Obesity and Asthma: Unveiling Metabolic and Behavioral Pathways
Phase: NA
Conditions: Asthma, Obesity
Sponsor: Icahn School of Medicine at Mount Sinai

Obesity and Asthma: Unveiling Metabolic and Behavioral Pathways 
Protocol
PI: Juan P. Wisnivesky, MD, DrPH 
NCT04113746
Document Date: June 29, 2022

Protocol Name:
Obesity and Asthma: Unveiling Metabolic and Behavioural 
Pathways
Principal Investigator: 
Juan Wisnivesky, MD, DrPH
Primary Contact 
Name/Contact Info:
Elisa McBratney / elisa.mcbratney@mountsinai.org / 212-824-7460
Date Revised:
1/25/21
Study Number:
STUDY-16-00079
1
Revised 8/31/2020
HRP-503 Application (Protocol)

This application can only be used in conjunction with a protocol. If this project does not
have a protocol from the sponsor or is already included in a grant application then a
comprehensive protocol should be developed. A comprehensive template and online wizard
is located at: NIH Wizard.

Note that, depending on the nature of your research, certain questions, directions, or entire sections below
may not be applicable, or may have been fully covered in the protocol. Provide information if and when
applicable. If the answer is found in the protocol please provide a page reference. If the question is not
applicable to the study, mark the section “N/A”.  Do not delete any sections.

Be sure to complete any supplement questions from one or another ancillary office that you
receive during the RUTH application process. Please make certain that the protocol, this
503 application and responses to ancillary offices do not contradict each other and the
information is incorporated in all documents where appropriate. Be sure to save the
Ancillary office responses you provided within RedCap and upload them to Ruth.

Throughout this application are references to checklists. These tools are used by the IRB to
make specific regulatory findings. To allow us to do that it is the applicant’s responsibility to
ensure that your protocol has sufficiently addressed these additional regulatory criteria for
approval, and that the applicant identifies those protocol specific findings required by the
checklist. how will they do that, here or a separate form?

Keep an electronic copy of this version of the document. You will need to modify this copy when making
changes.
1. Setting of the Human Research:

Where within the Mount Sinai health system or its affiliates will research activities take place
including subject recruitment?
The study sites will include New York City (the Mount Sinai Hospital System [MSHS]),
Denver (University of Colorado), and Toronto (The Hospital of Sick Children).
The research at Mount Sinai will take place in the Center for Advanced Medicine Building at
17 East 102nd St., New York, NY 10029. Follow-up interviews may take place at a location
other than the hospital campus if the subject requests that. Subjects can be recruited from
outpatient clinics and practices that treat asthma and other pulmonary conditions at Mount
Sinai Hospital.

If there are any differences in the recruitment or study procedures between the sites please
highlight them here.
Effective Date: 6/29/2022
End Date:6/28/2023

Protocol Name:
Obesity and Asthma: Unveiling Metabolic and Behavioural 
Pathways
Principal Investigator: 
Juan Wisnivesky, MD, DrPH
Primary Contact 
Name/Contact Info:
Elisa McBratney / elisa.mcbratney@mountsinai.org / 212-824-7460
Date Revised:
1/25/21
Study Number:
STUDY-16-00079
2
Revised 8/31/2020
The Hospital for Sick Children will not be recruiting subjects.

For research conducted outside MSSM and its affiliates under the supervision of the Sinai 
investigator:
N/A – each site has its own PI.
(a) Site-specific regulations, laws or customs affecting research.
(b) Local scientific and ethical review structure.
2. Resources Available to Conduct the Human Research: (the aim here is to 
assess if the research is likely to be successful and thus justify the efforts and risks taken by the 
subjects):

Explain the feasibility of meeting the recruitment goals of this project, and 
demonstrate (e.g., based on retrospective data) a potential for recruiting the 
required number of suitable subjects within the agreed recruitment period.  (For 
example, how many potential subjects do you have access to? What percentage of 
those potential subjects do you need to recruit? If this has been reviewed by a 
committee for recruitment feasibility [e.g. PR&MC], please indicate so.)
It will be feasible to meet our recruitment goals of 400 participants.  During 2014, 
there were ~2,500 unique adult asthmatics that had outpatient visits to the primary 
care and pulmonary practices. In our prior MSH-based cohort studies, 
approximately 30% were overweight and 30% obese. 

For research involving considerable data extraction or mining describe who will 
be providing those services.
Mount Sinai Data Warehouse (MSDW) will provide lists of potential eligible 
participants as well as daily report for any participants enrolled in our study 
hospitalized with asthma exacerbation.

For research conducted outside MSSM and its research affiliates, describe the 
facilities used for conducting the research. 
At the University of Colorado, The Asthma Clinical Research Center is located on 
the 6th Floor of the UCH, Anschutz Outpatient Pavilion Building, it has 
Approximately 5000 sq. ft. of clinical areas with eight patient exam rooms, which 
are equipped with exam tables, BP cuffs, otoscopes, spirometers, 2-Niox VEROs, 
and a negative pressure filter ventilated room for methacholine challenges. The 
Clinical Center sees over 2,000 patients with obesity and asthma per year.  The 
Asthma Center counts with a full time Asthma Nurse Educator who is involved 
Effective Date: 6/29/2022
End Date:6/28/2023

Protocol Name:
Obesity and Asthma: Unveiling Metabolic and Behavioural 
Pathways
Principal Investigator: 
Juan Wisnivesky, MD, DrPH
Primary Contact 
Name/Contact Info:
Elisa McBratney / elisa.mcbratney@mountsinai.org / 212-824-7460
Date Revised:
1/25/21
Study Number:
STUDY-16-00079
3
Revised 8/31/2020
with patient recruitment and consent. Administrative support staff are available to 
support research activities. Standard office supplies and capabilities, including 
confidential fax machine, mail, and photocopying are available. In addition, the 
research coordinators have dedicated 200 square feet of locked, shared office space 
immediately adjacent to the MICU at the University of Colorado Hospital. These 
office spaces constitute sufficient resources for the research coordinators and 
ancillary staff to conduct these research studies.
Dr. Grasemann’s lab is located on the 9th floor of SickKids new research facility, 
the Peter Gilgan Centre for Research and Learning (PGCRL). Completed in 2013, 
the PGCRL is the largest high-rise research facility in Canada and houses more 
than 2,000 research staff; consolidating scientists and core facilities under one roof. 
The state-of-the-art laboratory and learning space allow for interaction and 
interconnectivity among the various disciplines, enhancing the opportunities for 
long-term collaboration and hence promoting and fostering SickKids’ strengths in 
multidisciplinary inquiry.  For the purpose of this project Dr. Grasemann will 
extensively use the services of the Analytical Facility for Bioactive Molecules: this 
fee-for-service core facility (2000 sq. ft) is fully equipped for metabolomic and 
lipidomic analyses using state-of-art mass spectrometry (MS/MS, MALDI-TOF, 
IRMS, GC/MS), liquid chromatography (HPLC), and ELISA-based multiplexing 
assays

Describe your process to ensure that all persons assisting with the trial are 
adequately informed about the protocol, the investigational product(s), and their 
trial-related duties and functions. If research is being carried out in a clinical 
setting explain how the clinical staff will be informed of the trial and their 
involvement, e.g. medication administration.  If nursing or other services have 
reviewed and approved this project please upload the documentation. 
All study staff will be required to undergo all institutional-specific regulatory 
trainings prior to beginning the project and will also be required to update this 
training annually.  During data collection and the pilot phase, the PIs and research 
teams will meet biweekly to discuss all aspects of study administration and data 
collection.  
3. Study Design:
a) Recruitment Methods (see PPHS policy):

Describe the source of potential subjects. 
Potential subjects will be identified through queries of the registration systems at 
outpatient practices each site.
Effective Date: 6/29/2022
End Date:6/28/2023

Protocol Name:
Obesity and Asthma: Unveiling Metabolic and Behavioural 
Pathways
Principal Investigator: 
Juan Wisnivesky, MD, DrPH
Primary Contact 
Name/Contact Info:
Elisa McBratney / elisa.mcbratney@mountsinai.org / 212-824-7460
Date Revised:
1/25/21
Study Number:
STUDY-16-00079
4
Revised 8/31/2020

Describe the methods that will be used to identify potential subjects (e.g. 
ResearchMatch.org, social media, texting, etc.). 
We will request a list of potentially eligible participants from MSDW of patients 
from the outpatient primary care and pulmonary clinics at MSHS.  

Describe how potential subjects will be approached, the involvement of the treating 
clinicians, use of letter, emails, calls, or similar, opt-out provisions, etc. Describe 
materials that will be used to recruit subjects. Include copies of these documents 
with the application. For advertisements, submit the final copy of printed 
advertisements. When advertisements are taped for broadcast, provide the final 
audio/video file. You may submit the wording of the advertisement prior to taping 
for pre-approval but final audio/video recording has to receive IRB approval 
before use.
There will be no “cold-contact” of patients.  The RAs will obtain permission from 
physicians to contact their patients.  The RAs will contact the patient and they will 
be scheduled for an in-person interview. At time of scheduling, RAs will mail or 
email the consent document to the scheduled patient.  The RA will then follow up 
with the scheduled individual to review the consent over the phone and ask 
questions about asthma history. The patient should have an interview scheduled 
within four weeks of the phone consent.  Data will be recorded in the patient 
record. If the patient does not come in for the study visit or for rescheduled visits, 
the data collected over the phone will be destroyed. RAs will try to reschedule 
patient interviews up to 5 times, depending on the patient, before destroying the 
data collected during the phone consent process.  
RAs will obtain consent and administer the interview in a space that safeguards 
confidentiality. Based on preliminary data, we expect a distribution of participants 
well-balanced by obesity status and by age of asthma onset (early vs. late). We will 
recruit both obese and non-obese subjects. Obesity is defined as having a body 
mass index greater than or equal to 30 kg/m2. However, we will monitor these 
parameters during recruitment and conduct purposeful sampling if unbalances are 
identified. 
Acute Care Episodes: We will also interview participants (<30 minutes) and collect 
blood samples within 24 hours of admission when they have asthma exacerbations 
resulting in hospitalization at participating sites. There is a limit of one 
hospitalization interview within a 12 month period. The purpose is to determine 
whether L-arginine/ADMA ratios and arginase levels fall disproportionately among 
obese patients with late onset asthma during exacerbations. We will determine 
when hospitalizations occur by daily electronic queries of the hospitals’ registration 
systems.
Effective Date: 6/29/2022
End Date:6/28/2023

Protocol Name:
Obesity and Asthma: Unveiling Metabolic and Behavioural 
Pathways
Principal Investigator: 
Juan Wisnivesky, MD, DrPH
Primary Contact 
Name/Contact Info:
Elisa McBratney / elisa.mcbratney@mountsinai.org / 212-824-7460
Date Revised:
1/25/21
Study Number:
STUDY-16-00079
5
Revised 8/31/2020
For all interviews, acute and non-acute subjects will not sign the consent form 
unless they are comfortable with the research. Subjects can take as much time as 
they deem necessary to review the consent form and ask questions.

For social media, in addition to providing the content please explain how people 
will be selected or targeted to receive the ads. For websites used for screening or 
recruitment, provide details and access. Complete the INFO Sec screening 
questions and follow up as needed.
N/A
b) Inclusion and Exclusion Criteria:

Indicate any local changes not specified or differing from the protocol.
Inclusion criteria: participants that are > 64 years of age are eligible.
Exclusion criteria: participants that have a >15 pack-year smoking history are exluced.

Describe how you will screen for eligibility and if you will need a waiver of Informed 
Consent or HIPAA. If you are using an outside firm to screen or data mine for subjects 
please provide details here. 
We will request reports from MSDW for patients that fill our eligibility criteria detailed in 
the protocol.  The potential subjects will also be screened through a chart review.  
A HIPAA waiver has been requested and approved.

Any exclusions based on race, sex/gender, preferred language must be explained.
We are unable to recruit participants that do not speak English or Spanish as the study 
team is not equipped administer the study measures in languages other than Spanish or 
English.
 (NOTE: You may not include members of vulnerable populations as subjects in 
your research unless you indicate this in your inclusion criteria).
c) Number of Subjects:

Specify local recruitment numbers if not in the protocol
Please refer to the protocol.

Indicate the total number of subjects to be accrued locally. This will be the maximum 
number of subjects that can sign the consent form without additional IRB approval. Please 
be sure to account for screen failures, drop-outs, etc. If applicable, distinguish between the 
number of subjects who are expected to be pre-screened, enrolled (consent obtained), 
Effective Date: 6/29/2022
End Date:6/28/2023

Protocol Name:
Obesity and Asthma: Unveiling Metabolic and Behavioural 
Pathways
Principal Investigator: 
Juan Wisnivesky, MD, DrPH
Primary Contact 
Name/Contact Info:
Elisa McBratney / elisa.mcbratney@mountsinai.org / 212-824-7460
Date Revised:
1/25/21
Study Number:
STUDY-16-00079
6
Revised 8/31/2020
randomized, and complete the research procedures (i.e., numbers of subjects excluding 
screen failures) and between subgroups of subjects (e.g. healthy volunteer, disease cohort).
We will recruit 200 participants at Mount Sinai.

If this is a multicenter study, indicate the total number of subjects to be accrued across all 
sites.
We will recruit 400 participants between Mount Sinai and University of Colorado.
d) Study Timelines:

If not in the protocol, please clarify the how long an individual subject may be in the 
protocol, and for how long the protocol will be active at Mount Sinai.
Describe:

The duration of an individual subject’s participation in the study (including follow-up).
Subjects will participate in the study for 18 months.  If they are eligible to enroll in the 
pilot, subjects will participate for an additional 8 weeks.

The duration anticipated to enroll all study subjects.
We will enroll all subjects in 2.5 years.

The estimated date for the investigators to complete this study (complete primary analyses)
5 years
The study will take place from April1, 2016 to August 28, 2021.  The end date is 120 
calendar days after the end of the period of performance, as per the NIH Final Progress 
Report Guidelines. 
e) Specimen Banking for Future Uses Not Part of This Project:

If storage will be occur at Sinai and elsewhere (e.g. the sponsor) be sure to answer 
these questions for both sets of samples as, at the very least, governance of future uses 
will differ.
See below answers.

If specimens will be banked for future use, describe:
Specimens will be banked for future ADMA and L-arginine analyses.

Where the specimens will be stored, what access controls and security systems will be 
in place?
The specimens with be stored in Dr. Paula Busse’s laboratory in the Icahn Medical 
Institute at 1425 Madison Avenue 
.  The specimens will 
Effective Date: 6/29/2022
End Date:6/28/2023

Protocol Name:
Obesity and Asthma: Unveiling Metabolic and Behavioural 
Pathways
Principal Investigator: 
Juan Wisnivesky, MD, DrPH
Primary Contact 
Name/Contact Info:
Elisa McBratney / elisa.mcbratney@mountsinai.org / 212-824-7460
Date Revised:
1/25/21
Study Number:
STUDY-16-00079
7
Revised 8/31/2020
be stored in -80 degree freezer and locked securely to minimize the risk of a breach of 
confidentiality.  Specimens will then be shipped to Dr. Grasemann’s lab at the Hospital 
for Sick Children on the 9th floor of SickKids new research facility, the Peter Gilgan 
Centre for Research and Learning (PGCRL).  The specimens will be stored in freezer 
and locked securely to minimize the risk of a breach of confidentiality

How long they will be stored?
Samples will be stored indefinitely.

How will researchers gain access to the specimens? If there is a resource utilization 
committee please provide a description. 
These specimens will not be released to any additional requestors at any institution 
until a formal request has been submitted to the IRB and Dr. Wisnivesky.

List the information to be stored or associated with each specimen (including how the 
specimens are labeled/coded). 
Data specimens will be stored in an identifiable manner using indirect identifiers.  The 
patient study identifiers will be linked to the blood sample.  The file that links the study 
identifiers with the patient is stored on a secure server that is encrypted and password-
protected and encrypted.

If the specimens are part of bank where frequently sharing among several or more 
users is contemplated then a complete set of Standard Operating Procedures for the 
repository should be submitted.
N/A
f) Data Storage, Transmission and Confidentiality:
Describe the data and specimens to be sent out or received. If storage will occur at Sinai 
and elsewhere (e.g. the sponsor) be sure to answer these questions for both sets of samples 
as, at the very least, governance of future uses will differ.
As applicable, describe:

How will data be collected?
All data will be collected in a deidentified manner. Data will be collected through 
REDCap, Mount Sinai’s electronic research data capture platform.  Additional data will 
be collected through spirometry tests, FeNO tests, and asthma dosers.

How will data be transmitted? If clinical trials software or similar is being used 
provide the names as well as the security/regulatory specifications it complies with 
(e.g. FDA)
Effective Date: 6/29/2022
End Date:6/28/2023

Protocol Name:
Obesity and Asthma: Unveiling Metabolic and Behavioural 
Pathways
Principal Investigator: 
Juan Wisnivesky, MD, DrPH
Primary Contact 
Name/Contact Info:
Elisa McBratney / elisa.mcbratney@mountsinai.org / 212-824-7460
Date Revised:
1/25/21
Study Number:
STUDY-16-00079
8
Revised 8/31/2020
Data will be transmitted from other sites to Mount Sinai via the secure Mount 
Sinai-hosted OneDrive, a secure, HIPAA-compliant shared drive.  This will be 
used to transmit de-identified accelerometer and spirometry data. University of 
Colorado research staff will also have access to Mount Sinai’s REDCap, where 
they will input deidentified survey data.

How will data be stored? Provide data standards where known.
To preserve patient confidentiality, study subjects will be assigned code numbers. Using 
these codes, none of the collection forms will contain the names or medical record 
number of the patients or other personal identifiers. There will be a master list at each 
institution matching the names of the patients to the code numbers. The list will be 
safely stored in secure network drives. Paper-based consent and HIPAA documents will 
be stored in locked cabinets within locked offices, separate from the master lists. All 
electronic data will be stored on mainframe servers, and terminals and Tablet PCs will 
be password protected and maintained in locked offices. 
Database protection: Patient information will only be accessible to the PI, project 
manager, and research coordinators associated with the research. Data collected on 
Tablet personal computers (PC) will be uploaded on a daily basis to mainframe servers 
supported by the local institutions and encrypted using encryption software. These data 
will lack personal identifiers other than a study identification code.  Following the 
upload, the data on the Tablet PCs will be deleted.  Encrypted data from the other sites 
will be transferred electronically to Mount Sinai on a weekly basis. The transferred data 
will be free of personal data that qualifies as PHI.  All data received at the data 
coordinating center (Mount Sinai) will be entered into a computerized database and 
stored in encrypted files on a mainframe server that is backed up nightly by the Mount 
Sinai Hospital IT Department.

How long will data be stored?
Data will be stored for 7 years following the completion of data analysis.

What are the SOPs that govern data sharing?
No data will be shared outside of the investigators and study team named on this 
protocol.

If this project is not funded by NIH will a Certificate of Confidentiality be 
obtained? If not, why not?
Effective Date: 6/29/2022
End Date:6/28/2023

Protocol Name:
Obesity and Asthma: Unveiling Metabolic and Behavioural 
Pathways
Principal Investigator: 
Juan Wisnivesky, MD, DrPH
Primary Contact 
Name/Contact Info:
Elisa McBratney / elisa.mcbratney@mountsinai.org / 212-824-7460
Date Revised:
1/25/21
Study Number:
STUDY-16-00079
9
Revised 8/31/2020
N/A – this study is funded by the NIH.
g) Data and Safety Monitoring Plan:

For projects with a Data Safety Monitoring Board/Data Safety Committee
(DMSB/DMC):

If not included in the protocol, attach a description of the DMC/DSMB, including the
number, names (if available}  and area of professional expertise of the members. The
responsibilities of the DSMB/DMC must be clear as well as their powers and their degree
of independence. The DSMB charter must be provided to the PPHS before the study may
begin.  Reports of the DMC/DSMB must be made available to the local PI and the MSSM
PPHS.  The report need not contain specifics of the study or data, but there should be clear
statement if the study can continue as is, or requires changes or termination.
Please refer to the protocol for a description of the DSMB (pg. 126-127).  The DSMB
members and their roles are detailed below:
Name
Role
Title
Institution
Email
Joel Erblich
Biostatistician
Associate 
Professor; 
Psychology
City University of 
New York
jerblich@hunter.cuny.edu
Katie 
Krauskopf
Primary Care 
Physician
Medical 
Director, 
Outpatient 
Addiction 
Services
Providence 
Behavioral 
Health, Trinity 
Health Of New 
England
Katherine.krauskopf@sphs.com
Anne Dixon
Chair/Pulmonolog
ist
Professor; 
Pulmonary 
Disease and 
Critical Care 
Medicine
University of 
Vermont
Anne.dixon@uvmhealth.org
Sharmilee 
Nyenhuis
Behavioral Health 
Research 
Scientist
Assistant 
Professor; 
Medicine 
University of 
Illinois at 
Chicago
snyenhui@uic.edu
h) Withdrawal of Subjects:

Describe anticipated circumstances under which subjects will be withdrawn from the
research without their consent.
The PI, the sponsor or the institution may stop the participant's involvement in this
research study at any time without consent. This may be because the research study is
Effective Date: 6/29/2022
End Date:6/28/2023

Protocol Name:
Obesity and Asthma: Unveiling Metabolic and Behavioural 
Pathways
Principal Investigator: 
Juan Wisnivesky, MD, DrPH
Primary Contact 
Name/Contact Info:
Elisa McBratney / elisa.mcbratney@mountsinai.org / 212-824-7460
Date Revised:
1/25/21
Study Number:
STUDY-16-00079
10
Revised 8/31/2020
being stopped, the instructions of the study team have not been followed, the 
investigator believes it is in the participant's best interest, or for any other reason. If 
specimens or data have been stored as part of the research study, they too can be 
destroyed without the participant's consent.

Describe any procedures for orderly termination. 
Study participants have the option withdraw from further participation at any time. 
Voluntary withdrawal will in no way affect the quality of patient care that is provided 
to them within the Mount Sinai Health System. However, any data and/or biological 
samples that have already been collected will be retained unless the participant 
requesting in writing that his/her data and/or biological samples be destroyed. If a 
subject asks for complete withdrawal from the study, he/she must do so by notifying 
the site PI in writing.

Describe procedures that will be followed when subjects withdraw from the research, 
including partial withdrawal from procedures with continued data collection.
If participant withdraws from the study, they must do so in writing as specified in the 
consent.  The research team will not contact the participant further for study interviews.  
The participant will be asked if he/she will allow the study team to keep data and 
specimens that have already been collected.  If the participant refuses, the data 
recorded in REDCap will be destroyed and the samples collected will be destroyed.
4. Provisions for Research Related Harm/Injury: 

Explain how clinically important incidental results will be handled. Examples include an 
abnormal lab finding or a survey answer indicating possible danger to self or others.
This study does not collect blood or spirometry results that are clinically important.
If a patient indicates a possible danger to themselves or others, the PI or other qualified 
clinician will be immediately summoned to evaluate the participant.

Describe the availability of medical or psychological resources that subjects might 
need as a result of any anticipated adverse events that may be known to be associated 
with the Human Research.  
In order to further safeguard the mental health of the study participants: (1) Any 
participant who becomes discomforted or distressed will be given the opportunity to 
speak with a clinical psychologist, social worker or qualified medical professional 
immediately; (2) we will track the occurrence of these events and after two incident 
reports are filed for a participant, they will be flagged for a consultation with a 
counselor (clinical psychologist, social worker or qualified medical professional)
Effective Date: 6/29/2022
End Date:6/28/2023

Protocol Name:
Obesity and Asthma: Unveiling Metabolic and Behavioural 
Pathways
Principal Investigator: 
Juan Wisnivesky, MD, DrPH
Primary Contact 
Name/Contact Info:
Elisa McBratney / elisa.mcbratney@mountsinai.org / 212-824-7460
Date Revised:
1/25/21
Study Number:
STUDY-16-00079
11
Revised 8/31/2020

If the research involves more than minimal risk to subjects, explain any medical 
treatments that are available if research-related injury occurs, who will provide it, 
what will be provided, and who will pay for it.   
The expected risks include those related to performing a pulmonary function test. 
These may include dizziness related to performing a full inspiratory maneuver. Those 
who report dizziness will be promptly instructed to discontinue the test, and a qualified 
medical professional will be sought if symptoms persist. See answer to question above 
regarding procedure to patients that express a danger to themselves or others.
The pilot intervention does not involve any procedures that would result in research-
related injuries.
5. Recordings: N/A
6. Provisions to Protect the Privacy Interests of Subjects: 
[Note: This section is soliciting different information than the confidentiality information 
solicited in section #5f. Answers will vary widely based on the complexity of the research 
design, the sensitivity of the subject matter and the populations being recruited.] 

Describe the steps that will be taken to protect subjects’ privacy interests, particularly 
a person’s desire to control how, where and with whom, they interact and 
communicate, especially on issues that prospective research participants may deem 
sensitive or private.  Consider privacy interests that may arise from the time 
participants are identified for recruitment until they complete study participation.  
Consider privacy interests that may arise in communications with the study subjects 
(e.g. phone messages, mail, etc), including through long-term follow-up.
To protect the privacy interests of subjects, all communications with study subjects will 
be via face-to-face visit, telephone or email. Phone messages left will not refer to the 
study in which they are enrolled but only the site where they were enrolled. For 
example, the study team would leave a message such as, "This is XXXX calling from 
Mount Sinai." Patients will be asked whether they prefer phone contact or email 
contact for their follow-up.

Describe what steps you will take to make the subjects feel at ease with the research 
situation in terms of the questions being asked and the procedures being performed. 
“At ease” does not refer to physical discomfort, but the sense of intrusiveness a subject 
might experience in response to questions, examinations, and procedures. 
Effective Date: 6/29/2022
End Date:6/28/2023

Protocol Name:
Obesity and Asthma: Unveiling Metabolic and Behavioural 
Pathways
Principal Investigator: 
Juan Wisnivesky, MD, DrPH
Primary Contact 
Name/Contact Info:
Elisa McBratney / elisa.mcbratney@mountsinai.org / 212-824-7460
Date Revised:
1/25/21
Study Number:
STUDY-16-00079
12
Revised 8/31/2020
During the consent process and prior to every study visit, participants will be informed 
that some of the questions asked during the study visit may make them feel 
uncomfortable.  The study team will emphasize that each part of the study is voluntary 
and they are free to skip any part that causes them discomfort.  

Describe why it is acceptable and appropriate for members of the research team to 
approach the prospective participant about the research.
This project has been deemed of important scientific merit. Members of the research 
team have all completed ethical research training as well as extensive training in the 
protocols of this project. Measures are put into place to take the utmost care in 
contacting and interacting with prospective participants.
7. Economic Impact on Subjects:

Describe any foreseeable costs that subjects may incur through participation in the 
research (exclude billing for procedures that are part of clinical care e.g. copayments 
for studies that involve an overlap of clinical care & research).  
The study will have no foreseeable economic impact on participants.

In answering this question, the Financial Administration of Clinical Trials Services 
(FACTS) must be consulted in determining the appropriate responsible party for 
subject care costs incurred as part of the clinical research study.  Additional 
information can be found at (FACTS Office)
8. Payments/Reimbursements to Subjects:
Describe the amount and timing of any payments/reimbursements to subjects. Payments 
must be pro-rated. Completion bonuses may be permitted but may not represent undue 
inducement. Review ISMMS Finance webpage for restrictions on payments, requirements 
for tracking cash, gift card, etc. payments.
Subjects will be reimbursed for their time and effort.  Subjects may receive up to $380 for 
participating in the observational study. Subjects will receive $50 in cash after the completion of 
the baseline interview. Up to an additional $20 will be given to the subjects once they return the 
electronic monitoring device for the medication ($10) and accelerometer ($10). Subjects will 
receive $50 in cash after the completion of each follow-up interview (6 months, and 12 months 
and 18 months). Up to an additional $20 will be given to the subjects once they return the 
electronic monitoring device for the medication ($10) and accelerometer ($10) after each follow 
up interview. Subjects will receive $50 in cash after the completion of each post-hospitalization 
interview (limit of one interview within 12 months). Payment for each interview and device return 
is not contingent upon the completion of the entire study. 
Effective Date: 6/29/2022
End Date:6/28/2023

Protocol Name:
Obesity and Asthma: Unveiling Metabolic and Behavioural 
Pathways
Principal Investigator: 
Juan Wisnivesky, MD, DrPH
Primary Contact 
Name/Contact Info:
Elisa McBratney / elisa.mcbratney@mountsinai.org / 212-824-7460
Date Revised:
1/25/21
Study Number:
STUDY-16-00079
13
Revised 8/31/2020
Patients participating in the pilot phase of the study will be paid $20 for each visit of the pilot that 
they complete, including the 30-day follow-up visit. Subjects will be paid in cash for returning 
their devices at the next visit unless otherwise requested.  If devices are returned after the final in-
person interview or if subject should choose to withdraw from the study, payment for device 
return will be made by money order. This payment will be sent within a 6 week period by mail.
Interview 
Period
Payment
Amount
Medication
Device 
Return
Accelerometer 
Return
Possible
Total 
Payment
Baseline
$50
$10
$10
$70
6-month 
interview
$50
$10
$10
$70
12-
month 
interview
$50
$10
$10
$70
18-
month 
interview
$50
$10
$10
$70
Hospital 
interview
$50
-
-
$100
Each 
pilot visit
$20
$100
30-day 
follow-
up pilot 
visit
$20
$20
9. Consent Process:
Effective Date: 6/29/2022
End Date:6/28/2023

Protocol Name:
Obesity and Asthma: Unveiling Metabolic and Behavioural 
Pathways
Principal Investigator: 
Juan Wisnivesky, MD, DrPH
Primary Contact 
Name/Contact Info:
Elisa McBratney / elisa.mcbratney@mountsinai.org / 212-824-7460
Date Revised:
1/25/21
Study Number:
STUDY-16-00079
14
Revised 8/31/2020
This section always applies, please indicate whether consent will be obtained from subjects.  
(If not, proceed to the Waiver or Alteration of the Consent Process section below).   If you 
will be obtaining consent, describe:

The setting of the consent process. 
Informed consent will take place either in person or over the phone in a space that 
safeguards confidentiality.

Describe any waiting period available between informing the prospective subject and 
obtaining the consent.
The participant will have as much time as needed to review the consent.

If you will be following “SOP HRP-090 Informed Consent Process for Research”, 
after addressing the points above, indicate this. Otherwise, also describe:  
o
The role of the individuals listed in the application as being involved in 
the consent process. 
o
The time that will be devoted to the consent discussion. 
o
Steps that will be taken to minimize the possibility of coercion or undue 
influence.
o
Steps that will be taken to ensure the subjects’ understanding.
o
Describe any tools that will be utilized during the consent process 
The team will adhere to "SOP-HRP-090 Informed Consent Process".

Non-English Speaking Subjects (See PPHS policy)
Indicate what language(s) other than English are understood by prospective subjects or 
representatives. If subjects who do not speak English will be enrolled, describe the process 
to ensure that the oral and written information provided to those subjects will be in that 
language.  If you intend to exclude potential participants who do not speak English, 
provide a justification for doing so. 
Spanish-speaking participants will be enrolled. All study materials have been translated 
into Spanish and back-translated by study team members who are fluent in Spanish. The 
study team contains a Research Coordinator who is fluent in Spanish and will administer 
the study visits in Spanish to Spanish-speaking participants.
This study will exclude participants who do not speak English or Spanish as the study 
team is not equipped to administer the study visits in languages other than English or 
Spanish. 
Effective Date: 6/29/2022
End Date:6/28/2023

Protocol Name:
Obesity and Asthma: Unveiling Metabolic and Behavioural 
Pathways
Principal Investigator: 
Juan Wisnivesky, MD, DrPH
Primary Contact 
Name/Contact Info:
Elisa McBratney / elisa.mcbratney@mountsinai.org / 212-824-7460
Date Revised:
1/25/21
Study Number:
STUDY-16-00079
15
Revised 8/31/2020
Waiver or Alteration of the Consent Process
If the Human Research involves a request for a waiver or alteration of the consent 
process, review the “CHECKLIST HRP-410 Criteria for Waiver or Alteration of the 
Consent Process” and make sure your submission provides adequate information for the 
IRB to assess the criteria for approval.  It is highly recommended that you provide 
additional information here to address each of the criteria for approval (e.g. 
impracticability).  
N/A
Examples of when a waiver or alteration of the consent process may be applicable:

Research that does not obtain consent from subjects 

Research that omits some information that is required in the consent template

Research that involves deception 

Research that involves obtaining private information about third parties who 
have not provided consent

Research that requests a waiver of the consent process for planned emergency 
research.  Please review the “CHECKLIST HRP-506 Criteria for Waiver of the 
Consent Process for Planned Emergency Research” to ensure you have provided 
sufficient information for the IRB to make these determinations.
10.
Process to Document Consent in Writing:
a) If consent will be obtained at a distance using the written consent form as the official 
version, please provide details of how the subjects will receive a copy of the consent form, 
how the consent form will be reviewed with the subject, and how signature will be obtained 
and documented. 
In addition to consenting participants in person, we will also consent participants over the 
phone.  For any subject being consented via phone we will follow the following procedure:
1. Send the approved phone consent authorization to the prospective research subject 
for review.
2. Arrange for a conversation between the participant and an authorized member of 
the research team to allow for full discussion of the combined 
consent/authorization. If verbal consent is obtained, collect identifiable data as 
applicable.
3. If there is an adult witness on the phone at the time of the initial verbal consent, the 
documents will not be returned.
Effective Date: 6/29/2022
End Date:6/28/2023

Protocol Name:
Obesity and Asthma: Unveiling Metabolic and Behavioural 
Pathways
Principal Investigator: 
Juan Wisnivesky, MD, DrPH
Primary Contact 
Name/Contact Info:
Elisa McBratney / elisa.mcbratney@mountsinai.org / 212-824-7460
Date Revised:
1/25/21
Study Number:
STUDY-16-00079
16
Revised 8/31/2020
4. If there is no adult witness to the phone consent/authorization, the written 
document will be requested to be returned via regular mail, fax, or email. If after 
two weeks, the signed document is not returned the data will be stripped of all 
identifiers and links such that the de-identified data are permanently anonymized.
b) If using any sort of e-Consent on any device, including iOPEN, provide access to the 
PPHS  to allow us to review the built consent. e-Consent is defined as consent designed to 
be obtained with minimal human interaction, generally using specialized software.

If not iOPEN please provide details and complete the InfoSec “screening questions” 
for further instructions. 
N/A
c) If you want a waiver of written documentation, please review the “CHECKLIST HRP-
411” to ensure that your protocol has sufficiently addressed these additional regulatory 
criteria for approval, including protocol specific information to support the 
determinations. You will also need to request a waiver of HIPAA authorization. Unless you 
are eligible for a complete waiver of consent, your consent form or script should still 
contain the needed elements of consent as laid out in our consent template. 
N/A
11.
Vulnerable Populations:
a) Unless already detailed in the protocol, please indicate which of the following populations 
are either included or excluded in this project: Indicate specifically whether you will 
include (target) or exclude each of the following populations:
Include
Exclude
Vulnerable Population Type
x
Adults unable to consent
x
Individuals who are not yet adults (e.g. infants, children, teenagers)
x
Wards of the State (e.g. foster children)
x
Pregnant women
x
Prisoners
b) Describe other aspects of the subject population that may increase their vulnerability 
(marginalized populations, poverty, illiteracy and under-education, legal status, home/institution-
bound individuals; students participating in their professor’s research, cognitively-impaired 
Effective Date: 6/29/2022
End Date:6/28/2023

Protocol Name:
Obesity and Asthma: Unveiling Metabolic and Behavioural 
Pathways
Principal Investigator: 
Juan Wisnivesky, MD, DrPH
Primary Contact 
Name/Contact Info:
Elisa McBratney / elisa.mcbratney@mountsinai.org / 212-824-7460
Date Revised:
1/25/21
Study Number:
STUDY-16-00079
17
Revised 8/31/2020
minors, etc.). For those subjects at an increased risk of not understanding the aims, procedures, 
risks and benefits of this project, OR whom may be at increased vulnerability to coercion or undue 
influence, describe additional safeguards included to protect their rights and welfare.
There are no aspects of the research population that are anticipated to increase their 
vulnerability.
c) What steps are being taken to assure that a diverse group of research subjects are approached to 
participate in this study? What are the projected demographics of the enrolled subjects at study 
completion.
We are recruiting participants from a wide range of medical settings within the 
Mount Sinai Hospital System. The Mount Sinai Health System has locations 
throughout the New York metropolitan area and the demographic composition of its 
patients reflects the diversity of the surrounding communities.  
12.
Multi-Site Human Research:
a) Besides research sites within the Mount Sinai System please detail the PI’s responsibilities for 
other sites, or overall responsibility for the project?
Drs. Wisnivesky, Federman, and Holguin will be responsible for the oversight and coordination of 
the entire study.  More specifically, Drs. Wisnivesky and Federman will oversee subject 
recruitment and data collection at the Mount Sinai site.  They will supervise a project manager, a 
data analyst, and the research assistants. Dr. Wisnivesky will be the contact PI and responsible for 
all communication with NIH. Dr. Holguin will oversee the research assistants and study activities 
at University of Colorado.  
Mount Sinai will serve as the data coordinating center.  The study teams at ISMMS and University 
of Colorado will work together on recruitment. University of Colorado will recruit participants 
from its site only and will only have access to data from its site. 
b) If coordinating center functions are taking place at Sinai, whether or not it is also a clinical site, 
please answer the following with appropriate justification and documentation, if needed:
 
(i) Are the management, data analysis, and Data Safety and Monitoring (DSM) systems adequate, 
given the nature of the research involved?  Yes
(ii) Is the sample protocols and informed consent documents developed and distributed to each 
Effective Date: 6/29/2022
End Date:6/28/2023

Protocol Name:
Obesity and Asthma: Unveiling Metabolic and Behavioural 
Pathways
Principal Investigator: 
Juan Wisnivesky, MD, DrPH
Primary Contact 
Name/Contact Info:
Elisa McBratney / elisa.mcbratney@mountsinai.org / 212-824-7460
Date Revised:
1/25/21
Study Number:
STUDY-16-00079
18
Revised 8/31/2020
collaborating institution?; Yes
(iii) Does each collaborating institution hold an applicable OHRP-approved Assurance?; Yes
(iv)Will each protocol be reviewed and approved by the IRB at the collaborating institution prior 
to the enrollment of subjects?; Yes
(v) Have all substantive modifications by the collaborating institution to the  sample consent, 
especially  related to risks or alternative procedures, been appropriately justified?; Yes
(vi) Will informed consent be obtained from each subject in compliance with HHS regulations? 
Yes
If this is a multi-site study where you are the lead investigator, describe the management of 
information (e.g., results, new information, unanticipated problems involving risk to 
subjects or others, or protocol modifications) among sites to protect subjects.
The PIs will participant in biweekly study meetings to discuss all aspects of study 
administration and data collection.  The PIs will communicate as needed to discuss new 
information, unanticipated problems or protocol amendments.
13.
Community-Based Participatory Research
a) Describe involvement of the community in the design and conduct of the research.
N/A
(Note: “Community-based Participatory Research” is a collaborative approach to 
research that involves the community in all aspects of research process. Community-based 
Participatory Research begins with a research topic of importance to the community and 
has the aim of combining knowledge with action and achieving social change to improve 
health outcomes and eliminate health disparities. Simply recruiting participants from the 
community is not CBPR.  If your research does not involve the community in all aspects of 
the research process, mark N/A)
b) Composition and involvement of any community advisory board for research conducted 
outside of MSSM.
N/A
14.
Sharing of individual and study Results with Subjects:
Effective Date: 6/29/2022
End Date:6/28/2023

Protocol Name:
Obesity and Asthma: Unveiling Metabolic and Behavioural 
Pathways
Principal Investigator: 
Juan Wisnivesky, MD, DrPH
Primary Contact 
Name/Contact Info:
Elisa McBratney / elisa.mcbratney@mountsinai.org / 212-824-7460
Date Revised:
1/25/21
Study Number:
STUDY-16-00079
19
Revised 8/31/2020
a) If not in the protocol, or in response to other questions (e.g. Radiation Safety) add here. Be sure to 
remain compliant with NYS laws around genetic testing and the use of research tests, as only FDA 
or NYS DOH a approved tests from CLIA labs can be used to guide clinical decision making. If 
results are not being returned, explain the rationale.
See below.
b) Specify which results will be returned to subjects and/or their clinical care team. If results are not 
being returned, explain the rationale.
Results are not being returned to subjects and/or their clinical care teams.  Results of spirometry 
will not be shared with the participants as they were not administered by a respiratory technician 
or physician and they are not clinically relevant.  The blood tests collected for this study are for 
research purposes only and are not clinically relevant.
c) How and when will subjects be informed of the study results? The PPHS expects proactive 
outreach by the study team.
Study results will not be communicated with study participants as part of the study so as not to 
influence decision making.
15.
External IRB Review History
If you have previously submitted this protocol for review by an external IRB (non-Mount 
Sinai IRB), provide the name of the reviewing IRB and the associated project identification 
number. Please include the details of the review with appropriate documentation including 
the date of review and the IRB contact information.
N/A
16.
Control of Drugs, Biologics, or Devices:
a) If not included in the protocol, the supplemental questions of the Investigational Drug service or 
included in other uploaded documents please add here: 
N/A
o
If the Human Research involves drugs, biologics, or devices, describe the plans to 
store, handle, and control those drugs, biologics or devices so that they will be used 
only on subjects and be used only by authorized investigators.  This very well may 
involve OR personnel, nursing, central sterilization and supplies etc. The plan should 
be comprehensive and robust.
o
Note: If there are required departmental policies that regulate the control of drugs, 
biologics, or devices, provide that information here.
Effective Date: 6/29/2022
End Date:6/28/2023

Protocol Name:
Obesity and Asthma: Unveiling Metabolic and Behavioural 
Pathways
Principal Investigator: 
Juan Wisnivesky, MD, DrPH
Primary Contact 
Name/Contact Info:
Elisa McBratney / elisa.mcbratney@mountsinai.org / 212-824-7460
Date Revised:
1/25/21
Study Number:
STUDY-16-00079
20
Revised 8/31/2020
o
Note: For studies involving research drugs or biologics, you will need to obtain the 
approval of Investigational Drug Service (IDS) of the Mount Sinai Pharmacy, 
regardless of whether you will be utilizing the IDS to manage the control of research 
drugs and biologics. 
Effective Date: 6/29/2022
End Date:6/28/2023