A Virtual Cardiometabolic Health Program for African Immigrants: The Afro-DPP Program
Phase: NA
Conditions: Diabetes Mellitus, Diabetes Mellitus, Type 2, PreDiabetes, Hypertension, High Blood Pressure, High Blood Sugar, Obesity, Overweight, Overweight and Obesity, Overweight or Obesity
Sponsor: Johns Hopkins University

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JHM IRB - eForm A – Protocol 
 
 
 
A Virtual Cardiometabolic Health Program for African Immigrants: 
The Afro-DPP Program 
 
Date: September 14, 2021 
Principal Investigator: Yvonne Commodore-Mensah 
Application Number: IRB00251726,     
 
NCT: NCT05144737 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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• Use the section headings to write the JHM IRB eForm A, inserting the appropriate material 
in each. If a section is not applicable, leave heading in and insert N/A. 
• When submitting JHM IRB eForm A (new or revised), enter the date submitted to the field at 
the top of JHM IRB eForm A. 
 
**************************************************************************************
************* 
 
1. 
Abstract 
a. Provide no more than a one page research abstract briefly stating the problem, the research 
hypothesis, and the importance of the research. 
 
Black people and immigrants in the United States (US) are disproportionately affected by poor 
cardiometabolic health (CMH), defined by risk factors for cardiovascular disease (CVD) and type 2 
diabetes (T2D).  
African immigrants are among the fastest-growing segments of black immigrants in the U.S., 
increasing 137% from 2000 to 2013. More than a third are from West Africa-specifically Ghana and 
Nigeria. There are significant gaps in knowledge on African immigrants in the U.S. because "Blacks" 
are often studied as a homogeneous racial group in health disparities research.2 In the “Afro-Cardiac 
Study”5, a cross-sectional study (N=253) conducted by our team, 88% of the African immigrants were 
overweight/obese, 40% had hypertension, 16% had T2D, and only 52% had health insurance. In our 
ongoing study, “The African Immigrant Health Study”, only 60% of the 395 participants had health 
insurance. Participants from both studies were recruited from faith-based settings in the Baltimore-
Washington, D.C. area. 
To date, there are no existing community-based programs to improve the CMH of African immigrants 
at risk of developing CVD and T2D. Due to our prior success engaging African immigrants in faith-
based settings7, we propose a “Virtual Cardiometabolic Health Program” among African immigrants 
to build on our previous cross-sectional and community-engaged research with consideration of 
cultural values, practices, beliefs, and faith.  
Digital health interventions, defined as the different ways in which digital and mobile technologies 
are being used to support health needs, are promising complements to lifestyle interventions.8 Digital 
health interventions (i.e. interventions delivered via digital technologies such as smartphones, 
websites, text messaging) are effective, cost-effective, safe, and scalable which promote healthy 
behavior to promote CMH. 9 
The proposed study will address the CMH of community-dwelling African immigrants who have 
multiple cardiometabolic risk factors including hypertension, prediabetes, and overweight/obesity. 
We seek to improve CMH by offering a virtual program which will improve access to therapeutic 
lifestyle interventions amid the COVID-19 pandemic. We hypothesize that a combination of lifestyle 
intervention with a culturally specific curriculum and patient monitoring will improve participants’ 
blood pressure management and lead to a reduction in body weight.  
 
 
 
 
 
 

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2. Objectives (include all primary and secondary objectives) 
 
We seek to address the following specific aims: 
Aim 1: To examine whether a virtual, culturally-tailored, lifestyle intervention with remote 
monitoring of blood pressure and body composition (The Afro-DPP program) would reduce blood 
pressure and body weight compared to remote monitoring of blood pressure and body 
composition alone among African immigrants  
 
Aim 2: To examine whether The Afro-DPP program would reduce cardiovascular disease risk, 
body fat percentage, and body mass index compared to remote monitoring of blood pressure and 
body composition alone among African immigrants 
The primary outcomes are the reduction in blood pressure and body weight. We will also assess 
secondary outcomes including the reduction in global CVD risk, body fat percentage, and body mass 
index over a 12-month period. Global CVD risk, which will be calculated with the BMI-based CVD 
risk score, and body fat percentage are considered proximal outcomes. The distal outcomes which are 
unlikely to be observed in the timeframe of the pilot study include improvement in positive 
affect/well-being and quality of life (QoL). We will use the PROMIS global health measure to 
rigorously assess the QoL of participants to determine the impact of the intervention on patient-
reported outcomes.  
 
3. 
Background (briefly describe pre-clinical and clinical data, current experience with procedures, 
drug or device, and any other relevant information to justify the research) 
 
African immigrants are one of the fastest-growing segments of black immigrants in the U.S., 
increasing 137% from 2000 to 2013. More than a third are from West Africa-specifically Ghana and 
Nigeria. There are significant gaps in knowledge on African immigrants in the U.S. because "Blacks" 
are often studied as a homogeneous racial group in health disparities research.2  
The limited data that exist on African immigrants suggest that they are distinct from their African 
American counterparts but could provide valuable insight into health disparities among Black 
people. The triple epidemics of obesity, T2D, and hypertension have taken hold in Africa with 
Africans acquiring CVD risk at higher rates before migration.3 Hence, current African immigrants 
may have poorer CMH than previous generations. A prior clinical study at the National Institute of 
Health found that African immigrants were more likely to have prediabetes or diabetes compared to 
African Americans, and they were also more unaware of their risk.4  
Despite well-publicized guidelines on the appropriate management of CVD and T2D, the 
implementation of risk-reducing practices remains poor. The National Diabetes Prevention Program 
(DPP) has shown that lifestyle change involving a lifestyle coach, CDC-approved curriculum, or 
group support is effective for improving CMH and reducing T2D risk by 58% in a cost-effective 
manner.6,11 The National DPP Lifestyle Intervention curriculum is based on the curriculum from the 
DPP trial.6 However, evidence-based programs such as the DPP  have not been adapted to African 
immigrants, a vulnerable population that is predisposed to poor CMH. The evidence base supporting 
self-monitored blood pressure monitoring (SMBP), also known as home blood pressure monitoring, 
for patients with hypertension is strong.13 SMBP plus additional support, defined as one-on-one 
counseling, web-based or telephonic support and educational classes, leads to significant 
improvement in systolic blood pressure (SBP) (mean net reduction of 1.6-8.5 mm Hg) and diastolic 
blood pressure (DBP) (the mean net reduction of 1.9-4.4 mm Hg).13  
 
 

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PRELIMINARY DATA: 
In the “Afro-Cardiac Study”5, a cross-sectional study on African immigrants in the United States 
(N=253) conducted by our team, 88% were overweight/obese, 40% had hypertension, 16% had T2D, 
and only 52% had health insurance. In our ongoing study, “The African Immigrant Health Study”, 
only 60% of the 395 participants had health insurance. Participants from both studies were recruited 
from faith-based settings in the Baltimore-Washington, D.C. area. To date, there are no existing 
community-based programs to improve the CMH of African immigrants  
The proposed intervention is informed by the PEN 3 Model which was originally developed as a 
framework for designing culturally-appropriate health promotion and disease prevention 
interventions in African countries.14 The PEN 3 Model has also been successfully applied to other 
health promotion interventions targeting African Americans including the DPP. 15 The PEN-3 model 
completes cultural adaptions in two phases that support community input on the appropriate 
adaptation elements. The first phase, assessment, involves information gathering to learn about the 
community and its perspective, the resources that promote or inhibit behavioral change, and the roles 
that the social network plays in behavioral change. We have completed Phase 1of this process in our 
recent qualitative work among African immigrants. We have recently conducted seven focus groups 
with African immigrants from Ghana, Nigeria, Liberia, and Sierra Leone and will use the data 
collected in the focus groups to inform the co-creation of this program in faith-based settings. 
Community-based management of CVD risk factors and T2D has been previously implemented in 
ethnic/minority groups such as African Americans16,17, Hispanic immigrants18,19 and faith-based 
settings.20,21 However, it is unclear if these strategies can be translated to African immigrants in faith-
based settings. We are proposing an intervention that would potentially improve access to a cost-
effective intervention in a familiar environment with strong social networks. 
Digital health interventions, defined as the different ways in which digital and mobile technologies 
are being used to support health needs, are promising complements to lifestyle interventions.8 Digital 
health interventions (i.e. interventions delivered via digital technologies such as smartphones, 
websites, text messaging) are effective, cost-effective, safe, and scalable which promote healthy 
behavior to promote CMH. 9 
 
4. 
Study Procedures 
a. Study design, including the sequence and timing of study procedures   
(distinguish research procedures from those that are part of routine care).   
 
We will use a non-equivalent control group design to test the effectiveness of the intervention at two 
African churches in the Baltimore, Washington, D.C. area. The two churches will be randomly 
assigned to the intervention or delayed intervention group. At the end of a 6-month follow-up period, 
the control church will receive the intervention (delayed control group). We have opted for this design 
approach to allow both churches to benefit from the proposed intervention and address the ethical 
concerns and maintain good retention rates in the trial. 
Screening and Recruitment 
We will recruit a total of 60 participants,30 participants at each of the two African churches. Since 
the intervention includes a digital health component, participants who do not have smart phones will 
receive loaner phones to ensure equity in access to the program. The research team has already 
attained written authorization to contact participants from the African Immigrant Health Study (IRB 
00129394). Previous participants will be contacted to see if they are interested in joining the Afro- 
 

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DPP Program. We will also engage leaders of organizations that have participated in our previous 
studies to assist with engaging their constituents and reaching our targeted sample size.  
Two churches have agreed to participate in this project and provided letters of support to allow the 
study to be conducted at their locations. Their staff will help in advertising the study to their members 
and provide space for the study procedures. None of their staff will participate in the research. Their 
staff will not participate in the consent process or perform any roles outside of their normal functions. 
Only JHU-trained staff will conduct the study procedures.   
Informed Consent 
Once a person at one of the churches expresses interest in the study, a consent designee of the research 
study team will contact her/him by email or phone to schedule a time to obtain informed consent and 
discuss study activities. 
Study procedures 
All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that 
measures body composition including Body Weight, Body Fat percentage, Visceral Fat, Skeletal 
Muscle percentage, Resting Metabolism and Body Mass Index. A Bluetooth-enabled blood pressure 
monitor (Omron Model: BP7250) will also be distributed to all participants. All participants will 
download the Omron Connect app which will allow them to sync their blood pressure readings and 
body composition readings into the app. At the baseline visit, the participants will be educated on 
how to use these devices to take physical measurements at home. The research team will access these 
readings to monitor study outcomes and participants' progress during the follow-up period. 
 
The intervention curriculum will be delivered by a certified DPP Lifestyle Coach who is of African 
descent over two 6-month periods.  Participants in the 1st intervention group will immediately begin 
6 months of the adapted DPP lifestyle intervention with a Lifestyle Coaches and remote monitoring 
of blood pressure and body composition. This will be followed by a 6-month observation 
period where the intervention will be withdrawn. In this period, participants will be evaluated for 
the maintenance of lifestyle changes. Participants in the delayed intervention group will receive 
remote monitoring of blood pressure and body composition for the 1st 6 months and then will 
receive the adapted DPP lifestyle intervention after 6 months.The multicomponent intervention will 
focus on intensive lifestyle modification delivered by the Lifestyle Coach. The Lifestyle Coach of 
African origin will be responsible for delivering the intensive lifestyle intervention and 
implementing the adapted DPP curriculum.  The curriculum from the DPP program will be 
culturally-adapted with input from healthcare professionals and community leaders who are also 
African immigrants. Our goal is to adapt the DPP to African immigrants with consideration of 
African cultural values, practices, beliefs and faith by including culturally appropriate examples in 
the educational content to make the information more acceptable to the participants. For instance, 
the module titled “Shop and Cook to Prevent T2D” will be adapted “Shop and Cook to Promote 
Cardiometabolic Health” and include examples of African foods that are heart-healthy.  The CDC-
developed curriculum includes a facilitator’s guide and participant handouts which will be used by 
the Lifestyle Coach to implement the lifestyle intervention to all participants. The adapted DPP 
curriculum is described briefly in Table 1.    
 
 
 
 

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TABLE 1. Adapted DPP Curriculum   
Original Sessions  
Modified Sessions  
Week Adaptation   
1. 
Welcome to the National DPP Program  
Welcome to the National DPP 
Program   
      1 
- 
2. 
Be a Fat and Calorie Detective 
Fats: Detect and Eliminate  
3 
Incorporate examples of sources of fats 
in African foods such as palm oil   
3. 
Three Ways to Eat Less Fat and Fewer 
Calories  
 
4. 
Healthy Eating  
Healthy Eating the African Way: Part 
1  
5 
Provide examples of healthier versions 
of African food 
5. 
Move those Muscles  
Be Active: Move your body   
7 
Incorporate African dance lesson in the 
session  
6. 
Being Active – A Way of Life  
 
7. 
Tip the Calorie Balance  
Finding balance  
9 
- 
8. 
Take Charge of What’s Around You  
 
9. 
Problem Solving  
Same as Original  
11 
- 
10. Four Keys for Healthy Eating Out  
 
11. Talk Back to Negative Thoughts   
Taking Charge   
13 
Combine sessions on facing mental 
challenges related to healthy lifestyle 
practices  
12. The Slippery Slope of Lifestyle Change  
 
13. Jump Start Your Activity Plan  
Get to it  
15 
 
14. Make Social Cue Work for You  
 
15. You Can Manage Stress  
Managing Stress by Faith   
17 
Discuss unique stressors that African 
immigrants face  
Discuss mindfulness, meditation, and 
exercise for stress reduction 
16. Ways to Stay Motivated  
17. Fats- Saturated, Unsaturated, and Trans Fat  Cook for life  
19  
- 
18. Food Preparation and Recipe Modification  
19. Healthy Eating – Taking it One Meal at a 
Time  
Healthy Eating the African Way: Part 
2  
21  
Emphasize healthier African foods   
20. Healthy Eating with Variety and Balance  
21. More Volume, Fewer Calories  
22. Staying on Top of Physical Activity  
Keeping fit: the African way  
23  
Emphasize different options of meeting 
exercise recommendations  
23. Stepping up to Physical Activity  
24. Balance Your Thoughts for Long-Term 
Maintenance  
Face the Giants like King David   
25  
- 
25. Handling Holidays, Vacations, and Special 
Events  
26. Preventing Relapse  
27. Stress and Time Management  
Stress and your Cardiometabolic 
Health    
27  
- 
28. Heart Health  
29. A Closer Look at Type 2 Diabetes  
30. Final Session: Looking Back and Looking 
Forward  
Final Session: Looking Back and 
Looking Forward  
30  
-  

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At each in-person follow-up visit, blood pressure will be measured 3 times at intervals of one 
minute or longer using the Omron Model: BP7250, and the average of the three recorded.  
 
 
Hemoglobin A1c will be measure using the point of care testing system described in section 6 
below (this will not be measured at the 1 month visit).  BMI (height and weight) will be measured using 
Omron Model: BCM-500. The follow-up questionnaires will be competed online by participants to reduce 
the amount of time spent at the church location.  
 
Data Collection  
Data collection for this study will be performed by two trained JHU Research Assistants. A study 
protocol will be developed and utilized to ensure standardization of measurements. Table 
2 describes the measures which will be obtained for this study. We selected measures based on their 
psychometric properties as well their alignment with common data elements which have been 
identified by the Common Data Repository for Nursing Science and are being used in other pilot 
studies in the PROMOTE Center.    
 
 
Table 2. Participant measures by Study Visit   
 
Baseline  
1 month  
3 months  
6 months  
12 months  
Survey Measures  
  
  
  
  
  
Demographic Information (BRICS NINR 
Demographics)  
X  
  
  
  
  
Health Behaviors (smoking, alcohol use, diet, 
physical activity)  
X  
  
  
  
X  
BRICS NINR Social Determinants of Health   
X  
  
  
  
X  
Health History   
X  
  
  
  
  
PROMIS Global Health measure v126  
X  
  
  
X  
X  
PROMIS-Fatigue Short form 6a27  
X  
  
  
X  
X  
Brief Resilience Scale28  
X  
  
  
X  
X  
PROMIS Depression Short Form 6a29  
X  
X  
X  
Perceived Stress Scale 30  
X  
  
X  
X  
ENRICHD Social Support Inventory 31  
X  
  
  
X  
The CoRonavIruS Health Impact Survey (CRISIS)32  
X  
  
X  
X  
X  
Rand Health Care Short Form Health Survey (SF-36)  
X 
 
 
X 
X 
Physical and Biochemical Measures  
  
  
  
  
  
Systolic Blood Pressure   
X  
X  
X  
X  
X  
Diastolic Blood Pressure  
X  
X  
X  
X  
X  
Body Weight   
X  
X  
X  
X  
X  
Body Mass Index  
X  
X  
X  
X  
X  
Body Fat Percentage   
X  
X  
X  
X  
X  
Hemoglobin A1c 
X 
X 
X 
X 
Bold: Common Data Elements in the Common Data Repository for Nursing Science  
  
  
Data Management   

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We will use REDCap for the study database. Data from screening and intervention visits will be 
entered on standardized forms or directly into the REDCap database. The research assistants will 
check the standardized forms for completeness and appropriateness. During data entry, the 
participants will be assigned a unique identifying number that will be separated from their names and 
other identifying information and kept in a separate, secure data file. Confidentiality of participants 
will be ensured by using the unique identifying numbers attached to the participants’ responses. Only  
 
 
the study team members will have access to this file of identifying information for research purposes 
only. Identifying information, including names, will be kept separate from the participant’s survey  
responses and protected in a secure, password-protected and HIPAA compliant server or in a secure, 
locked filing cabinet in the PI’s locked office. Reporting of results will not involve identification of 
participants as data will be presented in collective or aggregate form.  
 
The duration of the study is 12 months and will have a total of 5 in-person follow-up time points. 
The project timeline is outlined in Table 3.  
 
TABLE 3: Project Timeline   
 
Year 1  
Year 2  
   
August 2020-July 2021  
August  2021-July 2022  
   
Aug-Oct  Nov-Jan  Feb-Apr  May-Jul  Aug-Oct  Nov-Jan  Feb-Apr  May-Jul  
Phase I: Development Phase    
   
   
   
   
   
   
   
   
Focus group with African immigrants  
   
   
   
   
   
   
   
   
IRB application   
   
   
   
   
   
   
   
   
Cultural adaptation of educational materials 
and DPP curriculum    
   
   
   
   
   
   
   
   
Finalize study materials including intervention and data 
collection protocols   
   
   
   
   
   
   
   
   
Recruitment and training of Lifestyle Coach and Research 
Assistants    
   
   
   
   
   
   
   
   
Phase II: Implementation Phase    
   
   
   
   
   
   
   
   
Baseline data collection   
   
   
   
   
   
   
   
   
Intervention delivery Site 1(N=30)  
   
   
   
   
   
   
   
   
Maintenance Phase Site 1  
 
 
 
 
 
 
 
 
Intervention delivery Site 2 (N=30)  
 
 
 
 
 
 
 
 
Monthly follow-up visits   
 
 
 
 
 
 
 
 
Quality Assessment monitoring   
   
   
   
   
   
   
   
   
Post-intervention data collection   
   
   
   
   
   
   
   
   
Phase III: Evaluation and Planning for R01 submission   
   
   
   
   
   
   
   
   
Data analysis   
   
   
   
   
   
   
   
   
Preparation of manuscripts and abstracts reporting on study 
methods and findings   
   
   
   
   
   
   
   
   
Prepare and submit proposals for funding for the next phase of 
research   
   
   
   
   
   
   
   
   
 
b. If your study involves data/biospecimens from participants enrolled under other research studies 
with a written consent or under a waiver of consent, please list the IRB application numbers for 
those studies.  Please note: Certificate of Confidentiality (CoC) protections applied to the data in 
source studies funded by NIH or CDC will extend to this new study if the funding was active in 
2016.  If this situation applies, Section 36, question 4 in the application will need to be answered 
“Yes” and “Hopkins Faculty” should be selected in question 7. No other documents are required. 
 

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This is not applicable to this study 
 
 
 
 
 
 
 
 
 
c. Study duration and number of study visits required of research participants. 
The duration of this study is 12 months. There will be 5 in-person  study visits at both churches. The 
study visits will take place at the Baseline, 1 month, 3-month, 6-month and 12-month points of the 
study in private rooms at the churches. The study team and participants will observe COVID-19 
Protocols during the in-person visits. 
 
d. Blinding, including justification for blinding or not blinding the trial, if applicable. 
 
We will use a non-equivalent control group to test the effectiveness of the intervention. The 
intervention group will receive the intervention at the start of the study whereas the delayed control 
group will receive the intervention after 6 months. While the participants will be blinded to which 
group they are in, study staff, data collectors and analysts will not be blinded given the interactive 
nature of the study.   
 
e. Justification of why participants will not receive routine care or will have current therapy stopped. 
N/A 
 
f. Justification for inclusion of a placebo or non-treatment group. 
 
We will use a non-equivalent control group design to test the effectiveness of the intervention at two 
African churches in the Baltimore, Washington, D.C. area. The two churches will be randomly 
assigned to the intervention or control group.  At the end of a 6-month follow-up period, the control 
church will receive the intervention (delayed control group). We have opted for this design approach 
to allow both churches to benefit from the proposed intervention and address the ethical concerns and 
maintain good retention rates in the trial. 
g. Definition of treatment failure or participant removal criteria. 
 
Participants will be excluded from the study if a cognitive challenge or serious illness arises that 
would interfere with study participation. If a participant does not attend at least 18 out of the 36 
total DPP sessions, then they would have failed to complete study participation.  
 
h. Description of what happens to participants receiving therapy when study ends or if a participant’s 
participation in the study ends prematurely. 
 
When the study ends, participants will keep study materials such as the scale and the blood pressure 
device, however loaner smart phones will be returned. If a participant chooses to withdraw from the 
research study, study personnel will inform the participant that compensation from the study will be 
withheld, due to prematurely ending participation. 
 
 
 

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5. Inclusion/Exclusion Criteria 
 
Inclusion criteria:  
We will include:  
• African immigrants who are aged 25-75 years  
• Participants who report being uninsured or have no access to a healthcare provider 
• Have at least two of the following chronic conditions: 
▪ Body-mass index ≥ 25 kg/m2 
▪ Self-reported fasting plasma glucose of 95 to 125 mg/d or HbA1c of 5.7-6.5% in the 
past 6 months 
▪ Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg  
Exclusion criteria:  
We will exclude:  
• Participants who cannot communicate in English 
• Participants who have cognitive challenges that would restrict them from participation  
• Participants who have any serious illness that would interfere with participation 
• Participants who are not members of the churches that are involved in this study  
 
6. Drugs/ Substances/ Devices 
a. The rationale for choosing the drug and dose or for choosing the device to be used. 
 
Hemoglobin A1CNOW®+ Point of Care System: A hemoglobin A1c (HbA1c) test that measures the 
amount of blood sugar (glucose concentrations) attached to hemoglobin will be obtained with a 
fingerstick (capillary blood) and measured using a point of care testing instrument (POCT)- 
A1CNOW®+. Accuracy and precision of the fingerstick measurements by using A1CNOW®+ have 
been examined in previous studies. 31Although laboratory measurements have traditionally been 
used for the evaluation of biochemical markers of Diabetes risk, this is only convenient in a 
hospital-based setting. With this community-based study, a laboratory-based approach has the 
limitations of transporting and storing of blood samples, delay in obtaining the results and the need 
to attempt to contact participants again after the results become available. Hence, this POCT meets 
the relevant National Glycohemoglobin Standardization Program (NGSP) certification, Diabetes 
Control and Complications Trial (DCCT) and United Kingdom Prospective Diabetes Study 
(UKPDS) which established the direct relationships between HbA1c levels and outcome risks in 
patients with diabetes. The A1C results ranged from 5.0 % A1C to 12.8 % A1C, with a mean of 7.3 
% A1C. Accuracy of A1CNow+, with fingerstick samples was, on average, 99%. This means that, 
on average, a true 7.0% A1C could read approximately 6.9% A1C. An individual A1CNow+ result 
may differ by as much as -1.0% A1C to +0.8% A1C from the true result. This represents the 95% 
confidence limits of a Bland-Altman plot. 32 This will allow for the provision of immediate 
counseling that can lead to behavior changes and healthier lifestyles. The Hemoglobin A1c results 
would be shared with the participants on a report card. 

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b. Justification and safety information if FDA approved drugs will be administered for non-FDA 
approved indications or if doses or routes of administration or participant populations are changed. 
            N/A 
c. Justification and safety information if non-FDA approved drugs without an IND will be 
administered.  
 
 
N/A  
 
7. Study Statistics 
 
a. Primary outcome variable. 
 
The primary outcome variable is reduction in blood pressure and body weight.  
 
b. Secondary outcome variables. 
 
The secondary outcome variable is the reduction in global CVD risk, body fat percentage, and body 
mass index. 
 
c. Statistical plan including sample size justification and interim data analysis. 
 
 
 
 
 
We plan to recruit 30 participants from each of the two churches.  Given that this is a pilot study, we will 
only have sufficient power to detect large effect sizes.  Based on the results of the Afro-Cardiac Study5,  
we assume the rate of elevated CVD risk assessed with the Pooled Cohort Equation will be 28%.  With 
statistical power of 0.80, alpha of 0.05 and 30 participants per arm, we will be able to detect significant 
differences if groups differ by 25% at 6-month follow-up.  The effect sizes observed in this pilot study 
will be used to conduct power analyses to inform sample size estimates for a future randomized controlled 
effectiveness trial. The planned enrollment is described in Table 4. 
 
TABLE 4: Planned Enrollment Report   
Racial Categories 
Ethnic Categories 
 
Not Hispanic or Latino 
Hispanic or Latino 
Total 
 
Female 
Male 
Female 
Male 
 
American Indian/ Alaska 
Native 
- 
- 
- 
- 
- 
Asian 
- 
- 
- 
- 
- 
Native Hawaiian or Other 
Pacific Islander 
- 
- 
- 
- 
- 
Black or African American 
30 
30 
- 
- 
- 
White 
- 
- 
- 
- 
- 
More than One Race 
- 
- 
- 
- 
- 
Total 
30 
30 
 
 
60 
 
d. Early stopping rules. 

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Though minimal risks are involved within this research study; risk events, problems, and protocol 
deviations will be reported by the Principal Investigator directly to the IRB. 
 
 
 
 
 
 
 
8. Risks 
a. Medical risks, listing all procedures, their major and minor risks and expected frequency. 
 
Minor risks involving physical activities and dietary changes may include an increase for risk of 
injury or affect the cardiovascular system. Participants will be encouraged to recognize their 
capabilities and limits prior to being involved in physical activities scheduled throughout the 
program.  The potential risks are associated with local bleeding from the site of the finger stick. 
However, since capillary blood samples instead of venous samples will be obtained, the risk of 
gross bleeding will be lowered. 
 
b. Steps taken to minimize the risks. 
Recruitment and Informed consent 
 
 Informed consent will be obtained from all study participants. The informed consent document and 
the explanation of the study will make it clear that participation in the proposed study is completely 
voluntary and can be stopped at any point and for any reason. 
In addition to ensuring that participants are well-informed on the risks associated with the study, 
only trained research assistants will conduct the capillary blood draws and strict adherence to 
universal precautions will be maintained. It will be emphasized the tests are not diagnostic and 
follow-up is necessary for an actual diagnosis of hypertension and diabetes. Participants will be 
referred to their primary care providers or if uninsured, referred to community health services if 
they have blood pressures greater than 180/120 mmHg or Hemoglobin A1c levels greater than 
6.5%.  911 would be called in the case of any emergency. 
 
 
c. Plan for reporting unanticipated problems or study deviations. 
 
We do not expect any deviations from the study. However, any deviations from the study plan or 
unanticipated problems will be reported immediately to the JHM IRB. 
 
d. Legal risks such as the risks that would be associated with breach of confidentiality. 
 
During data entry, the participants will be assigned a unique identifying number that will be 
separated from their names and other identifying information and kept in a separate, secure data file. 
Confidentiality of participants will be ensured by the use of the unique identifying numbers to the 
participants’ responses. Only the study team members will have access to this file of identifying 
information for research purposes only. Identifying information, including names, will be kept 
separate from the participant’s survey responses and protected in a secure, password-protected and 
HIPAA compliant server or in a secure, locked filing cabinet in the PI’s locked office. Reporting of 
results will not involve identification of participants as data will be presented in collective or 
aggregate form. 
 

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e. Financial risks to the participants. 
 
There will be no financial risks to the participants. Study materials such as the Bluetooth-enabled 
digital scale (Omron Model: BCM-500) and a Bluetooth-enabled blood pressure monitor (Omron 
Model: BP7250) will be distributed to all participants. The Omron Connect application is free for all 
users.  
 
 
9. Benefits 
a. Description of the probable benefits for the participant and for society. 
 
We hope that the that the group-based lifestyle intervention will improve the presence of positive 
emotions in daily activities, participation in society, satisfying relationships, and overall life 
satisfaction. 
 
10. Payment and Remuneration 
a. Detail compensation for participants including possible total compensation, proposed bonus, and 
any proposed reductions or penalties for not completing the protocol. 
 
During the Baseline and first month research visits, all participants enrolled in this research study 
will receive a compensation of $30.00 (thirty dollars) upon successfully completing the Baseline 
and first month research visits.  
 
During the third month research visit, all participants enrolled in this research study will receive a 
compensation of $40.00 (forty dollars) upon successfully completing the third month research visit. 
 
During the sixth month and twelfth (last) month research visits, all participants enrolled in this 
research study will receive a compensation of $75.00 (seventy-five dollars) upon successfully 
completing the sixth month and twelfth month research visits. Total potential payment for all 
participation in the study equals $250.00 (sum of all five research visits)  
 
11. Costs 
 
a. Detail costs of study procedure(s) or drug (s) or substance(s) to participants and identify who will 
pay for them. 
Study participants recruited and enrolled will not be responsible for any study related costs. 
 
 
 
 
 
 
 
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