign a video release form and participants will 
consent to being recorded in case of audio being picked up on the video. Only the research 
team and participants in the pilot RCT will have access to the catalog of yoga videos. No 
identifiable information will be shared over the videos. 
 
20.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
 
20.1 Data Integrity Monitoring. 
Drs. Barr-Anderson and Pereira will be responsible for monitoring the safety of this study, 
executing the Data and Safety Monitoring Plan (DSMP), complying with any reporting 
requirements, and consulting with the DSMB about any adverse events that may occur. If 
funding agency-mandated DSMB will receive formal reports from the research staff twice per 
year. The DSM report will include the participants’ socio-demographic characteristics, expected 
versus actual recruitment rates, retention rates, quality assurance, or regulatory issues that 
occurred during the past year, a summary of Adverse Events (AEs) and Serious Adverse Events 
(SAEs) and any actions or changes with respect to the protocol. The DSM report will also 
include, when available, the results of any interim outcome analyses. In addition to the annual 
DSM report, the PIs will be responsible for informing NIH of any IRB actions within two weeks of 
their occurrence as well as any substantial changes or amendments to the study protocol prior 
to their implementation. 
20.2 Data Safety Monitoring. 
No Adverse Events (AEs) or Serious Adverse Events (SAEs) are expected as a result of the 
study procedures or intervention. If any AEs or SAEs occur during the study, they will be 
documented by the research staff and reviewed by UMN IRB and DSMB to determine if 
further action needs to be taken. Quality control videos will be collected biweekly (i.e., 
every other week – weeks 2, 4, 6, 8, 10, 12). Although these videos are intended to 
make sure yoga instructors are following the training protocol, the research staff will be 
able to use the videos to identify any participants who may be performing yoga poses 
that could put her at an increased risk for injury. Yoga instructors will review and correct 
any injury risks participants. Please note that all yoga instructors will be 200-hour 
certified (Yoga Alliance registered) with current CPR certification and at least one year 
experience teaching yoga. The yoga proposed for this pilot intervention will be a 
combination of hatha and restorative yoga, which is lower intensity and typical for 
beginner yoga practitioners. Additionally, the instructors will be trained on the pilot 
study’s yoga protocol by three experienced yoga teachers: two 500-hour and one 250-
hour certified yoga teachers. 

 
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21.0 Compensation for Research-Related Injury 
21.1 Compensation for Research-Related Injury:  
This research does not involve greater than minimal risk to participants. 
21.2 Contract Language: 
N/A 
22.0 Consent Process 
22.1 Consent Process (when consent will be obtained):  
This study will have two separate consent processes. Participants engaged in the formative 
assessment focus groups will be consented to complete those focus groups only. Participants 
enrolled in the pilot RCT will be consented to: a) participate in the study and to be randomized 
to either the intervention or control condition, and b) participate in the post-intervention focus 
groups, if allocated to the intervention group. After a participant is screened and identified as 
having met the eligibility criteria, participants will be asked to “consent and sign” the informed 
consent form. This will take place virtually for the formative assessment focus groups and in-
person for the pilot RCT.  
22.2 Waiver or Alteration of Consent Process (when consent will not be obtained, 
required information will not be disclosed, or the research involves deception):  
N/A 
22.3 Waiver of Written/Signed Documentation of Consent (when written/signed 
consent will not be obtained):  
N/A 
22.4 Non-English Speaking Participants: 
N/A 
22.5 Participants Who Are Not Yet Adults (infants, children, teenagers under 18 years of 
age): 
N/A 
22.6 Cognitively Impaired Adults, or adults with fluctuating or diminished capacity to 
consent: 
N/A 
22.7 Adults Unable to Consent: 
● 
Permission: N/A 
● 
Assent: N/A 
23.0 Setting 

 
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23.1 Research Sites:  
Formative assessment focus groups: Participants for the formative assessment focus groups will 
be identified through radio, newspaper, email list and social media posts and will be screened 
via phone; all other study activities for these focus groups will take place virtually using Zoom as 
the platform. 
Pilot RCT and post-intervention focus groups: Participants for the pilot RCT and post-
intervention focus groups will be identified through radio, newspaper, email list and social 
media posts and will be screened via phone; baseline, post-intervention, and 3-month follow-
up data collection will take place at University of Minnesota’s Epidemiology Clinical Research 
Center. Participants randomized to the intervention group will engage in yoga sessions, 
workshops, and post-intervention focus groups at two intervention locations, 612 Jungle and 
The Zen Bin.  
23.2 International Research: 
N/A 
23.3 Community Based Participatory Research: 
N/A 
24.0 Multi-Site Research 
N/A 
25.0 Coordinating Center Research 
N/A 
26.0 Resources Available 
26.1 Resources Available:  
The time devoted in conducting and completing the outlined research is substantial. Funding 
for this project is for three years with a total of 0.40 FTE per year for PIs and co-investigators 
and 0.50 FTE for a graduate research assistant in years 1 and 3 and 1.00 FTE for a graduate 
research assistant in year 2. 
The bulk of the research will be conducted remotely from the School of Kinesiology and Division 
of Epidemiology and Community Health at the University of Minnesota. Both have the 
technological and computing assistance to support the proposed research. Due to the COVID-
19 global pandemic, formative assessment focus groups will be conducted via Zoom, which is 
fully supported by the UM’s Office of Information Technology. The pilot RCT and post-
intervention focus groups will take place at two intervention locations, 612 Jungle and The Zen 
Bin.  
All research staff will be IRB-approved and human subjects research-trained. Drs. Barr-
Anderson and Pereira will meet with each on a bi-weekly basis to discuss the overall research 
project. Each of them will meet weekly with their graduate research assistant overseeing 
research duties and tasks. Meetings with the co-investigators and consultant will take place as 

 
25 of 29 
 
needed (approximately once a month over the life of the study and more often, when 
appropriate). 
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Ministry of Health. Eating and Activity Guidelines for New Zealand Adults. Wellington, 
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chronic low back pain in a predominantly minority population: a pilot randomized 
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50. 
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