Insulin Superheroes Club: Diabetes Prevention Program in Youth (12-month Supplement to the CDC DPP for Adults)
Phase: NA
Conditions: Pre Diabetes
Sponsor: University of Tennessee

Study Protocol and Statistical Analysis Plan 
 
Title: “Insulin Superheroes Club: Diabetes Prevention Program in 
Youth (12-month Supplement to the CDC DPP for Adults)” 
 
NCT: 03042936 
 
Date: 03/08/2017 

UTHSC IRB Memphis Form 1: Study/Project Application (Version 1.21)
1.0
General Information
*Please enter the full title of your study. 
The UTHSC IRB (Memphis) may add to your title using brackets; please do not amend the information 
within the brackets. 
Insulin Superheroes Club
 
 
*Please enter a working title up to 15 characters.
Insulin Superheroes Club
Working Title
 
 
2.0
Add Department(s)
2.1
 List all departments and affiliate institutions associated with this study/project, and 
*
always mark the Principal Investigator's UTHSC department as the primary department. If 
any of your study/project activities are being conducted at the following sites, list these 
organizations as well: Methodist and/or Le Bonheur, Regional One Health, Clinical Research 
Center (CRC), Office of Clinical Research, UTMG, Graduate School of Medicine, University 
Health System, University of Tennessee, Knoxville, Oak Ridge National Laboratories, 
University Family Physicians, UT Genetics Center, etc. 
Primary 
Dept?
Department Name
LeBonheur - LeBonheur Children's Hospital
UTHSC - 
 - Peds - General Pediatrics
COM
 
3.0
Assign key study personnel(KSP) access to the study
3.1 *Please add a Principal Investigator for the study:
 
Mantilla, Chantis, Ph.D.
Select if applicable
Student
Department Chair
Resident
Fellow
If the Principal Investigator is a Student, Resident, or Fellow, the name of the Faculty Advisor 
must be supplied below.
 
3.2 If applicable, please select the Research Staff personnel:
 
A) Additional Investigators
Han, Joan C, MD 
 Co-Investigator
Hare, Marion Elizabeth, MD, MS 
 Co-Investigator
N

Jones, Tamekia, PhD 
 Co-Investigator
Smith, Webb A, PhD 
 Co-Investigator
B) Research Support Staff
Alshibli, Noor 
 Research Staff
Chow, Christopher R 
 Research Staff
Cole, Shelby, MS 
 Research Staff
Cunningham, Christopher 
 Research Staff
Cutshall, Michael Bartley 
 Research Staff
DECKER, KRISTINA, MS 
 Research Assistant
Gray, Emily, MSN 
 Research Nurse
HARRELL, CAMDEN 
 Data Clerk
Harlan, Matthew Shea 
 Research Staff
Kiley, Shannon 
 Research Staff
Mack, Raquel T, BSN, CCRP 
 Research Nurse
Morrison, Annie Ruth 
 Research Staff
Parvathareddy, Rohith 
 Research Staff
Pulusani, Srinidhi Reddy 
 Research Staff
3.3 *Please add a Study Contact:
 
Kiley, Shannon 
Mantilla, Chantis, Ph.D. 
The Study/Project Contact(s) will receive all important system notifications. (The study/project 
contact(s) are typically the Study Coordinator(s) and the Principal Investigator).
3.4 If applicable, please add a Faculty Advisor:
 
3.5 If applicable, please select the Designated Department Approval(s):
 
McCullers, Jon, M.D. 
Department Chair
Add the name of the individual authorized to approve and sign off on this protocol from your 
Department (e.g., the Department Review Chair, Dean, and/or Division Chief).

3.6 If applicable, please select the Research Administrative Specialist(s):   Add the appropriate 
Research Administrative Specialist if any of the following activities will occur at the 
institutions listed below: identification of subjects through review of their medical records; 
recruitment of subjects; consent of subjects; performance of screening procedures; 
interventions or interactions with subjects; follow-up visits; or collection of private 
information about subjects. If none of the activities described will occur at any of these 
  
locations, you do not need to complete this section of the application.   
 Le Bonheur Children's Hospital - Ashley Thompson, MHA, CCRP
 Regional One Health/UT Regional One Physicians (UTROP) -  Amira Wohabrebbi, PhD, 
BSN, RN
 
 
Sentiff, Lisa, MPH, CCRC 
4.0
 (415) Key Project Personnel Contact Information
4.1  
 * For the Principal Investigator and all Study Contacts (as listed in sections 3.1 & 3.3 above), answer ALL questions asked 
below.  All OTHER key study personnel (as listed in sections 3.2A & B) must be added below ONLY if they will obtain 
consent or have access to research records; however, you do not have to complete any other questions for those persons (i.e., 
just the last 2 questions).
:  All iMedRIS correspondence will be sent automatically to the Study Contacts' UT email account.  You may contact 
Note
the HELP Desk at (901) 448-2222 to have your UT email forwarded to another account at Methodist, yahoo, gmail, etc. 
revised 12/05/2016
       Entry 1       
Name
Mantilla, Chantis, Ph.D.
Office Address
50 North Dunlap Street RM 477R
Office Phone Number
(901) 287-6867
Cell Number
3057932552
Pager
E-mail Address
cmantill@uthsc.edu
Degree
PhD
Rank
Assistant Professor
Will obtain informed consent
Yes
Access to research records
/specimens
Yes
       Entry 2       
Name
Mack, Raquel T, BSN, CCRP
Office Address
50 North Dunlap Street, Room 367R
Memphis, TN 38103
Office Phone Number

(901) 287-6869
Cell Number
Pager
E-mail Address
rmack7@uthsc.edu
Degree
BSN
Rank
Staff
Will obtain informed consent
Yes
Access to research records
/specimens
Yes
       Entry 3       
Name
Han, Joan C, MD
Office Address
50 North Dunlap Street RM 476R
Office Phone Number
(901) 287-6408
Cell Number
Pager
E-mail Address
jhan14@uthsc.edu
Degree
MD
Rank
Associate Professor
Will obtain informed consent
NA
Access to research records
/specimens
Yes
       Entry 4       
Name
Smith, Webb A, PhD
Office Address
50 North Dunlap Street RM 447R
Office Phone Number
901 287 6878
Cell Number
Pager
E-mail Address
wsmith74@uthsc.edu
Degree
PhD
Rank
Assistant Professor
Will obtain informed consent
No
Access to research records
/specimens
Yes

       Entry 5       
Name
DECKER, KRISTINA, MS
Office Address
50 North Dunlap Street RM 308R
Office Phone Number
(901) 287-6399
Cell Number
6184096093
Pager
E-mail Address
kdecker2@uthsc.edu
Degree
M.S.
Rank
Staff
Will obtain informed consent
Yes
Access to research records
/specimens
Yes
       Entry 6       
Name
Jones, Tamekia, PhD
Office Address
50 North Dunlap Street RM R
Office Phone Number
(901) 287-5355
Cell Number
Pager
E-mail Address
tjone100@uthsc.edu
Degree
PhD
Rank
Assistant Professor
Will obtain informed consent
Yes
Access to research records
/specimens
Yes
       Entry 7       
Name
Gray, Emily, MSN
Office Address
49 N. Dunlap Room 137, Memphis, TN 38104
Office Phone Number
901-287-7494
Cell Number
Pager
E-mail Address
egray22@uthsc.edu
Degree

MSN
Rank
Staff
Will obtain informed consent
No
Access to research records
/specimens
Yes
       Entry 8       
Name
Kiley, Shannon, BS
Office Address
50 North Dunlap St RM 448R
Office Phone Number
901-287-6876
Cell Number
Pager
E-mail Address
skiley@uthsc.edu
Degree
BS
Rank
Staff
Will obtain informed consent
Yes
Access to research records
/specimens
Yes
       Entry 9       
Name
Cole, Shelby, MS
Office Address
50 N. Dunlap, Rm 367R
Memphis, TN 38103
Office Phone Number
Cell Number
Pager
E-mail Address
scole28@uthsc.edu
Degree
MS
Rank
Staff
Will obtain informed consent
Yes
Access to research records
/specimens
No
       Entry 10       
Name
Parvathareddy, Rohith
Office Address
50 N. Dunlap, Rm 367R
Memphis, TN 38103

Office Phone Number
Cell Number
Pager
E-mail Address
rparvath@uthsc.edu
Degree
BS
Rank
Staff
Will obtain informed consent
No
Access to research records
/specimens
Yes
       Entry 11       
Name
Morrison, Annie Ruth
Office Address
50 N. Dunlap, Rm 367R
Memphis, TN 38103
Office Phone Number
Cell Number
Pager
E-mail Address
amorri49@uthsc.edu
Degree
Rank
Student
Will obtain informed consent
Yes
Access to research records
/specimens
Yes
       Entry 12       
Name
Alshibli, Noor
Office Address
50 N. Dunlap, Rm 367R
Memphis, TN 38103
Office Phone Number
Cell Number
Pager
E-mail Address
nalshibl@uthsc.edu
Degree
Rank
Student
Will obtain informed consent
Yes
Access to research records
/specimens
Yes

       Entry 13       
Name
Pulusani, Srinidhi Reddy
Office Address
50 N. Dunlap, Rm 367R
Memphis, TN 38103
Office Phone Number
Cell Number
Pager
E-mail Address
spulusan@uthsc.edu
Degree
Rank
Student
Will obtain informed consent
Yes
Access to research records
/specimens
Yes
       Entry 14       
Name
Chow, Christopher R
Office Address
50 N. Dunlap
Memphis, TN 38103
Office Phone Number
Cell Number
Pager
E-mail Address
cchow@uthsc.edu
Degree
Rank
Student
Will obtain informed consent
Yes
Access to research records
/specimens
Yes
       Entry 15       
Name
Cunningham, Christopher
Office Address
50 N. Dunlap
Memphis, TN 38103
Office Phone Number
Cell Number
Pager
E-mail Address
CCUNNI25@uthsc.edu
Degree
Rank

Student
Will obtain informed consent
Yes
Access to research records
/specimens
Yes
       Entry 16       
Name
Harlan, Matthew Shea
Office Address
50 N. Dunlap
Memphis, TN 38103
Office Phone Number
Cell Number
Pager
E-mail Address
mharlan4@uthsc.edu
Degree
Rank
Student
Will obtain informed consent
Yes
Access to research records
/specimens
Yes
       Entry 17       
Name
HARRELL, CAMDEN
Office Address
50 N. Dunlap
Memphis, TN 38103
Office Phone Number
Cell Number
Pager
E-mail Address
charre15@uthsc.edu
Degree
Rank
Staff
Will obtain informed consent
No
Access to research records
/specimens
Yes
       Entry 18       
Name
Hare, Marion Elizabeth, MD, MS
Office Address
Doctors Office Building
66 North Pauline Street
Memphis, TN
Office Phone Number
901-448-3752

Cell Number
Pager
E-mail Address
mhare@uthsc.edu
Degree
Rank
Associate Professor
Will obtain informed consent
No
Access to research records
/specimens
Yes
5.0
 (418) IRB Submission
5.1  
 Please indicate the correct status of this submission:
*
Note: If you are submitting a Form 2 for revision, DO NOT change your answer in this section.
I am requesting initial approval for research. 
I am registering the use of an anonymized human cell line purchased or acquired from commercial 
vendors, IRB approved repositories or government tissue banks. 
I am registering research that was originally approved on paper by the UTHSC IRB before 2009. 
I am submitting my research in accord with the St. Jude Cooperative Agreement where the St. Jude 
IRB has already approved it. 
I am submitting my research in accord with an IRB Authorization Agreement where another IRB has 
already approved it.  
I am registering a research study that was approved by the NCI CIRB. 
I am requesting initial approval for the use of a Humanitarian Use Device (HUD). 
I am notifying the IRB regarding the emergency use of an investigational device. 
I am notifying the IRB regarding the emergency use of an investigational drug, or biologic.  
I am requesting approval for compassionate use of an unapproved medical device. 
I am requesting approval for the treatment use of an unapproved medical device. 
I am requesting approval for the treatment use of an unapproved drug or biologic. 
I am requesting waiver of the HIPAA authorization preparatory to research. 
6.0
 (420) Other Committees Should be Consulted
6.1  
Does this research project involve any of the following?
 *
Radiation Safety Committee (RSC)
1. Exposure to X-rays and other machine-produced ionizing radiation for purposes other than providing or guiding the 
treatment of individual subjects
  Yes   
  No
2. Exposure to non-FDA approved radioisotopes solely for purposes other than providing or guiding the treatment of 
individual subjects
 
  Yes   
  No
3. Exposure to FDA approved radioisotopes solely for purposes other than providing or guiding the treatment of individual 
subjects

  Yes   
  No
If the answer to any of the 3 items above is “Yes”, add 
, Pharm.D. as a Research Administrative 
Note: 
Vivian Loveless
Specialist in section 3.6 of this application.
 
 If you have any dosimetry questions related to machine-produced ionizing radiation or radioisotopes used 
Also note:
solely for research purposes, please contact 
, Ph.D. at (901) 448-8323 or at 
.
Thad Wilson
tawilson@uthsc.edu
Institutional Biosafety Committee (IBC)
1. Recombinant/ Synthetic nucleic acids (DNA/RNA)
  Yes   
  No
2.
 experiments that involve introduction of human-derived cells/ tissues/ products (e.g., introduction of human 
 In vivo
tumor cells into mice)
  Yes   
  No
3.
 experiments that involve infectious agents (bacterial, viral, fungal, or parasite) that require BSL-2 or BSL-3 
 In vivo
containment practices
  Yes   
  No
4. Select agents or toxins (see this website for a list:  
)
http://www.selectagents.gov/SelectAgentsandToxinsList.html
  Yes   
  No
 If the answer to any of the 4 items above is “Yes”, you will need to have an approved IBC protocol before initiation 
Note:
of this project. For information, please visit the IBC website (https://www.uthsc.edu/research/compliance
/ibc/ ) or contact the IBC Coordinator via email at 
 or via telephone at (901) 448-2164.
IBC@uthsc.edu
Institutional Animal Care and Use Committee (IACUC)
1. Live Animals
  Yes   
  No
 If the answer to the above question is “Yes”, you will need to have an approved IACUC protocol before initiation of 
Note:
this project. For information, please visit the IACUC website (https://www.uthsc.edu/research/compliance
/iacuc/ ) or contact the IACUC Coordinator via email at 
 or via telephone at (901) 448-3904.
IACUC@uthsc.edu
7.0
 (468) Funding Source/Sponsor
7.1  
 Is there a funding source associated with the study/project? This includes a source that will provide study drug/biologic
*
/device at no cost.
Yes 
No 
8.0
 (485)  Study/Project Information

8.1  
 Are you requesting Full Board, Expedited, Exempt or NHSR review by the IRB?
*
 
Full Board 
Expedited 
Exempt or NHSR (Not Human Subjects Research) 
Not sure 
8.2  
 Please indicate the type of study/project:
*
Studies/Projects that merely observe outcomes in patients who receive a drug/biologic or device as part of their standard 
care, but do not involve administration of the drug/biologic or device as part of study/project procedures, should be 
checked "No drug/biologic or device."
A drug/biologic is being administered and evaluated as part of the study/project procedures. 
A device is being administered and evaluated as part of the study/project procedures. 
A drug/biologic AND a device is being administered and evaluated as part of the study/project 
procedures. 
No drug/biologic or device is being administered and evaluated as part of study/project procedures. 
9.0
 (495) Multi-Site, Externally Sponsored Protocol
9.1  
 Is this a multi-site, externally sponsored study for which a master protocol has been written by a commercial entity, 
*
cooperative study group, non-profit foundation, or NIH grantee?
  Note: For a local investigator-initiated study, you must answer "no" to this question.  Your application serves as the 
protocol and it is not necessary to attach any additional protocol document. However, if this local investigator-initiated 
study is funded through a grant, then the relevant sections of the grant describing study procedures should be attached.
Yes. There is a multi-site master protocol written by an external sponsor of this study/project.  
No. There is NOT a multi-site master protocol written by an external sponsor of this study/project.  
10.0
 (701) Define "Expedited" and Minimal Risk
10.1  
 
"Expedited Review" is a speedier process than "Full Board Review." Proposals that may qualify for Expedited 
Review include:  Research activities that
 
1)  present no more than minimal risk to human subjects
                                                    AND
2) involve only procedures listed in one or more of seven Expedited Review Categories.
  By answering the following questions, you will assist the IRB in determining if your proposal will be granted an 
 
 
Expedited Review. Please hit "Save and continue..." in the upper right corner.
10.2  
 Do the research activities present 
 to human subjects?
*
no more than minimal risk
For a definition of "no more than minimal risk" please click on the Question Mark in the right margin.
Yes. The research activities present no more than minimal risk to human subjects. 
No. The research activities DO present more than minimal risk to human subjects. 
10.3  
 Would identification of the subjects and/or identification of their responses reasonably place them at risk of criminal or 
*
civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing?
Yes. Identification of subject or subject responses could place the subject at risk. 
No. Identification of subject or subject responses would not place subject at risk. 
11.0
 (706) Classified Research

11.1  
 Is this project considered to be "classified" research?
*
For a discussion of the definition of "classified," please mouse over the question mark in the right margin and click on 
"Definition of Classified Research."
Yes. This research is considered classified. 
No. This research is NOT considered classified. 
12.0
 (720) Category 2:  Blood Collection
12.1  
 Does this research involve the collection of blood?
*
Yes. This study/project does involve the collection of blood. 
No. This study/project DOES NOT involve the collection of blood. 
13.0
 (722) Mode of Blood Collection
13.1  
Will the collection of blood samples be solely by finger stick, heel stick, ear stick, and/or venipuncture?
* 
Yes. Blood will be collected ONLY by the methods listed above. 
No. Blood may be collected by other methods that do not meet requirements for expedited review. 
14.0
 (723) Study/Project Population
14.1  
 Does the study/project population include the following? Check all that apply.
*
Healthy, NON-pregnant adults who weigh at least 110 pounds
Unhealthy adults, pregnant females, children, AND/OR persons who weigh less than 110 pounds (Click 
on the question mark in the right margin to review the definition of 'Children.'')
15.0
 (726) Vulnerable Population Blood Collection
15.1  
 Please check the amount of blood that will be collected from the unhealthy adults, pregnant women, children, and 
*
persons who weigh less than 110 pounds:
NO MORE than the lesser of: [50 ml] OR [3-ml-per-kg] of blood will be collected in an 8 week period.  
MORE than the lesser of: [50 ml] OR [3-ml-per-kg] of blood will be collected in an 8 week period. 
15.2  
 Please check the frequency of blood collection for the unhealthy adults, pregnant women, children, and persons who 
*
weigh less than 110 pounds:
Blood will be collected NO MORE than 2 times per week. 
Blood may be collected MORE THAN 2 times per week. 
16.0
 (730) Category 3:  Prospective Biological Specimen Collection for Research Purposes
16.1  
 Does this research entail prospective biological specimen collection other than blood for research purposes?  Prospective 
*
specimen collection means the specimens will be collected AFTER this research application is submitted and approved.
Yes. This research includes prospective biological specimen collection other than blood for research 
purposes. 

No. This research DOES NOT include prospective biological specimen collection other than blood for 
research purposes. 
17.0
 (740) Category 4:  Non-Invasive Procedures
17.1  
 If this study/project involves physical diagnostic and/or monitoring procedures, is it true that ALL are NON-INVASIVE 
*
and do not include general anesthesia, sedation, x-rays or microwaves?
For a definition of "Non-invasive Procedures" as defined in the Federal Register, please click on the Question Mark in the 
right margin.
Yes. The study/project involves physical diagnostic and/or monitoring procedures, all of which are non-
invasive and do not include general anesthesia, sedation, x-rays or microwaves. 
No. The study/project involves physical diagnostic and/or monitoring procedures, some of which are 
invasive or include general anesthesia, sedation, x-rays or microwaves. 
Not applicable. The study/project does not involve physical diagnostic and/or monitoring procedures. 
18.0
 (750) Category 5:  Use of Retrospective and Prospective Non-Research Materials
18.1   * Does this proposal involve using materials (data, documents, records, or specimens) that have been or will be collected 
solely for CLINICAL CARE PURPOSES?
Yes. This proposal involves using materials (data, documents, records, or specimens) that have been 
or will be collected solely for CLINICAL CARE PURPOSES. 
No. This proposal does not involve using materials (data, documents, records, or specimens) that have 
been or will be collected solely for CLINICAL CARE PURPOSES.  
19.0
 (760) Category 6:  Recordings
19.1  
 Does this proposal involve the collection of data from voice, video, digital or image recordings made for research 
*
purposes?
Yes. This proposal does involve data from recordings as noted above. 
No. This proposal does NOT involve data from recordings as noted above. 
20.0
 (770) Category 7:  Characteristic, Behavioral, Methodology Research
20.1  
Is this research on individual or group characteristics or behavior (including but not limited to research on perception, 
* 
cognition, motivation, identity, language, communication, cultural beliefs or practices and social behavior)
or
research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality 
assurance methodologies?
Yes. This research is on characteristics, behaviors and/or involves one of the specified methodologies. 
No. This research does not fall into the behavior, characteristic or methodology categories above. 
21.0
 (925) Study/Project Synopsis
21.1  
 Click on the gray bar below and provide a synopsis of the research study/project addressing the following
items 
*
 
 
SIX
USING these numbered subheadings:
1. Purpose, 
2. Rationale,

3. Study/Project Population,
4. Research Design,
5. Study/Project Procedures, and
6. Outcome Measures.
 
Title: Memphis Superheroes Club
1. Purpose,
The primary purpose of this project is to develop and implement the culturally-tailored, comprehensive, 
and out-of-school program, Insulin Superheroes Club (ISC). This is a diabetes prevention program for 
youth based on the CDC curriculum designed for adults. This will be accomplished through collaborations 
with the University of Tennessee Health Science Center (UTHSC), Le Bonheur Children’s Hospital (LBCH), 
and the YMCA. The goals are to improve participant health and prevent diabetes by improving metabolic 
parameters, physical fitness, and health habits.
 
2. Rationale, Background and Significance:
Engagement in regular physical activity is widely accepted as an effective preventative measure for a 
variety of health risk factors across all ages, genders, race/ethnicities, and socioeconomic groups 
(Janssen, 2010.) However, levels of physical activity remain low and obesity rates continue to rise 
(Odgen, 2014,) with significant disparities among Hispanic and African-American youth, nationally and 
specifically in Tennessee (Tennessee Department of Education, 2008.) The impact of obesity is evident in 
the worsening rates of metabolic functioning, especially among children who are experiencing greater rise 
in blood pressure (National Center for Chronic Disease Prevention and Health Promotion (NIHCM), 2008,) 
hyperlipidemia (NIHCM, 2008,) and increased prevalence of type 2 diabetes (Sinha, 2002.)
Type 2 diabetes occurs when there is an imbalance between insulin secretion and insulin resistance. 
Among youth populations, the prevalence of developing type 2 diabetes increases during puberty due to 
the natural transient state of insulin resistance (Caprio, 1989.) Type 2 diabetes in youth when compared 
that in adults has particular characteristics; the transition from glucose deregulation to overt diabetes 
occurs at a faster rate. In adults, the transition from pre-diabetic to a diabetic state takes about 10 years 
with a 7% reduction of beta cell function per year (Kahn, 2001, Matthews, 1998.) In pre-diabetic youth, 
the mean transition period is significantly reduced to about 2.5 years with a 15% reduction of beta cell 
function per year (Gungor, 2004.)
Along with decrease beta-cell function, youth with type 2 diabetes become resistance to pharmacological 
mono-therapy (metformin or rosiglitazone) and lifestyle intervention such as change in diet and physical 
activity. Due to these limiting factors, once a pre-diabetic child or adolescent develops type 2 diabetes, it 
is considered irreversible (Zeitler et al, 2012.) Given this, the focus is on early prevention of on-set pre-
diabetes or type 2 diabetes among the obese youth population. Early lifestyle prevention and intervention 
programs consist of changing diet, physical activity and lifestyle habits (i.e taking the stairs instead of the 
elevator) through education. A number research study-programs have shown promising results in regards 
to diabetes prevention such as: 42% reduction of whole body insulin sensitivity, a two- fold greater 
change in body fat than body weight, increase lean body mass, and normalized fasting, two-hour plasma 
blood glucose levels, and decrease LDL cholesterol levels (Shaw, 2009, Wadden, 2012.)
In addition to the physical and metabolic impact of obesity, research supports the relationship between 
obesity, mental health, and health behaviors. Generally, overweight and obese youth have increased 
mental health concerns compared to their normal weight peers (Sinha, 2002.) Specifically, obesity has 
been linked to presence of depression, anxiety, attention deficit hyperactivity disorder, and conduct 
disorder among children (Halfon, 2013, Puder, 2010.) Difficulty coping with stress and decreased self-
esteem are also associated with obesity (BeLue, 2009.) Studies have also shown that individuals, adults 
and youth, with type 2 diabetes have decreased cognitive functioning including mental processing speed, 
flexibility, memory, and learning (Puder, 2010.) Physical activity participation has been linked with 
improved academic performance, mental health, and cognitive function (Hillman, 2008.) Despite these 
findings, the best treatment or weight management for childhood obesity is still uncertain. A few studies 
have examined the cumulative impact of improving physical activity, fitness, nutrition, and overall health 
behaviors in children.
The specific aims of this research project are to:
1) Examine the change of health status of youth participants over time as a result of the 12-month (16 
weekly, 3 biweekly, and 6-monthly session) ISC intervention through the evaluation of metabolic, physical 
fitness, and health habit parameters
2) Examine the change of health status of parent participants over time as a result of the 12-month (16 
weekly, 3 biweekly, and 6-monthly session) DPP adult sessions through the evaluation of metabolic, 
physical fitness, and health habit parameters.
3. Study/Project Population,

Potential subjects and their parents will be informed of the study through flyers, community events, and 
physician referrals. Flyers will be distributed/posted at all YMCA sites and physician offices and clinics, 
throughout Memphis.
Inclusion criteria for youth participants will include:
1) Between 7-15 years-old
2) Hemoglobin A1C 5.7-6.4% or BMI ≥ 85
 percentile, parent 
 grandparent with pre/type II Diabetes
th
or
3) Able to participate in physical activity
4) Parent or caregiver participation
Exclusion criteria for youth participants will include:  
1) Pregnant females
2) Those with mental health illness (e.g. depression, ADHD, etc.)
3) Medications that would interfere with testing results (e.g. metformin, insulin)
Inclusion criteria for parent participants will include:
1) ≥18 years-old
2) At least one child enrolled in ISC
3) Able to participate in physical activity
Exclusion criteria for parent participants will include:  
1) Those with mental health illness (e.g. depression, ADHD, etc.)
2) Medications that would interfere with testing results (e.g. metformin, insulin).
Inclusion and exclusion criteria will be assessed via parent and child self/physician referral form. The 
UTHSC/LBCH subcommittee will approve all procedures for the Use and Protection of Human Subjects. 
ISC and control group participants will be assigned on a fist come first serve basis.
Consenting and Questionnaires:
On the day of registration, parents or guardians will receive project information packets from the trained 
research team. The packets will include a parent/guardian consent form, a child assent form, and detailed 
participation requirements, benefits, and incentives. Once the researcher consents the parent and assents 
the child face-to-face, the child and parent will be asked to sit with the researcher to complete the study 
questionnaires. The parent will complete the Healthy Habits Questionnaire (parent version), the child and 
parent will complete the Healthy Habits Questionnaire (child version), and the child (child version) and 
parent (parent version) will complete the mental health questionnaire separately. Trained research team 
members will complete all face-to-face consenting and surveys/questionnaires. Upon consenting the 
family (parent and child/children) will be assigned, to either the ISC. Once completed the participant will 
return the following week to complete their pre-evaluation assessment.
The parents will be encouraged to contact the research team if they should have any questions regarding 
the study procedures. All questionnaires, consents, and assent forms must be completed prior to the data 
collection days with the assistance of a research team member. The research staff will review all materials 
and assign a study id prior to the child's participation in data collection. Following completion of the 
project parents or guardians of all children enrolled in the project will receive a report of their health 
behaviors, physical fitness, and mental health performance with strategies to improve/maintain their 
outcomes. The research team member will also inform the parent and child that video recording and 
pictures of the educational sessions, physical activity sessions, and evaluation sessions (only physical 
fitness measures) will be taken by a research team member for the use of dissemination and 
presentations regarding the findings. If parents do not wish to consent and child does not wish to assent 
to video recordings or photography of this nature the research team will make a note and respect the 
participants’ wishes.
4. Research Design,
This project will employ a quasi-experimental non-control group design with an intervention group (ISC). 
The intervention group will receive the ISC curriculum, which promotes healthier physical activity, 
nutrition, sleep, and stress coping practices. The intervention phase will consist of 12-months: 
registration, six evaluation sessions (2-3 hours per evaluation: Week 1, 8, and 16, 6-month, 9-month, 
and 12-month), and 16-weekly, 3-bi weekly, 6-monthly educational and physical activity sessions (1.5 
hours per session: 45-minutes of health education and 45-minutes of physical activity).
Youth between the ages of 7-15 throughout Shelby County will be recruited to participate in this study. 
Recruitment, data collection, and program implementation will be accomplished through a community-
academic partnership between UTHSC/LBCH and the YMCA. Upon obtaining parental consent and child 
assent, all data collection will occur at the Gaisman Community Center site under the supervision of 
UTHSC/LBCH staff.
Incentives
Pre, post, and follow-up evaluations: $50 gift card for participant
Programs sessions: attendance raffle: participants will be provided with a raffle ticket for attending 
sessions and will be able to select a n item for a prize box (water bottles, t-shirts, jump ropes, hand 
sanitizer, myPlates, etc.)
5. Study/Project Procedures
Research and Program Setting. The YMCA of Memphis & the Mid-South’s mission is to put faith-based 
principles into practice through programs that build healthy spirit, mind, and body while strengthening 
communities. The YMCA is the largest provider of before/after school services serving children in the 
Shelby County, Tennessee and Desoto County, Mississippi School Districts, and selected schools in the 

Marion School District in Marion, Arkansas; thus being a major provider of after school care in the Mid-
South.
All data collection and program activities with youth and their families will be located at the Gaisman 
Community Center. All tests and program activities will be under the supervision of UTHSC/LBCH and 
YMCA staff by trained researchers and staff.
The YMCA will collaborate and commit to the following throughout this study: 1) assist the research team 
to identify the cohort of children, 2) identify the staff members who will be trained to deliver the weekly 
lessons, 3) make the arrangements for staff training and development, and 4) provide administrative and 
financial oversight support to site directors and study staff. This collaboration is a mutually agreeable 
effort as it will result in gained scientific knowledge about factors that influence youth well being in 
Memphis. The expansive footprint of the YMCA and its own involvements with various populations in the 
community provides many opportunities for community translation of the research findings. Nationally, 
YMCAs are forging relationships and seeking ways to engage underrepresented racial and ethnic 
populations with close relations established with the Hispanic and African-American communities.
The Department of Human Services licenses all facilities of the YMCA; most program sites are located in 
school cafeterias and have access to outdoor playgrounds, computer laboratories, and school classrooms. 
The staff ratio is maintained at 1 staff: 12 participants, with two staff members present at all times. 
Annually, staff members are provided 20-25 hours of in-service training to include: first aid, CPR/blood 
borne pathogens, child abuse prevention, stewards of children, and sexual harassment. Through the study 
collaboration staff will receive an additional 40-50 hours of training and continued education.
All data collection and program activities will occur on YMCA sites under the supervision of UTHSC/LBCH. 
In total, 
 will be required to complete all measures during the evaluation sessions. Youth will be 
1-2 hours
provided with healthy snacks and beverages throughout the testing period, and will be encouraged to take 
breaks as needed. Each curriculum session will last 
 and lessons will be taught by the YMCA 
1.5 hours
trained Life Coaches under the supervision of a research team member.
Data Collection Evaluation Days.
Prior to the initial pre-evaluation a registration/consent day will be offered. Research staff will consent 
parents, assent children, and sit face-to-face with the parent and child to complete the Healthy Habits and 
mental health questionnaire. On evaluation days the participants will rotate through stations to complete 
all the measures collected by the research team members.
Questionnaires:
Health Behaviors. A Healthy Habits Questionnaire (HHQ) will be used to measure knowledge and 
behaviors toward developing a healthier lifestyle. The Healthy Habits questionnaire will take 
approximately 30 minutes to complete and will be administered by a research team member. These 
questions will be completed by the child and parent and includes questions about: demographics (i.e. age, 
race/ethnicity, SES, home environment); child's academic status; family health history; weight 
perception, and frequency and range of typically consumed foods, exercise, sleep, and healthy-living 
behaviors. To obtain a valid measure, questions from previously published school-based intervention 
studies will be selected (Prochaska, 1994; Perry, 1998; Stevens, 1999) and reviewed by our team of 
experts. The parent-child relationship will be assessed with measures of parent involvement (BeLue 2009) 
parent monitoring (O’Donnell, 2002) and family cohesion (Resnick, 1997.)
Evaluation Measures:
Physical Activity. An accelerometer (Computer Science and Applications, Inc., Shalimar, FL), will be used 
to assess physical activity (Epistein, 1996; Sallis 1990) The child will be asked to wear the accelerometer 
for 7-days. To ensure good reliability of devices use the children and parents will be taught how to use the 
accelerometers during a home visit and reminded of wear via a phone call. The PI and a research team 
member will schedule and conduct the home visits (pick-up and drop-off) with the parent and child. The 
home visits will provide an opportunity for detailed instruction and demonstration of device use as well as 
provide accountability of the device. The home visits will take approximately 30 minutes to complete.
Metabolic Parameters. The metabolic parameters will take approximately 30 minutes to complete and will 
be administered by a trained health specialist under supervision of a medical director. The Inbody-570 
multi-frequency bioimpedance analyzer (Biospace, Beverly Hills, CA), will be used to assess body 
composition (Inbody 570, 2006.) Information recorded will include: body weight, percent body fat, and 
BMI. Height (centimeters) will be measured using a Weigh Beam Eye-Level physicians’ scale in cm 
(DETECTO, Webb City, MO, USA). A portable anthropometer (Lafayette Instrument Company, Lafayette, 
IN) will be used to measure sagittal abdominal height (SAH), as a predictor of visceral abdominal fat( 
Sampaio, 2007.) A Gulick spring loaded measuring tape (Dunlee, Aurora, IL) will be used to indicate 
central obesity (Center of Disease and Control, 2012.) Systolic and diastolic blood pressure (SBP and DBP 
respectively) will be taken using a manual sphygmomanometer (blood pressure cuff) with a child’s cuff 
placed over the brachial artery (Tycos Instruments Inc., Arden, NC) using standard procedures (Kirkenale, 
1967.) Resting heart rate will be measured manually after five minutes of seated rest through palpating 
radial pulse over 60 seconds and will be recorded as beats per minute (American Heart Association, 
1996.) A1C will be assessed from a fingerstick capillary whole-blood sample using an A1CNow device 
(John & Edwards, 1994) (PTS Diagnostics, Indianapolis, IN). Lipid profile will measure total cholesterol, 
triglycerides, and LDL and HDL levels using Cholestech LDX (Alere, San Diego, CA.)
Physical Fitness. The physical fitness assessments will take approximately 1 hour to complete and will be 
administered by a trained research staff under supervision of an exercise physiologist. The National 
Institute of Health’s (NIH) two-minute walk test will be used to measure aerobic endurance (NIH, 2012). 
A Jamar plus handgrip dynamometer (Sammons Preston, Bolingbrook, IL) will used to measure grip 

strength with the elbow bent at a 90-degree angle (National Institute of Health, 2012.) Components of 
the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2), an array of goal-directed 
activities, will be used to measure fine and gross motor control skills, balance, abdominal, and upper body 
strength (Bruinimks, 2005). The wall squat test was used to assess lower body strength and endurance, 
specifically for the quadriceps muscle group (Welk, 2008). The vertical jump test data were used to 
estimate average power (watts) according to the Lewis formula (Fox, 1974): Average Power (Watts) = √4.
9 x mass (kg) x √VJ (m) x 9.81. A sit-and-reach box (Flexer-tester, Novel Product Inc., USA) was used to 
assess lower back and hamstrings flexibility.
ISC Educational and Physical Activity Sessions:
Education Curriculum Overview: The lesson portion will include health education session (e.g. 
nutrition, exercise, etc.) and session activity. This will take about 45 minutes to complete in each 
session.
Physical Activity Curriculum Overview: All physical activities will include low to moderate 
intensity (body weight only) exercises such as: push-ups, dancing, jumping jacks, curl-ups, 
squats, skipping, stretching, brisk walking, and jogging/marching in place. Sports and games will 
also be offered such as: basketball, badminton, volleyball, tag, jump rope, and scavenger hunts. Th
is will take about 45 minutes to complete in each session.
Intervention Session and Evaluation Timeline and Dates:
Visit 1: Consent, register participants, questionnaire completion
The first visit will be for program registration and consenting at the Gaisman Community Center. 
Research staff will consent parents, assent children, and sit face-to-face with the parent and child 
to complete the Healthy Habits and mental health questionnaire. This will take about 1-2 hours to 
complete.
Visit 2: Pre-Evaluation
All physical activity, physical fitness, and health measures described will be collected at the 
Gaisman Community Center. 
 The drop-off/pick-up 
This will take about 1-2 hours to complete.
home visit appointments will also be scheduled in order to collect physical activity data described 
in the health behaviors measures. The child will be asked to wear the activity monitor for 7-days 
 
hours. The drop-off home will take 30 minutes. The pick-up home visit will take 30 minutes. Both 
home visits will add up to 60 minutes to complete.
Visit 3: Session 1: Welcome to the YMCA’s Insulin Superheroes Club
Visit 4: Session 2: Nutrition Basics
Visit 5: Session 3: Physical Activity
Visit 6: Session 4: Label Reading
Visit 7: Session 5: Stronger Muscles and Bones
Visit 8: Session 6: Sweetness Without Sacrifice
Visit 9: Session 7: Aerobic Exercise
Visit 10: Session 8: Vitamins
Visit 11: Mid-Evaluation
All physical activity, physical fitness, and health measures (except the blood glucose and 
cholesterol) described above will be collected at the Gaisman Community Center. This will take 
about 2 hours to complete.
Visit 12: Session 9: De-stress and Motivation
Visit 13: Session 10: Grains
Visit 14: Session 11: Fats
Visit 15: Session 12: Protein
Visit 16: Session 13: Shopping Healthier Options
Visit 17: Session 14: Keeping Track
Visit 18: Session 15: Goal Setting
Visit 19: Session 16: Jeopardy
Visit 20: Post-Evaluation
Research staff will sit face-to-face with the parent and child to complete the Healthy Habits and 
mental health questionnaire. All physical activity, physical fitness, and health measures described 
above will be collected. 
at the Gaisman Community 
This will take about 1-2 hours to complete 
Center. The drop-off/pick-up home visit appointments will also be scheduled in order to collect 
physical activity data described in the health behaviors measures. The child will be asked to wear 
 
the activity monitor for 7-days. The drop-off home will take 30 minutes. The pick-up home visit 
will take 30 minutes. Both home visits will add up to 60 minutes to complete.
Visit 21: Wrap-up Celebration

This visit will be the wrap-up/celebration party where subjects will enjoy a healthy potluck and 
dancing at the Gaisman Community Center.
Visit 22: Session 17: Mindful Eating
Visit 23: Session 18: Rethink Your Drink
Visit 24: Session 19: FITT Brain
Visit 25: Evaluation
All physical activity, physical fitness, and health measures described above will be collected at the 
Gaisman Community Center. 
 The drop-off/pick-up 
This will take about 1-2 hours to complete.
home visit appointments will also be scheduled in order to collect physical activity data described 
in the health behaviors measures. 
 
The child will be asked to wear the activity monitor for 7-dasy. T
he drop-off home will take 30 minutes. The pick-up home visit will take 30 minutes. Both home 
visits will add up to 60 minutes to complete.
Visit 26: Session 20: Brain Food
Visit 27: Session 21: Practicing Self-Love
Visit 28: Session 22: Flexibility and Stretching
Visit 29: Evaluation
All physical activity, physical fitness, and health measures described above will be collected at the 
Gaisman Community Center. 
 The drop-off/pick-up 
This will take about 1-2 hours to complete.
home visit appointments will also be scheduled in order to collect physical activity data described 
in the health behaviors measures. 
 
The child will be asked to wear the activity monitor for 7-days. T
he drop-off home will take 30 minutes. The pick-up home visit will take 30 minutes. Both home 
visits will add up to 60 minutes to complete.
Visit 30: Session 23: Healthy Holidays & Fit Solutions
Visit 31: Session 24: Label Reading & Shop Smart
Visit 32: Session 25: Healthier Life: Goals & Keeping Track
Visit 33: Final Evaluation and Farewell Celebration (Pot-luck and a dance party)
Research staff will sit face-to-face with the parent and child to complete the Healthy Habits and 
mental health questionnaire. All physical activity, physical fitness, and health measures described 
above will be collected. 
at the Gaisman Community 
This will take about 1-2 hours to complete 
Center. This visit will also be the wrap-up/celebration party where subjects will enjoy a healthy 
potluck and dancing. The drop-off/pick-up home visit appointments will also be scheduled in order 
to collect physical activity data described in the health behaviors measures. The child will be asked 
 
to wear the activity monitor for 7-days. The drop-off home will take 30 minutes. The pick-up home 
visit will take 30 minutes. Both home visits will add up to 60 minutes to complete.
6. Outcome Measures.
Research methods:
Outcome Measures:
Primary Predictors:
Physical Activity: An accelerometer (Computer Science and Applications, Inc., Shalimar, FL), will be used 
to assess physical activity. To ensure good reliability of devices used, children and parents will be taught 
how to use the accelerometers and reminded to wear them via a phone call. Self-report measures of 
physical activity and sedentary habits will also be obtained.
Physical fitness (cardiorespiratory, muscular strength and endurance, and motor skills): The fitness 
battery will include the NIH two-minute walk test (aerobic fitness), handgrip strength, wall-sit (lower body 
strength), push-ups (upper body strength), curl-ups (abdominal strength), unilateral balance, 50-foot 
shuttle run (agility), and sit-and-reach box (lower body flexibility).
Metabolic Parameters (total and central adiposity, blood pressure, physiological stress): These measures 
include the Inbody-570 multi-frequency bioimpedance analyzer (body composition), Weigh Beam Eye-
Level physicians’ scale (height), anthropometer (sagittal abdominal height), Gulick spring loaded 
measuring tape (central obesity), sphygmomanometer (systolic and diastolic blood pressure), radial pulse 
(resting heart rate), A1C (blood glucose levels) and lipid profile (total cholesterol, triglycerides, and LDL 
and HDL levels.)
Health Habits (physical activity, nutrition, self-efficacy): Self-report measures will include knowledge, 
physical activity, sedentary habits, nutrition, and stress management.
Mediators: A parent- and child-report healthy habits questionnaire (adapted from previous research) will 
be used to assess demographics (i.e. age, race/ethnicity, SES, home environment), child's academic 
status, family health history, weight perception, and frequency and range of typically consumed foods, 
exercise, sleep, and healthy-lifestyle behaviors.
Analysis: We will use mixed repeated measures ANOVA model time as the outcome and physical fitness, 
metabolic parameters, and health habits as our predictor variables. We will also include possible 
covariates (race, ethnicity, SES, age, and BMI-Z) in the models.

22.0
 (1075) Background & Current Status of Work in the Field
22.1  
 Provide a discussion of the background and current status of work in the field.
*
 This section must provide a justification and rationale for conducting the study/project.
*
Engagement in regular physical activity is widely accepted as an effective preventative measure for a 
variety of health risk factors across all ages, genders, race/ethnicities, and socioeconomic groups 
(Janssen, 2010.) However, levels of physical activity remain low and obesity rates continue to rise 
(Odgen, 2014,) with significant disparities among Hispanic and African-American youth, nationally and 
specifically in Tennessee (Tennessee Department of Education, 2008.) The impact of obesity is evident in 
the worsening rates of metabolic functioning, especially among children who are experiencing greater rise 
in blood pressure (National Center for Chronic Disease Prevention and Health Promotion (NIHCM), 2008,) 
hyperlipidemia (NIHCM, 2008,) and increased prevalence of type 2 diabetes (Sinha, 2002.)
Type 2 diabetes occurs when there is an imbalance between insulin secretion and insulin resistance. 
Among youth populations, the prevalence of developing type 2 diabetes increases during puberty due to 
the natural transient state of insulin resistance (Caprio, 1989.) Type 2 diabetes in youth when compared 
that in adults has particular characteristics; the transition from glucose deregulation to overt diabetes 
occurs at a faster rate. In adults, the transition from pre-diabetic to a diabetic state takes about 10 years 
with a 7% reduction of beta cell function per year (Kahn, 2001, Matthews, 1998.) In pre-diabetic youth, 
the mean transition period is significantly reduced to about 2.5 years with a 15% reduction of beta cell 
function per year (Gungor, 2004.)
Along with decrease beta-cell function, youth with type 2 diabetes become resistance to pharmacological 
mono-therapy (metformin or rosiglitazone) and lifestyle intervention such as change in diet and physical 
activity. Due to these limiting factors, once a pre-diabetic child or adolescent develops type 2 diabetes, it 
is considered irreversible (Zeitler et al, 2012.) Given this, the focus is on early prevention of on-set pre-
diabetes or type 2 diabetes among the obese youth population. Early lifestyle prevention and intervention 
programs consist of changing diet, physical activity and lifestyle habits (i.e taking the stairs instead of the 
elevator) through education. A number research study-programs have shown promising results in regards 
to diabetes prevention such as: 42% reduction of whole body insulin sensitivity, a two- fold greater 
change in body fat than body weight, increase lean body mass, and normalized fasting, two-hour plasma 
blood glucose levels, and decrease LDL cholesterol levels (Shaw, 2009, Wadden, 2012.)
In addition to the physical and metabolic impact of obesity, research supports the relationship between 
obesity, mental health, and health behaviors. Generally, overweight and obese youth have increased 
mental health concerns compared to their normal weight peers (Sinha, 2002.) Specifically, obesity has 
been linked to presence of depression, anxiety, attention deficit hyperactivity disorder, and conduct 
disorder among children (Halfon, 2013, Puder, 2010.) Difficulty coping with stress and decreased self-
esteem are also associated with obesity (BeLue, 2009.) Studies have also shown that individuals, adults 
and youth, with type 2 diabetes have decreased cognitive functioning including mental processing speed, 
flexibility, memory, and learning (Puder, 2010.) Physical activity participation has been linked with 
improved academic performance, mental health, and cognitive function (Hillman, 2008.) Despite these 
findings, the best treatment or weight management for childhood obesity is still uncertain. A few studies 
have examined the cumulative impact of improving physical activity, fitness, nutrition, and overall health 
behaviors in children. The specific aims of this research project are to: 
1) Examine the change of health status of youth participants over time as a result of the 12-month (16 
weekly, 3 biweekly, and 6-monthly session) ISC intervention through the evaluation of metabolic, physical 
fitness, and health habit parameters 
2) Examine the change of health status of parent participants over time as a result of the 12-month (16 
weekly, 3 biweekly, and 6-monthly session) DPP adult sessions through the evaluation of metabolic, 
physical fitness, and health habit parameters. 
3) Examine the differences over time in metabolic, physical fitness, and health habit parameters among 
participants in the ISC group versus those in educational control group.
23.0
 (1200) Site and Research Procedure Information
23.1  
 Please list all sites and research procedures that will occur at each site.
*
 Research Site(s): If any of the following activities 
are being done, then include the site(s) below: identification of participants through review of their medical records; 
recruitment of participants; consent of participants; performance of screening procedures; interventions or interactions 
 
with participants; follow-up visits; collection of private information about participants; specimen storage; etc. Note: If any 

activities are being conducted at any of the following: CRC, Methodist/Le Bonheur, Regional One Health, or University 
Clinical Health, review the corresponding institution's guidelines prior to submitting your application. The website listing 
the institution's point of contact is posted under the "Question Mark" icon to the right.
Site Name and Address
Additional Site Information 
include suite #
Procedure(s) at this location
Institution: Other
YMCA 245 Madison Avenue, 
Memphis, TN 38103
Program staff training will be 
conducted at this site.
Institution:
University of 
Tennessee - 
Health Science 
Center
CFRI-50 North Dunlap Street 
RM 477R
All consenting, data 
collection, data storage, data 
input and analysis will be at 
this site.
Gaisman Community Center, 
4221 Macon Rd, Memphis, TN
ISC and WSC programs will 
be in held at this site.
23.2  
 Is this a multicenter study/project (one that is conducted across many institutions in the U.S. or in the world and usually 
*
run by one sponsor)?  Select "Not Applicable" if you are using a HUD, or engaging in treatment use of an unapproved 
drug/biologic or device, emergency use of an unapproved drug/biologic or device, or compassionate use of an unapproved 
device.
Yes. This is a multicenter study/project. 
No. This is NOT a multicenter study/project. 
Not Applicable. 
23.3  
 Please state the intended number of multicenter sites in aggregate; state “0” if this is not a multicenter study (one that is 
*
conducted across many institutions in the U.S. or in the world and usually run by one sponsor).
0
24.0
 (1400) Subject Population
24.1  Please state the anticipated number and age range of the subjects to be studied.
 Number of subjects to be accrued locally [This is the total number of subjects you expect to accrue (consent), including 
*
anticipated screen failures and withdrawals.  For studies with pregnant women where information will be collected about 
both the mother and fetus/baby, both should be counted as subjects.  For studies that are requesting an alteration or waiver 
of consent, subjects are considered accrued at the time ANY study interventions are performed, including medical record 
abstraction.]:
100
Overall number of subjects for sponsored multi-center studies [This is the total number of subjects that the protocol states 
will participate in the study across all centers.]:
 Age range of subjects to be accrued locally:
*
7-15 and 18+
25.0
 (1488) Vulnerable Subjects
25.1  
 Does your study require the inclusion of (i.e., are you targeting) any of the following categories of vulnerable subjects? 
*

Check all that apply.
Children (0-17 years) Who Are Not Wards of the State
Children (0-17 years) Who Are Wards of the State
Pregnant Females and Their Fetuses
Neonates Who Are Nonviable or of Uncertain Viability
Prisoners
Developmentally Disabled Persons (Who Are Not Institutionalized)
Developmentally Disabled Persons Who Are Institutionalized
Persons Who Are Mentally Ill (But Who Are Not Institutionalized as Mentally Ill)
Persons Who Are Institutionalized as Mentally Ill
Students of a School Associated With This Project
Employees of an Institution/Agency Associated With This Project
Other Vulnerable Population Not Identified Above
Not Applicable Subjects Not Classified as Vulnerable
25.2  Might any of the following categories of vulnerable subjects be incidentally included in your study, even 
though their inclusion is not necessary?  Check all that apply.
Children (0-17 years) Who Are Not Wards of the State
Children (0-17 years) Who Are Wards of the State
Pregnant Females and Their Fetuses
Neonates Who Are Nonviable or of Uncertain Viability
Prisoners
Developmentally Disabled Persons (who are not institutionalized)
Developmentally Disabled Persons Who Are Institutionalized
Persons Who Are Mentally Ill (but who are not institutionalized as mentally ill)
Persons Who Are Institutionalized as Mentally Ill
Students of a School Associated with this Project
Employees of an Institution/Agency Associated with this Project
Please explain how a certain category of vulnerable subjects might be incidentally included:
26.0
 (1494) Study/Project Duration
26.1  
 What is the anticipated duration of a single subject's participation in the study/project?
*
1 year
26.2  
 How long will the entire study last locally, including time for data analysis?
*
5 years
27.0
 (1500) Inclusion Exclusion Criteria
27.1  Identify inclusion criteria.
Order 
Number
Criteria
1 
1) Ages 7-15
 
Parent Inclusion Criteria: 18 and older

1 
 
2 
2) Prediabetes-A1C 5.7-6.4% 
 BMI of an 85th percentile or above 
a grandparent
or
or 
/parent with diabetes
 
2 
Parent Inclusion Criteria: at least one child enrolled in ISC
 
3 
3) Able to participate in physical activity
 
3 
Parent Inclusion Criteria: Able to do physical activity
 
4 
4) Parent enrolls in the adult DPP
 
27.2  Identify exclusion criteria.
Order 
Number
Criteria
1 
1) pregnant females
 
1 
Parent Exclusion Criteria: those with mental disorder (e.g. depression, ADHD, etc.) and/or 
severe mental illness which requires immediate treatment (e.g., active psychotic episode)
 
2 
2) those with mental disorder (e.g. depression, ADHD, etc.) and/or severe mental illness 
which requires immediate treatment (e.g., active psychotic episode)
 
3 
3) medications that would interfere with testing results (eg. metformin, insulin)
 
3 
Parent Exclusion Criteria: medications that would interfere with testing results (eg. 
metformin, insulin)
 
28.0
 (1600) Subject Selection and Recruitment
28.1  
How will subjects be selected? 
* 
 Subjects identified through medical record screening
*
 Yes   
 No
 Contact by investigator with his/her patients in the clinical setting
*
 Yes   
 No
 Referral from non-investigator practitioner
*
 Yes   
 No
 Subjects recruited from among students and/or employees
*
  Yes   
  No
 Telephone pre-screening
*

 Yes   
 No
 Website pre-screening
*
  Yes   
  No
 Advertising
*
 Yes   
 No
 Other
*
  Yes   
  No
28.2  
Recruitment Materials
 *
At the end of this application, you are required to attach all recruitment materials which you intend to use for this study
/project.
No recruitment materials will be used in this research. 
Recruitment materials to be used in this research will be attached at the end of this application. 
Recruitment materials will be submitted at a later date.  
 Describe how/where EACH of your recruitment materials (by name) will be used, in the text box below; e.g., on a 
*
website, sent to an email list, posted on campus, in a newspaper, etc.
Flyers and project information that will be posted on campus and throughout the community.
29.0
 (1710) Study/Project Procedures
29.1  
Describe the procedures that will be performed to determine whether prospective subjects satisfy inclusion
 *
/exclusion criteria for study/project participation.
* Medical Record Review should be included as a procedure if it is used to determine whether prospective subjects satisfy 
the criteria for study/project participation.
Prospective subjects will be screened by a research staff personnel or screened by a health professional 
that is referring the participant. They will determine whether they qualify for the program if they meet the 
inclusion/exclusion criteria.
29.2  
Do the study/project procedures involve administration of a drug, device or other intervention to determine 
 *
its efficacy, safety, and/or tolerability 
?
for treatment purposes
Yes. The study/project procedures involve administration of a drug, device or other intervention to 
determine its efficacy, safety, and/or tolerability for treatment purposes. 
No. The study/project procedures DO NOT involve administration of a drug, device or other 
intervention to determine its efficacy, safety, and/or tolerability for treatment purposes. 
30.0
 (1730) Procedures other than Treatments
30.1  
Describe all procedures, other than treatments, that will be performed.
* 
For studies/projects that involve multiple study/project visits, specify the timing of each visit, and in chronological order, 
list what will be done at each visit.

Click on "Add a new row" to list each procedure of each visit.
If you do not wish to use the table, click on the Text Editor and type in the information (specify the timing of each visit 
and list in chronological order, using bullet points, what will be done at each visit).
Also use the Text Editor to further describe any procedures that are not self-explanatory.
Visit Name
Visit Timing
Procedure
Consent, registration
1-2 hours
Consenting
Pre-evaluation
1-2 hours
Pre-evaluation-- see below 
for details
Mid-evaluation
1-2 hours
Mid-evaluation--see below for 
details
post-evaluation ( 3 month)
1-2 hours
post-evaluation--see below 
for details
Consent, register participants, questionnaire completion
The first visit will be for program registration and consenting at the Gaisman Community Center. 
Research staff will consent parents, assent children, and sit face-to-face with the parent and child 
to complete the Healthy Habits and mental health questionnaire. This will take about 1-2 hours to 
complete.
Pre-Evaluation
All physical activity, physical fitness, and health measures described will be collected at the 
Gaisman Community Center. 
 The drop-off/pick-up home 
This will take about 1-2 hours to complete.
visit appointments will also be scheduled in order to collect physical activity data described in the 
health behaviors measures. 
 
The child will be asked to wear the activity monitor for 7-days hours. Th
e drop-off home will take 30 minutes. The pick-up home visit will take 30 minutes. Both home visits 
will add up to 60 minutes to complete.
Mid-Evaluation
All physical activity, physical fitness, and health measures (except the blood glucose and 
cholesterol) described above will be collected at the Gaisman Community Center. This will take 
about 2 hours to complete.
Post-Evaluation
Research staff will sit face-to-face with the parent and child to complete the Healthy Habits and 
mental health questionnaire. All physical activity, physical fitness, and health measures described 
above will be collected. 
at the Gaisman Community 
This will take about 1-2 hours to complete 
Center. The drop-off/pick-up home visit appointments will also be scheduled in order to collect 
physical activity data described in the health behaviors measures. The child will be asked to wear 
 
the activity monitor for 7-days. The drop-off home will take 30 minutes. The pick-up home visit will 
take 30 minutes. Both home visits will add up to 60 minutes to complete.
31.0
 (1731) Incidental Findings
31.1  
How will abnormal incidental findings be handled?
* 
The subject will be referred for follow-up to his/her primary care physician. 
The study doctor will provide follow up for the abnormal finding. 
Other 
Not Applicable; incidental findings are not expected in this project. 

32.0
 (1733) Creation of Specimen & Data Repositories/Registries
32.1  
Does this study include creating a specimen repository or a data registry/repository?  A repository is being 
* 
established when there is a plan to make stored data and/or specimens available for later use in other 
research studies.
Yes 
No 
33.0
 (1734) Use of Other Data/Specimen Repositories
33.1  
Will this project/study involve using data/specimens from other repositories?
* 
Yes 
No 
34.0
 (1735) Discontinuation, Endpoints, Analyses
34.1  
Describe the criteria for discontinuation of treatment and withdrawal of the subject from the study/project.
* 
N/A
34.2  
 Describe the endpoints or outcomes being assessed in the study/project, such as efficacy and safety endpoints.
*
Outcome Measures: 
Change Over Time: Intervention 
Baseline (Time: 0) by changes over time (mid-intervention (Time: 1), and post-intervention (Time: 2))
Change Over Time: Maintenance
Baseline (Time: 0) by changes over time (3-months out (Time: 3), 6 months out (Time: 4), 9 months out 
(Time: 5), 12 months out (Time: 6)
Post-intervention (Time: 2) by changes over time (3-months out (Time: 3), 6 months out (Time: 4), 9 
months out (Time: 5), 12 months out (Time: 6))
34.3  
 Describe the statistical analysis that will be used.
*
Primary Predictors: 
Physical Activity: An accelerometer (Computer Science and Applications, Inc., Shalimar, FL), will be used 
to assess physical activity. To ensure good reliability of devices used, children and parents will be taught 
how to use the accelerometers and reminded to wear them via a phone call. Self-report measures of 
physical activity and sedentary habits will also be obtained.
Physical fitness (cardiorespiratory, muscular strength and endurance, and motor skills): The fitness 
battery will include the American Thoracic Society six-minute Walk Endurance Test (aerobic fitness) while 
monitoring pulse oximeter (blood oxygen), Jamar plus handgrip dynamometer (grip strength), MicroFET-2 
handheld dynamometer (maximal isometric strength), sit-and-reach box (lower body flexibility), 30-foot 
shuttle run (agility), and Bruininks-Oseretsky Test of Motor Proficiency (fine and gross motor control 
skills, abdominal, and upper body strength). 
Metabolic Parameters (total and central adiposity, blood pressure, physiological stress): These measures 
include the Inbody-570 multi-frequency bioimpedance analyzer (body composition), Weigh Beam Eye-
Level physicians’ scale (height), anthropometer (sagittal abdominal height), Gulick spring loaded 
measuring tape (central obesity), sphygmomanometer (systolic and diastolic blood pressure), radial pulse 
(resting heart rate), salivary cortisol collected using Oragene (physiological stress), HbA1c (blood glucose 
levels) and lipid profile ( total cholesterol, triglycerides, and LDL and HDL levels.) 
Cognition and Mental Health (self-efficacy, quality of life, brief general intellectual functioning, overall 
cognitive functioning,): General cognitive ability will be assessed using the Wechsler Abbreviated Scale of 

Intelligence-II and the NIH toolbox computer-based cognitive battery will be used to measure specific 
cognitive abilities. Self-report measures will include the PedsQL a measure of health-related quality of 
life33; knowledge and self-efficacy about physical activity, sedentary habits, nutrition, and stress 
management. 
Mediators: A parent- and child-report healthy habits questionnaire (adapted from previous research) will 
be used to assess demographics (i.e. age, sex, race/ethnicity, SES, home environment), child's academic 
status, family health history, weight perception, and frequency and range of typically consumed foods, 
exercise, sleep, and healthy-lifestyle behaviors.
Specific Statistical Analysis: We will use mixed repeated measures ANOVA model time as the outcome and 
health habits, physical fitness, and metabolic parameters as our predictor variables. We will also include 
possible mediators (e.g., parent-child relationship, family health history, weight perception), and 
covariates (race, ethnicity, SES, age, and grade) in the models.
35.0
 (2000) Risks
35.1  
 Please click on "Add a new row" to list the name of the study/project document and the pages in that document where 
*
the risks of this research are discussed.
For example:
Study/Project Protocol 33-37
Investigators Brochure 90-101 and 105-128
There are no other documents in which the risks of the study/project are discussed. 
Study/Project risks are also discussed in the attached documents listed below. 
35.2  
Please utilize the following table to describe the risks associated with participation in this research.  Include physical, 
* 
psychological, social, legal, and any other risks.
Column 1: Type in the name of the procedure.
Columns 2-6:  Identify the risks and their rate of occurrence in the appropriate column.
NOTE:  If the study/project literature or the sponsor cannot provide the rate of occurrence of a risk, make an educated 
guess as to its rate of occurrence and type the word "Estimated:" before typing in the description of the risk.
Procedure
Very Common: 
occurs >50 
times out of 
every 100
Common: 
occurs 21-50 
times out of 
every 100
Occasional: 
occurs 6-20 
times out of 
every 100
Rare: occurs 1-
5 times out of 
every 100
Very Rare: 
occurs less 
than 1 time out 
of every 100
Estimated: 
Risks are 
expected to 
be 
minimal. 
There is a 
small risk 
that during 
the 
physical 
fitness 
measures 
and 
sessions, a 
student 
may fall, 
but will be 
no greater 
risk than 
that seen 
during 
normal 

Physical 
Activity
None
None
None
None
physical 
activity and 
outdoor 
play. All 
steps will 
be taken to 
prevent 
injury to 
your child 
and reduce 
risk. Water 
and first 
aid kits will 
be 
available. 
All 
personnel 
will also be 
First Aid
/CPR 
certified. 
Furthermor
e, both the 
YMCA and 
UTHSC 
personnel 
will be 
chaperoning
all 
students. 
The UTHSC 
staff will 
follow the 
YMCA 
emergency 
procedures.
UTHSC 
personnel 
will be 
present to 
oversee 
and 
evaluate 
educational 
and 
physical 
activity 
curriculum 
implementa
tion, which 
will be 
conducted 
by YMCA 
staff.
Questionnai
re and 
None
None
None
None
Estimated: 
Completion 
of the 
health 
questionnair
e may 
make you 
feel 
uncomforta
ble or 
cause 
troublesom
e feelings 
or 

Surveys
emotions. 
You may 
refuse to 
answer any 
of the 
questions 
and you 
may take a 
break at 
any time 
during the 
study.
Videotaping
, 
Photograph
y and 
Audio 
recording
None
None
None
None
Estimated: 
Having 
your 
photograph 
taken, your 
voice 
recorded, 
and being 
videotaped 
may make 
you feel 
uncomforta
ble. You 
may take a 
break 
during any 
time of the 
study. 
There is 
also a 
potential 
risk of loss 
of 
confidentiali
ty that 
someone 
who views 
your video 
and 
photograph
er listens 
to your 
audio 
recording 
of the 
educational,
physical 
activity, 
and 
evaluation 
sessions 
might 
identify 
you.
Estimated: 
With 
wearing 
the activity 
monitors, if 
irritation of 
the skin 
occurs due 
to wearing 
the device, 

Activity 
Monitor
None
None
None
None
discontinue 
wearing 
the device 
and consult 
a doctor for 
treatment. 
Although 
the 
Polycarbona
te and 
Polyvinyl 
Chloride 
materials 
are not 
known to 
be irritating 
to the skin, 
some 
irritation to 
people with 
sensitive 
skin may 
occur. If 
this 
happens, 
consult 
your doctor 
for 
treatment 
and stop 
wearing 
the device. 
Also, notify 
a research 
team 
member 
that gave 
you the 
activity 
monitor 
that you 
have taken 
the device 
off since 
data 
collection 
will be 
effected.
Health 
Measures
None
None
None
None
Estimated: 
Possible 
risk of 
infection 
and 
bruising 
may occur 
with the 
finger stick 
procedure 
done to 
collect 
blood 
glucose 
and 
cholesterol 
levels, 
even if 
rare. Also, 
there is 

possible 
risk of 
being 
uncomforta
ble while 
the health 
measures 
are 
performed.
If some risks noted above require further discussion by the PI in order for the IRB to review this research, please discuss 
those risks here:
N/A
36.0
 (2210) AE's and Data Monitoring
36.1  
 Has an independent data and safety monitoring board (DSMB) been established for the conduct of the study/project?
*
Yes. An independent data and safety monitoring board (DSMB) HAS been established for the conduct 
of the study/project. 
No. An independent data and safety monitoring board (DSMB) HAS NOT been established for the 
conduct of the study/project. 
 Please explain so that the IRB understands the data and safety monitoring arrangements that are in place for this 
*
research, or indicate that it is explained in the sponsor protocol:
The research team leverage the strengths of the collaboration between CFRI Biomedical Informatics Core 
(BMIC) and the Pediatric Obesity Program of the University of Tennessee Health Science Center (UTHSC)
/Le Bonheur Children’s Hospital (LBCH) to facilitate many aspects of statistical design, data storage, and 
analysis. Such strengths include infrastructure support from the UTHSC Information Technology Services 
(ITS) computer center and skilled personnel with expertise in diverse fields of clinical data management, 
clinical trials, registries, specific analytics, and well-resourced database technologies. The UTHSC network 
and computing facilities are owned and managed by UTHSC and all database instances are physically 
housed in the UTHSC ITS department computer center. 
CFRI Biomedical Informatics Core (BMIC) 
The Biomedical Informatics Core (BMIC) provides best-in-class informatics support to CFRI’s operation 
and administration. This capability includes research information databases and web sites to provide 
information and foster communication among CFRI clinical and translational investigators. Vanderbilt 
University (VU), with collaboration from the Clinical & Translational Award (CTSA) consortium of 
institutional partners, has developed the Research Electronic Data Capture (REDCap™) for electronic 
collection and management of research and clinical trial data. The REDCap™ system provides secure, web-
based applications that comprise intuitive interfaces for users to enter data. REDCap™ is flexible for 
various research areas. With planning assistance from BMIC informatics team, all members of the 
research team use a study-specific data dictionary, adaptive logic, and real time validation rules (features 
in REDCap™) which results in well-planned data collection strategy for individual research studies. 
Because REDCap™ is web- based, users with appropriate permissions can access the system from 
anywhere in the world with via an Internet connection. 
REDCap™ also provides a standard export mechanism to various types of common statistical packages 
(SPSS, SAS, Stata, R/S-Plus). This allows the Principal Investigator (PI) to generate data that are truly 
independent of the data entry method, thereby generating usable, collaborative datasets for outcome 
analysis. REDCap™ was designed specifically to comply with HIPAA security and privacy guidelines. BMIC 
REDCap™ servers are housed in a HIPAA-class server room with key card and passcode access protection. 
All web- based information transmission is encrypted and uses Secure Hypertext Transfer Protocol 
(HTTPS) employing SSL (Secure Sockets Layer) encryption technology. SSL creates the secure 
connection, and HTTPS transmits the data securely. REDCap™ currently supports over 240 academic and 
non-profit consortium partners with over 26,000 research end-users (www.project-redcap.org). 
UTHSC Information Technology Services (ITS) 
UTHSC owns and manages its network and computing facilities. All REDCap™ instances are physically 
housed in the UTHSC ITS department computer center. This center has electric power conditioning, 
battery backup for short-term outages, and a backup diesel generator for long-term outages. The 

computer center also has fire suppression, temperature and humidity control, card key controlled access 
and video monitoring. The UTHSC police force monitors the building which has after-hour access controls. 
Networking equipment across the campus is housed in dedicated and locked wiring closets with battery 
backups; access is limited to UTHSC network services personnel. 
A 100-MB switched network with fully redundant network cores provides connections to both the Internet 
and Internet 2. Network traffic crossing the UTHSC network boundary is examined by a Cisco firewall 
against its Access Control Lists. A Cisco intrusion prevention system has been deployed to further 
examine traffic indicative of known exploits, and traffic is shunned or trapped as appropriate. Access from 
outside the UTHSC network for public data is to known web server ports and services. VPN (Virtual Private 
Network) access is available to authorized users by personalized NetID. No device may have network 
connectivity until its owner registers it; registration requires a University NetID and agreement with the 
UTHSC policy on acceptable use of computer resources. Systems at UTHSC are required to run current 
anti-virus software. All UTHSC systems are required to maintain current software patch levels. 
Data security 
The CFRI BMIC follows and implements all required information security standards. All deployed web 
applications use the standard industry practice of a dual server, consisting of a “front-end” web server 
accessible to the general Internet and a “back-end” database server accessible only to connections from 
the private network (and not from the public internet). All servers reside behind the UTHSC ITS unified 
threat management system, which is actively monitored. To provide greater data security and 
performance, the web server and database server are separated and do not reside on the same computer. 
To enable compliance with Good Clinical Practice (GCP) and regulatory guideline 21 CFR Part 11/45 CFR 
164, user-controlled privileges are implemented in our central registry database. 
To satisfy the NIST SP 800-44 requirement, the BMIC corporate information infrastructure includes an 
integrated firewall and intrusion detection system, backed up by continuous monitoring and automatic 
detection and alerts. The corporate network is divided into physical segments and logical zones. Network 
traffic crossing segments and zone boundaries is monitored and controlled. Access to and from the 
internet is limited to particular ports and firewall zones. Access to the host Web Server requires users to 
log in through Secure Hypertext Transfer Protocol (HTTPS) connections. 
To maintain HIPAA compliance across our system, all Personal Identifiable Information (PII) and Limited 
Data Set are encrypted by FIPS 140-2 compliance encryption standard for the NIST. All communications 
use HTTPS, which employs state-of-the-art Transport Layer Security (TLS) protocol and SSL (Secure 
Sockets Layer) encryption technology. SSL creates the secure connection and HTTPS transmits the data 
securely. 
Additionally, the CFRI BMIC recently participated in the Web Application Security Consortium (WASC) and 
Open Web Application Security Project (OWASP) community mailing list, wiki, and blog. The WASC and 
OWASP are 501(c)3 not-for-profit worldwide groups of experts focused on improving the security of 
application software and the best-practice security standards for the World Wide Web. Furthermore, CFRI’
s BMIC informatics architecture separates database and application functionality across servers. All 
servers are protected by UTHSC firewalls. Development/staging environments are separate from 
production environments. All coding design and implementation in REDCapTM are implemented through 
the development environment and source control. Security is considered in all phases of the system 
development life cycle and is treated as an integral part of the system development and implementation 
process, including system modifications. CFRI’s BMIC development team leader ensures that adequate 
and effective management, operational and technical control mechanisms are integrated into the system 
development lifecycle. 
Secure data access 
REDCap™ has the ability to strictly control access to the data using role-based control. Granted access is 
based on the role of individual user. Examples include a general user or a privileged user such as an 
administrator, regular user, principal investigator, co-investigator, etc. Audit records include date and 
time of the event, subject identity, and success or failure of the event. The database can be queried 
through the web- based interface with an appropriate control access through Virtual Private Network 
(VPN) and login authentication. We will provide a unique assigned username and password, which will be 
required for authentication. 
Our database (REDCap™) uses system authentication to connect to the application. The application 
enforces rights limitations and information flow control. Connectivity between application and database, 
and between users and applications, is limited by VPN, firewall filtering and service/application access 
control. Passwords for all user accounts expire every 90 days as part of our Standard Operating 
Procedures (SOPs). Users will be warned that their passwords are about to expire, beginning at least 14 
days prior to the expiration date. User are notified via Rules of Behavior (RoB) that they must not share 
password with others and to report lost or compromised password immediately to the CFRI BMIC. The 
user session is dropped after 20 minutes of navigation inactivity. Because these applications are browser-
based, user session is terminated. To continue, a user must log in to the application and establish a new 
session. 
Data storage 
Data are stored on a MySQL database server that is housed in UTHSC ITS HIPAA-class server room and 
protected by the UTHSC firewall. Access to the server room is protected by the use of key cards and 
personal security passcode access protection. The server uses a Redundant Array of Independent Disks 

(RAIDs) configuration on the hard drives available in the event of a drive failure so drives can be replaced 
immediately. All data is moved to a backup server nightly. A tape backup is made of the two most recent 
full backups. These tapes are encrypted and stored in the server room before entering the rotation again. 
To militate data loss in the event of the disaster, CFRI’s BMIC follows the UTHSC Disaster Recovery Plan 
(DRP) and Business Continuity Plan (BCP). 
Vulnerability scan 
The CFRI BMIC actively monitors for vulnerabilities in our security plan. This monitoring takes place at 
various levels of granularity. The top-level review is our internal Risk Assessment Retreat. This is 
quarterly meeting engages all developers, supervisors, and data managers as well as the systems, 
network, and database administrators to discuss perceived risks to our system. Attendees are invited to 
spend a number of hours preparing through the use of system reviews, log analysis, feasibility analysis, 
and white hat analysis. Internal CFRI BMIC policy dictates that a risk assessment be performed when 
configuration changes are made. This includes any creation or modifications of firewall rules, backup plan, 
database, roles, and internal user access. This ongoing review aims to identify possible problems or 
attacks on our servers early on. There could be unexpected utilization of the central processing unit 
(CPU), a large number of refused connections, or a drastic increase in web server traffic.
37.0
 (2730) If Subjects Were Not to Participate
37.1  
 List all of the procedures (including those such as medical record abstraction or survey administration) that will be 
*
performed 
because the subject is in this study/project. This means even listing how many additional blood draws, 
ONLY 
visits, etc., would occur beyond the number of standard of care blood draws, visits, etc. If all procedures are being 
performed solely for research purposes, you may simply state this.
All procedures are being performed solely for research purposes.
38.0
 (2748) Privacy
38.1  
Confirm that ALL of the following are true:
* 
 
the collection of private information will be limited to the minimum necessary to meet the 
objectives of the study; AND
the number of key study personnel (KSP) who have access to private information will be 
limited to the minimum number necessary to meet the objectives of the study; AND
research records will be kept separate from other records, such as medical or educational 
records, unless the information is useful for the welfare of the subject, or unless the clinic
/hospital’s policy is to include research consent forms in the patient’s medical record.
Yes, all of the above statements are true. 
No, one or more of the above statements are not true. 
38.2  
 Check off all of the following approaches that will be used to assure that prospective subjects are screened, recruited, and
*
/or invited to participate in a way that protects them from being witnessed, overheard, or viewed in a manner that violates 
their privacy.
Patients will initially be approached for participation by their physician, not a stranger to the patient, 
unless there is documented permission from the physician to approach the patient.
Recruitment letters will only be sent by the patient’s physician, or will state that the researcher 
obtained permission from the patient’s physician.
Recruitment letters will only be addressed to the prospective subject or their legally authorized 
representative, as appropriate.
Recruitment will not be conducted in an open area or in a group setting when medical conditions, 
sensitive topics (such as criminal behavior; sexual practices; alcohol and drug use; physical, 
emotional, or sexual abuse; etc.), or other private matters are being studied.
Screening will not be conducted in an open area or in a group setting when medical conditions, 
sensitive topics (such as criminal behavior; sexual practices; alcohol and drug use; physical, 
emotional, or sexual abuse; etc.), or other private matters are being studied.
If screening requires the prospective subject to disrobe partially or completely, the prospective subject 
will do so in a private room and will have a gown or proper cover to put on while he/she waits in the 

room.
Other
Not applicable. This study does not involve screening or recruitment.
38.3  
 Check off all of the following approaches that will be used to assure that interventions and 
*
interactions with subjects provide protections against them being witnessed, overheard, or viewed 
in a manner that would violate their privacy.
Interventions and interactions with subjects will not be conducted in an open area or in a group setting 
when medical conditions, sensitive topics (such as criminal behavior; sexual practices; alcohol and 
drug use; physical, emotional, or sexual abuse; etc.), or other private matters are being studied.
If interventions require the subject to disrobe partially or completely, the subject will do so in a private 
room and will have a gown or proper cover to put on while he/she waits in the room.
If photographs, voice recording, or video recording will be performed, the subject is aware of this fact 
and informed about who will be viewing them and/or receiving them, and the subject has given written 
permission for these procedures.
Other
38.4  
 Check off all of the following ways in which tracking non-compliant subjects or subjects lost to 
*
follow-up will assure that their medical condition and/or participation in the research is not 
disclosed to persons outside the research.
Written permission will be secured from subjects regarding all of the methods that may be utilized to 
track them.
The subject’s phone number(s) will be called, and if the subject is not the person who answers, the 
researcher will not divulge the title of the study or the fact that the subject is/was participating in a 
study.
Certified mail will be sent to the subject.
The return address nor any markings on the envelope of a letter to the subject will not identify the title 
of the study or the fact that the subject is/was participating in a study.
Any letter sent to subjects will not reveal the topic of the study if a medical condition and/or sensitive 
issue is being studied (such as criminal behavior; sexual practices; alcohol and drug use; physical, 
emotional, or sexual abuse; etc.).
The topic of the study or the fact of the subject’s participation will not be disclosed to any person 
outside the study who is contacted to determine the whereabouts of subjects.
Other
Not Applicable. We will not attempt to track non-compliant subjects or subjects lost to follow-up.
39.0
 (2750) Confidentiality 1a
39.1   Will you collect, for screening purposes, individually identifiable, private information (including health 
*
information) about prospective subjects?  (This includes information that you abstract from the medical 
record or information you collect via telephone, mobile app, or website for screening purposes prior to 
obtaining written informed consent.) (Consult the question mark icon for definitions.)
Yes 
No 
40.0
 (2755) Confidentiality 1b
40.1   Explain what will be done with the individually identifiable, private information (including health information) 
*
that you collect about prospective subjects who fail screening or who do not agree to participate (consult the 
question mark icon for definitions):
The information will be destroyed; e.g., shredded or properly deleted from a computer. 
Items of individually identifiable, private information such as names, contact information, and health 
information will be maintained by the local investigator (either locked and stored if on paper; computer 

password protected and accessible only to research personnel, or stored in an encrypted fashion on a 
thumb drive, laptop, or desktop computer). 
Information will be forwarded to sponsor/CRO using an encrypted method and then destroyed at the 
local site. 
Other 
41.0
 (2800) Confidentiality 2
41.1  
 Will all paper research records containing identifiable, private information (including the original 
*
signed consent form) from individual subjects be locked and stored and be accessible only to 
research personnel? (Consult the question mark icon for definitions.)
Yes. All paper research records containing identifiable, private information from individual subjects 
(including the original signed consent form) will be locked and stored and will be accessible only to 
research personnel. 
No. Not all paper research records containing identifiable, private information from individual subjects 
(including the original signed consent form) will be locked and stored and will be accessible only to 
research personnel. 
Not applicable. There will be no paper research records containing identifiable, private information 
from individual subjects. 
41.2  
Check off all of the following items that apply regarding the electronic storage of identifiable, private 
* 
information collected in this project (consult the question mark icon for definitions.): 
All electronic research records containing identifiable, private information from individual subjects will 
be computer password protected and accessible only to research personnel.
All electronic research records containing identifiable, private information from individual subjects will 
be stored in an encrypted fashion (e.g., on an encrypted, password protected thumb drive; on an 
encrypted laptop; on an encrypted desktop computer; in an encrypted, password protected file on a 
laptop/computer; etc.).
Other or additional methods of secure storage (e.g., data will have inter-file linkage, error inoculation, 
top coding, bracketing, data brokering, etc.)
Not applicable. Electronic research records will NOT contain identifiable, private information from 
individual subjects.
Not applicable. There will be NO electronic research records.
41.3  
Select the following item that applies regarding the electronic transmission (either locally or 
* 
externally) of identifiable, private information collected in this project (consult the question mark 
icon for definitions):
All electronic research records containing identifiable, private data from individual subjects will be 
transmitted electronically via an encrypted method (e.g., UT Vault, Xythos, a federal or industry-
sponsor cleared web-based portal, etc.). 
All electronic research records containing identifiable, private data from individual subjects will be 
coded before transmitted electronically, and the master key will be maintained at the local site. 
Other or additional methods of secure electronic transmission 
Not applicable. NO electronic transmission of identifiable, private data will occur. 
42.0
 (2805) Biological Specimens
42.1  
Will biological specimens be collected in this study/project?
 *
Yes. Biological specimens will be collected in this study/project. 
No. Biological specimens will NOT be collected in this study/project. 
43.0
 (2820) Confidentiality 3

43.1  
 Will information obtained from procedures performed only for research purposes be placed in the medical record of 
*
subjects?
Yes. Information obtained from procedures performed only for research purposes MAY BE placed in the 
medical record of subjects. 
No. Information obtained from procedures performed only for research purposes WILL NOT BE placed 
in the medical record of subjects. 
Not applicable: There will be no procedures performed only for research purposes. 
Not applicable: This project does not include access to or use of the medical record of the subjects. 
43.2  
 Will documentation of the participation of the subject in the research study, such as a copy of the consent form or other 
*
notation, be placed in the medical record of the subject?
Yes. Documentation of the participation of the subject in the research study, such as a copy of the 
consent form or other notation, MAY BE placed in the medical record of the subject. 
No. Documentation of the participation of the subject in the research study, such as a copy of the 
consent form or other notation, WILL NOT BE placed in the medical record of the subject. 
Not applicable: This project does not include access to or use of the medical record of the subjects. 
44.0
 (2825) Confidentiality 4
44.1  
 Will a federal Certificate of Confidentiality be obtained for this study/project (
*
http://www.uthsc.edu/research
/compliance/irb/researchers/documents/certificates-confidentiality.pdf)? 
Yes. A federal Certificate of Confidentiality WILL be obtained for this study/project. 
No. A federal Certificate of Confidentiality WILL NOT be obtained for this study/project. 
45.0
 (3045) Payment
45.1  
 Will any type of payment (money, gift card, or other item) be provided to the subject for participation?
*
 Yes   
 No
46.0
 (3050) Describe Payment
46.1  
 Indicate the 
of money to be paid (including reimbursement pay) per visit 
total maximum payment, the 
*
AMOUNT 
AND 
of payment (check, cash, gift card and value), as well as the monetary worth of any 
tangible item provided 
TYPE 
OTHER 
as payment for study/project participation.  
For each data collection session the child attends they will receive an incentive of their choice (ex. food 
log, water bottle, jump rope, exercise band, label reading guides, pedometer, etc.). After the completion 
of the pre-evaluation the participant and parent will be provided with a YMCA gym family membership for 
3 months (value: $75 for family registration, $32 per family member monthly, and tax; therefore the 
value for a family of four would be approximated $240 for a 3 month membership). After the post-
evaluation the participant and parent will be given an additional 3 month YMCA gym family membership. 
This amount is based on previous incentives provided for similar YMCA programs. Also, at the end of the 
study you and your child will receive a full report with all the information collected and an explanation that 
can help you and your child with health and fitness goals. 
Incentives: 
Pre, post, and follow-up evaluations: $50 gift card (from Kroger or Walmart) for participant 
Programs sessions: attendance raffle: participants will be provided with a raffle ticket for attending 
sessions and will be able to select a n item for a prize box (water bottles, t-shirts, jump ropes, hand 
sanitizer, myPlates, etc.)
46.2  
 To whom will the payment [money, gift certificate, other items] be paid/given?
*

The subject 
The subject's legally authorized representative 
Mixed arrangement, depending on the age or health of subjects 
 Please explain:
*
Child: incentive of their choice (ex. food log, water bottle, jump rope, exercise band, label reading guides, 
pedometer, etc.)
Parent/Child: YMCA memberships, $50 gift cards (from Kroger or Walmart) for the family each data 
collection section
46.3  
How will the actual amount of money received by the subjects or their legally authorized representative be determined?
* 
Lump sum payment will be made at completion of the study/project (Note: if paying per visit, the 
payment must not be held until the end of the study because of potential undue inducement; the same 
applies if a rather large sum of money will be paid only at the end of the study.) 
Prorated payments will be processed or issued at the time specific visits and/or procedures are 
completed 
Prorated payments will be processed or issued at the time specific visits and/or procedures are 
completed, plus a bonus will be paid for completing the entire study/project 
Not applicable; no money will be paid to the subjects 
 If your answer is the second option, "Prorated payments for...procedures," please describe the schedule of payments for 
*
specific visits and/or procedures.
 If your answer is the third option, "Prorated payments... plus a bonus for completing the entire study," describe the 
*
schedule of payment for specific visits and/or procedures, as well as the bonus for completing the entire study/project.
 
The payment (YMCA membership) will be prorated based on the completion on evaluation session. At 
consenting/registration the parent/child will be given a 3 month YMCA family membership. At the 
completion of the intervention portion or the program and post evaluation the parent/child will be given 
an additional 3 month YMCA family membership. Therefore 2 payment amounts will be given.
47.0
 (3100) Financial Obligations
47.1  
 Will any drug/biologic, device or intervention being administered and evaluated as a diagnostic, monitoring or treatment 
*
procedure in this study/project be provided free of charge?
Not Applicable. No drug/biologic, device or other intervention is being evaluated as treatment in the 
study/project. 
Yes. The drug/biologic, device or other intervention being evaluated as treatment WILL be provided 
free of charge. 
No. The drug/biologic, device or other intervention being evaluated as treatment WILL NOT be 
provided free of charge. 
47.2  
 With respect to study/project procedures other than any treatments being evaluated in the study/project, will there be 
*
any costs to the subject as a result of research procedures that exceed what would be incurred with standard treatment (e.
g., additional diagnostic tests, monitoring procedures, hospitalization, etc.)?
Not applicable. The procedures of this research do not correlate to any standard treatment.  
No costs will exceed what would be incurred with standard treatment. 
Costs to exceed what would be incurred with standard treatment. 
48.0
 (3200) Research Injuries
48.1  
Does the research include procedures that have the potential to cause physical injury to the subjects?
* 

Yes. The research includes procedures that have the potential to cause physical injury to the subjects. 
No. The research DOES NOT include procedures that have the potential to cause physical injury to the 
subjects. 
49.0
 (3210) Potential Injury
49.1  
Who will be responsible for the costs of treating research-related physical injuries?
* 
Write “the subject & his/her insurance” or “the subject & his/her insurance, and the sponsor” below, regarding who will be 
responsible for the costs of treating research-related physical injuries, or specify any other arrangements.
the subject & his/her insurance
49.2  
 Will research personnel provide treatment or referral for research-related physical injuries as needed or requested by 
*
the subject? 
Research personnel will provide acute care for research-related physical injuries. 
Research personnel will refer subjects for appropriate care for research-related physical injuries. 
Research personnel will provide acute care for research-related physical injuries and will refer subjects 
for appropriate care. 
Other. 
49.3  
 Will compensation be available to subjects for any ancillary expenses incurred as the result of research-related physical 
*
injuries, such as additional hospital bills, lost wages, travel expenses, etc.?
Yes. Compensation will be available to subjects for any ancillary expenses incurred as the result of 
research-related physical injuries, such as additional hospital bills, lost wages, travel expenses, etc.  
No. Compensation will NOT be available to subjects for any ancillary expenses incurred as the result of 
research-related physical injuries, such as additional hospital bills, lost wages, travel expenses, etc. 
50.0
 (3230) Compensation for Non-Physical Injuries
50.1  
Will compensation be available to subjects for any non-physical injuries that may be incurred as a result of research 
* 
participation, such as exposure to criminal or civil liability, or damage to their reputation, financial standing, or 
employability?
Yes. Compensation will be available to subjects for any non-physical injuries that may be incurred as a 
result of research participation, such as exposure to criminal or civil liability, or damage to their 
reputation, financial standing, or employability. 
No. Compensation will NOT be available to subjects for any non-physical injuries that may be incurred 
as a result of research participation, such as exposure to criminal or civil liability, or damage to their 
reputation, financial standing, or employability. 
51.0
 (3300) Conflict of Interest
51.1  
For any publically traded entity whose monetary worth may be directly affected by the results of this research study, 
* 
have any individuals among the key research personnel listed in section 3.0 above [including their spouses (whether or not 
they commingle assets), parents, and children (both dependent and non-dependent, and including stepchildren and foster 
children)] received salary for services or any other payments (e.g., consulting fees, honoraria, paid authorship) from that 
entity during the previous 12 months, and/or hold an equity interest in that entity, such that the combined value, when 
aggregated, exceeds $5,000?
Yes. Key study personnel (or their spouses, parents, or children as defined above) have received 

remuneration and/or possess equity interests which, when aggregated, exceed $5,000. 
No. Key study personnel (or their spouses, parents, or children as defined above) have NOT received 
remuneration and/or possess equity interests which, when aggregated, exceed $5,000. 
Not Applicable. There is no publicly traded entity whose monetary worth may be directly affected by 
the results of this research. 
51.2   For any non-publically traded entity whose monetary worth may be directly affected by the results of this 
*
research study, have any individuals among the key research personnel listed in section 3.0 above [including 
their spouses (whether or not they commingle assets), parents, and children (both dependent and non-
dependent, and including stepchildren and foster children)] received salary for services or any other 
payments (e.g., consulting fees, honoraria, paid authorship) from that entity during the previous 12 months 
which exceeds $5,000, or hold any equity interest in that entity?
Yes. Key study personnel (or their spouses, parents, or children as defined above) have received 
remuneration from the entity which, when aggregated exceeds $5,000, or hold some equity interest in 
the entity. 
No. Key study personnel (or their spouses, parents, or children as defined above) have received NOT 
remuneration from the entity which, when aggregated exceeds $5,000, and do NOT hold any equity 
interest in the entity. 
Not Applicable. There is no non-publicly traded entity whose monetary worth may be directly affected 
by the results of this research. 
51.3   Do any individuals among the key research personnel listed in section 3.0 above [including their spouses 
*
(whether or not they commingle assets), parents, and children (both dependent and non-dependent, and 
including stepchildren and foster children)] have intellectual property rights (patents, trademarks, licensing 
agreements or copyrights) in any test article being evaluated in the research and have already received 
income related to such rights and interests?
Yes. Key study personnel (or their spouses, parents, or children as defined above) have intellectual 
property rights related to the test article being evaluated and have already received income related to 
such rights and interests. 
No. Key study personnel (or their spouses, parents, or children as defined above) do not have 
intellectual property rights related to the test article being evaluated or have not received income 
related to such rights and interests. 
Not Applicable. No test article involving intellectual property rights is being evaluated in this study. 
52.0
 (3329) Informed Consent
52.1  
 Check each of the following that apply to your study/project:
*
Informed consent will be secured from adult subjects who are able to consent for themselves.
Informed consent will be secured from legally authorized representatives for adult subjects who are 
not able to consent for themselves.
Permission will be secured from legally authorized representatives for children who are subjects.
Assent will be secured from child subjects 8-17 years of age and/or from adult subjects who do not 
have the capacity to consent.
A request is being made to waive or alter consent for some or all of the subjects. (Note: Informed 
consent normally requires the use of a consent form prepared according to the IRB format and the 
conduct of an individual in-person interview with the prospective subject. WAIVER of consent is a 
request to forego consent entirely. ALTERATION of consent is a request to alter the normal process, e.
g., by using a shorter consent statement or conducting consent over the phone.)
Consent will be secured from the subjects, but a request is being made to NOT obtain a signed consent 
form for some or all of the subjects. (For example, you are conducting an online survey study.)
A request is being made to waive informed consent under the emergency medicine research provisions 
of the FDA regulations.
Non-English speaking subjects will be included in the study population.
53.0
 (3440) Consent & Assent Process

53.1  
 Briefly explain when and where informed consent of the subject or Legally Authorized Representative (LAR), assent of 
*
 
the subject (if applicable), and permission from parents (if applicable) will be sought.  Explain whether you will 
 
obtain consent (not assent) when a child subject turns 18 while still in the study (if applicable).  If consent is provided by 
a Legally Authorized Representative when a subject is temporarily not capable of consenting or assenting, explain whether 
you will obtain consent or assent from the subject when he/she becomes capable of consenting while still in the study.  
On the day of registration, parents or guardians will receive project information packets from the trained 
research team. The packets will include a parent/guardian consent form, a child assent form, and detailed 
participation requirements, benefits, and incentives. Once the researcher consents the parent and assents 
the child face-to-face, the child and parent will be asked to sit with the researcher to complete the study 
questionnaires. The parent will complete the Healthy Habits Questionnaire (parent version), the child and 
parent will complete the Healthy Habits Questionnaire (child version), and the child (child version) and 
parent (parent version) will complete the mental health questionnaire separately. Trained research team 
members will complete all face-to-face consenting and surveys/questionnaires.
Once completed the participant will return the following week to complete their pre-evaluation 
assessment. 
The parents will be encouraged to contact the research team if they should have any questions regarding 
the study procedures. All questionnaires, consents, and assent forms must be completed prior to the data 
collection days with the assistance of a research team member. The research staff will review all materials 
and assign a study id prior to the child's participation in data collection. Following completion of the 
project parents or guardians of all children enrolled in the project will receive a report of their health 
behaviors, physical fitness, and mental health performance with strategies to improve/maintain their 
outcomes.
54.0
 (3450) HIPAA
54.1  
In order to conduct this research, or to identify or recruit potential subjects, are you requesting to use 
* 
SOURCE 
 or 
 
 that contain the Protected Health Information of persons without their 
DOCUMENTS
SOURCE MATERIALS
authorization (or with their limited authorization) AND/OR are you obtaining Protected Health Information of persons 
without their authorization (or with their limited authorization), such as through telephone screening?  
Note: Source documents/materials are documents/materials from which you are going to abstract information in order to 
conduct this research or to identify or recruit potential subjects, for example, a patient's medical record.
Yes. I am requesting to use source documents/materials that contain Protected Health Information 
(PHI) of persons (living or dead) without their authorization (or with limited or altered authorization) to 
conduct the study, or to identify or recruit potential subjects. 
No. I am not requesting to use source documents/materials that contain Protected Health Information 
(PHI) of persons (living or dead) without their authorization (or with limited or altered authorization) to 
conduct the study, or to identify or recruit potential subjects. 
55.0
 (3455) HIPAA Type of Waiver Requested
55.1  
Please identify the regulatory category under which the request is being made to view, record, and/or retain Protected 
* 
Health Information (PHI) without subject authorization.   
Waiver of subject authorization is being requested because some or all of the PHI is being viewed, 
recorded, and/or retained without the subject (or potential subject) signing a HIPAA authorization.
Some or all Protected Health Information (PHI) to be viewed, recorded, and/or retained is from 
individuals who were deceased prior to the date this research proposal was submitted.
Some or all Protected Health Information (PHI) to be viewed, recorded, and/or retained is a limited 
data set. A limited data set is a medical record, database, or other source document being accessed 
for this research which does NOT contain 16 of the 18 HIPAA-specified identifiers. (The 16 identifiers 
can be found by clicking on the question mark to the right of this section.)
Some or all Protected Health Information (PHI) to be viewed, recorded, and/or retained is de-identified 
data. De-identified data is a medical record, database, or other source document being accessed for 
this research which does NOT contain ANY of the 18 HIPAA-specified identifiers. (The 18 identifiers can 
be found by clicking on the question mark to the right of this section.)
56.0
 (3460) Section A:  PHI

56.1  
Briefly describe the Protected Health Information (PHI) to be used in the research activity.  If this study 
* 
involves a review of records for which all the records will be in existence and completed at the time that the 
study is initiated, then specify the beginning and ending dates of those records. 
A referring non-investigative M.D. may provide a potential subject's name, date of birth, telephone 
number, Hemoglobin A1c, BMI. Research staff will need the telephone number to contact the subject and
/or the parent/legal guardian as well as the potential subject's name to be able to identify the subject 
during a telephone contact to inquire.
56.2   If Protected Health Information (PHI) will be disclosed to the investigator by another covered entity or 
*
entities, briefly describe these entities.  
N/A
56.3   Briefly explain who will receive and use the Protected Health Information (PHI) and where it will be stored.  
*
Primary investigator, co-investigators, and research staff will receive the PHI to contact potential subjects 
who contacted the study coordinator or were referred by a non-investigator MD. PHI will be stored on a 
spreadsheet that is password protected. The spreadsheet will be stored on a password protected 
computer. The computer will be stored in a locked office to which only designated research staff will have 
access to. PHI will be stored in electronic form and only accessible by appointed study personnel.
57.0
 (3462)  Section B:  Use of PHI Under the Waiver
57.1  
 Protected Health Information (PHI) will be used without a signed consent form containing a HIPAA authorization: 
*
to identify potential subjects for recruitment (e.g., where a chart review will be conducted before 
asking the potential subject to sign a consent form containing the HIPAA authorization).
to contact potential subjects regarding study participation (e.g., obtaining a phone number from the 
medical record in order to call potential subjects to conduct a survey).
for the collection of data for the study (e.g., a retrospective chart review).
58.0
 (3466)  HIPAA Waiver or Alteration
58.1  
- health information with identifiers
Briefly describe the plan to protect the Protected Health Information (PHI) 
* 
.  
PHI will be stored on a password protected database. The database will be stored on a password 
protected computer. The computer and any paper PHI will be stored in a locked office to which only 
designated research staff will have access.
58.2  
Briefly describe the plan to destroy the identifiers at the earliest opportunity consistent with the conduct of the 
* 
research.  If there is a justification for retaining the identifiers or such retention is otherwise required by law, this should 
be explained.  
PHI identifiers will be removed and assigned a unique identification code. Subject identifiers will be 
destroyed at the earliest opportunity consistent with the conduct of research.
58.3  
- health information with identifiers - 
Will the Protected Health Information (PHI) 
* 
be reused or disclosed to any 
other person or entity than those listed in (415) and (470)? 
  Yes   
  No
58.4  
 Is it true that the Protected Health Information (PHI) will not be reused or disclosed to any other person or entity 
*
EXCEPT as required by law, for authorized oversight of the research study, or for other research for which the use or 
disclosure of the PHI is approved by the IRB?

True. PHI will not be reused or disclosed unless as excepted above. 
Not true. PHI may be reused or disclosed. 
58.5  
 Briefly explain why you must have access to the PHI in order to complete your research.
*
PHI is needed to identify and recruit potential participants for study project.
59.0
 (3468)  HIPAA Waiver Practicality
59.1  
 Why can the research not be practicably carried out without the waiver of the authorization requirement?
*
Funds and personnel do not exist to contact all potential subjects to secure their authorization.
Failure to include all potential subjects might result in skewed analysis of the results of the study.
Other reason.
60.0
 (5000) References
60.1  
Please list all literature references in support of this research.
* 
Janssen I, LeBlanc AG. Systematic review of the health benefits of physical activity and fitness in 
school-aged children and youth. Int J Behav Nutr Phys Act 2010, 7(40).
Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United 
States, 2011-2012. JAMA 2014;311:806-814. doi:10.1001/jama.2014.732.
Tennessee Department of Education. Tennessee Coordinated School Health 2008-2009 Executive 
Summary. Available from: 
.
http://www.tennessee.gov/education/schoolhealth/
National Center for Chronic Disease Prevention and Health Promotion (NIHCM), Division of Adolescent 
and School Health. (2008). Healthy Youth! YRBSS Youth Online: Comprehensive Results Retrieved 
. 
September12th, 2010, from http://apps.nccd.cdc.gov/yrbss/CategoryQuestions.asp?
Cat=6&desc=Physical%20Activity
Sinha R, Fisch G, Teague B, Tamborlane WV, Banyas B, Allen K, et al. Prevalence of impaired glucose 
tolerance among children and adolescents with marked obesity. N Engl J Med 2002;346:802-810.
Caprio S, Plewe G, Diamond MP, Simonson DC, Boulware SD, Sherwin RS, et al. Increased insulin 
secretion in puberty: a compensatory response to reductions in insulin sensitivity. J Pediatr 1989;114:
963-967.
Kahn SE. The importance of B-cell failure in the development and progression of type 2 Diabetes. J 
Clin Endocrinol Metab 2001;86:4047-4058.
Matthews DR, Cull CA, Stratton TM, Holman RR, Turner RC. UKPDS 26: sulfonylurea failure in non-
insulin dependent diabetic patients over six years. UK Prospective Diabetes Study (UKPDS) Group. 
Diabet Med 1998;15:297-303.
Gungor N, Arslanian S. Progressive beta cell failure in type 2 diabetes mellitus of youth. J Pediatr 2004;
144:656-659.
TODAY Study Group, Zeitler P, Hirst K, Pyle L, Linder B, Copeland K, et al. A clinical trial to maintain 
glycemic control in youth with type 2 diabetes. N Engl J Med 2012;366:2247-2256.
Shaw M, Savoye M, Cali A, Dziura J, Tamborlane WV, Caprio S. 2009. Effect of a successful intensive 
lifestyle program on insulin sensitivity and glucose tolerance in obese youth. Dia Care. 32(1): 45-47.
Wadden TA, Webb VL, Moran CH, Bailer BA. 2012. Lifestyle modification for obesity: New 
developments in diet, physical activity, and behavior therapy. Circ. 125(1): 1157-1170.
BeLue, R., Francis, L., & Colaco, B. (2009). Mental health problems and overweight in a nationally 
representative sample of adolescents: effects of race and ethnicity. 
, 
(2), 697-702. doi:
Pediatrics 123
10.1542/peds.2008-0687.
Halfon, N., Larson, K., and Slusser W. (2013). Associations between obesity and comorbid mental 
health, development, and physical health conditions in a nationally representative sample of US 
children aged 10 to 17. Academic Pediatrics, 13 (1), 6-13.
Puder, J. J., & Munsch, S. (2010). Psychological correlates of childhood obesity. International Journal 
, 
(Suppl 2), S37-S43. doi:10.1038/ijo.2010.238.
Of Obesity 34
McCrimmon RJ, Ryan CM, Frier BM: Diabetes and cognitive dysfunction. Lancet June 9, epub ahead of 
print:DOI:10.1016/S0140-6736(1012)60360-60362, 2012.
Hillman CH, Erickson KI, Kramer AF. Be smart, exercise your heart: Exercise effects on brain and 
cognition. Nature Reviews Neuroscience 2008;9:58-65. Physical Activity Guidelines Advisory 
Committee. Physical activity guidelines for Americans Washington, DC: US Department of Health and 
. 
Human Services 2008;15-34.

Prochaska JO, Marcus BH. (1994). The transtheoretical model: Applications to exercise.  In R. K. 
Dishman (Ed.), Advances in exercise adherence.  Champaign, IL: Human Kinetics, pp.161-180.
Perry CL, Bishop DB, Taylor G, et al. Changing fruit and vegetable consumption among children: the 5-
a-day power plus program in St Paul, Minnesota. Am J Public Health 1998;88:603–609.
Stevens J, Cornell CE, Story M, et al. Development of a questionnaire to assess knowledge, attitudes, 
and behaviors in American children. Am J Clin Nutr 1999;69:773S–781S.
O'Donnell D, Schwab-Stone M, Muyeed A. Multidimensional resilience in urban children exposed to 
community violence. Child Dev 2002;73:1265-1282.
Resnick MD, Bearman PS, Blum RW, Bauman KE, Harris KM, Jones J, Tabor J, Beuhring T, Sieving RE, 
Shew M, Ireland M, Bearinger H, Udry JR. Protecting adolescents from harm. Findings from the 
national longitudinal study on adolescent health. JAMA 1997;278:823-832.
Epstein LH, Paluch RA, Coleman KJ, Vito D, Anderson K. Determinants of physical activity in obese 
children assessed by accelerometer and self-report. Med Sci Sports Exerc 1996;28:1157-1164.
Sallis JF, Buono MJ, Roby JJ, Carlson D, Nelson JA. The Caltrac accelerometer as a physical activity 
monitor for school-age children. Med Sci Sports Exerc 1990;22:698-703.  
American Thoracic Society (2002). Guidelines for the Six-Minute Walk Test. American Journal of 
Respiratory and Critical Care Medicine. 166:1, 111-117.
Choice Medical MD  Fingertip Pulse Oximeter. Choice Medical MD, Inc. Beijing, China
National Institute of Medicine [NIH]. (2012). 
Neuroscience 
NIH Toolbox Administrator Manual. 
Research and the Office of Behavioral and Social Sciences Research, National Institutes of Health.
Bruininks RH, Bruininks BD. (2005). BOT2: Bruininks-Oseretsky Test of Motor Proficiency: 
. Pearson Assessments. I
Administration Easel
Inbody570. (2006). 
 Beverly Hills, California, USA: Biospace.
Instruction Manual.
Sampaio LR, Simoes EJ, Assis AM, Ramos LR. Validity and reliability of the sagittal abdominal diameter 
as a predictor of visceral abdominal fat. Arquivos Brasileiros Endocrinologia Metabologia 2007;51:980-
986.
Center for Disease and Control (CDC). National Health and Nutrition Examination Survey (NHANES): 
Anthropometry Procedures Manual. Retrieved August 1, 2013 from http://www.cdc.gov/nchs/data
/hus/hus12.pdf
Kirkenale NM, Burton AC, Epstein FH, Freis ED. Recommendation for human blood pressure 
determination by sphygmomanometers. Report of a subcommittee of the postgraduate education 
committee. Circulation 1967;36:980-988.
American Heart Association. Heart Rate Variability: Standards of Measurement, Physiological 
Interpretations and Clinical Use.1996; 93: 1043-1065
.DNA Genotek. Oragene DX: Salivary DNA Testing. Ontartio,Canada
W.G. John, R. Edwards, C.P. Price Laboratory evaluation of the DCA 2000 clinic HbA1c immunoassay 
analyser 1994
Alere. Cholestech DX System: Lipid Profile. San Diego,CA.
Wechsler, D (2011). Wechsler Abbrieviated Scale of Intelligence – Second edition. San Antonio, TX; 
Pearson Assessments.
Moos RH, Moos BS. “Family Environment Scale Manual and Samplet Set: Development, Applications, 
and Research.” 4th Ed. Mind Garden, Inc.: Palo Alto, CA. 2009.
Silverberg SB, Small SA. Parenting monitoring, family structure and adolescent substance use. Paper 
presented at the meeting of the Society of Research in Child Development, Seattle, WA, 1991.
Varni JW, Burwinkle TM, Seid M, Skarr D (2003).The PedsQL 4.0 as a pediatric population health 
measure: feasibility, reliability, and validity. Ambulatory Pediatrics 3(6): 329-41.
Mayo Clinic (2013). Symptoms of Hypoxemia.  Website. http://www.mayoclinic.org/symptoms
/hypoxemia/basics/definition/SYM-20050930. Retrevied February 27, 2015.
61.0
 Save and Attach Documents
61.1  
The following text box is provided in the event that you need to share additional information with the Review Board.
Kristina Decker is a UT graduate assistant.
61.2  After clicking the “Save and Continue” button, you will advance to the routing form in order to attach any 
supporting documents (such as consent forms) and to send the submission to the necessary personnel for 
their signatures.
CLICK on "Save and continue..."