TEEN HEED: An Adolescent Diabetes Prevention Intervention Incorporating Novel Mobile Health Technologies
Phase: NA
Conditions: Type 2 Diabetes
Sponsor: Icahn School of Medicine at Mount Sinai

 
 
TEEN HEED Protocol 
Protocol Number*: <1> 
National Clinical Trial (NCT) Identified Number:  <Number, once assigned by 
CT.gov> 
Principal Investigator*: Nita Vangeepuram, MD, MPH 
Sponsor: Icahn School of Medicine at Mount Sinai 
Grant Title: TEEN HEED 
Grant Number*: <Grant Number> 
Funded by: <National Institutes of Diabetes and Digestive and Kidney Diseases> 
Version Number:  1 
23 April 2021 
 
 

NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans 
CONFIDENTIALITY STATEMENT 
This document is confidential communication. Acceptance of this document constitutes agreement by the 
recipient that no unpublished information contained herein will be published or disclosed without prior 
approval of the Principal Investigator or other participating study leadership and as consistent with the 
NIH terms of award.  
 

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Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................. 1 
INVESTIGATOR’S SIGNATURE .............................................................................................................................. 2 
1 
PROTOCOL SUMMARY ............................................................................................................................... 3 
1.1 
Synopsis ................................................................................................................................................ 3 
1.2 
Schema .................................................................................................................................................. 4 
1.3 
Schedule of Activities .......................................................................................................................... 5 
2 
INTRODUCTION ............................................................................................................................................ 6 
2.1 
Study Rationale .................................................................................................................................... 6 
2.2 
Background ........................................................................................................................................... 6 
2.3 
Risk/Benefit Assessment .................................................................................................................... 8 
2.3.1 
Known Potential Risks ..................................................................................................... 8 
2.3.2 
Known Potential Benefits ................................................................................................ 8 
2.3.3 
Assessment of Potential Risks and Benefits ............................................................... 8 
3 
OBJECTIVES AND ENDPOINTS ................................................................................................................ 8 
4 
STUDY DESIGN ............................................................................................................................................. 9 
4.1 
Overall Design ...................................................................................................................................... 9 
4.2 
Scientific Rationale for Study Design .............................................................................................. 10 
4.3 
Justification for Intervention .............................................................................................................. 10 
4.4 
End-of-Study Definition ..................................................................................................................... 11 
5 
STUDY POPULATION ................................................................................................................................. 11 
5.1 
Inclusion Criteria................................................................................................................................. 11 
5.2 
Exclusion Criteria ............................................................................................................................... 12 
5.3 
Lifestyle Considerations .................................................................................................................... 12 
5.4 
Screen Failures .................................................................................................................................. 12 
5.5 
Strategies for Recruitment and Retention ...................................................................................... 12 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ............................................ 14 
6.1 
Study Intervention(s) or Experimental Manipulation(s) Administration ..................................... 14 
6.1.1 
Study Intervention or Experimental Manipulation Description ................................ 14 
6.1.2 
Administration and/or Dosing ....................................................................................... 14 
6.2 
Fidelity .................................................................................................................................................. 19 
6.2.1 
Interventionist Training and Tracking .......................................................................... 15 
6.3 
Measures to Minimize Bias: Randomization and Blinding........................................................... 15 
6.4 
Study Intervention/Experimental Manipulation Adherence ......................................................... 15 
6.5 
Concomitant Therapy ........................................................................................................................ 15 
6.5.1 
Rescue Therapy ............................................................................................................. 15 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL ......................................................................................... 15 
7.1 
Discontinuation of Study Intervention/Experimental Manipulation ............................................. 15 
7.2 
Participant Discontinuation/Withdrawal from the Study ............................................................... 16 
7.3 
Lost to Follow-Up ............................................................................................................................... 16 
8 
STUDY ASSESSMENTS AND PROCEDURES...................................................................................... 16 
8.1 
Endpoint and Other Non-Safety Assessments .............................................................................. 17 
8.2 
Safety Assessments .......................................................................................................................... 17 
8.3 
Adverse Events and Serious Adverse Events ............................................................................... 17 
8.3.1 
Definition of Adverse Events ........................................................................................ 17 
8.3.2 
Definition of Serious Adverse Events .......................................................................... 17 

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8.3.3 
Classification of an Adverse Event .............................................................................. 17 
8.3.4 
Time Period and Frequency for Event Assessment and Follow-Up ...................... 18 
8.3.5 
Adverse Event Reporting .............................................................................................. 19 
8.3.6 
Serious Adverse Event Reporting ............................................................................... 19 
8.3.7 
Reporting Events to Participants ................................................................................. 19 
8.3.8 
Events of Special Interest ............................................................................................. 19 
8.3.9 
Reporting of Pregnancy................................................................................................. 19 
8.4 
Unanticipated Problems .................................................................................................................... 19 
8.4.1 
Definition of Unanticipated Problems .......................................................................... 19 
8.4.2 
Unanticipated Problems Reporting .............................................................................. 19 
8.4.3 
Reporting Unanticipated Problems to Participants ................................................... 20 
9 
STATISTICAL CONSIDERATIONS ........................................................................................................... 20 
9.1 
Statistical Hypotheses ....................................................................................................................... 20 
9.2 
Sample Size Determination .............................................................................................................. 21 
9.3 
Populations for Analyses .................................................................................................................. 21 
9.4 
Statistical Analyses ............................................................................................................................ 21 
9.4.1 
General Approach .......................................................................................................... 21 
9.4.2 
Analysis of the Primary Endpoint(s) ............................................................................ 21 
9.4.3 
Analysis of the Secondary Endpoint(s) ....................................................................... 21 
9.4.4 
Safety Analyses .............................................................................................................. 21 
9.4.5 
Baseline Descriptive Statistics ..................................................................................... 21 
9.4.6 
Planned Interim Analyses ............................................................................................. 21 
9.4.7 
Sub-Group Analyses ...................................................................................................... 21 
9.4.8 
Tabulation of Individual Participant Data .................................................................... 22 
9.4.9 
Exploratory Analyses ..................................................................................................... 22 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 22 
10.1 
Regulatory, Ethical, and Study Oversight Considerations........................................................... 22 
10.1.1 
Informed Consent Process ........................................................................................... 22 
10.1.2 
Study Discontinuation and Closure ............................................................................. 22 
10.1.3 
Confidentiality and Privacy ........................................................................................... 23 
10.1.4 
Future Use of Stored Specimens and Data ............................................................... 24 
10.1.5 
Key Roles and Study Governance .............................................................................. 24 
10.1.6 
Safety Oversight ............................................................................................................. 26 
10.1.7 
Clinical Monitoring .......................................................................................................... 26 
10.1.8 
Quality Assurance and Quality Control ....................................................................... 26 
10.1.9 
Data Handling and Record Keeping ............................................................................ 27 
10.1.10 
Protocol Deviations ........................................................................................................ 27 
10.1.11 
Publication and Data Sharing Policy ........................................................................... 28 
10.1.12 
Conflict of Interest Policy............................................................................................... 28 
10.2 
Additional Considerations ................................................................................................................. 29 
10.3 
Abbreviations and Special Terms .................................................................................................... 29 
10.4 
Protocol Amendment History ........................................................................................................... 31 
11 
REFERENCES .............................................................................................................................................. 32 
 

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STATEMENT OF COMPLIANCE 
 
[The trial will be carried out in accordance with International Council on Harmonisation Good 
Clinical Practice (ICH GCP) and the following:  
 
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 
46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812).  
 
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are 
responsible for the conduct, management, or oversight of NIH-funded clinical trials have 
completed Human Subjects Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the IRB for review and approval. Approval of both the protocol and the consent 
form(s) must be obtained before any participant is consented. Any amendment to the protocol 
will require review and approval by the IRB before the changes are implemented to the study. All 
changes to the consent form(s) will be IRB approved; a determination will be made regarding 
whether a new consent needs to be obtained from participants who provided consent, using a 
previously approved consent form.] 
 
 

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INVESTIGATOR’S SIGNATURE 
The signature below constitutes the approval of this protocol and provides the necessary assurances 
that this study will be conducted according to all stipulations of the protocol, including all statements 
regarding confidentiality, and according to local legal and regulatory requirements and applicable US 
federal regulations and ICH guidelines, as described in the Statement of Compliance above. 
 
Principal Investigator or Clinical Site Investigator: 
Signed: 
 
Date: 
 
 
Name*:  
 
Title*:  
 
Investigator Contact Information 
Affiliation*: 
Address: 
Telephone: 
Email: 
 
[For multi-site studies, the protocol should be signed by the clinical site investigator who is responsible 
for the day to day study implementation at his/her specific clinical site.] 
Signed: 
 
Date: 
 
 
Name:  
 
Title: 
 
 
Affiliation: 
 
 
 
 
 

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1 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
 
Title: 
TEEN HEED: An Adolescent Peer Led Diabetes Prevention 
Intervention 
Grant Number: 
<Grant Number> 
Study Description: 
Specific Aims: 1) Explore strategies for using peer educators and 
novel mobile health technologies as part of a group lifestyle change 
program for diabetes prevention among at-risk ethnic minority 
youth in a New York City community with high disease burden. 2) 
Refine, implement, and evaluate outcomes for the intervention. 
Using preliminary data, we will use CBPR to refine our 
developmentally and culturally appropriate lifestyle intervention for 
pre-diabetic ethnic minority adolescents. We will then screen at-
risk adolescents for pre-diabetes and related lifestyle and 
biological measures and compare outcomes in adolescents in 
intervention and wait list control groups to test intervention 
effectiveness. 3) Further refine the intervention for a larger RCT 
based on an examination of intervention feasibility, acceptability, 
and sustainability. 
 
Objectives*: 
 
The specific aims of the TEEN HEED (Help Educate to Eliminate 
Diabetes) Trial are to: 
 
1. Use an iterative process between academic and 
community partners to adapt and modify the pilot TEEN 
HEED intervention  
 
2. Use qualitative methods to evaluate strategies for using 
peer educators and novel mobile health technologies as 
part of a group lifestyle change program for diabetes 
prevention among at-risk ethnic minority youth 
 
3. Use community-based participatory research strategies to 
refine, test, and evaluate outcomes of a peer education 
diabetes prevention program for pre-diabetic ethnic 
minority adolescents.  
 
4. Examine intervention feasibility, acceptability, and 
sustainability. 

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Endpoints*: 
Evaluation of the intervention’s impact on the primary study 
outcome, participants’ weights: We hypothesize that the TEEN 
HEED intervention will result in maintenance or decrease in BMI 
percentile. 
 
Evaluation of the effectiveness of the TEEN HEED 
intervention on behaviors and mediators related to weight 
loss and diabetes prevention: 
We hypothesize that the 
intervention will lead to observable changes to diet, physical 
activity and weight control behaviors and that these and other 
mediators explain weight loss. 
Study Population: 
This study involves adolescents ages 13-19. 
Phase* or Stage: 
N/A 
Description of 
Sites/Facilities Enrolling 
Participants: 
All programming will be offered via Zoom. In-person study visits for 
baseline, 5m, and 12m, will be conducted at our pediatric clinic.  
Description of Study 
Intervention/Experimental 
Manipulation: 
12 week virtual workshop (offered via zoom) that covers behavioral 
skills including goal setting, self-monitoring, problem solving, 
contingency management, coping skills, and social support. Workshop 
topics included explanation of pre-diabetes/diabetes, label reading, 
healthy plate planning, portion control, finding affordable healthy 
foods, strategies to increase physical activity, and coping with eating 
triggers and social pressures. Participants create and report on action 
plans with weekly goals, brainstorm to solve problems, and 
communicate between sessions. 
Study Duration*: 
3 years  
Participant Duration: 
12m 
1.2 
SCHEMA  
 
 
 

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Flow Diagram (e.g., randomized controlled trial) 
 
 
 
1.3 
SCHEDULE OF ACTIVITIES (VIRTUAL TEEN HEED) 
 
 
 
 
 
Pre-screening 
(Pre-consent) 
 
Visit 1 
Baseline 
12-week 
workshop 
3m visit 
EMR Review Eligibility 
X 
 
 
 
Informed Consent 
 
X 
 
 
Demographics 
 
X 
 
 
Clinical history 
 
X 
 
 
Height & Weight 
 
X 
 
X 
Outcome Evaluation 
 
 
 
 
Workshop 
assessments/Action 
Planning 
 
 
X 
 
Health and Lifestyle 
Questionnaire 
 
X 
 
X 
Debrief session 
 
 
X 
 
Adverse Events Reporting 
 
X 
X 
X 

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2 
 
INTRODUCTION 
2.1 
STUDY RATIONALE  
The number of youth with type 2 diabetes in the U.S. is projected to increase by 49 
percent by 2050, with higher rates among minority youth. The Diabetes Prevention Program 
(DPP) is recognized as a sentinel study demonstrating the effectiveness of lifestyle interventions 
for diabetes prevention among pre-diabetic adults but has not yet been replicated in youth. In 
addition, such intensive interventions are often not sustainable in high risk communities with 
limited resources. One strategy that has been successfully employed in adults from such 
communities is peer based health education. Research suggests that like adults, young people 
are more likely to hear and personalize messages, and thus to change their attitudes and 
behaviors, if they believe the messenger is similar to them and faces the same concerns and 
pressures. However, there have been no peer led interventions in ethnic minority teens and no 
interventions focused specifically on weight loss for diabetes prevention. Finally, another 
challenge identified in existing youth health intervention programs is keeping youth engaged to 
enhance program participation and impact. One potential strategy is the use of mobile 
technologies (text messaging, mobile applications, social media) to support weight management 
programs, but to date use of such technologies has not been studied in youth. This study’s 
overall objective is to use community-based participatory research (CBPR) to develop and pilot 
test a youth peer-led diabetes prevention intervention incorporating novel mobile health 
technologies for at-risk adolescents in a vulnerable New York City community. The central 
hypothesis is that such an intervention will lead to maintenance or decrease in BMI, improved 
dietary, physical activity and weight control behaviors, and decrease in diabetes risk.  
2.2 
BACKGROUND  
Our Previous Study: People who develop diabetes go through a period when they have “pre-
diabetes,” defined by the American Diabetes Association as fasting blood glucose of 100-125 
mg/dl, and/or 2-hour post-prandial blood glucose of 140-199 mg/dl, and/or hemoglobin A1c of 
5.7-6.4%.  Diabetes and pre-diabetes are being diagnosed more in children, likely related to 
increasing rates of obesity. National estimates are that about 16% of all adolescents have pre-
diabetes with higher rates in obese adolescents or those with a family history of diabetes. 
Weight loss is the single therapy proven to prevent diabetes. In clinical settings, overweight adults 
with pre-diabetes who reduce their weight by 5-10% can reduce their risk of developing diabetes 
by 55-60%.  While there have been no large diabetes prevention trials in children and adolescents, 
school based, clinic-based and community-based trials have led to reduction in diabetes risk 
(improvements in body measurements and glucose or insulin levels) with intensive lifestyle 
interventions.  
An effective low-resource diabetes prevention strategy devised for adults in high-risk communities 
is the use of peer leaders to promote lifestyle change. Investigators from the adult HEED study 
(GCO#05-0463) conducted a randomized-controlled trial to compare the effectiveness of peer-
led community-based workshops, versus usual care (delayed intervention) in achieving weight 

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loss and prevention of diabetes among overweight (BMI > 25) adults with pre-diabetes in East 
Harlem.  Over 400 adults with pre-diabetes were identified through the standard protocol for pre-
diabetes screening, an oral glucose tolerance test (OGTT) (a fingerstick test with an instant read 
glucose analyzer).  The OGTT is performed by measurement of glucose, both at fasting and after 
administration of a 75 gram oral glucose load. Adults with pre-diabetes were randomized to 
intervention and delayed intervention groups to test the effectiveness of the HEED intervention. 
Pre-diabetics in the intervention group had statistically significant weight loss maintained at one 
year and a leveling of their glucoses, as compared with controls. 
Research suggests that like adults, young people are more likely to hear and personalize 
messages, and thus to change their attitudes and behaviors, if they believe the messenger is 
similar to them and faces the same concerns and pressures. However, relatively few studies 
have focused on peer led lifestyle interventions in youth. In the first pilot phase of the TEEN 
HEED intervention (GCO # 11-1711), we adapted the HEED intervention for East Harlem 
adolescents. We conducted community based screening for pre-diabetes among 56 at-risk 
obese adolescents. We measured glucoses using oral glucose tolerance tests. Adolescents 
completed a survey to assess diet and physical activity knowledge, attitudes and behaviors and 
diabetes risk.  They also underwent detailed body measurements (i.e. height, weight, body fat, 
waist circumference) and blood pressure testing. 
Nineteen adolescents diagnosed with pre-diabetes had more detailed assessment of their 
dietary intake and physical activity levels. Pre-diabetic adolescents were then invited to take 
part in an initial version of the TEEN HEED intervention.  Trained adolescent peer educators 
partnered with experienced adult HEED workshop leaders to run the workshops. At follow up, 
participants again completed the oral glucose tolerance test, verbally administered 
questionnaire, body measurements (i.e. height, weight, body fat, waist circumference) and blood 
pressure testing.  Out of 9 adolescents who completed at least 4 out of 8 workshop sessions led 
by trained teens, 5 had decreased BMI and 5 no longer had pre-diabetes at 3 month follow up. 
To supplement what we have learned through the pilot study, we completed additional 
qualitative studies to further develop our intervention. We conducted focus groups to explore 1) 
peer influences on eating behaviors, physical activity, and other individual factors related to 
weight management, 2) strategies for further adapting our peer education diabetes prevention 
intervention for urban minority adolescents, and 3) use of mobile technologies (such as text 
messaging, mobile applications and social media) as an adjunct to the peer-led intervention.  
We then recruited participants ages 13-19 who are at risk for diabetes through community youth 
organizations, health centers and schools, determined eligibility (overweight/obese by measured BMI), 
and invited them to return fasting for further evaluation. Those ages 13-17 required assent/parental 
consent, while those >18 signed their own consent. We screened teens for pre-diabetes using an oral 
glucose tolerance test (OGTT),59 obtained body measurements, blood pressure and metabolic tests, and 
administered a health and lifestyle survey. We screened 148 teens, of whom 90 were diagnosed with pre-
diabetes (61%) and were randomized to intervention (n=41) and wait list control (n=49) groups. Each 
workshop group (10-15 teens) met for 90 minutes weekly for 12 weeks. All activities were delivered under 
the supervision of experienced adult health educators by youth peer leaders who underwent training 
including team building, group facilitation, and review of the workshop curriculum. We collected 5 and 12 

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month follow up data (73% retention at both time points). Information from this previous cohort will be 
used to refine our study.  
 In order to maximize the reach of this intervention, and with increasing need due to the 
pandemic, we are proposing a virtual component to the TEEN HEED program.  
2.3 
RISK/BENEFIT ASSESSMENT  
2.3.1 KNOWN POTENTIAL RISKS  
The loss of information always exists, however provisions have been made to mitigate these risks. 
Participants may feel uncomfortable with the survey questions, or being in a group setting. We discuss 
this with participants at all times to measure their comfort and mitigate any concerns. Participants are 
also able to skip questions with which they are particularly uncomfortable.  
 
2.3.2 KNOWN POTENTIAL BENEFITS  
 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
3 
OBJECTIVES AND ENDPOINTS  
 
OBJECTIVES 
ENDPOINTS 
Primary 
 
Use an iterative process 
between academic and 
community partners to 
adapt and modify the pilot 
TEEN HEED intervention  
 
Use qualitative methods to 
evaluate strategies for 
using peer educators and 
novel mobile health 
technologies as part of a 
group lifestyle change 
program for diabetes 
prevention among at-risk 
ethnic minority youth 
 
Use community-based 
participatory research 
strategies to refine, test, 
and evaluate outcomes of 
a peer education diabetes 
prevention program for 
pre-diabetic ethnic minority 
adolescents.  
1) maintain/reduce body 
mass index (BMI) 
 
2) improve adolescent 
dietary, physical activity and 
weight control behaviors, 
and  
 
3) improve other measures 
of diabetes risk.  We are 
collecting data at baseline 
and post intervention. We 
are also obtaining additional 
qualitative data and 
examining feasibility and 
acceptability for a text 
messaging program to 
support teens as they make 
lifestyle changes. 

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4 
STUDY DESIGN 
 
4.1 
OVERALL DESIGN 
We are now testing and evaluating outcomes of our refined intervention to reduce diabetes risk 
among ethnic minority pre-diabetic adolescents. We will further adapt the program for virtual 
delivery via a video conferencing platform to enhance access and attendance, and refine the 
text messaging platform to better support and engage teens.  
We will identify at risk for diabetes adolescents and recruit adolescents (BMI in the 
overweight/obese range and HbA1c 5.7-6.4%) through electronic medical record data queries 
and referrals from clinical and community sites. Participation will be contingent on adolescent 
assent/parental consent (ages 13-17) or participant consent (ages 18 years or older). We will 
randomize pre-diabetic adolescents into intervention and wait list control (delayed intervention) 
groups to test intervention effectiveness. We will also evaluate the virtual and mHealth 
components of the intervention through usability testing and data analytics. 
The intervention is 12 weekly 90-minute workshops based on feedback from our community 
advisory board and experts in peer led health education programs. The intervention will be 
offered via an online platform, Zoom, which is HIPAA compliant. We are testing the 
effectiveness of a virtual component versus our previous in-person workshop. 
We are currently developing a technology-based component of the intervention based on 
findings from focus groups and with input from our Community Advisory Board (CAB). The 
technology-based tool is a secure mobile health platform we are developing in collaboration with 
a company called mPulse Mobile. The platform will allow us to securely send and track text 
messages, help participants set goals and monitor their behaviors, and provide participants with 
individualized feedback and positive reinforcement. Messages will be sent via an SMS text 
messaging mobile health platform to provide motivational messages regarding healthy eating, 
physical activity and healthy weight maintenance and to follow up on weekly goals made by the 
participants. The platform supports interactive dialogues including automated interactions using 
rule-based branching logic that allows participants to navigate through the program based on 
their message responses. In addition, natural language understanding allows real-time 
interpretation of text responses for more sophisticated dialogues. Beyond processing responses 
through automated dialogues, natural language understanding allows for responses that fall 
outside the scope of the dialogue’s rules. mPulse Mobile’s Engagement Console allows project 
staff to manage individual interactions with participants. The Console identifies any responses 
that cannot be handled by the messaging program’s rules and flags these messages for staff to 
resolve. Additionally, staff can use the Console to manually initiate messages, and high-priority 
messages that must be reviewed can be escalated in real-time.   
All information within the mPulse Mobile platform and cloud server is protected and secure. The 
platform ensures privacy and confidentiality of information shared and messages sent.  The 
HITRUST Common Security Framework (CSF) is the most widely-accepted information 
technology security control audit framework developed explicitly for the protection of healthcare 
information. The framework integrates requirements from sources such as ISO, NIST, PCI, 
HIPAA, and others. To successfully complete the HITRUST CSF audit, mPulse Mobile had to 

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undergo a rigorous third-party vetting process consisting of baseline controls across many 
domains including information protection, endpoint protection, configuration management, 
disaster recovery, risk management, and physical security.  
mPulse Mobile messaging programs follow compliance principles guided by Telephone 
Consumer Protection Act, Mobile Marketing Association’s Consumer Best Practices, and CTIA 
Mobile Compliance Assurance Handbook. Dr. Nita Vangeepuram will be the application 
manager.  
All participants will also be advised about privacy issues surrounding responses to text 
messages. It will be recommended that they use a password to protect their cell phones. 
(Please see the previously submitted IT Security Risk Assessment Report).  
We will be piloting the texting program with participants who had previously been enrolled in 
earlier version of the TEEN HEED study. We will obtain parental permission to allow mPulse 
Mobile to receive their cell phone numbers and send SMS text messages to participants. This 
information will be included in the study consent form with a separate place within the consent 
form for parents to initial to give this permission. Participants aged 18-19 will be asked to sign 
their own permission to receive SMS text messages from mPulse Mobile. We will make it very 
clear to participants that what is shared through the mobile dialogue is private, secure, and not 
shared with anyone beyond the program. We will also express that standard data and 
messaging rates from participant’s provider may apply and that they can request that messages 
stop being sent at any time.  
We will also conduct audio-recorded debriefing sessions with participants and peer leaders in 
which we will ask about their experiences with the intervention, reactions to the intervention, and 
ideas for intervention refinement. To monitor the community-academic partnership, we are 
tracking activities such as the communication between community-academic partners, number of 
participants at CAB meetings, number of manuscripts and presentations by academic-community 
partners, and policy-related outcomes. Additionally, we are investigating youth involvement in 
CBPR, through audio-recorded one-on-one interviews and qualitative analysis. This will help us 
understand how young people have helped shape the project. We are interviewing study 
participants, peer leaders, community action board members, interns, and study coordinators. 
They are being consented and asked questions about their personal experience with the study 
and their views on how young people have contributed to the project and how they may continue 
to do so in the future. 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
Research suggests that like adults, young people are more likely to hear and personalize 
messages, and thus to change their attitudes and behaviors, if they believe the messenger is 
similar to them and faces the same concerns and pressures. However, relatively few studies have 
focused on peer led lifestyle interventions in youth. 
4.3 
JUSTIFICATION FOR INTERVENTION 
Rates of new diagnosed cases of type 2 diabetes are increasing among youth in the United States, with a 
disproportionate increase among minority youth. Lifestyle interventions leading to weight loss have 

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proven to be effective for diabetes prevention among overweight prediabetic adults, but few have been 
developed and tested in youth. 
4.4 
END-OF-STUDY DEFINITION 
A participant is considered to have completed the study if he or she has completed the baseline 
assessment and the follow-up assessment or has completed the text messaging program.  
 
The end of the study is defined as completion of the 3-month follow-up assessment shown in the Schedule 
of Activities (SoA), Section 1.3. 
 
5 
STUDY POPULATION 
 
5.1 
INCLUSION CRITERIA 
  
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 
INCLUSION CRITERIA: 
• 
Adolescents ages 13-19 years of age 
• 
Residents of East or Central Harlem, members of an East or Central Harlem Institution, 
or patients seen in the Mount Sinai Health System.  Membership in an East or Central 
Harlem institution includes the following: 1) attending a school in East or Central Harlem, 
2) attending an after school or recreational activity in East or Central Harlem, or 3) 
receiving health care in East or Central Harlem. We will not ask participants for any 
identification for proof of address or membership in an East or Central Harlem institution. 
After informed consent is obtained for the adolescent to take part in the study, we will ask 
for the adolescent’s full residential address. We will include those participants who live in 
supportive housing (such as shelters) and do not have plans to relocate from N.Y.C in the 
next year.   
• 
Body mass index (BMI) percentile consistent with overweight/obesity (>85th percentile for 
age and gender based on Centers for Disease Control and Prevention definition). 
• 
Hemoglobin A1c in prediabetes range (>5.7% or <6.5%) 
• 
English speaking (resources available to us at this time limit inclusion of English speaking 
participants only). Note: only adolescents must be English speaking. Parental consent 
forms will be available in English and Spanish. The Spanish consent form will be submitted 
for IRB review with a letter of attestation from the translator after approval of the English 
consent form.  
• 
Able to communicate verbally to participate in a group education class.  
• Demographics: 
 
(a) Gender:  
Males  
 
yes
  
no
 
 
 
Females  
 
yes
  
no
 

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(b) Age range:  
 
 
from 13 
to 19 
(c) Racial and Ethnic Groups: 
 
 
Caucasian  
 
yes
  
no
  
 
 
Black  
 
yes
  
no
 
 
 
Hispanic 
 
yes
  
no
 
 
 
American Indian 
yes
  
no
 
 
 
Alaskan Native 
yes
  
no
 
 
 
Asian/Pacific Islander yes
  
no
  
Other (specify) ______________  
5.2 
EXCLUSION CRITERIA 
 
An individual who meets any of the following criteria will be excluded from participation in this study: 
 
• 
<13 or >19 years of age 
• 
Previous diagnosis of diabetes 
• 
BMI percentile <85th percentile for age and gender based on Centers for Disease Control 
and Prevention definition 
• 
Hemoglobin A1c outside of the prediabetes range (<5.7% or >6.4%) 
• 
Currently pregnant 
• 
Speaking a language other than English (resources to translate and implement all study 
activities in other languages are limited at this time) 
• 
Cognitive or physical impairment that would preclude comprehension of a conversation 
and communicating as part of a group (i.e., dementia, deafness, inability to speak)  
• 
On medications that may raise or lower blood sugar 
• 
Plans to relocate from New York City within one year of enrollment 
• Had, or is planning to have gastric bypass surgery 
• Has a pacemaker or other implanted electronic device 
5.3 
LIFESTYLE CONSIDERATIONS 
N/A 
5.4 
SCREEN FAILURES 
Screen failures are defined as participants who consent to participate in this study but are not 
subsequently assigned to the study intervention or entered in the study. Individuals who do not meet the 
criteria for participation in this trial (screen failure) because of meeting one or more exclusion criteria that 
are likely to change over time may be rescreened. Examples include the successful treatment of a previous 
affective disorder, and the lifting of physical activity restrictions previously in place. Rescreened 
participants will be assigned the same participant number as for the initial screening. 
 
5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
The Principal Investigator Dr. Vangeepuram, Research Coordinator Ms. Elaiho and community 
partners working on this study previously identified venues for recruitment of adolescents in East 

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and Central Harlem including youth community based organizations, after school programs, and 
health care centers.  
Recruitment sites may include the following community organizations in East Harlem with whom 
we have previously collaborated: Union Settlement Association, Harlem RBI, East Harlem Boys 
Club, Children’s Aid Society, Stanley Isaacs Neighborhood Center, SCAN(SUPPORTIVE 
CHILDREN'S ADVOCACY NETWORK), Harlem Children’s Zone, and other interested 
organizations to be identified by our community partners and project board. Possible clinical sites 
for recruitment include Mount Sinai’s Adolescent Health Center, Mount Sinai’s pediatric endocrine 
clinic, Mount Sinai’s Pediatrics Associates practice, Settlement Health, Boriken Neighborhood 
Health Center, the Institute for Family Health, Mount Sinai School Based Health Clinics, and 
Mount Sinai Pediatric Emergency Rooms.  
We will obtain provider referrals from community based clinics. We will use Mount Sinai’s Data 
Warehouse and/or EPICs slicer/dicer to identify potentially eligible subjects for recruitment from 
the Mount Sinai General Pediatric Faculty Practice, Pediatric Endocrinology and Diabetes 
Center, and the School Based Health Clinics. We will request the following fields:  
Name, medical record number, date of birth/age, address. gender, parent or guardian name, 
contact information for teens 18-19 (including telephone number or other numbers provided), 
parent or guardian contact information for teens ages 13-17 (including telephone number or 
other numbers provided), BMI (BMI percentile when available), medications prescribed, and 
laboratory values from the past year: Glucose/preserved glucose, hemoglobin A1c (values), 
total insulin (values), and lipid panels (values).We will request information for eligible patients 
whose medical records contain the following diagnoses codes: overweight, obesity, prediabetes, 
insulin resistance, and acquired acanthosis nigricans.  
We will obtain only the minimum amount of PHI necessary to contact potentially eligible 
teenagers. We will meet with providers and ask them to consent to contacting their patients who 
they think may be eligible. Contact information will be immediately deleted from the server for 
those who are not interested in participating or who are not eligible for the study. Participants 
will be given the opportunity to decline being re-contacted should they not be interested in 
participating. 
For Collaborating Community sites – As described above, site leaders will verbally inform potential 
subjects about TEEN HEED and provide interested children with a letter for parents. For 
adolescents ages 18 or 19 years who meet eligibility requirements and are interested in the study, 
we will obtain informed consent prior to participation in the study. For adolescents ages 13-17 
years, who meet eligibility requirements and are interested in the study, we will obtain assent of 
the adolescent and obtain consent from his/her parent or guardian. The combined Parental 
Consent and HIPAA Authorization Form will be obtained in person or over the phone by a member 
of the study staff. After consent is obtained, we will invite adolescents for their official baseline 
visit. Eligible adolescents will be randomized into intervention and wait list control groups. 
Intervention participants will attend a 12-week peer led workshop and follow up assessments. 
We will recruit potential peer leaders through our contacts at community youth organizations in 
East and Central Harlem and local schools. Peer leaders will attend training sessions, workshop 

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sessions and debriefing sessions. All classes will be led by trained adolescent peer leaders.  
Qualifications to be a peer leader are: 1) older than 18 years of age 2) fluency in English and 3) 
ability to communicate well in a group setting.  Peer leader training will include information about 
not divulging information (e.g., conditions, treatments, personal background or any other 
confidential or non-public information) concerning participants attending the classes.  We will 
also have the leaders sign a Statement of Confidentiality.  Peer leaders will be paid $100 to 
attend the training session and $300 for leading each 12 week workshop 
 
Participants will be given a $40 gift card at each study visit as compensation for their time. 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
6.1 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION 
6.1.1 STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION 
Teen-led workshops cover behavioral skills including goal setting, self-monitoring, problem 
solving, contingency management, coping skills, and social support. Workshop topics include 
explanation of pre-diabetes/diabetes, label reading, healthy plate planning, portion control, 
finding affordable healthy foods, strategies to increase physical activity, and coping with eating 
triggers and social pressures. Participants create and report on action plans with weekly goals, 
brainstorm to solve problems, and communicate between sessions. The intervention is 12 
weekly 90-minute workshops based on feedback from our community advisory board and 
experts in peer led health education programs. The intervention will be offered via an online 
platform, Zoom, which is HIPAA compliant. We are testing the effectiveness of the virtual 
program. 
For participants in the text message pilot program we will obtain parental permission to allow 
mPulse Mobile to receive their cell phone numbers and send SMS text messages to 
participants. This information will be included in the study consent form with a separate place 
within the consent form for parents to initial to give this permission. Participants aged 18-19 will 
be asked to sign their own permission to receive SMS text messages from mPulse Mobile. We 
will make it very clear to participants that what is shared through the mobile dialogue is private, 
secure, and not shared with anyone beyond the program. We will also express that standard 
data and messaging rates from participant’s provider may apply and that they can request that 
messages stop being sent at any time. Participants in the waitlist control will also be asked to 
consent to giving their phone numbers to mPulse  
6.1.2 ADMINISTRATION AND/OR DOSING 
Full-Dose: Attendance to all 12 workshops 
 
Half-dose: Attendance to 6-11 workshops  
 
Participants attending less than 4 workshops will be considered as “not adhering to the project”; 
however, they will not be removed from the study.  
 
6.2 
FIDELITY 

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6.2.1 INTERVENTIONIST TRAINING AND TRACKING 
The principal investigator and clinical research coordinator will be responsible for 
screening potential peer leaders to ensure that they are appropriate for being in a 
leadership position with younger teens. Potential peer leaders will likely be referred by 
staff at our collaborating youth organizations who have been working with these youth 
for years. Interested youth will complete applications. We will conduct thorough 
interviews and also contact adult references provided as part of the leader selection 
process. Youth peer leaders will receive training about the workshops and 
communication/leadership skills and will be supervised by experienced adults 
throughout the study. 
All members of the study team will be adequately trained on the protocol through planning 
meetings prior to the launch of this study.  New study members will be trained through the use of 
scripts and a training manual developed for all trial-related functions. This training manual 
includes detailed instructions for each recruitment event, including participant checklists, device 
protocols, and results explanations. Research staff will use the scripts provided in the training 
manual for all study events. Debriefing will occur after each recruitment and follow-up event to 
confirm procedures and adherence to protocol. 
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
We are not randomizing participants for this pilot study.  
6.4 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
 
6.5 
CONCOMITANT THERAPY 
N/A 
 
6.5.1 RESCUE THERAPY 
N/A 
 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1 
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
When a subject discontinues from the study intervention (12-week workshop) but not from the study, 
remaining study procedures will be completed as indicated by the study protocol.  If a clinically significant 
finding is identified (including, but not limited to changes from baseline) after enrollment, the investigator 
or qualified designee will determine if any change in participant management is needed.  
 
The data to be collected at the time of study intervention discontinuation will include the following: 

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• 
The reason(s) for discontinuing the participant from the intervention, and methods for 
determining the need to discontinue 
• 
If the participant is due to complete assessments within 2 weeks of being discontinued from the 
study intervention, those assessments will be administered at the time of discontinuation; if the next 
scheduled assessments are more than 2 weeks from the discontinuation date, the discontinued 
participant will wait for the next scheduled assessment. Thereafter, the participant will be included in all 
future scheduled assessments, even though not participating in the intervention. 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Participants are free to withdraw from participation in the study at any time upon request. 
An investigator may discontinue a participant from the study for the following reasons: 
 
• 
Significant study intervention non-compliance, unless varying compliance is an aspect of the study 
objectives  
• 
Lost-to-follow up; unable to contact subject (see Section 7.3, Lost to Follow-Up) 
• 
Any event or medical condition or situation occurs such that continued collection of follow-up  
study data would not be in the best interest of the participant or might require an additional 
treatment that would confound the interpretation of the study 
• 
The participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation 
 
Subjects who sign the informed consent form, and subsequently withdraw, or are discontinued from the 
study, will not be replaced. 
 
7.3 
LOST TO FOLLOW-UP 
A participant will be considered lost to follow-up if he or she fails to return for the follow up visit scheduled 
visit and study staff are unable to contact the participant after at least 3 attempts.  
 
The following actions must be taken if a participant fails to return to the clinic for a required study visit: 
 
• 
The site will attempt to contact the participant, reschedule the missed visit within 1 month, 
counsel the participant on the importance of maintaining the assigned visit schedule and ascertain 
if the participant wishes to and/or should continue in the study 
• 
Before a participant is deemed lost to follow-up, the investigator or designee will make every 
effort to regain contact with the participant (where possible, 3 telephone calls, emails and text 
messages and, if necessary, a certified letter to the participant’s last known mailing address or 
local equivalent methods). These contact attempts will be documented in the participant’s 
medical record or study file.  
• 
Should the participant continue to be unreachable, he or she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up] 
8 
STUDY ASSESSMENTS AND PROCEDURES 

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8.1 
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
Evaluation of the intervention’s impact on the primary study outcome, participants’ 
weights: We hypothesize that the TEEN HEED intervention will result in maintenance or 
decrease in BMI percentile. We chose this outcome because weight loss is consistently shown 
as the most powerful and effective diabetes prevention strategy.  
Evaluation of the effectiveness of the TEEN HEED interv
ention on behaviors and 
mediators related to weight loss and diabetes prevention: 
We hypothesize that the 
intervention will lead to observable changes to diet, physical activity and weight control 
behaviors and that these and other mediators explain weight loss. We will assess whether the 
intervention leads to improvements in diet and physical activity behaviors and related mediators 
such as knowledge, attitudes, beliefs, self-efficacy, and social influences, and improvements in 
other measures of diabetes risk (such as HbA1c). Hypotheses will be tested by comparing 
changes in outcomes between baseline post-intervention follow-up. We will also conduct 
exploratory analyses to begin to understand whether any of these factors appear closely linked 
to pre-diabetes diagnosis or weight loss. 
8.2 
SAFETY ASSESSMENTS 
We will adhere to the minimum DSMP standards of the PPHS as this study does not involve 
more than minimal risk to subjects. 
8.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
8.3.1 DEFINITION OF ADVERSE EVENTS 
This protocol uses the definition of adverse event from 21 CFR 312.32 (a): any untoward medical 
occurrence associated with the use of an intervention in humans, whether or not considered intervention-
related. 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS 
 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
8.3.3.1 SEVERITY OF EVENT 
For adverse events (AEs) not included in the protocol defined grading system, the following guidelines will 
be used to describe severity.  
 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities.  
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 

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• 
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug 
therapy or other treatment. Severe events are usually potentially life-threatening or 
incapacitating.  Of note, the term “severe” does not necessarily equate to “serious”.] 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
All adverse events (AEs) will have their relationship to study procedures, including the intervention, 
assessed by an appropriately-trained clinician based on temporal relationship and his/her clinical 
judgment. The degree of certainty about causality will be graded using the categories below.  
 
• 
Related – The AE is known to occur with the study procedures, there is a reasonable possibility 
that the study procedures caused the AE, or there is a temporal relationship between the study 
procedures and the event. Reasonable possibility means that there is evidence to suggest a causal 
relationship between the study procedures and the AE. 
• 
Not Related – There is not a reasonable possibility that the study procedures caused the event, 
there is no temporal relationship between the study procedures and event onset, or an alternate 
etiology has been established. 
 
8.3.3.3 EXPECTEDNESS  
A clinician with appropriate expertise in pre-diabetes will be responsible for determining whether an 
adverse event (AE) is expected or unexpected. An AE will be considered unexpected if the nature, severity, 
or frequency of the event is not consistent with the risk information previously described for the study 
procedures. 
 
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel during study visits and interviews of a study participant presenting for medical care, or 
upon review by a study monitor. 
 
All AEs, not otherwise precluded per the protocol, will be captured on the appropriate case report form 
(CRF). Information to be collected includes event description, time of onset, clinician’s assessment of 
severity, relationship to study procedures (assessed only by those with the training and authority to make 
a diagnosis), and time of resolution/stabilization of the event. All AEs occurring while on study will be 
documented appropriately regardless of relationship. All AEs will be followed to adequate resolution. 
 
Any medical or psychiatric condition that is present at the time that the participant is screened will be 
considered as baseline and not reported as an AE. However, if the study participant’s condition 
deteriorates at any time during the study, it will be recorded as an AE.  
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. Documentation of onset and duration of each episode will be 
maintained for AEs characterized as intermittent. 

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<Insert role or name> will record events with start dates occurring any time after informed consent is 
obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.  At 
each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit.  Events 
will be followed for outcome information until resolution or stabilization. 
 
8.3.5 ADVERSE EVENT REPORTING  
 
8.3.6 SERIOUS ADVERSE EVENT REPORTING  
N/A 
 
8.3.7 REPORTING EVENTS TO PARTICIPANTS  
N/A 
 
8.3.8 EVENTS OF SPECIAL INTEREST  
N/A 
 
8.3.9 REPORTING OF PREGNANCY  
N/A 
 
8.4 
UNANTICIPATED PROBLEMS 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS 
This protocol uses the definition of Unanticipated Problems as defined by the Office for Human Research 
Protections (OHRP).  OHRP considers unanticipated problems involving risks to participants or others to 
include, in general, any incident, experience, or outcome that meets all of the following criteria: 
 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-
approved research protocol and informed consent document; and (b) the characteristics of the 
participant population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
• 
Suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized. 
 
8.4.2  UNANTICIPATED PROBLEMS REPORTING  
 

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The investigator will report unanticipated problems (UPs) to the reviewing Institutional Review Board 
(IRB) and to the Data Coordinating Center (DCC)/lead principal investigator (PI). The UP report will include 
the following information: 
 
• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project 
number 
• 
A detailed description of the event, incident, experience, or outcome  
• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP 
• 
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline:   
 
• 
UPs that are serious adverse events (SAEs) will be reported to the IRB and to the DCC/study 
sponsor/funding agency within <insert timeline in accordance with policy> of the investigator 
becoming aware of the event  
• 
Any other UP will be reported to the IRB and to the DCC/study sponsor/funding agency within 
<insert timeline in accordance with policy> of the investigator becoming aware of the problem  
• 
All UPs should be reported to appropriate institutional officials (as required by an institution’s 
written reporting procedures), the supporting agency head (or designee), and the Office for 
Human Research Protections (OHRP) within <insert timeline in accordance with policy> of the 
IRB’s receipt of the report of the problem from the investigator 
 
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  
N/A 
 
9 
STATISTICAL CONSIDERATIONS  
9.1 
STATISTICAL HYPOTHESES 
Evaluation of the intervention’s impact on the primary study outcome, participants’ 
weights: We hypothesize that the TEEN HEED intervention will result in maintenance or 
decrease in BMI percentile. We chose this outcome because weight loss is consistently shown 
as the most powerful and effective diabetes prevention strategy. 
Evaluation of the effectiveness of the TEEN HEED intervention on behaviors and 
mediators related to weight loss and diabetes prevention: 
We hypothesize that the 
intervention will lead to observable changes to diet, physical activity and weight control 
behaviors and that these and other mediators explain weight loss. We will assess whether the 
intervention leads to improvements in diet and physical activity behaviors and related mediators 
such as knowledge, attitudes, beliefs, self-efficacy, and social influences, and improvements in 
other measures of diabetes risk (such as HbA1c). Hypotheses will be tested by comparing 
changes in outcomes between baseline and post-intervention follow-up. We will also conduct 

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exploratory analyses to begin to understand whether any of these factors appear closely linked 
to pre-diabetes diagnosis or weight loss. 
9.2 
SAMPLE SIZE DETERMINATION 
9.3 
POPULATIONS FOR ANALYSES 
 
9.4 
STATISTICAL ANALYSES 
9.4.1 GENERAL APPROACH 
We will use descriptive statistics to summarize the variables. Analyses will primarily test the hypothesis 
that intervention participants will have maintenance/reduction of BMI. Secondary analyses will assess 
whether the intervention leads to improvements in diet and physical activity behaviors and related 
mediators such as knowledge, attitudes, beliefs, self-efficacy, and social influences. Hypotheses will be 
tested by comparing changes in outcomes between baseline and follow up. Initial bivariate comparisons 
will use t tests to compare continuous endpoints and the Wilcoxon matched pairs signed-rank test to 
compare ordinal endpoints. We will then conduct multivariable analyses (using logistic regression, 
general linear models, and mixed models) to adjust for potential confounders (such as age, race/ethnicity, 
gender, SES, and baseline BMI) and to account for the repeated observations per participant. Analyses 
will include the baseline level of each endpoint as a covariate and a continuous variable for time.  
Confidence intervals will be constructed around each parameter estimate of the intervention. We will 
estimate effect sizes for each measure using correction for small sample bias.  
To monitor the community-academic partnership, we will track activities such as the communication 
between community-academic partners, number of participants at CAB meetings, number of manuscripts 
and presentations by academic-community partners, and policy-related outcomes. We will also ask CAB 
members to complete annual surveys to gauge how closely the research project aligns with principles of 
CBPR, including factors they may feel less comfortable discussing in a group, such as level of inclusion 
and trust. 
9.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
9.4.4 SAFETY ANALYSES 
 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
Demographics: Age, Sex, BMI, Height, Weight, Waist Circumference, etc.  
 
9.4.6 PLANNED INTERIM ANALYSES  
N/A 
9.4.7 SUB-GROUP ANALYSES 

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Evaluation of the intervention’s impact on the primary study outcome, participants’ 
weights: We hypothesize that the TEEN HEED intervention will result in maintenance or 
decrease in BMI percentile. We chose this outcome because weight loss is consistently shown 
as the most powerful and effective diabetes prevention strategy.  
Evaluation of the effectiveness of the TEEN HEED intervention on behaviors and 
mediators related to weight loss and diabetes prevention: 
We hypothesize that the 
intervention will lead to observable changes to diet, physical activity and weight control 
behaviors and that these and other mediators explain weight loss. We will assess whether the 
intervention leads to improvements in diet and physical activity behaviors and related mediators 
such as knowledge, attitudes, beliefs, self-efficacy, and social influences, and improvements in 
other measures of diabetes risk (such as HbA1c). Hypotheses will be tested by comparing 
changes in outcomes between baseline and post-intervention follow-up. We will also conduct 
exploratory analyses to begin to understand whether any of these factors appear closely linked 
to pre-diabetes diagnosis or weight loss. 
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
• 
We aim to Recruit and enroll adolescents from clinical and community sites starting in the 
Spring 2021. Provisions may be made depending on the novel coronavirus pandemic. 
9.4.9 EXPLORATORY ANALYSES 
We hypothesize that the intervention will lead to observable changes to diet, physical activity, and 
weight control behaviors and that these, and other, mediators explain weight loss. We will also 
conduct exploratory analyses to begin to understand whether any of these factors appear closely 
linked to pre-diabetes 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
10.1.1 INFORMED CONSENT PROCESS 
10.1.1.1 CONSENT/ASSENT 
AND 
OTHER 
INFORMATIONAL 
DOCUMENTS 
PROVIDED 
TO 
PARTICIPANTS 
The study team will follow “SOP HRP -090 Informed Consent”. Consent forms describing in detail the study 
intervention, study procedures, and risks will be given to the participant and written documentation of 
informed consent will be completed prior to starting the study intervention.  The following consent 
materials are submitted with this protocol adult consent and parental consent in both English and Spanish. 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
After participants are determined to be eligible for our study we will obtain informed consent over the 
phone, through REDCap, or in person. Due to the nature of the ongoing pandemic and many individuals 
limiting their exposure, multiple methods of obtaining consent are necessary.  
10.1.2 STUDY DISCONTINUATION AND CLOSURE 

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This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, will be provided 
by the suspending or terminating party to <study participants, investigator, funding agency, and 
regulatory authorities>. If the study is prematurely terminated or suspended, the Principal Investigator 
(PI) will promptly inform study participants, the Institutional Review Board (IRB), and sponsor/funding 
agency and will provide the reason(s) for the termination or suspension. Study participants will be 
contacted, as applicable, and be informed of changes to study visit schedule. 
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Demonstration of efficacy that would warrant stopping    
• 
Insufficient compliance of study staff to the protocol   (ie, significant protocol violations) 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination that the primary endpoint has been met 
• 
Determination of futility 
 
The study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the funding agency, sponsor, IRB, Food and Drug Administration (FDA), or other relevant 
regulatory or oversight bodies (OHRP, DSMB). 
 
10.1.3 CONFIDENTIALITY AND PRIVACY  
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their staff, 
the safety and oversight monitor(s), and the sponsor(s) and funding agency. This confidentiality is 
extended to the data being collected as part of this study. Data that could be used to identify a specific 
study participant will be held in strict confidence within the research team. No personally-identifiable 
information from the study will be released to any unauthorized third party without prior written approval 
of the sponsor/funding agency.  
 
All research activities will be conducted in as private a setting as possible. 
 
The study monitor, other authorized representatives of the sponsor or funding agency, representatives of 
the Institutional Review Board (IRB), regulatory agencies or representatives from companies or 
organizations supplying the product, may inspect all documents and records required to be maintained 
by the investigator, including but not limited to, medical records (office, clinic, or hospital) and pharmacy 
records for the participants in this study. The clinical study site will permit access to such records. 
 
The study participant’s contact information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as 
long a period as dictated by the reviewing IRB, Institutional policies, or sponsor/funding agency 
requirements. 
 
Measures Taken to Ensure Confidentiality of Data Shared per the NIH Data Sharing Policies  

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It is NIH policy that the results and accomplishments of the activities that it funds should be made available 
to the public (see https://grants.nih.gov/policy/sharing.htm). The PI will ensure all mechanisms used to 
share data will include proper plans and safeguards for the protection of privacy, confidentiality, and 
security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be 
traceable to a specific study participant). Plans for archiving and long-term preservation of the data will 
be implemented, as appropriate.  
 
Certificate of Confidentiality  
To further protect the privacy of study participants, the Secretary, Health and Human Services (HHS), has 
issued a Certificate of Confidentiality (CoC) to all researchers engaged in biomedical, behavioral, clinical 
or other human subjects research funded wholly or in part by the federal government.  Recipients of NIH 
funding for human subjects research are required to protect identifiable research information from forced 
disclosure per the terms of the NIH Policy (see https://humansubjects.nih.gov/coc/index). As set forth 
in 45 CFR Part 75.303(a) and NIHGPS Chapter 8.3, recipients conducting NIH-supported research covered 
by this Policy are required to establish and maintain effective internal controls (e.g., policies and 
procedures) that provide reasonable assurance that the award is managed in compliance with Federal 
statutes, regulations, and the terms and conditions of award. It is the NIH policy that investigators and 
others who have access to research records will not disclose identifying information except when the 
participant consents or in certain instances when federal, state, or local law or regulation requires 
disclosure. NIH expects investigators to inform research participants of the protections and the limits to 
protections provided by a Certificate issued by this Policy. 
 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  
Data collected for this study will be analyzed and stored at Icahn School of Medicine at Mount Sinai. After 
the study is completed, the data will be stored for the recommended time of seven years after study 
completion. No samples or data will be stored for future use outside of the research designated by this 
protocol. 
 
10.1.5 KEY ROLES AND STUDY GOVERNANCE 
 
Principal Investigator 
Medical Monitor or 
Independent Safety Monitor 
Nita Vangeepuram, MD, MPH, 
Associate Professor 
Name, degree, title 
Icahn School of Medicine at Mount 
SInai 
Institution Name  
1 Gustave L. Levy Place Box 1198 
Address 
917.478.2106 
Phone Number 
Nita.vangeepuram@mssm.edu 
Email 
 

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Nita Vangeepuram, MD, MPH  is an Assistant Professor of Pediatrics, Preventive Medicine and 
Population Health Science and Policy at the Icahn School of Medicine at Mount Sinai (ISMMS) 
and a practicing general pediatrician. Dr. Vangeepuram’s clinical, research and programmatic 
experience will help her develop the proposed adolescent diabetes prevention intervention. Dr. 
Vangeepuram helped to develop a pediatric weight management program (Junior Urban 
Movement Program, JUMP) at ISMMS. She received a grant from the American Academy of 
Pediatrics Community Pediatrics Training Initiative for Obesity Prevention to implement 
provider, community and advocacy initiatives related to pediatric obesity. Prior research work 
includes study of associations between obesity, diet, physical activity, neighborhood factors and 
asthma, as well as examination of disparities in diet and physical activity behaviors in children 
from different ethnic minority subgroups. Dr. Vangeepuram was a co-investigator in the East 
Harlem Diabetes Center of Excellence, and has experience conducting in depth interviews of 
community youth leaders and focus groups with East Harlem adolescents. She then obtained 
funding from an Empire Clinical Investigator Research Program grant and Mount Sinai’s CTSA, 
which provided protected research time and support for the early pilot phase of the project. She 
was awarded an NIH Mentored Patient-Oriented Research Career Development Award (K23), 
and currently has R03 funding from NIH and funding from CIGNA Foundation which provide 
protected research time and project funding. She is the Engagement Core Lead for the Institute 
for Health Equity Research.  
Carol R. Horowitz, MD, MPH, is Professor of Population Health Science and Policy and 
Medicine at Mount Sinai, and a practicing general internist. With a focus on using Community-
Based Participatory Research to address health disparities, she has been the Principal 
Investigator of several NIH funded community-based interventions, and of a Centers for Disease 
Control, REACH Center grant to eliminate diabetes disparities among African Americans and 
Latinos. She is director of the East Harlem Diabetes Center of Excellence, Dean for Gender 
Equity, Director of the Institute for Health Equity Research, and the Principal Investigator of the 
Community Engagement and Research Core for Mount Sinai’s Institutes for Clinical and 
Translational Sciences. She has implemented numerous community-based health improvement 
interventions, and mentors students, residents and faculty interested in addressing disparities 
and partnering with communities on research to improve local health and influence policy. Dr. 
Horowitz has an MD degree from Cornell University, and received an MPH from the University 
of Washington as a Robert Wood Johnson Clinical Scholar. 
Cordelia Elaiho, MPH,  is the clinical research coordinator who will assist with study participant 
outreach and coordination of study events. Cordelia will assist in collecting study information 
using electronic databases, corresponding with study participants, maintaining study files, 
survey administration, and consent/assent.  Cordelia has completed all necessary CITI and 
HIPAA trainings and has filed an FCOI disclosure in Sinai Central.  
Bian Liu, PhD,  is an Assistant Professor in the Department of Population Health Science and 
Policy at Mount Sinai with many years experience working with complicated data sets.  Dr. Liu  
will work with the research team and CAB to analyze and interpret the data and findings.  She 
will work closely with the research team, the programmer, and the evaluation team to implement 
the evaluation plan.  Dr. Liu will collaborate with the programmer to ensure the integrity of the 

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data collected.  She will provide technical assistance on the analytical needs of program staff 
and CAB members.   
Yannan Li, MD, MPH, is a Senior Data Analyst in the Department of Population Health Science 
and Policy at Mount Sinai with many years of experience working with complicated data sets.  
Dr. Li will assist Dr. Liu in analysis, data interpretation and findings.  She will work closely with 
the research team, the programmer, and the evaluation team to implement the evaluation plan.   
TBD. We will recruit potential peer leaders through our contacts at community youth 
organizations in East and Central Harlem. Leaders should be older than 18 years, English 
speaking, may be male or female and may be of any racial/ethnic background. Individuals will 
be interviewed and chosen based on prior leadership experience, personal interest in diabetes 
prevention and level of commitment. Peer leaders will attend training sessions, workshop 
sessions and debriefing sessions. Peer leaders will complete all necessary CITI training and a 
FCOI disclosure in Sinai Central prior to involvement in any study related activities. 
 
10.1.6 SAFETY OVERSIGHT 
N/A 
10.1.7 CLINICAL MONITORING 
N/A 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
Each clinical site will perform internal quality management of study conduct, data and biological specimen 
collection, documentation and completion. All sites will follow a common quality management plan. 
 
Quality control (QC) procedures will be implemented as follows: 
 
Informed consent --- Study staff will review both the documentation of the consenting process as well as 
a percentage of the completed consent documents.  This review will evaluate compliance with GCP, 
accuracy, and completeness.  Feedback will be provided to the study team to ensure proper consenting 
procedures are followed.  
 
Source documents and the electronic data --- Data will be initially captured on source documents (see 
Section 10.1.9, Data Handling and Record Keeping) and will ultimately be entered into the study 
database.  To ensure accuracy site staff will compare a representative sample of source data against the 
database, targeting key data points in that review. 
 
Intervention Fidelity — Consistent delivery of the study interventions will be monitored throughout the 
intervention phase of the study. Procedures for ensuring fidelity of intervention delivery are described in 
Section 6.2.1, Interventionist Training and Tracking.  
 

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Protocol Deviations – The study team will review protocol deviations on an ongoing basis and will 
implement corrective actions when the quantity or nature of deviations are deemed to be at a level of 
concern. 
 
Should independent monitoring become necessary, the PI will provide direct access to all trial related 
sites, source data/documents, and reports for the purpose of monitoring and auditing by the 
sponsor/funding agency, and inspection by local and regulatory authorities. 
 
10.1.9 DATA HANDLING AND RECORD KEEPING  
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Data collection will be the responsibility of the clinical trial staff at the site under the supervision of the 
site investigator. The investigator will be responsible for ensuring the accuracy, completeness, legibility, 
and timeliness of the data reported. 
 
All source documents will be completed in a neat, legible manner to ensure accurate interpretation of 
data.   
 
Hardcopies of the study visit worksheets will be provided for use as source document worksheets for 
recording data for each participant consented/enrolled in the study.  Data recorded in the electronic case 
report form (eCRF) and into REDCap derived from source documents will be consistent with the data 
recorded on the source documents.  
 
Clinical data (including adverse events (AEs), concomitant medications, and expected adverse reactions 
data) and clinical laboratory data will be entered into REDCap, a 21 CFR Part 11-compliant data capture 
system provided by the Icahn School of Medicine at Mount Sinai. The data system includes password 
protection and internal quality checks, such as automatic range checks, to identify data that appear 
inconsistent, incomplete, or inaccurate. Clinical data will be entered directly from the source documents. 
 
10.1.9.2 STUDY RECORDS RETENTION  
Study documents will be retained for a minimum of 2 years after the last approval of a marketing 
application in an International Council on Harmonisation (ICH) region and until there are no pending or 
contemplated marketing applications in an ICH region or until at least 2 years have elapsed since the 
formal discontinuation of clinical development of the study intervention. These documents should be 
retained for a longer period, however, if required by local regulations. No records will be destroyed 
without the written consent of the sponsor/funding agency, if applicable. It is the responsibility of the 
sponsor/funding agency to inform the investigator when these documents no longer need to be retained. 
 
10.1.10 
PROTOCOL DEVIATIONS   

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This protocol defines a protocol deviation as any noncompliance with the clinical trial protocol, 
International Council on Harmonisation Good Clinical Practice (ICH GCP), or Manual of Procedures (MOP) 
requirements. The noncompliance may be either on the part of the participant, the investigator, or the 
study site staff. As a result of deviations, corrective actions will be developed by the site and implemented 
promptly.  
 
These practices are consistent with ICH GCP:  
• 
Section 4.5 Compliance with Protocol, subsections 4.5.1, 4.5.2, and 4.5.3  
• 
Section 5.1 Quality Assurance and Quality Control, subsection 5.1.1  
• 
Section 5.20 Noncompliance, subsections 5.20.1, and 5.20.2.  
 
It will be the responsibility of the site investigator to use continuous vigilance to identify and report 
deviations within 14 working days of identification of the protocol deviation, or within 30 working days of 
the scheduled protocol-required activity. All deviations will be addressed in study source documents, 
reported to the PI. Protocol deviations will be sent to the reviewing Institutional Review Board (IRB) per 
their policies. The site investigator will be responsible for knowing and adhering to the reviewing IRB 
requirements. Further details about the handling of protocol deviations will be included in the MOP. 
10.1.11 
PUBLICATION AND DATA SHARING POLICY  
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
 
National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for 
publication. 
 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As 
such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be 
submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed 
journals. Considerations for ensuring confidentiality of these shared data are described in Section 10.1.3. 
10.1.12 
CONFLICT OF INTEREST POLICY 
The independence of this study from any actual or perceived influence, such as by the pharmaceutical 
industry, is critical. Therefore, any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. Furthermore, 
persons who have a perceived conflict of interest will be required to have such conflicts managed in a way 
that is appropriate to their participation in the design and conduct of this trial. The study leadership in 
conjunction with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDKD) has 
established policies and procedures for all study group members to disclose all conflicts of interest and 
will establish a mechanism for the management of all reported dualities of interest. 

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10.2 ADDITIONAL CONSIDERATIONS 
 
10.3 ABBREVIATIONS AND SPECIAL TERMS 
 
AE 
Adverse Event 
ANCOVA 
Analysis of Covariance 
CFR 
Code of Federal Regulations 
CLIA 
Clinical Laboratory Improvement Amendments 
CMP 
Clinical Monitoring Plan 
COC 
Certificate of Confidentiality 
CONSORT 
Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DSMB 
Data Safety Monitoring Board 
DRE 
Disease-Related Event 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Forms 
FDA 
Food and Drug Administration 
FDAAA 
Food and Drug Administration Amendments Act of 2007 
FFR 
Federal Financial Report 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
GMP 
Good Manufacturing Practices 
GWAS 
Genome-Wide Association Studies 
HIPAA 
Health Insurance Portability and Accountability Act  
IB 
Investigator’s Brochure 
ICH 
International Council on Harmonisation  
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigational Device Exemption 
IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
ITT 
Intention-To-Treat 
LSMEANS 
Least-squares Means 
MedDRA 
Medical Dictionary for Regulatory Activities 
MOP 
Manual of Procedures 
NCT 
National Clinical Trial 
NIH  
National Institutes of Health 
NIH IC 
NIH Institute or Center 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 

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SMC 
Safety Monitoring Committee 
SOA 
Schedule of Activities 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States 
 
 
 

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10.4 PROTOCOL AMENDMENT HISTORY 
The table below is intended to capture changes of IRB-approved versions of the protocol, including a 
description of the change and rationale. A Summary of Changes table for the current amendment is 
located in the Protocol Title Page.  
 
Version 
Date 
Description of Change  
Brief Rationale 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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11 REFERENCES  
Include a list of relevant literature and citations for all publications referenced in the text of the protocol.  
Use a consistent, standard, modern format, which might be dependent upon the required format for the 
anticipated journal for publication (e.g., N Engl J Med, JAMA, etc.).  The preferred format is International 
Committee of Medical Journal Editors (ICMJE).  
 
Examples: 
 
• 
Journal citation 
Veronesi U, Maisonneuve P, Decensi A. Tamoxifen: an enduring star. J Natl Cancer Inst. 2007 Feb 
21;99(4):258-60. 
• 
Whole book citation 
Belitz HD, Grosch W, Schieberle P. Food chemistry. 3rd rev. ed. Burghagen MM, translator. Berlin: 
Springer; 2004. 1070 p. 
• 
Chapter in a book citation 
Riffenburgh RH. Statistics in medicine. 2nd ed. Amsterdam (Netherlands): Elsevier Academic 
Press; c2006. Chapter 24, Regression and correlation methods; p. 447-86. 
• 
Web Site citation 
Complementary/Integrative Medicine [Internet]. Houston: University of Texas, M.D. Anderson 
Cancer Center; c2007 [cited 2007 Feb 21]. Available from: 
http://www.manderson.org/departments/CIMER/. 
• 
Electronic Mail citation 
Backus, Joyce. Physician Internet search behavior: detailed study [Internet]. Message to: Karen 
Patrias. 2007 Mar 27 [cited 2007 Mar 28]. [2 paragraphs] 
• 
References to package insert, device labeling or investigational brochure 
Cite date accessed, version number, and source of product information.