Sugar Champ: Pilot Social Network Intervention to Reduce Intake of Sugary Drinks
Phase: NA
Conditions: Overweight and Obesity
Sponsor: Johns Hopkins University

  
  
  
  
 
 
 
 
Sugar Champ: Pilot Social Network Intervention to Reduce 
Intake of Sugary Drinks 
 
 
 
 
 
 
NCT02138240 
 
 
 
 
January 23, 2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Date: January 23, 2017    
Principal Investigator: Kimberly Gudzune, MD MPH Application 
Number: IRB00107116  
JHMIRB eFormA  01  
Version 3 Dated:   06/2007  
  
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JHM IRB - eForm A – Protocol  
  
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1.  
Abstract  
The 1.2 million households living in public housing are disproportionately affected by obesity, 
where prevalence is estimated at 50%. An ecologic framework hypothesizes that this disparity is 
related, in part, to social and environmental factors within these neighborhoods that influence 
residents’ lifestyles. Social networks and the built environment may work together to promote or 
inhibit lifestyle behaviors; however, combined social network-built environment interventions have 
not previously targeted changes in diet. We hypothesize that an intervention that combines a social 
network approach with strategies that address public housing residents’ challenges related to the 
built environment will improve dietary habits. Our overall aim is to develop a combined social 
network-built environment intervention to reduce intake of beverages high in added sugars and to 
pilot test the intervention among residents of public housing developments in Baltimore, MD.   
  
2.  
Objective  
Objective:  
To develop a combined social network-built environment intervention to 
reduce intake of beverages high in added sugars and to pilot test the 
intervention among residents of public housing developments in Baltimore, 
MD.   
  
Hypothesis 1: A combined social network-built environment intervention will be 
feasible and acceptable in promoting reduced intake of beverages high in added 
sugars.  
  
Hypothesis 2: A combined social network-built environment intervention 
promoting reduced intake of beverages high in added sugars will alter diet 
among public housing residents.   
  
3.  
Background   
Ecologic Framework of Obesity. Over one-third of U.S. adults are now obese, a condition linked 
to increased risk of type 2 diabetes mellitus (T2DM), cardiovascular disease, and cancer. An 
ecologic framework hypothesizes that macro- and micro-level elements of the built and social 
environments influence obesity. This framework is supported by evidence that links neighborhood 
factors with obesity.   
  
Public Housing and Obesity. The U.S. House Ways and Means Committee estimates that 1.2 
million households reside in public housing, which are often located in neighborhoods that have a 
confluence of negative environmental factors including low socioeconomic status (SES), limited 
access to grocery stores, and few safe places to exercise. As compared to the general population, the 
obesity epidemic disproportionately impacts adults living in public housing, where 20% have 
hemoglobin A1c ≥6.5% and over 50% are obese. The 10-year outcomes from the “Moving to 
Opportunities” demonstration project suggested that public housing residents who had the 
opportunity to move to a higher SES neighborhood had a reduced prevalence of T2DM and extreme 
obesity as compared to residents who did not have this opportunity. This evidence implies that 

Date: January 23, 2017    
Principal Investigator: Kimberly Gudzune, MD MPH Application 
Number: IRB00107116  
JHMIRB eFormA  01  
Version 3 Dated:   06/2007  
  
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living in low-SES public housing confers an increased risk of obesity and T2DM to its residents, 
and there is a critical need to design and test interventions that decrease the burden of T2DM and 
obesity among this population.   
  
Built Environment and Obesity. Many studies have described environmental factors associated 
with obesity. For example, proximity to grocery stores, exercise facilities, and parks has been 
associated with lower body mass index (BMI). The availability of grocery stores and recreation 
facilities tends to be limited in low-SES neighborhoods, which results in poor access to healthy 
foods and exercise. Interventions have attempted to address food access disparities in Baltimore. 
Local stores increased their stocking of healthy foods and used point of purchase materials to 
promote these items, which increased purchasing of promoted foods but had no effect on 
consumers’ healthy eating habits. Addressing access alone seems insufficient to change behavior.   
  
Social Networks and Obesity. An individual’s social networks can influence behaviors through 
social influence such as social norms and behavior modeling. The potential for social networks to 
promote behavior change has been studied in smoking cessation, where clusters of people 
simultaneously stop smoking. Social network interventions with drug users have successfully 
increased HIV risk reduction behaviors such as using clean needles and condoms. Obesity has been 
associated with social networks among adolescents and Framingham Heart Study participants. 
Mathematical simulations have illustrated the spread of obesity through social networks and how 
social networks might be used to mitigate the obesity epidemic. While these studies show the 
diffusion of obesity, social network interventions have yet to be used to target lifestyle change. It 
has been postulated that social networks may interact with the built environment to influence health 
behaviors. Therefore, an intervention that uses a social network approach in combination with 
strategies that address residents’ challenges related to their built environment could improve diet, 
eating, and exercise habits that may result in weight loss and decreased risk or improved control of 
T2DM.   
  
Preliminary Work. In 2011, we completed focus groups with Baltimore public housing residents 
exploring perceptions of health and community. Potential facilitators of behavior change included 
support from family members and cohesion among neighbors in housing courts; however, 
individuals reported limited access to fresh foods and safe areas for recreation. We completed a 
cross-sectional survey characterizing the personal diet, eating, and exercise habits and the 
perceptions of these habits among the social networks of over 350 adults living in Latrobe Homes 
and Gilmor Homes public housing developments in September 2015. We captured data on 
perceptions of the built environment along with observer ratings of the community environment and 
geographic information system (GIS) data. While analyses are ongoing, preliminary results show 
that over 50% are obese (BMI ≥30 kg/m2) and proportion with self-reported diabetes mellitus is 
20%. We found that the median added sugar intake was 21.1 tsp per day as compared to the 6 to 9 
tsp per day recommended by the American Heart Association. In multivariate models, individuals 
who perceived a greater proportion of their social networks drank sugar-sweetened beverages or ate 
sweets daily had significantly higher added sugar intake. We used this prior study to inform the 
development of a social network-built environment intervention to reduce added sugar intake 
among public housing residents, which will be tested in this pilot study.   
  

Date: January 23, 2017    
Principal Investigator: Kimberly Gudzune, MD MPH Application 
Number: IRB00107116  
JHMIRB eFormA  01  
Version 3 Dated:   06/2007  
  
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The study team has prior experience conducting focus groups and a cross-sectional survey among 
public housing residents in Baltimore City, and has a long-term relationship with the Housing 
Authority of Baltimore City to conduct this research.  
  
  
4.  
Study Procedures  
a. Study design   
We will conduct a 6-month non-randomized trial of the social network intervention described 
below. This will be a single arm trial in which we compare the outcomes of interest pre- and 
post- intervention. We have elected to use a pre-post design in this pilot study, given the 
preliminary nature of this work. We will adapt an HIV risk reduction social network 
intervention to create a new social network intervention targeting reduction in intake of added 
sugars. Our primary outcomes will be to test the acceptability and feasibility of the intervention 
and its components as well as estimate the likely effect of the intervention.   
  
In the intervention, individuals will be recruited and trained to be “Peer Educators” who will 
participate in group sessions and then communicate this information with members of their 
social network (“Sidekick”) and work to make changes to reduce intake of added sugars 
together. Given the frequent intake of sugar-sweetened beverages (SSB) in this population, the 
intervention will focus on reducing added sugar intake through the reduced consumption of 
SSB. Peer Educators will participate in 6 core group sessions over a 6-week period as well as 3 
additional booster sessions over the subsequent 3 months after completing the core curriculum.  
All sessions will be delivered by a facilitator and assistant facilitator using a guide (Appendix 
A). All groups will be held in a room in each public housing development’s administrative 
building. Participants will receive a healthy meal or snack during each group session. We 
anticipate each group will last approximately 90 minutes.  
  
We will recruit participants from Latrobe Homes and Gilmor Homes. We will recruit a total of  
24 overweight Peer Educators along with 24 of their social network members (12 Peer  
Educators from Latrobe and 12 Peer Educators from Gilmor). We will require that both Peer 
Educators and Sidekicks consume sugar-sweetened beverages at least twice a day. We will 
require that the Peer Educator and Sidekicks have had in person contact at least once during the 
past month, which suggests a more significant relationship. We will not require Sidekicks to 
live in the housing development, as many individuals’ social networks extend beyond their 
immediate neighborhood.   
  
We will mail an invitation (Appendix B) to all overweight respondents daily that participated in 
our prior survey and agreed to be contacted for future research directing them to call our study 
office if they are interested in participating. These individuals will be eligible to be Peer 
Educators. Only one person per household will be eligible to be a Peer Educator. We will use a 
telephone script to handle all calls generated from this letter (Appendix C). If we do not meet 
our recruitment target through the letter, we will contact participants via telephone or 
doorknocking from our previous survey in these communities who agreed to be contacted for 
future research studies. We will make two telephone or door-knocking attempts before 
considering the individual a non-responder. We will use the same telephone screening script to 
recruit these participants. If we have not met our recruitment target after exhausting two contact 

Date: January 23, 2017    
Principal Investigator: Kimberly Gudzune, MD MPH Application 
Number: IRB00107116  
JHMIRB eFormA  01  
Version 3 Dated:   06/2007  
  
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attempts, then we will mail a letter (Appendix B) to all other residences in Latrobe and Gilmor 
Homes to identify additional Peer Educators. We will use a telephone script to handle all calls 
generated from this letter (Appendix C). If we still do not meet our recruitment target through 
the letter, we will contact these other households in Latrobe and Gilmor Homes via a single 
doorknocking attempt using the telephone screening script to recruit these participants. To 
address privacy issues during recruitment, all participants who are contacted or approached for 
recruitment will be assured that the research staff at Johns Hopkins will be the only ones to see 
their information, and that the information we collected will be kept private and be used only for 
the research study we are discussing. If the potential participant chooses not to enroll in the 
study or does not qualify to be in the study, then his/her information will be destroyed. Each 
Peer Educator will be responsible for recruiting one member of their social network to be 
his/her Sidekick.   
  
Peer Educators will give their potential Sidekicks an invitation (Appendix D) describing the 
study, the roles of Peer Educators and Sidekicks, and directions on how to contact study staff 
for screening. We will use a telephone script to handle all calls generated from this letter 
(Appendix E). To address privacy issues during recruitment, all participants who are contacted 
or approached for recruitment will be assured that the research staff at Johns Hopkins will be 
the only ones to see their information, and that the information we collected will be kept private 
and be used only for the research study we are discussing. If the potential participant chooses 
not to enroll in the study or does not qualify to be in the study as a Sidekick, then his/her 
information will be destroyed.  
  
Peer Educators and Sidekicks will complete a baseline study visit for data collection, along with 
3- and 6-month follow up visits for data collection (Appendices F-H). At baseline and 6-month 
follow up, data collection will include a survey that has individual-level questions, biometric 
measurements, and an egocentric social network inventory.   
 Individual-level questions:   
o Demographics including age, gender, race/ethnicity, and address  
o Dietary content with brief food frequency questionnaire using the 5-Factor NHIS 
screener  
o Modified 3-Factor Eating Questionnaire R18  Biometric measurements:   
o Height using rafter square method where respondents remove their shoes and 
stand on a smooth surface with their heels and shoulders against a wall. 
Interviewer will then place a rafter square on the respondent’s head, mark the 
height on a wall, and then measure it in inches (to the nearest quarter inch) using 
a tape measure.  
o Weight on portable scale   
o Blood pressure via automated sphygmomanometer  Egocentric social network 
inventory:   
o At baseline, each study participant will begin by listing 10 people he/she knows 
and has had contact with sometime during the past year. Only first names or 
initials of these alters will be recorded, so they are not identifiable to the research 
team and will not be sought out as research subjects. The ego will then answer 
questions regarding the natures of his/her relationship with these alters and list 
characteristics of each alter including demographics, socioeconomic status, body 

Date: January 23, 2017    
Principal Investigator: Kimberly Gudzune, MD MPH Application 
Number: IRB00107116  
JHMIRB eFormA  01  
Version 3 Dated:   06/2007  
  
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size via pictogram, as well as lifestyle behaviors. Finally, we will assess for ties 
among these alters.   
o At 3- and 6-months, we will repeat questions on body size via pictogram, 
lifestyle behaviors, and ties among these alters of the 10 original alters named at 
baseline. We will also ask each study participant to list up to 5 additional people 
who have become a part of their social network over the last 3 and 6 months, 
respectively. The ego will then answer questions regarding the natures of his/her 
relationship with these alters and list characteristics of each alter including 
demographics, socioeconomic status, body size via pictogram, as well as lifestyle 
behaviors.   
At 6 months, we will also ask questions regarding satisfaction with the intervention. At 3 
months, an abbreviated survey will be conducted that includes only individual-level questions, 
biometric measurements, and satisfaction with the intervention. Study visits will be held either 
in the administrative building of the public housing developments or during home visits based 
on participant preference. Two data collectors will be present during surveys administered in the 
respondent’s home. The survey will be administered in-person by trained research assistants. 
During the intervention, we will also collect sheets on which the Peer Educators and Sidekicks 
track their SSB intake (Appendix N).     
  
Informed consent will be obtained from each participant during the baseline study visit for data 
collection. In particular, residents will be advised of the voluntary and confidential nature of 
participation. Residents will be asked questions about the study procedures to test their 
understanding and will be given materials, written at <5th grade level, to read and take home. 
They will also be provided the contact information of the principal investigator. We will 
emphasize that their participation in the study will not affect their clinical care.   
  
All survey responses will be collected on password protected laptop computers and entered into 
the EgoNet software. EgoNet facilitates the collection of survey and egocentric social network 
data. The data is immediately stored onto the laptop’s hard drive. At the end of each day, all 
data will be transferred to a secure network share drive on the password protected desktop 
computer in a study investigator’s office (Dr. Gudzune). Once successful download is 
confirmed, the data will be erased from the laptop computer. Data will not be stored on servers 
external to the institution.   
  
b. Study duration and number of study visits required of research participants.  
Study duration will be 6 months. Peer Educators will be required to attend 6 core sessions and 3 
booster sessions for the intervention. Peer Educators and Sidekicks will complete a baseline 
study visit for data collection, along with 3- and 6-month follow up visits for data collection. 
Study visits will be held either in the administrative building of the public housing 
developments or during home visits based on participant preference.  
  
c. Blinding  
Not applicable  
  
d. Justification of why participants will not receive routine care or will have current therapy 
stopped.  

Date: January 23, 2017    
Principal Investigator: Kimberly Gudzune, MD MPH Application 
Number: IRB00107116  
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Version 3 Dated:   06/2007  
  
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Not applicable  
  
e. Justification for inclusion of a placebo or non-treatment group.  
Not applicable  
  
f. Definition of treatment failure or participant removal criteria.  
Not applicable  
  
g. Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely. Not applicable  
  
  
5.  
Inclusion/Exclusion Criteria  
For Peer Educators to participate in the pilot, one of their social network members (“Sidekicks”) 
who consume foods with added sugars daily must also enroll. Peer Educators and Sidekicks must be 
at least 18 years old and consume sugar-sweetened beverages at least twice daily. Peer Educators 
must have a BMI ≥25 kg/m2.   
  
We will exclude subjects with any underlying medical conditions that could seriously reduce their 
life expectancy, their ability to participate in the trial, or for which dietary change may be 
contraindicated and/or require medical supervision by a physician such as medication-dependent 
diabetes mellitus, cancer or malignant tumor, lung disease requiring supplemental oxygen, dementia 
or cognitive impairment, angina, or diagnosis in the last 12 months of myocardial infarction, 
congestive heart failure, transient ischemic attack or stroke, liver disease or kidney disease. We will 
also exclude women who are pregnant or breastfeeding. Only one person per household will be 
eligible to be a Peer Educator, and additional eligible household members can participate as a 
Sidekick.   
  
  
6.  
Drugs/ Substances/ Devices  
Not applicable   
  
  
7.  
Study Statistics  
a. Primary outcome variables.  
Our feasibility outcomes will include recruitment and retention rates, as well as program attendance. 
Our acceptability outcomes will include participant satisfaction with the intervention and 
willingness to recommend that a friend participate as a Peer Educator. Our effect outcome will be 
change in intake in added sugars among Sidekicks using the relevant elements in the NHIS 5-factor 
screener. With a sample size of 24, the minimal detectable intervention effect is reduction of added 
sugar intake by 16.1 tsp per day (assuming a type I error of α=0.05 (two-tailed), 80% power, and 
assuming SD of outcome of 19 based on our prior survey). Of note, a 12 oz can of soda has 
approximately 10 teaspoons of added sugars and a 20 oz bottle has approximately 17 teaspoons.  
  
b. Secondary outcome variables.  

Date: January 23, 2017    
Principal Investigator: Kimberly Gudzune, MD MPH Application 
Number: IRB00107116  
JHMIRB eFormA  01  
Version 3 Dated:   06/2007  
  
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Our secondary outcome will be change in intake in added sugars among Peer Educators using the 
NHIS 5-factor screener. We will also examine change in cognitive restraint related to intake of 
foods high in added sugars using elements modified from the Three-Factor Eating Questionnaire 
R18. We will also examine weight change both Sidekicks and Peer Educators.   
  
c. Statistical plan including sample size justification and interim data analysis.  
We will conduct descriptive analyses comparing pre- and post-intervention. We will examine 
feasibility and acceptability outcomes with t-tests and Chi Square tests. We will compare the values 
of the Sidekicks’ intake of added sugars before and after intervention with a paired, two-tailed 
ttests. We will use paired, two-tailed t-tests to compare Peer Educators’ intake of added sugars, 
Sidekicks’ weight, and Peer Educators’ weight before and after the intervention. If our outcomes are 
not normally distributed, then we will use Wilcoxon signed-rank tests in lieu of t-tests.   
  
d. Early stopping rules.  
Not applicable  
  
8.  
Risks  
a. Medical risks, listing all procedures, their major and minor risks and expected frequency. Risks 
related to the intervention include time required for participation in the group-based training 
sessions for the Peer Educators. The group sessions that will be used for Peer Educator training 
involves group discussions where individuals may feel uncomfortable and there is a risk of 
group members disclosing information about other members to people outside the group. In 
addition, making dietary changes may also pose risks such as needing to adjust the dose of 
certain medications (e.g., hypoglycemic agents) or may be inappropriate for people with certain 
medical conditions.   
  
Risks related to the data collection include loss of confidentiality, and potential discomfort, 
boredom or inconvenience from answering survey questions and undergoing measurements of 
height, weight and blood pressure. There are also risks related to interview location. We have plans 
in place to address occurrence of 1) uncontrolled hypertension and 2) participant medical illness, 
medical concerns or needs for medical services.  
  
b. Steps taken to minimize the risks.  
We will minimize risk of group discussions by advising participants that by agreeing to be in this 
study, they are agreeing not to talk about any personal details that other peer educators share in the 
group. Participants will be informed that they do not have to participate in any group discussion 
where they feel uncomfortable and can leave the session at any time. We will attempt to minimize 
the risk of dietary change by excluding participants who have medical conditions that require 
specific dietary requirements or conditions associated with decreased life expectancy (as listed in 
eligibility criteria above). We will advise all participants to talk with their doctor about making 
dietary changes before participating in this program. If patients do not have a primary care provider, 
then study staff will provide a resource listing for primary care clinics and safety-net clinical 
facilities to establish primary care. In addition, we will encourage all participants to follow up 
regularly with their doctor during the study period or if any symptoms should occur, as lifestyle 
changes can often result in the need to adjust the dose of medications.  
  

Date: January 23, 2017    
Principal Investigator: Kimberly Gudzune, MD MPH Application 
Number: IRB00107116  
JHMIRB eFormA  01  
Version 3 Dated:   06/2007  
  
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There is a risk of the loss of confidentiality of medical information. We will ensure protection of the 
data and any personal health information. Only the study team will have access to patient’s 
identifying information. Each participant will be assigned an identification (ID) number at the time 
of recruitment. The database that links the ID with the participant will only be accessible by the 
principal investigator. Data will be stored on the Johns Hopkins Department of Medicine Network 
Drive, which is password- protected and backed-up each night. If a participant changes his/her mind 
and does not wish to complete the study s/he may withdraw at any point.   
  
There is a risk of potential stress, discomfort, boredom or inconvenience from answering survey 
questions and undergoing biometric measurements. Participants will be informed that they do not 
have to answer any questions that they do not wish or have their blood pressure, height, or weight 
measured.  
  
There are risks related to interview location. Interviews will occur either at the public housing 
developments’ administrative buildings or in the participant’s home, depending upon participant 
preference.   
Interviews in the administrative or community building(s). To ensure participants’ privacy, 
we will conduct interviews in a private room or private screened booth in a conference 
room. We will play background music to decrease risk of others overhearing the interviews.   
  
Interviews in the participant’s home. To ensure the safety of our research assistants during 
data collection, we will require two data collectors to attend all home interviews. Research 
assistants will also be trained in safety procedures, and will be encouraged to halt interviews 
if they have concerns for their personal safety. There is also the potential for a member of 
our research team to encounter a potential emergency situation that is not related to study 
participation (e.g., dehydration, environmental risk, medical emergency). We refer to such 
events as “alerts” and have procedures for their management, which are outlined in Table 2.  
  
Table 2. Proposed algorithm for home emergencies  
Alert  
Action  
Medical emergency  
  
Examples:  
- Chest pains  
- Excessive bleeding  
- Fall and cannot get up  
- Difficulty breathing  
- 
If situation occurs within the home, then staff person calls 911 immediately, 
and stays with participant until help arrives.    
- 
JHU research coordinator (RC) and PI are informed within 24 hours of the 
event.  Research staff member completes Protocol Alert Reporting Form (Appendix 
H) and gives to JHU RC/PI.  
- 
RC then contacts individual as a follow-up within two days.   
Evidence of physical abuse  
  
Examples:  
- 
Participant or other person in 
household states to research staff that 
abuse occurs  
- 
Research staff observes 
physical evidence (e.g., black eye, 
black and blue marks on arms/legs)  
- 
Research staff member informs participant that a RC/PI will contact him/her 
later that day.  Staff member informs RC/PI immediately upon completion of 
interview. Research staff member completes Protocol Alert Reporting Form 
(Appendix H) and gives to JHU RC/PI.   
- 
RC/PI contacts participant to obtain further information. Participant is 
strongly encouraged to call his/her physician and/or Baltimore City Social Services 
(Adult or Child Protective Services as appropriate)(phone number will be provided).    
- 
Based on the situation, the RC/PI may notify Adult or Child Protective 
Services.  
RC (or designate) completes Alert form.  

Date: January 23, 2017    
Principal Investigator: Kimberly Gudzune, MD MPH Application 
Number: IRB00107116  
JHMIRB eFormA  01  
Version 3 Dated:   06/2007  
  
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Extreme home hazards  
  
Examples:  
-Exposed electrical  
-External door missing or cannot be 
locked  
-Ceiling, floors caved in  
-No temperature control in 
extreme weather conditions -Major 
infestation  
- JHU research coordinator (RC) and PI are informed within 24 hours of the event.  
Research staff member completes Protocol Alert Reporting Form (Appendix H) and 
gives to JHU RC/PI.  
-RC/PI will notify HABC service coordinator or maintenance staff of situation.  
  
  
  
We address the protections against the additional risks below:  
1) 
Plan for occurrence of uncontrolled hypertension. During blood pressure assessment, we 
may discover that a subject has uncontrolled hypertension. We will develop a blood pressure safety 
alert algorithm to handle this scenario. Data collectors will be instructed to complete the algorithm 
after every blood pressure measurement. We will specify blood pressure ranges for various levels of 
adequate and inadequate control based on current guidelines from the Joint National Committee on 
Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC 7). Based on the 
blood pressure level, the algorithm will indicate advice that the data collectors/project staff should 
provide the participant and will also indicate questions that they should ask the participant when an 
abnormal value is obtained. Research staff will complete the Protocol Alert Reporting Form 
(Appendix I). Dr. Gudzune, the study physician, will be available to the data collectors and study 
staff to assist in this algorithm. We anticipate that the some of our participants will not have access 
to a primary care provider. We plan to provide participants with a resource listing for primary care 
clinics, safety-net clinical facilities and urgent care centers in their area. If an emergency arises we 
will call 911. Table 3 provides additional details on our proposed blood pressure safety alert 
algorithm. We will provide each participant with a letter documenting their biometric values 
(including blood pressure) that they can share with their healthcare provider (Appendix J).  
  
Table 3. Proposed algorithm for elevated blood pressure  
 
Blood Pressure  
Control  
Advice  
Check  
SBP ≤139  
DBP≤ 89  
Adequate  
N/A  
Compliance with diet and 
medications (if prescribed)  
SBP 140-159 DBP 
90-99  
Inadequate  
Stage I hypertension  
Advise to discuss with physician at 
next scheduled visit  
Compliance with diet and 
medications (if prescribed)  
SBP 160-179  
DBP 100-109  
Inadequate  
Stage II hypertension  
Advise to make an appointment to see 
physician for repeat blood pressure 
check in 7 days  
Make sure participant has taken 
daily medication (if prescribed), if 
they have not taken meds then 
advise to do so  
SBP ≥180  
DBP ≥110  
Inadequate  
Stage II hypertension  
Call study physician to discuss  
Refer to emergency department  

Date: January 23, 2017    
Principal Investigator: Kimberly Gudzune, MD MPH Application 
Number: IRB00107116  
JHMIRB eFormA  01  
Version 3 Dated:   06/2007  
  
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2) 
Plan for occurrence of participant medical illness, medical concerns or need for medical 
services during the study. We anticipate that the some of our participants will not have access to a 
primary care provider and may look to the study staff for help with personal or family medical 
concerns or illness. If these concerns arise during the study, we plan to provide participants with a 
resource listing for primary care clinics, safety-net clinical facilities and urgent care centers in their 
area  (Appendices K & L). If an emergency arises we will recommend calling 911. We will also 
have a list of social services resources for residents who report issues with food insecurity 
(Appendices K & L).  
  
c. Plan for reporting unanticipated problems or study deviations.  
Unanticipated problems or study deviations will be reported to the IRB, the NIH, and if applicable 
to all study participants in a letter.  
  
d. Legal risks such as the risks that would be associated with breach of confidentiality. None  
  
e. Financial risks to the participants.  
None  
  
9.  
Benefits  
Participants may benefit from participating in the training to increase their knowledge about healthy 
diet. This study will provide benefit to society at-large, as our results will fill an important gap in 
the medical literature to understand how social networks may help facilitate lifestyle change and 
alter the development of obesity, which is now an epidemic in the U.S. We believe that the risks to 
subjects are low and reasonable given the knowledge to be gained.   
  
10.  
Payment and Remuneration  
We will offer all participants an incentive to complete the baseline and follow up assessments ($50 
for baseline and 6-month assessments; $25 for 3-month assessment). Total possible compensation 
for data collection is $125. In addition, we will offer Peer Educators an additional $300 incentive to 
compensate them for the time required to attend the training sessions. We will require that Peer 
Educators attend at least two-thirds of all sessions (at least 6 out of the 9 sessions) to be eligible for 
this compensation. This additional compensation will be distributed during the final booster session. 
For Peer Educators eligible for this compensation that do not attend the final booster session, the 
study team will attempt to contact the Peer Educator to arrange a time to personally deliver the gift 
card to them.   
  
11.  
Costs  
There are no costs to participants. Participants who require a letter of excuse from work or school 
will be provided with a signed letter explaining that they participated in a medical study at Johns 
Hopkins with the appropriate date and time of participation (Appendix M).