Feasibility of a Soccer-based Adaptation of the Diabetes Prevention Program
Phase: NA
Conditions: Diabetes
Sponsor: Emory University

Feasibility of a Soccer-based Adaptation of the Diabetes Prevention Program 
 
Soccer DPP 
 
Scientific Protocol 
 
 
Principal Investigator - Felipe Lobelo, MD, Emory University Rollins School of Public 
Health, Global Health 
 
 
 
 
Sponsor: Georgia Center for Diabetes Translation Research  
 
NCT Number: NCT03595384 
 
Protocol Version 3, dated 11-6-2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Background and Rationale 
Football (soccer) has proven successful as a health intervention globally, owing in large part to its extreme 
popularity with over 500 million active participants worldwide.(1) The Federation Internationale de Football 
Association (FIFA) developed the initiative “Football for Health” to help reduce NCDs starting in Africa (2) and 
later in adolescents in Mexico as “FIFA 11 for Health.”(1, 3) Additionally in 2010, FIFA marketed the evidence-
based phrase “Playing football for 45 minutes twice a week – best prevention of NCDs.”(4) Soccer has also 
been leveraged to deliver lifestyle intervention programming in several European countries. (5, 6) 
 
Recreational soccer (RS) is effective in reducing cardio-metabolic risk in both children and adults of all shapes 
and backgrounds, which stems from its varied movement patterns and highly functional training throughout a 
single session. (7) Generally, RS participants achieve more than 100 high-intensity runs and specific 
intense actions such as dribbles, shots, tackles, turns and jumps over a typical 1-hour training session, with 
average heart rates being around 80% of maximal heart rate, irrespective of age, fitness status and 
previous experience of football training. These high intensity intervals result in broad-ranging physiological 
effects such as reduced insulin resistance, chronic inflammation and arterial stiffness and have positive effects 
on T2DM and cardiovascular disease (CVD) risk factors.(8, 9) Evidence indicates that high intensity interval 
training (HIIT) modalities such as RS are not only highly efficacious but also safe and engaging interventions 
for cardio-metabolic risk reduction.(10-12) In addition, RS also builds social capital and is associated with 
positive motivational factors.(4)  
 
In a two-arm, pragmatic, randomized controlled trial (n=747 men aged 35–65 years with a BMI of ≥ 28 kg/m2) 
soccer program, an average 4.36% weight-loss effect (95% CI 3.64% to 5.08%) was reported in favor of the 
intervention.(13) Highly significant improvements on waist, percentage body fat, systolic and diastolic blood 
pressure, self-reported PA, diet and indicators of well-being and physical aspects of quality of life were also 
observed. At an estimated cost £862 per additional participant maintaining a 5% weight reduction at 12 months 
and £13,847 per additional QALY, compared with no active intervention, there was an 89% probability for the 
program to be cost-effective at the prevailing £30,000/QALY threshold in the UK health care system.(13) 
 
Adherence to PA in sedentary individuals is an ongoing challenge with barriers including lack of intrinsic 
motivation, time and resources.(14) Rate of perceived exertion plays a key role for PA sustainability in 
untrained individuals (15) and is lower when activity intensity is self-selected. (16) There is no difference 
between RS sessions of 3v3, 5v5 or 7v7 when the pitch is adapted for number of players. (17). Despite the 
high heart rates, small-sided RS had the lowest perceived exertion rate (4 out of 10) when compared to 
other forms of HIIT such as interval running. (17) This may explain the high adherence rates (> 90%) for 
participants in RS interventions and high enjoyment reports while also maintaining interest in playing RS 
even after the intervention period was over.(18) RS could be a key intervention to engage the Hispanic male 
community in Atlanta in health promoting PA. 
 
Men, in general, are harder to engage in traditional disease prevention programs using traditional diet and PA 
interventions (19), Several studies have translated the DPP to be culturally-specific to the Hispanic community 
in various settings but predominantly in females.(20, 21) Hispanic men are significantly understudied and 
we are not aware of DPP translational programs tailored to Hispanic male populations. These community-
based approaches had retention rates ranging between 63-93% after the core sessions at 6 months. These 
approaches worked well in females, but there was little discussion on what drove the lack of recruitment 
in males. Furthermore, previous DPP translation trials typically lack reporting of PA results, one of the pillars of 
the program, specifically objectively-measured PA.(22) 
 
Using technology in an intervention setting can be a simple, efficient, motivational substitute to the traditional 
DPP format. An abbreviated mobile application version of the DPP was employed effectively in a multiethnic 
population in San Francisco. This study provided an iOS mobile app in combination with an in-person five 
month DPP. (23) This group of mostly middle-aged (mean 55 years) females had a retention rate of 93% at 
five months with a mean 7% weight loss. (23) A 13-week diabetes prevention program was implemented in 
Northern Mexico, in which 63% of the 184 participants completed the intervention. This mostly female cohort 
improved their fasting glucose by 7.5 ng/dL after a 3-month follow up. (24) In summary, the DPP can be 
adapted to a Hispanic community and abbreviated to coincide with a RS intervention.  
 
Our objective is to harness the popularity of RS in local Atlanta Hispanic males and determine the feasibility of 
a RS implementation in combination with online education and facilitated lifestyle coaching to decrease T2DM 

risk. Translating the DPP with a simple online tool and alongside a free opportunity to play a venerated sport in 
a supportive atmosphere may prove to be exactly what is needed for adherence in Hispanic males. 
Protocol Synopsis 
 
Study Design: A longitudinal pre-post pilot intervention study evaluating feasibility of implementation of a 
soccer-based Diabetes Prevention Program and preliminary changes in physical activity and diet-related 
measures. 
 
Planned Sample Size: 40 subjects 
 
Subject population: Hispanic overweight males age 35 to 55 years with a CDC pre-diabetes risk score ≥ 9 
and not currently engaged in soccer or other regular physical activity. 
 
Specific Aims 
 
We will test the following central hypothesis: A soccer-based adaptation to the DPP can be feasibly 
implemented in a population of middle-age Latino men at high risk for T2DM.  
 
Aim 1: 1a: To adapt the current National Diabetes Prevention Program (NDPP) curriculum to a novel,  
 
translational soccer-based DPP programming and delivered by trained coaches as facilitators.  
 
1b: To conduct formative research addressing barriers and acceptability for implementation of this 
soccer-based DPP adaptation among Latino adults via questionnaires and key informant interviews. 
 
Aim 2: 2a: To assess implementation feasibility of this novel soccer-based DPP adaptation by conducting a 
single-arm, pre-post pilot study among Latino males (n=40; 35-55 years) residing in the Atlanta metro area. 
 
 
2b: To explore preliminary signals for improvements in objectively-measured PA, dietary  behaviors, 
physical fitness and body composition outcomes with our soccer-based DPP adaptation.  
 
Overweight (BMI between 25 and 60 kg/m2) participants at high risk for T2DM (CDC pre-diabetes screening tool 
score >9)(25) will be recruited through soccer interest groups, local leagues and Hispanic health organizations. 
After a baseline assessment visit, participants will attend soccer practice twice/week for 12-weeks while 
completing NDPP core curriculum modules with facilitated discussion by trained coaches during each soccer 
practice. Participants will then be invited to join an established small-sided soccer league in their community (12-
weeks) offering one game/week and also complete the NDPP maintenance modules and PA/diet self-tracking 
via mobile health technologies. After the core (12-weeks) and maintenance intervention periods (24- weeks) 
baseline measurements will be repeated. We will also conduct a 1-year follow up assessment after 6 months of 
minimal contact. Data on the feasibility of this DPP soccer-based adaptation will inform future randomized, 
controlled trials testing the effectiveness of this translation model to reduce T2DM risk while extrapolating to 
other sports-based adaptation and age, gender and racial sub-populations. 
 
 
Research Design: 
 
Organizational structure of study team: This study was investigator initiated and proposed to the Georgia 
Center for Diabetes Translation Research at Emory University as part of an internal pilot grant. The funder’s 
expectation was for the investigator to conduct feasibility or pilot research to support a larger grant. Funder will 
provide a speedtype for all expenses related to the study. 
 
Setting: Aim 1 will be conducted in the field at Latino community health fairs put on by Ventanillas de Salud. 
The majority of Aim 2 will be conducted on rented soccer fields, no permission is needed to conduct the study, 
but field owners are aware of the study be conducted. All data will be collected on paper and transferred to a 
RedCap database at Emory University Rollins School of Public Health. 
 
Aim 1a. During the first phase of this pilot study, we will adapt the CDC’s NDPP to an electronic online curriculum 
dissemination, accelerated to conform to our planned 24-week soccer intervention while maintaining the 
separation between core and maintenance modules.  
 
Experienced soccer coaches will be identified and hired from the local area to deliver the RS program. These 
coaches will be trained in two key aspects of the program: 1) leading small-sided RS training designed to safely 

engage pre-diabetic participants in HIIT conditioning; 2) facilitate the lifestyle coaching in the NDPP curriculum 
by devoting time during each soccer training session to reviewing the NDPP material, fostering discussion and 
using the groups’ social dynamics to promote sustained lifestyle behavior change and increase self-efficacy. 
These coaches will be the primary facilitator of the study, conducting both soccer specific activities and online 
education discussion. The study staff will conduct consent and all measurements and assessments. 
 
 
 
Aim 1b. Secondly, we will conduct a brief survey among middle-aged adult Latino community members to 
determine potential barriers to participation in the soccer-adapted NDPP program and usability of mobile health 
technologies. These interviews will inform scheduling and recruitment for Aim 2. We will focus recruitment in 
Clayton (13%), Cobb (12.8%), and Gwinnett (20.5%) counties which have the highest percentages of Hispanic 
residents.  
 
 
Aim 2. We will conduct a pilot feasibility study in 40 males recruited from the local Atlanta community.  
 
Inclusion criteria  
 
1) Hispanic/Latino men aged 35-55 years 
 
2) BMI ≥ 25 kg/m2 
 
3) CDC pre-diabetes risk score ≥ 9 (25) 
 
4) Not currently engaged in soccer practice or league or other PA or lifestyle intervention program 
 
5) Ability to read in English or Spanish and provide inform consent 
 
Exclusion criteria 
 
1) T2DM diagnosis or medication 
 
2) BMI ≥ 41 
 
3) Resting blood pressure ≥165/100 at screening  
 
4) Any mobility issues or contraindications for HIIT PA program (26)  
 
 
Recruitment: Participants will be recruited from the mentioned local Atlanta area organizations using online a 
study recruitment flier in both print and electronic format. Interested participants will be provided an online survey 
to ascertain eligibility (CDC pre-diabetes screening, demographic questions and PA habits) and those meeting 
inclusion criteria will be invited to an informative session at one of participating soccer field for informed consent 
and confirmatory baseline assessments including BMI, blood pressure, HbA1c and exercise pre-participation 
risk screening. Siemens DCA Vantage HbA1c point-of-care devices will be used for screening of diabetes. (27) 
A cut off point of 6.5% will be used as a putative definition of diabetes and these individuals will be referred to a 
local clinic for confirmatory testing and appropriate management. (28) Both systolic and diastolic blood pressure 
will be measured while sitting using a calibrated electronic blood pressure sphygmomanometer prior to any 
activity and after five minutes of rest. Participants meeting inclusion and exclusion criteria will be invited to 
participate in the study. 
 
 
Study Assessments. Prior to testing, subjects will be asked to refrain from physical activity for 48 hours prior 
to test day, refrain from alcohol 24 hour prior to testing, and refrain from caffeinated drinks, smoking and other 
stimulants one hour prior to testing. Assessments will be conducted at baseline during the first soccer practice 
and after the 12-week initial soccer conditioning phase. Assessments will also be repeated at 24-weeks and 1 
year from study initiation at the final monthly meeting after the soccer league (maintenance phase of the 
program) has been completed. Blood pressure, HbA1c, height and weight, waist circumference, aerobic and 
musculoskeletal fitness assessments will be performed. In addition, questionnaires will be used for self-
reported physical and mental health, quality of life, PA and diet self-efficacy, program satisfaction and injuries.  
Dietary recalls will be conducted at baseline, 12, 24 weeks, and 1 year and by trained staff and analyzed using 
Nutrition Database System for Research.(29) Participants will participate in online education modules located 
on the CDC website during an initial 12 week conditioning phase where they will participate in soccer drills and 
other fitness routines (two 1-hour sessions per week). At the 12 week mark participants will transition onto a 
soccer league team for the following 12 weeks where they will continue to complete online modules and meet 
with the soccer coach monthly to discuss. There will be a 1-year follow up to be conducted 6 months from the 
final soccer session to complete all measurements again. During the soccer sessions/games participants will 

be fitted with a wearable soccer-specific device to measure how much they move and their heart rate.  All of 
these measurements will done on the soccer field. In addition, they will also be asked to wear a Garmin fitness 
tracker for the duration of the study to measure steps and moderate and vigorous activity. The online education 
will be a version of the Diabetes Prevention Program and can be completed on a phone or computer with 
internet access. We will send reminders by text message to do the online education and the soccer coach will 
talk to the soccer team during soccer practice about what they’ve learned and answer any questions they may 
have about the education material. 
Informed Consent Process: 
Adult consent forms in both English and Spanish will be prepared for this study. The consent form will describe 
the purpose of the study, the procedures and risks. Participant will be presented with the consent form by the 
PI of the project, who is a native Spanish speaker and has conducted many research studies in the Hispanic 
community in the US as well as Latin America, in person and given time to read and ask questions. A signed 
consent form will be obtained from the participant. A copy of the consent form will be given to the participant 
and this process will be documented. 
 
Risks: 
There is minimal risk in this study. Potential risks are related to 1) Finger sticks 2) Physical injury related to 
sport and 3) Confidentiality. 1) A single-use finger stick device will be used during assessments along with 
alcohol to clean the site prior to stick to reduce chances of infection. 2) Exercise can cause muscle soreness, 
weakness and in some cases muscle strains, ligament sprains and rarely bone fractures can occur. In very 
rare cases exercise can induce chest pain or a heart attack or other medical emergency. The training program 
led by the soccer coach is designed to minimize risk of injuries or events by slowly progressing on the practice 
of soccer using soccer and exercise drills appropriate for your age and level of fitness. Soccer sessions will be 
led by trained professionals who are able to offer suggestions to limit and prevent these adverse events. They 
are trained to recognize medical emergencies, will have basic equipment available, and seek emergency care 
if needed.  3) There is a risk of loss of confidentiality. Efforts will be made to keep all personal information 
confidential. All data will be stored in locked offices and password-protected computers. Personal identity will 
be protected in any publication. 
Benefits:  There are no direct benefits of this study beyond opportunity to exercise and information about 
healthy behaviors. 
Compensation: 
Participants will receive free entry into soccer leagues in their local area for the maintenance portion of the 
study. (A ~$100 value) Subjects that complete the study will be allowed to keep the Garmin fitness tracker. 
 
Data Analytics and Statistical Plan: 
Data and statistics will be managed by the PI and the study team using RedCap. Any paper forms will be kept 
in a locked cabinet in a locked office. Demographics and characteristics of the overall cohort will be tabulated 
using means and standard deviations or counts and percentages, as appropriate. Prior to analysis, continuous 
measures will be tested for normality. Non-normally distributed variables will be transformed prior to analysis or 
non-parametric approaches will be utilized. Linear regression will be used to control for anthropometrics and 
other factors that may influence improvement and will contain no more than five predictors at a time, given our 
sample size of 40. Standardized mean differences and effect sizes with associated 95% CI will be calculated 
for outcomes of interest.  
 
Training of study team: 
 As stated above all staff and soccer coaches will receive adequate training of all study procedures. All study 
staff and collaborators will take CITI training upon hire. 
 

Confidentiality: Screens will be used on the soccer fields for consent and study measurements. All 
participants will receive a study ID and this will be used on all paper and electronic forms. We will destroy all 
identifiers and any audio from key interviews after the study is complete. 
 
 
References 
1. 
Barriguete Melendez JA, Dvorak J, Cordova Villalobos JA, Juan Lopez M, Davila Torres J, Compean Palacios J, et 
al. FIFA 11 for Health in Mexico: a school-based intervention for the prevention of obesity and non-communicable 
diseases. Br J Sports Med. 2014;48(12):940-1. 
2. 
Fuller CW, Junge A, DeCelles J, Donald J, Jankelowitz R, Dvorak J. ‘Football for Health’—a football-based health-
promotion programme for children in South Africa: a parallel cohort study. Br J Sports Med. 2010;44(8):546-54. 
3. 
Correa JE, Meneses-Echavez JF, Barengo NC, Tovar G, Ruiz-Castellanos E, Lobelo F, et al. Iniciativas escolares y 
deportivas lideradas desde la Federation Internationale de Football Association (FIFA): revision sistematica. Global 
health promotion. 2015;22(3):67-76. 
4. 
Blatter JS, Dvorak J. Football for health - science proves that playing football on a regular basis contributes to the 
improvement of public health. Scand J Med Sci Sports. 2014;24 Suppl 1:2-3. 
5. 
van Nassau F, van der Ploeg HP, Abrahamsen F, Andersen E, Anderson AS, Bosmans JE, et al. Study protocol of 
European Fans in Training (EuroFIT): a four-country randomised controlled trial of a lifestyle program for men delivered 
in elite football clubs. BMC Public Health. 2016;16:598. 
6. 
Hunt K, Wyke S, Gray CM, Anderson AS, Brady A, Bunn C, et al. A gender-sensitised weight loss and healthy living 
programme for overweight and obese men delivered by Scottish Premier League football clubs (FFIT): a pragmatic 
randomised controlled trial. Lancet. 2014;383(9924):1211-21. 
7. 
Krustrup P, Dvorak J, Junge A, Bangsbo J. Executive summary: the health and fitness benefits of regular 
participation in small-sided football games. Scand J Med Sci Sports. 2010;20 Suppl 1:132-5. 
8. 
de Sousa MV, Fukui R, Krustrup P, Pereira RM, Silva PR, Rodrigues AC, et al. Positive effects of football on fitness, 
lipid profile, and insulin resistance in Brazilian patients with type 2 diabetes. Scand J Med Sci Sports. 2014;24 Suppl 1:57-
65. 
9. 
Bangsbo J, Hansen PR, Dvorak J, Krustrup P. Recreational football for disease prevention and treatment in 
untrained men: a narrative review examining cardiovascular health, lipid profile, body composition, muscle strength and 
functional capacity. Br J Sports Med. 2015;49(9):568-76. 
10. 
Jung ME, Bourne JE, Beauchamp MR, Robinson E, Little JP. High-intensity interval training as an efficacious 
alternative to moderate-intensity continuous training for adults with prediabetes. Journal of diabetes research. 
2015;2015:191595. 
11. 
Ramos JS, Dalleck LC, Tjonna AE, Beetham KS, Coombes JS. The impact of high-intensity interval training versus 
moderate-intensity continuous training on vascular function: a systematic review and meta-analysis. Sports Med. 
2015;45(5):679-92. 
12. 
Rognmo O, Hetland E, Helgerud J, Hoff J, Slordahl SA. High intensity aerobic interval exercise is superior to 
moderate intensity exercise for increasing aerobic capacity in patients with coronary artery disease. European journal of 
cardiovascular prevention and rehabilitation : official journal of the European Society of Cardiology, Working Groups on 
Epidemiology & Prevention and Cardiac Rehabilitation and Exercise Physiology. 2004;11(3):216-22. 
13. 
Wyke S, Hunt K, Gray CM, Fenwick E, Bunn C, Donnan PT, et al. Public Health Research.  Football Fans in Training 
(FFIT): a randomised controlled trial of a gender-sensitised weight loss and healthy living programme for men - end of 
study report. Southampton (UK): NIHR Journals Library; 2015. 
14. 
Bautista L, Reininger B, Gay JL, Barroso CS, McCormick JB. Perceived barriers to exercise in Hispanic adults by 
level of activity. Journal of physical activity & health. 2011;8(7):916-25. 
15. 
Dishman RK, Sallis JF, Orenstein DR. The determinants of physical activity and exercise. Public Health Rep. 
1985;100(2):158-71. 
16. 
Elsangedy HM, Krinski K, Machado DG, Agricola PM, Okano AH, Gregorio da Silva S. Self-selected intensity, 
ratings of perceived exertion, and affective responses in sedentary male subjects during resistance training. Journal of 
physical therapy science. 2016;28(6):1795-800. 

17. 
Randers MB, Nielsen JJ, Bangsbo J, Krustrup P. Physiological response and activity profile in recreational small-
sided football: no effect of the number of players. Scand J Med Sci Sports. 2014;24 Suppl 1:130-7. 
18. 
Nielsen G, Wikman JM, Jensen CJ, Schmidt JF, Gliemann L, Andersen TR. Health promotion: the impact of beliefs 
of health benefits, social relations and enjoyment on exercise continuation. Scand J Med Sci Sports. 2014;24 Suppl 1:66-
75. 
19. 
Hunt K, McCann C, Gray CM, Mutrie N, Wyke S. "You've got to walk before you run": positive evaluations of a 
walking program as part of a gender-sensitized, weight-management program delivered to men through professional 
football clubs. Health Psychol. 2013;32(1):57-65. 
20. 
Merriam PA, Tellez TL, Rosal MC, Olendzki BC, Ma Y, Pagoto SL, et al. Methodology of a diabetes prevention 
translational research project utilizing a community-academic partnership for implementation in an underserved Latino 
community. BMC Medical Research Methodology. 2009;9:20. 
21. 
Ruggiero L, Oros S, Choi YK. Community-based translation of the Diabetes Prevention Program's lifestyle 
intervention in an underserved Latino population. The Diabetes Educator. 2011;37(4):564-72. 
22. 
Eaglehouse YL, Kramer MK, Rockette-Wagner B, Arena VC, Kriska AM. Evaluation of physical activity reporting in 
community Diabetes Prevention Program lifestyle intervention efforts: A systematic review. Prev Med. 2015;77:191-9. 
23. 
Fukuoka Y, Gay CL, Joiner KL, Vittinghoff E. A Novel Diabetes Prevention Intervention Using a Mobile App: A 
Randomized Controlled Trial With Overweight Adults at Risk. Am J Prev Med. 2015;49(2):223-37. 
24. 
Denman CA, Rosales C, Cornejo E, Bell ML, Munguia D, Zepeda T, et al. Evaluation of the community-based 
chronic disease prevention program Meta Salud in Northern Mexico, 2011-2012. Prev Chronic Dis. 2014;11:E154. 
25. 
Centers for Disease Control and Prevention. CDC prediabetes screening test. In: Program NDP, editor. Atlanta, 
GA2016. 
26. 
Riebe D, Franklin BA, Thompson PD, Garber CE, Whitfield GP, Magal M, et al. Updating ACSM's 
Recommendations for Exercise Preparticipation Health Screening. Med Sci Sports Exerc. 2015;47(11):2473-9. 
27. 
Siemens Healthineers. DCA Vantage Analyzer 2017 [Available from: http://usa.healthcare.siemens.com/point-of-
care/diabetes/dca-vantage-analyzer. 
28. 
American Diabetes Association. Standards of Medical Care in Diabetes. Diabetes Care. 2017;40(Supp 1). 
29. 
Harnack L, Stevens M, van Heel N, Schakel S, Dwyer JT, Himes J. A computer-based approach for assessing 
dietary supplement use in conjuction with dietary recalls. Journal of Food Composition and Analysis. 2008;21:S78-82. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Protection of Human Subjects 
Risk to the Subjects 
Human Subjects Involvement and Characteristics. We will recruit 40 subjects for this study who are overweight 
or obesity class 1. Subjects will be required to meet the following inclusion criteria: 1) Hispanic/Latino men aged 
35-55 years; 2) BMI ≥ 27 kg/m2; 3) CDC pre-diabetes risk score ≥ 9; 4) not currently engaged in soccer practice 
or other PA or lifestyle intervention program; 5) ability to read in English or Spanish and provide inform consent; 
Exclusion criteria are participants with 1) T2DM diagnosis or medication; 2) BMI ≥ 33; 3) resting blood pressure 
≥165/100 at screening 4) any mobility issues or contraindications for HIIT PA program Subjects will be recruited 
from local Atlanta area Latino health centers. Each subject will receive a free intervention performed by trained 
soccer coaches in a small group format. Enrollment fees for league play will be covered by the study. Retention 
of these subjects will be aided by text messages give through the app technology used to track physical activity. 
Research Material Collected: These will include medical history (previous diagnoses), demographic 
information, anthropometrics, blood pressure, HbA1c, physical activity assessments and tracking of physical 
activity via a fitness tracker throughout the study. 
Potential Risks: 
There is some mild discomfort with the finger stick required by the HbA1c point-of-care device. Standard sterile 
techniques will be used; thus, infection is unlikely. There is small-to-moderate risk of injury with the most 
common being muscle strains and joint sprains while playing soccer and during conditioning. However, we will 
implement an evidence-based approach proven to reduce in up to 40% the risk of common soccer injuries and 
protocols to screen for exercise-related adverse events. Soccer coaches will be certified in cardio-pulmonary 
resuscitation and soccer field protocols for emergency situations reviewed and improved as needed, including 
availability of AED’s. There is a small risk of loss of confidentiality.  We will follow all procedures required by 
Emory University to protect participants.  Efforts will be made to ensure that all personal information remains 
confidential.  All data will be stored in locked offices and password-protected computers. The study app we will 
be using is HIPAA compliant and approved by Emory IT services.  Personal identity will be protected in any 
publication. 
Adequacy of Protection Against Risks 
Recruitment and Informed Consent: Aim 2 will require prospective recruitment of 70 (expect 30 screen fails for 
an enrollment of 40) subjects. Recruitment will be through Latino health centers. Permission to perform this 
study will be sought from the Emory University IRB.  At the time of screening, the trained study staff will 
discuss the study with the subject and give them all the information listed above in language understandable at 
the level of the subject and all information needed to make an informed choice about participation. Informed 
consents will be obtained prior to initiating any study procedure.  
Protection Against Risk: Risk will be minimized to the subjects by continuous monitoring and water breaks 
when needed.  Risk to confidentiality will be reduced by using non-identifying participant numbers and 
removing all identifiers as early as feasible.  Only study personnel will have access to identifying data.  
Coaches will be on a first name basis with subjects but not have access to non-relevant data. 
Potential Benefits of the Proposed Research to the Participants and Others 
The proposed research has substantial potential benefits for these men. The positive engagement of Hispanic 
men in a successful diabetes prevention program will allow for expansion into other communities as well as 
with children and adolescents and women, ultimately resulting in improved quality of life in the Hispanic 
community.  Each man in the study will undergo assessments not typically clinically available.  
Any new diagnosis of diabetes or potential hypertension that occurs during the research studies will be shared 
with the subject and they will be referred to their doctor or health clinic.