Daily Self-weighing Feedback for Wheelchair Users to Promote Weight Loss Through Use of the E-scale
Phase: NA
Conditions: Overweight and Obesity, Depression
Sponsor: Jonathan Pearlman

Title of the study: Daily Weight Feedback for Wheelchair Users to Promote Weight Loss 
 NCT number: 03264248 
Date: June 5th, 2018  

Section: Triage
     [reviewer notes¬] 
Provide a short title for this study (200 characters or less):
Daily weight feedback for wheelchair users to promote weight loss 
T1.0
Select the type of application:
New Research Study  
 
T2.0
Is the proposed research study limited to the inclusion of deceased individuals? 
* No
T2.1
Are any research activities being conducted at the VA Pittsburgh Healthcare
System or with VA funds? 
* No
 
  
     [reviewer notes¬] 
T3.0
What is the anticipated risk to the research participants?
Minimal Risk
 
T3.1
Why do you feel that all aspects of this research study, including screening and
follow-up, involve no more than minimal risk to the research subjects?
This study is a standard behavioral weight loss study focusing on diet, physical activity, and
behavioral strategies to effectively make lifestyle changes. It will also include using a new
scale (E-scale) which has minimal risk as it will continuously record the weight of the bed
which will allow for capturing the weight of the person when they are in bed.
T4.0
Does the proposed study qualify for 'exempt' IRB review or for a determination of
either 'not research' or 'no human subject' involvement?
* No
 
T5.0
Does the proposed research study qualify for 'expedited' IRB review status?
* Yes

  

Section: Cover Sheet
     [reviewer notes¬] 
CS1.0
What is the reason for this submission?
New Research Protocol Submission
CS1.1
Has this research study been approved previously by the University of Pittsburgh
IRB?
*  No
CS1.1.1
Has this research study (or a substantially similar research study) been previously
disapproved by the University of Pittsburgh IRB or, to your knowledge, by any other
IRB?
*  No
  
     [reviewer notes¬] 
CS2.0
Title of Research Study:
Daily weight feedback for wheelchair users to promote weight loss
CS2.0.1
   
Requested approval letter wording:
CS2.1
Research Protocol Abstract:
The goals of the proposed study are to test the usability, feasibility and preliminary efficacy
of the E-Scale with wheelchair users. Up to fifteen overweight or obese wheelchair users will
be enrolled in a 13 week study that includes standard behavioral treatment (SBT) for weight
loss that focuses on diet, physical activity, and behavioral strategies (e.g., goal setting, self-
monitoring) to support lifestyle changes specifically for people with mobility impairments.
The subjects will also be provided the E-scale to track their weight daily. The primary
outcomes will be usefulness (subjective feedback from a survey about the program/E-
scale), feasibility (accuracy and repeatable measurements from the E-scale) and efficacy
(improvements in weight and other measures of health) of the weight loss program coupled
with the E-scale at the end of 13 weeks. The results could inform the refinement of this
technology to increase its applicability for wheelchair users to independently monitor their
weight in their own homes while attempting to lose weight.
 
 
CS2.2
Select the category that best describes your research:
Hybrid - includes aspects of BOTH types of research (check this option if your research is
mainly social/behavioral but also involves specimen collection or blood draws to look at
biological measures)
     [reviewer notes¬] 
CS3.0
Name of the Principal Investigator:

Jonathan Pearlman
Note: Adjunct faculty of the University, including lecturers and instructors, are not
permitted to serve as a PI or Faculty Mentor but may serve as co-investigators. Refer to
Chapter 4 on the HRPO website for more information.
CS3.1
Affiliation of Principal Investigator:
UPitt faculty member 
 
If you chose any of the Pitt options, please indicate the specific campus:
Main Campus - Pittsburgh
 If you chose the UPi/ faculty member op6on, provide the PI’s University Faculty Title:
Associate Professor  
CS3.2
Address of Principal Investigator:
6425 Penn Ave Suite 400
Pittsburgh, PA 15206 
CS3.3
Recorded Primary Affiliation of the Principal Investigator:
U of Pgh | School of Health and Rehabilitation Sciences | Rehabilitation Science and
Technology 
CS3.4
Identify the School, Department, Division or Center which is responsible for
oversight of this research study:
U of Pgh | School of Health and Rehabilitation Sciences 
 
 
CS3.5
Telephone Number of Principal Investigator:
412-822-3685 
CS3.6
Recorded Current E-mail Address of Principal Investigator to which all
notifications will be sent:
jlp46@pitt.edu
CS3.7
Fax Number:
412-822-3699
CS3.8
Does this study include any personnel from Carnegie Mellon University, and/or
use any CMU resources or facilities (e.g., Scientific Imaging and Brain Research
Center (SIBR)?
*  No

CS3.9
Is this your first submission, as PI, to the Pitt IRB?  
*  No
  
     [reviewer notes¬] 
CS4.0
List of Co-Investigators: 
Last
First
Organization
Duvall Jonathan U of Pgh | School of Health and Rehabilitation Sciences | Rehabilitation
Science and Technology
Gold
Elizabeth Other
Karg
Patricia
U of Pgh | School of Health and Rehabilitation Sciences
 
 
 
     [reviewer notes¬] 
CS5.0
Name of Primary Research Coordinator:
Patricia Karg
 
 
 
CS5.1
Address of Primary Research Coordinator:
6425 Penn Ave
Suite 401
Pittsburgh, PA 15206
CS5.2
Telephone Number of Primary Research Coordinator:
412-624-6207
CS6.0
Name of Secondary Research Coordinator:
CS6.1
Address of Secondary Research Coordinator: 
 
CS6.2
Telephone Number of Secondary Research Coordinator:
 
CS6.3
Key Personnel/Support Staff (Only list those individuals who require access to
OSIRIS): 
Last
First
Organization
There are no items to display
     [reviewer notes¬] 
CS7.0
Will this research study use any Clinical and Translational Research Center (CTRC)
resources?
No

  
     [reviewer notes¬] 
CS8.0
Select the entity responsible for scientific review.
 
External Scientific Review Completed – The scientific merit of this research
protocol has been confirmed by an external scientific review committee as a condition of
funding. 
 
  
     [reviewer notes¬] 
CS9.0
Does this research study involve the administration of an investigational drug or
an FDA-approved drug that will be used for research purposes?
* No  
CS10.0
Is this research study being conducted under a University of Pittsburgh-based,
sponsor-investigator IND or IDE application?
 
*  No 
If YES, you are required to submit the IND or IDE application and all subsequent FDA
correspondence through the Office for Investigator-Sponsored IND and IDE Support
(O3IS).  Refer to applicable University policies posted on the O3IS website
 (www.O3IS.pitt.edu).
  
     [reviewer notes¬] 
CS11.0
Use the 'Add' button to upload one or more of the following:
the sponsor protocol (including investigator initiated studies) and/or
other brochures
the multi-center protocol and consent form template, if applicable
Name Modified Date
Is this research study supported in whole or in part by industry?  This includes the
provision of products (drugs or devices).  
 
*  No
Is this a multi-centered study?
*  No
 
 
     [reviewer notes¬] 
CS12.0
Does your research protocol involve the evaluation or use of procedures that emit
ionizing radiation?

*  No 
CS13.0
Does this research study involve the deliberate transfer of recombinant or
synthetic nucleic acid molecules into human subjects?
 
*  No
Upload Appendix M of NIH Guidelines:
Name
Modified Date
 
CS14.0
Are you using UPMC facilities and/or UPMC patients during the conduct of your
research study?
 
*  No 
If Yes, upload completed Research Fiscal Review Form:
Name
Modified Date
  
     [reviewer notes¬] 
CS15.0
Indicate the sites where research activities will be performed
and/or private information will be obtained.
Choose all sites that apply and/or use Other to include sites not listed:
Sites:
University of Pittsburgh
 
University of Pittsburgh
Campus:
Main Campus - Pittsburgh
List university owned off-campus research sites if applicable:
Bakery Square
 
 
If you selected School, International or Other, list the sites:
 
*For research being conducted at non Pitt or UPMC sites, upload a
site permission letter granting the researcher permission to
conduct their research at each external site:
Name Modified Date
 
CS15.1
Have you, Jonathan Pearlman , verified that all members of the
 

research team have the appropriate expertise, credentials, and if
applicable, hospital privileges to perform those research
procedures that are their responsibility as outlined in the IRB
protocol?
*  Yes
CS15.2
Describe the availability of resources and the adequacy of the
facilities to conduct this study:
*  Our facilities at the Human Engineering Research Laboratories has all of
the capabilities needed to conduct this study. We have the equipment
needed to conduct the baseline and final measurements (scale, body-fat
monitor, and tape measure). We have a locked file room and protected
servers for consent and other confidential information. There is a private
room for conducting screening and consent procedures. The study has
been fully funded by a grant from the Paralyzed Veterans of America
foundation.
 
  
     [reviewer notes¬] 
CS16.0
Special Research Subject Populations: 
Categories
None
     [reviewer notes¬] 
CS17.0
Does your research involve the experimental use of any type of human stem cell?
*  No
 
     [reviewer notes¬] 
 
NIH Definition of a Clinical Trial
A research study1 in which one or more human subjects2 are prospectively
assigned3 to one or more interventions4 (which may include placebo or other
control) to evaluate the effects of those interventions on health related biomedical
or behavioral outcomes.5
1 See Common Rule definition of research at 45 CFR 46.102(d) .
2 See Common Rule definition of human subject at 45 CFR 46.102(f) .
3 The term “prospectively assigned” refers to a pre-defined process (e.g.,
randomization) specified in an approved protocol that stipulates the assignment of
research subjects (individually or in clusters) to one or more arms (e.g., intervention,
placebo, or other control) of a clinical trial.
4 An intervention is defined as a manipulation of the subject or subject’s environment
for the purpose of modifying one or more health-related biomedical or behavioral
processes and/or endpoints.  Examples include:  drugs/small molecules/compounds;
biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g.,

telemedicine, face-to-face interviews); strategies to change health-related behavior
(e.g., diet, cognitive therapy, exercise, development of new habits); treatment
strategies; prevention strategies; and, diagnostic strategies.
5 Health-related biomedical or behavioral outcome is defined as the pre-specified
goal(s) or condition(s) that reflect the effect of one or more interventions on human
subjects’ biomedical or behavioral status or quality of life.  Examples include:  positive
or negative changes to physiological or biological parameters (e.g., improvement of
lung capacity, gene expression); positive or negative changes to psychological or
neurodevelopmental parameters (e.g., mood management intervention for smokers;
reading comprehension and /or information retention); positive or negative changes
to disease processes; positive or negative changes to health-related behaviors; and,
positive or negative changes to quality of life.
CS18.0
* Based on the above information, does this study meet the NIH definition of a
clinical trial?
  
Yes 
No 
 
 
If Yes, click Save and then Click Here For Study Team's CITI Training Records .  Please
ensure all personnel's training is up to date

Section: Section 1 - Objective, Aims, Background and Significance
     [reviewer notes¬] 
1.1
Objective: What is the overall purpose of this research study?  (Limit response to 1-
2 sentences.)
To determine the usefulness, feasibility and efficacy of the E-scale system coupled with a
standardized behavioral treatment weight-loss intervention for overweight or obese
wheelchair users. 
 
 
1.2
Specific Aims: List the goals of the proposed study (e.g., describe the relevant
hypotheses or the specific problems or issues that will be addressed by the
study).
Aim 1. To investigate the usefulness and feasibility of the E-scale system and efficacy of the
E-scale coupled with a weight-loss intervention to assist overweight or obese wheelchair
users with losing weight. 
Hypothesis 1a: The E-scale will be useful based on self-reported feedback from wheelchair
users by more than 50% stating that the E-scale is easy to use, their preferred weight
monitoring system, them feeling that they would use the E-scale if it was available for them
to purchase.
Hypothesis 2b: The E-scale will be feasible by providing accurate (+/- 2 lbs. from a
calibrated scale measurement) and repeatable (<3lbs difference from day-to-day) weight
measurements and by the wheelchair users continuing to use the scale more than 70% of
the days of the study.
Hypothesis 2c: The E-scale coupled with the weight loss intervention will demonstrate
efficacy by wheelchair users having significant improvements in weight, abdominal girth,
body fat percentage and score on the Self-Rated Abilities for Health Practices Scale
(SRAHP).
 
1.3
Background: Briefly describe previous findings or observations that provide the
background leading to this proposal. 
Wheelchair users have about twice the prevalence of obesity than the general population.
There is also very little or no technology to which they have access to measure their weight
frequently in their homes. Research however, has shown that monitoring your body weight
frequently (i.e. daily) yields significantly better weight loss and weight maintenance results.
This research has never included wheelchair users because they have not had access to
technology to be able to measure their weight daily. The E-scale was developed as a weight
monitoring technology for wheelchair users and has been tested for precision and accuracy
in the laboratory. 
 
 
1.4
Significance: Why is it important that this research be conducted? What gaps in
existing information or knowledge is this research intended to fill? 
This research will tell whether wheelchair users find the E-scale to be useful and feasible as
a way to monitor their weight in their homes. It will also show whether wheelchair users,
like the general population, have better weight loss outcomes if they monitor their weight
daily. This could lead to refinement of the E-scale and a push for more available technology
for wheelchair users to monitor their weight at home which could in turn lead to a decrease
in the prevalence of obesity among wheelchair users.
  

Section: Section 2 - Research Design and Methods
     [reviewer notes¬] 
2.1
Does this research study involve the use or evaluation of a drug, biological, or
nutritional (e.g., herbal or dietary) supplement?
*  No
  
     [reviewer notes¬] 
2.2
Will this research use or evaluate the safety and/or effectiveness of one or
more devices?
 
*  Yes 
 
2.2.1
Does this research study involve an evaluation of the safety and/or effectiveness
of one or more devices not currently approved by the FDA for general marketing?
* Yes
 
If YES, describe your plan to prevent unauthorized use of the investigational device:
The E-scale is a non-invasive device which measures the weight of each of the four legs of a
bed. As such there would be no benefit or harm from unauthorized use.
2.2.1.1
List each of the unapproved devices being evaluated in this research study.  
Specify for each listed device the corresponding Investigational Device Exemption (IDE)
number or provide a justification for why you feel that this device and its use, as proposed
in this research study constitute a non-significant risk (i.e., to include potential failure of the
device) to the research subjects:
 
Unapproved
device
IDE
#
Non-significant risk justification
View E-scale
 
The E-scale is a set of weight sensors for each leg of a bed. This
device does not have potential for serious risk to the health, safety, or
welfare of a subject since (1) The device is not an implant; (2) The
device is not used in supporting or sustaining human life; or (3) The
device is not of substantial importance in diagnosing, curing,
mitigating, or treating disease, or otherwise preventing impairment of
human health. It has also been used in the home without any adverse
events in IRB # PRO14080007
 
  
     [reviewer notes¬] 
2.2.2
Does this research study involve the use or evaluation of the safety and/or
effectiveness of one or more devices approved by the FDA for general marketing?
*  No
 
  
     [reviewer notes¬] 

2.3
Summarize the general classification (e.g., descriptive, experimental) and
methodological design (e.g., observational, cross-sectional, longitudinal,
randomized, open-label single-blind, double-blind, placebo-controlled, active
treatment controlled, parallel arm, cross-over arm) of the proposed research
study, as applicable.
This study will be experimental. It will be a 13 week longitudinal efficacy study.
2.3.1
Does this research study involve a placebo-controlled arm?
*  No
     [reviewer notes¬] 
2.4
Will any research subjects be withdrawn from known effective therapy for the
purpose of participating in this research study?
*  No 
 
  
     [reviewer notes¬] 
2.5
Will screening procedures (i.e., procedures to determine research subject
eligibility) be performed specifically for the purpose of this research study?
*  Yes
2.5.1
List the screening procedures that will be performed for the purpose of this
research study.  Do NOT include the inclusion/exclusion criteria in this section as
they will be addressed in section 3; questions 3.13 and 3.14.
A self-report questionnaire will be administered when the person first contacts us and prior
to informed consent, this includes most of the screening for inclusion and exclusion criteria.
When the person comes into the laboratory, and after consent, weight and height
measurements will be taken, and the Center for Epidemiologic Studies Depression Scale
(CES-D) and the Eating Disorder Diagnosis Scale (EDDS) will be administered. We will also
ask as part of our first contact that the potential subjects obtain a doctor's note approving
their participation in the study and record their diet for 3 days. The note and food record can
be provided anytime up until they start the intervention. If they do not complete these two
tasks they will be excluded.
  
     [reviewer notes¬] 
 
2.6
Provide a detailed description of all research activities (e.g., all drugs or devices;
psychosocial interventions or measures) that will be performed for the purpose of
this research study. 
This description of activities should be complete and of sufficient detail to permit
an assessment of associated risks.  
 

At a minimum the description should include:
all research activities
personnel (by role) performing the procedures
location of procedures
duration of procedures
timeline of study procedures
Potential subjects will be screened over the phone or in person with a list of questions that
may exclude them from the study. If it is determined that they are likely to be eligible, they
will be asked to contact their doctor for a letter approving their participation in a weight loss
program and scheduled to come to the lab where they will be consented into the study.
They will also be asked to record their diet for 3 days to determine if they are willing to
comply with this key component of the study. When they come into the lab, informed
consent will be performed first. After the consent process is complete, subjects will be given
the Center for Epidemiologic Studies Depression Scale (CES-D) and the Eating Disorder
Diagnosis Scale (EDDS) to determine if they would be considered to have a current eating
disorder or are currently depressed. Next the subject’s weight and height will be measured
in the lab by having the subjects drive onto a calibrated roll-on scale to get the weight of
their chair with them in it. Then they will transfer out of their wheelchair (with assistance of
the research team or trained member of our lab if requested) onto a mat table where they
will be asked to lay flat on their back so that their height can be measured with a tape
measure. While they are on the mat table, a member of the research team will take their
chair back to the roll-on scale to weigh the chair. The subject’s weight will be determined by
subtracting the weight of the chair from the weight of the subject in the chair. The subject’s
Body Mass Index (BMI) will then be calculated. They will then transfer (or be assisted) back
to their chair.
After the subjects’ have been determined to be eligible, they will have their abdominal girth
measured with a tape measure and their body-fat percentage will be measured with a
hand-held BIA inductance measuring tool. They will also be given a demographics
questionnaire and the Self-Rated Abilities for Health Practices questionnaire to answer. The
LoseIt! (diet and activity journal) and E-scale apps will be installed on their phones/android
devices or they will be provided with an android device with the apps already installed to
use during the study. De-identified login and passwords will be provided to the subjects to
use during all of the study procedures so no identifiable data will ever be collected by these
apps. Some training on use of the E-scale and LoseIt! apps will be provided to the subjects
as well as the first lesson of the 13-week curriculum. Over the next few days, the study
team will go to all of the subject’s homes to install the E-scale under their beds. 
During the next 12 weeks, subjects will be asked to weigh themselves every day with the E-
scale app and record their diet, exercise and weight every day with the LoseIt! app. The
data that is reported in the LoseIt! app by the subjects will be monitored by the study team
using the ascendapp for LoseIt!, which allows a “coach” to monitor all of the data submitted
by a client. The weight loss curriculum involves weekly lessons for the participants to learn
and practice things like counting calories and fat, reorganizing their kitchens, doing more
cardio work around the house, etc. This curriculum was adapted from the Diabetes
Prevention Program Group Lifestyle Balance (DPP GLB) curriculum at Pitt specifically for
people with mobility impairments. The study team will send periodic emails with comments
to the participants encouraging their progress and adherence to the protocol and lesson
materials for that week. Every week at a pre-defined time, a group chat room will be
conducted with all of the subject’s and the research team invited to attend to go over the
lesson for that week and to have a group discussion for the participants to share successes
and difficulties with the group. The chat room will be hosted using Adobe Connect with the
audio and video capabilities disabled. The link to the chat room for each week will be
emailed to the subjects along with the lesson materials. The curriculum disbursement,
progress emails, and chat rooms will be led by a dietitian/nutritionist with experience in
leading group weight loss programs.
During the last week of the study (week 13). The subjects will be asked to come back to the
lab in-person where their weight will again be measured using the roll-on scale. Their

abdominal girth and body-fat percentage will also be measured again. The SRAHP will be
administered to the subjects again and they will also be given the final questionnaire,
System Usability Scale (SUS), which will evaluate how they felt about the E-scale and some
aspects of entire study. Any android devices that were loaned to the subjects during the
study will be collected and the apps on their personal devices will be deleted if they wish.
Over the next few days, the study team will visit all of the subject’s homes to remove the E-
scales or the participants can bring them with them to the lab.
If a participant indicates during the study that the E-scale they are using is malfunctioning,
an investigator may talk to the participant on the phone and/or schedule a time to travel to
the subjects home to troubleshoot and/or replace the E-scale with one that is working
properly. 
2.6.1
Will blood samples be obtained as part of this research study?
*  No 
*If submitting a protocol for expedited review, it should be clear that the planned blood
draws are within the parameters described here:
http://www.hhs.gov/ohrp/policy/expedited98.html  (see Expedited Research Category #2)
If Yes, address the frequency, volume per withdrawal, the total volume per visit, and the
qualifications of the individual performing the procedure:
 
 
Study Flow Chart:
Name
Modified Date
Flowchart
4/17/2017 10:46 AM
     [reviewer notes¬] 
2.7
Will follow-up procedures be performed specifically for research purposes? 
Follow-up procedures may include phone calls, interviews, biomedical tests or
other monitoring procedures.
*  No
  
     [reviewer notes¬] 
2.8
Does this research study involve the use of any questionnaires, interview or
survey instruments?
*  Yes
 
 
Upload a copy of all materials except for the SCID or KSADS which are on file at
the IRB.  The use of all instruments must be addressed in question 2.6 and/or
question 2.7 (except for an exempt submission where they should be addressed
on the appropriate uploaded exempt form).

Name
Modified Date
EDDS
6/24/2017 2:48 PM
Screening tool
7/17/2017 4:35 PM
Final Survey
1/29/2018 9:45 AM
CES-D
6/24/2017 2:47 PM
Demographics
6/24/2017 2:50 PM
SRAHP
6/24/2017 2:50 PM
Previously the name and publisher for commercially available materials
were listed in the textbox below but effective 9/1/2015, all materials (except for
the SCID and KSADS) must be uploaded using the Add button above.
     [reviewer notes¬] 
2.9
If subjects are also patients, will any clinical procedures that are being used for
their conventional medical care also be used for research purposes?
*  n/a
 
If Yes, describe the clinical procedures (and, if applicable, their frequency) that will be
used for research purposes: 
2.10
The blood sample question was moved to 2.6.1.
     [reviewer notes¬] 
2.11
What is the total duration of the subject's participation in this research study
across all visits, including follow-up surveillance?
*  13 weeks
     [reviewer notes¬] 
 
2.12
Does this research study involve any type of planned deception? 
If Yes, you are required to request an alteration of the informed consent process (question
4.7)
*  No
  
     [reviewer notes¬] 
 
2.13
Does this research study involve the use of UPMC/Pitt protected health
information that will be de-identified by an IRB approved "honest broker" system?
 
*  No
  
     [reviewer notes¬] 
 

 
2.14
Will protected health information from a UPMC/Pitt HIPAA covered entity be
accessed for research purposes or will research data be placed in the UPMC/Pitt
medical record?
*  No
 
2.14.1
Will protected health information from a non-UPMC/Pitt HIPAA covered entity be
obtained for research purposes or will research data be placed in the non-
UPMC/Pitt medical record?  
*  No
  
     [reviewer notes¬] 
2.15
Does this research study involve the long-term storage (banking) of biological
specimens? 
 
*  No
  
     [reviewer notes¬] 
2.16
Will research participants be asked to provide information about their family
members or acquaintances?
*  No
  
     [reviewer notes¬] 
2.17
What are the main outcome variables that will be evaluated in this study?
Subjective feedback from the survey about the usefulness and participants' satisfaction with
portions of the program and E-scale.
Accuracy and repeatability of the E-scale measurements
Weight change, abdominal girth change, body-fat percentage change and Self-Rated Abilities
for Health Practices (SRAHP) change 
 
2.18
Describe the statistical approaches that will be used to analyze the study data.
*  Addressed below:
Since there is only one group, most outcome variables will be analyzed using summary
statistics. Baseline and final measurements will also be analyzed using paired t-tests.
     [reviewer notes¬] 
2.19
Will this research be conducted in (a) a foreign country and/or (b) at a site (e.g.,
Navajo Nation) where the cultural background of the subject population differs
 

substantially from that of Pittsburgh and its surrounding communities?
*  No
Note that copies of training records, licenses, certificates should be maintained in the
study regulatory binder and are subject to audit by the Research Conduct and Compliance
Office (RCCO).
In addition, individuals planning to conduct human subject research outside the United
States must complete an optional module on the CITI training website: International
Studies.  Click here to access the instruction sheet for accessing optional CITI modules.
 
  
     [reviewer notes¬] 
2.21
Will this research study be conducted within a nursing home located in
Pennsylvania?
*  No 
 
  

Section: Section 3 - Human Subjects
     [reviewer notes¬] 
Section 3 - Human Subjects
3.1
What is the age range of the subject population?
18-80 
 
3.2
What is their gender?
*  Both males and females 
 Provide a justification if single gender selected:
3.3
Will any racial or ethnic subgroups be explicitly excluded from participation?
*  No  
If Yes, identify subgroups and provide a justification: 
 
3.4
For studies conducted in the U.S., do you expect that all subjects will be able to
comprehend English?
*  Yes 
  
     [reviewer notes¬] 
3.5
Participation of Children: Will children less than 18 years of age be studied?
*  No
 
If No, provide a justification for excluding children: 
Since we are investigating weight changes or weight loss, we do not want to include
children who may be growing.
  
     [reviewer notes¬] 
3.6
Does this research study involve prisoners, or is it anticipated that the research
study may involve prisoners?
*  No
 
  
     [reviewer notes¬] 
3.7
Will pregnant women be knowingly and purposely included in this research study?
*  No
  
     [reviewer notes¬] 

3.8
Does this research study involve neonates of uncertain viability or nonviable
neonates?
*  No
 
  
     [reviewer notes¬] 
3.9
Fetal Tissues: Does this research involve the use of fetal tissues or organs?
*  No
  
     [reviewer notes¬] 
--->
3.10
What is the total number of subjects to be studied at this site, including subjects
to be screened for eligibility?
Note: The number below is calculated by summing the data entered in question 3.11. Any
additions or changes to the values entered in 3.11 will be reflected in 3.10.
*  20
 
3.11
Identify each of the disease or condition specific subgroups (include healthy
volunteers, if applicable) that will be studied.  
Click on the "Add" button and specify for each subgroup:
1) how many subjects will undergo research related procedures at this site; and
2) if applicable, how many subjects will be required to undergo screening
procedures (e.g., blood work, EKG, x-rays, etc.) to establish eligibility.  Do Not
include subjects who will undergo preliminary telephone screening.
* 
 
Subgroup Number to undergo research
procedures
Number to undergo screening
procedures
View All
subjects
15
20
 
 
 
3.12
Provide a statistical justification for the total number of subjects to be enrolled
into this research study at the multicenter sites or this site.
*  Described below: 
 
Since this is an efficacy and exploratory study no sample size calculation was needed or
conducted. Similar weight loss studies include 10-20 people in each group session or
cohort.
 
     [reviewer notes¬] 

3.13
Inclusion Criteria: List the specific criteria for inclusion of potential subjects.
• Use Wheelchair as primary means of mobility
• Uses a bed with 4 legs
• BMI ≥27 and ≤40.0 
• age 18-80
• Has daily access to Internet to access LoseIt website and/or app and weekly chat meeting
(Adobe Connect)
• Currently owns or willing to use an android device
• Provides physician’s clearance to participate in a weight loss intervention
• Speaks English
 
3.14
Exclusion Criteria: List the specific criteria for exclusion of potential subjects from
participation.
• Presence of an unstable condition requiring physician-supervised diet and exercise (e.g.,
diabetes, recent myocardial infarction)
• Presence of condition precluding engagement in exercise at moderate intensity (e.g.,
asthma, congestive heart failure, etc.)
• Pregnancy or intention to become pregnant during study
• Currently being treated for any psychological issues or problems, taking any psychotropic
medications, or receiving treatment with psychotropic medications within the previous 6
months
• Reported alcohol intake > 4 drinks/day
• Reported participation in a formal weight loss program, loss of ≥5% weight in the past 6
months, or current use of weight loss medication.
• History of bariatric surgery (lap-band, gastric bypass, etc.)
• Planned extended vacations, absences, or relocation during study
• A score ≥20 on the Center for Epidemiologic Studies Depression Scale (CES-D)
• A classification of Anorexia Nervosa, Bulimia Nervosa or Binge Eating Disorder on the
Eating Disorder Diagnosis Scale (EDDS)
• Unwilling to provide a diary of 3 days diet prior to beginning the intervention
3.15
Will HIV serostatus be evaluated specifically for the purpose of participation in
this research study?
*  No 
If Yes, provide a justification:
 

Section: Section 4 - Recruitment and Informed Consent Procedures
     [reviewer notes¬] 
4.1
Select all recruitment methods to be used to identify potential subjects:
Advertisements
Research Registry
Pitt + Me
Other Strategies: Described below
 
Advertisements  
Upload the advertisements for review:
Name
Modified Date
PRO16110460 Pearlman.pdf 10/10/2017 10:29 AM
Flyer
4/18/2017 3:45 PM
 
 
 
 
Research Registry
List the IRB approval number and title for each registry source:
Human Engineering Research Laboratories (Pitt IRB #PRO12080311) 
Department of Physical Medicine and Rehabilitation (Pitt IRB #PRO12030122)
 
4.2
Provide a detailed description of your recruitment methods, including identifying
and initiating contact with participants:  
We will distribute and post flyers at locations where wheelchair users meet (i.e., doctors
offices, support groups, adaptive sporting events, etc.). We will also send flyers to
wheelchair users in two wheelchair research registries and through the CTSI registry. We
will also utilize social media to spread the word about the study and the Pitt+me registry.
This would include posts with our flyer, a link to the Pitt+me study page, etc.
  
Note: Questions jump from 4.2 to 4.6 as questions 4.3-4.5 have been removed and the information is now
captured in 4.1
     [reviewer notes¬] 
4.6
Are you requesting a waiver to document informed consent for any or all
participants, for any or all procedures? (e.g., a verbal or computerized consent
script will be used, but the subjects will not be required to sign a written informed

consent document.  This is not a waiver to obtain consent.
*  Yes
4.6.1
Identify the specific research procedures and/or the specific subject populations
for which you are requesting a waiver of the requirement to obtain a signed
consent form.
Addressed below:
If not all, identify the specific procedures and/or subject populations for which you are
requesting a waiver: 
The only activities that will be conducted before obtaining written consent is a phone or in-
person screening to determine that the potential participant meets most of the eligibility
criteria prior to having them travel to our lab.
4.6.2
Indicate which of the following regulatory criteria is applicable to your request for
a waiver of the requirement to obtain a signed consent form.
  45 CFR 46.117(c)(2)
45 CFR 46.117(c)(1) That the only record linking the subject and the research would be
the consent document and the principal risk would be potential harm resulting from a
breach of confidentiality. Each subject will be asked whether the subject wants
documentation linking the subject with the research, and the subject's wishes will govern;
or
45 CFR 46.117(c)(2) That the research presents no more than minimal risk of harm to
subjects and involves no procedures for which written consent is normally required outside
of the research context.
4.6.2.1
Address why the specific research procedures for which you are requesting a
waiver of the requirement to obtain a signed consent form present no more than
minimal risk of harm to the research subjects:
We will go through a series of questions over the phone that determine if a person meets
some of the criteria. The least personal and invasive questions that are similar to everyday
conversations will be asked, followed by questions similar to those asked when making a
clinical appointment. Questions will be discontinued and no information will be maintained if
the person is ineligible for any criteria.
4.6.2.2
Justify why the research listed in 4.6.1 involves no procedures for which written
informed consent is normally required outside of the research context:
The screening will only involve questions that occur during normal conversation and making
a clinical appointment, and no identifiable information will be recording with the screening
unless they complete the screening and are willing to participate.
4.6.3
Address the procedures that will be used and the information that will be provided
(i.e., script) in obtaining and documenting the subjects' verbal informed consent
for study participation:
When a potential subject responds to the ads, a member of the research team will go
through the attached phone or in person screening script. The participant will be asked if it

is okay that we go through a series of questions to determine if they are eligible for the
study, and instructed that they may discontinue and choose not to answer at any time. As
soon as an answer to a screening question makes them ineligible, no information about
them will be saved and the screening discontinued. If they meet the screening eligibility
requirements, they will be invited to come to the lab and their screening answers will be
kept on the secured server in our department.
Upload Scripts:
Name
Modified Date
Screening.docx 6/24/2017 3:07 PM
  
     [reviewer notes¬] 
4.7
Are you requesting a waiver to obtain informed consent or an alteration of the
informed consent process for any of the following? 
 
* No
 
4.7.1
If Yes, select the reason(s) for your request:
There are no items to display
General Requirements: The Federal Policy [45 CFR 46.116 (d)] specifies in order for a
waiver of consent to be approved, the request must meet four criteria. For each request,
you will be asked to provide a justification addressing how each of these criterion is met.
 
 
 
 
 
 
  
     [reviewer notes¬] 
4.8
Are you requesting an exception to the requirement to obtain informed consent
for research involving the evaluation of an 'emergency' procedure?
Note: This exception allows research on life-threatening conditions for which available
 

treatments are unproven or unsatisfactory and where it is not possible to obtain informed
consent.
*  No
     [reviewer notes¬] 
 
4.9
Upload all consent documents for watermarking:
Draft Consent Forms for editing:
Name Modified Date
ICF
10/19/2017 3:33 PM
Approved Consent Form(s):
Name Modified Date
ICF
12/13/2017 11:35 AM
 
     
     [reviewer notes¬] 
4.10
Will all potential adult subjects be capable of providing direct consent for study
participation? 
* 
Yes 
 
  
     [reviewer notes¬] 
4.11
At what point will you obtain the informed consent of potential research subjects
or their authorized representative?
After performing certain of the screening procedures, but prior to performing any of the
research interventions/interactions 
 
4.11.1
Address why you feel that it is acceptable to defer obtaining written informed
consent until after the screening procedures have been performed.
The questionnaire portion of the screening procedures will be done over the phone or in
person prior to the subject coming to the lab so that the subjects will not have to make a
trip to the lab location if they will not be eligible. Once the subject is at the lab in person,
informed consent will be obtained before their weight and height are measured and they are
asked to complete the Center for Epidemiologic Studies Depression Scale (CES-D) and the
Eating Disorder Diagnosis Scale (EDDS).
4.11.2
Taking into account the nature of the study and subject population, indicate how
the research team will ensure that subjects have sufficient time to decide whether
to participate in this study.  In addition, describe the steps that will be taken to

minimize the possibility of coercion or undue influence.
The study will be described to the potential subjects over the phone or in person prior to
them coming to the lab. Once they come to the lab, informed consent will be obtained where
they will be given time to decide if they want to proceed with the study.
  
     [reviewer notes¬] 
4.12
Describe the process that you will employ to ensure the subjects are fully
informed about this research study. 
*  Addressed below: 
This description must include the following elements:
who from the research team will be involved in the consent process (both
the discussion and documentation);
person who will provide consent or permission; 
information communicated; and
any waiting period between informing the prospective participant about the study
and obtaining consent
In addition, address the following if applicable based on your subject population:
process for child assent and parental permission
continued participation if a child subject turns 18 during participation
process for obtaining proxy consent and assent for decisionally impaired subjects
continued participation if subject regains capacity to consent
All members of the research team will be involved with discussing and obtaining informed
consent at the beginning of the subject's initial visit. The information about the study will be
described during the screening and again when the potential subject comes into the lab,
and all questions answered. This will give the subjects adequate time to decide to
participate or not. The subjects will provide their own consent. 
 
4.13
Are you requesting an exception to either IRB policy related to the informed
consent process?
For studies involving a drug, device or surgical procedures, a licensed physician who
is a listed investigator is required to obtain the written informed consent unless an
exception to this policy has been approved by the IRB 
For all other studies, a listed investigator is required to obtain consent (Note: In
order to request an exception to this policy, the study must be minimal risk)
*  No
If Yes, provide a justification and describe the qualifications of the individual who will
obtain consent:
 
 
4.14
Will you inform research subjects about the outcome of this research study
following its completion?
*  No 
 
If Yes, describe the process to inform subjects of the results:

Section: Section 5 - Potential Risks and Benefits
     [reviewer notes¬] 
5.1
Describe potential risks (physical, psychological, social, legal, economic or
other) associated with screening procedures, research interventions/interactions,
and follow-up/monitoring procedures performed specifically for this study: 
* 
View
Research Activity:
Consent, measurements and questionnaires 
Common Risks:
No Value Entered 
Infrequent Risks:
breach of privacy and confidentiality 
Other Risks:
No Value Entered 
View
Research Activity:
Installation and removal of escale 
Common Risks:
No Value Entered 
Infrequent Risks:
damage to bed or surrounding areas 
Other Risks:
No Value Entered 
View
Research Activity:
Transfers for weighing 
Common Risks:
No Value Entered 
Infrequent Risks:
Falling during transfers 
Other Risks:
No Value Entered 
View
Research Activity:
Using apps and adobe connect 
Common Risks:
No Value Entered 
Infrequent Risks:
breach of privacy and confidentiality 
Other Risks:
No Value Entered 
View
Research Activity:
Using E-scale 
Common Risks:
No Value Entered 
Infrequent Risks:
Breach of privacy with motion being detected. Height of the bed is
increased by approximately 1/2 inch which could make transfers
more difficult. 
Other Risks:
No Value Entered 
 
 
5.1.1
Describe the steps that will be taken to prevent or to minimize the severity of the
potential risks:
 
Consent, measurements and questionnaires: During all activities of consent, measurements
and questionnaires we will provide the subjects will a private location to answer the
questions. Subject codes will be used on all data collection forms. All identifiable
information will be stored in a locked file room separate from the research data. The only
linkage code will be stored on a password protected department server.
Installation and removal of E-scale: The study team will visit the participants' homes to
install and remove the E-scale. It is possible that during this time, damage could be caused
 

to the participant's bed or surrounding areas. The investigator is liable for any damage that
occur as a result of participation in the study and damage will be reimbursed accordingly.
During the first visit, the investigator will assess the condition of the bed and items placed
near the bedside. After such verification, it is to the discretion of the investigator if he
wishes to continue with installation of E-Scale or disqualify the participant due to concerns
with the bed. IRB # PRO14080007 is a past study using these scales with no adverse
events. 
Use of E-scale: During the use of the E-scale, the bed height will be raised by approximately
1/2 in when the sensors are under the bed legs. This may make transfers to and from bed
more difficult for the wheelchair users. We will describe this risk during the consent process
so they are aware and can withdraw from the study if they feel it will be an issue. The E-
scale also collects the weight from the bed legs continuously and as such changes in weight
distribution may make it possible to detect when the person is in or out of bed and if they
are moving. We will also make the participants aware of this risk during the consent
process.
Transfers for weighing: During the process of measuring the participant's height and weight,
we will have them transfer to a mat table independently or with assistance. During the
transfers, we will have a spotter for all transfers and will provide someone who has been
trained to assist with transfers help if needed.
Using apps and adobe connect: During the study we will have the participants using the
LoseIt! app, the E-scale app and adobe connect. LoseIt! and E-scale apps will be installed
on their android device or one will be provided to them to use during the study. Non-
personal logins for these devices will be provided to them so that no identifiable information
is ever communicated with these apps. Adobe connect will be used to conduct weekly chat
sessions with no audio or video being used. We will email the participants a link to join the
chat room and ask them to join using their first names only. 
5.2
What steps will be taken in the event that a clinically significant, unexpected
disease or condition is identified during the conduct of the study?
*  Not Applicable
5.3
All the risk questions (screening, intervention/interaction, follow-up) have been merged into
one question (5.1).
     [reviewer notes¬] 
5.4
Do any of the research procedures pose a physical or clinically significant
psychological risk to women who are or may be pregnant or to a fetus?
* No
  
     [reviewer notes¬] 
5.5
Do any of the research procedures pose a potential risk of causing genetic
mutations that could lead to birth defects?
*  No
  
     [reviewer notes¬] 
5.6
Are there any alternative procedures or courses of treatment which may be of
 

benefit to the subject if they choose not to participate in this study?
*  No
If Yes, describe in detail:
 
     [reviewer notes¬] 
5.7
Describe the specific endpoints (e.g., adverse reactions/events, failure to
demonstrate effectiveness, disease progression) or other circumstances
(e.g., subject's failure to follow study procedures) that will result in discontinuing
a subject’s participation?
*  Describe below:
If the subject is admitted to the hospital for more than 5 days we will remove them from the
study. Also if the subject has not participated in any study procedures for 2 weeks they will
be removed from the study. 
 
     [reviewer notes¬] 
5.8
Will any individuals other than the investigators/research staff involved in the
conduct of this research study and authorized representatives of the University
Research Conduct and Compliance Office (RCCO) be permitted access to research
data/documents (including medical record information) associated with the
conduct of this research study?
*  Yes
  
5.8.1
Identify the 'external' persons or entity who may have access to research
data/documents and the purpose of this access:
The sponsoring agency (The Paralyzed Veterans of America) may access the research data
and documents.
5.8.2
Will these 'external' persons or entity have access to identifiable research
data/documents?
*
No; the research data/documents will be coded and subject identifiers removed prior to
access by the external persons
If Yes, describe how they will protect the confidentiality of the research data:
5.9
Has or will a Federal Certificate of Confidentiality be obtained for this research
study?
*  No
 
5.10
Question has been moved to 5.17

5.11
Question has been moved to 5.16
  
     [reviewer notes¬] 
5.12
Does participation in this research study offer the potential for direct benefit to
the research subjects?
Yes - Describe the direct benefit that subjects may receive as a result of study participation.
Indicate if all, or only certain, of the subjects may derive this potential benefit. 
 
Describe the benefit:
All subjects may lose weight, which could benefit their overall health 
 
5.13
Describe the data and safety monitoring plan associated with this study. If the
research study involves multiple sites, the plan must address both a local and
central review process.
A data safety and monitoring plan will be implemented to ensure that there are no changes
in the benefit/risk ratio during the study and that confidentiality of research data is
maintained. All investigators, study personnel, and the clinical coordinators involved in the
study will meet quarterly to discuss the study (e.g., study goals, progress, modifications,
documentation, recruitment, retention, data analysis, and confidentiality) and address any
issues or concerns at this time. The PI holds weekly lab meeting, in which progress is
reviewed and issues addressed. Any instances of adverse effects will be reported
immediately using the standard forms and/or procedures set forth by the Institutional
Review Board. In addition, clinical coordinators will periodically review study documentation
and/or consent forms to ensure that subject’s confidentiality is maintained. A summary
report of all data and safety monitoring activities will be included in the annual IRB renewal
application.
 
 
     [reviewer notes¬] 
Section 5 - Potential Risks and Benefits of Study Participation
5.14
What precautions will be used to ensure subject privacy is respected? (e.g. the
research intervention will be conducted in a private room; the collection of sensitive
information about subjects is limited to the amount necessary to achieve the aims of the
research, so that no unneeded sensitive information is being collected, drapes or other
barriers will be used for subjects who are required to disrobe)
 
During consent and collection of questionnaires and measurements, the subjects will be
provided a private space. The collection of sensitive information about subjects is limited to
the amount necessary to achieve the aims of the research, so that no unneeded sensitive
information is being collected.
 
5.15
What precautions will be used to maintain the confidentiality of the research data
during collection, transmission and storage? It is important that you indicate the
data security measures for all data types. 
Go to the A-Z Guidance, download the Data Security Assessment Form, complete, and
upload using the Add button below.  Depending on the data type, you may need to consult
with your data manager to address some of the sections.  Email irb@pitt.edu if you have
any questions.
 
 
 
 
 

* Upload Data Security Form:
Name
Modified Date
Data Security Assessment form 10/10/2017 11:04 AM
Address what precautions will be used to maintain the confidentiality of the
research data collected in paper format if applicable: 
Records will be coded by assigning a case number unique to this study. The linkage code
will be stored electronically and not with other paper based files. All electronic data will be
stored on the University of Pittsburgh network. Paper based records will be kept in a locked
file room within the Human Engineering Research Laboratories. Access to both the
electronic and paper based files is restricted to the Principal Investigator and the associated
research staff working on the project.
5.15.1
Does your research study require a data security review? Answer Yes if any of the
following conditions are met:
Identifiable or *coded data will be collected, stored, or transmitted using any of the
following technologies: mobile app, web-based site or survey, wearable device, text
messaging, electronic audio, photographic, or video recording or
conferencing and/or
The IRB requested a data security review during their review of the study
*  Yes
*Coded: Identifying information (such as name) that would enable the investigator to
readily ascertain the identity of the individual to whom the private information or
specimens pertain has been replaced with a code (number, letter, symbol, or any
combination) and a key to decipher the code exists, enabling linkage of the identifying
information to the private information or specimens
5.16
If the subject withdraws from the study, describe what, if anything, will happen to
the subject’s research data or biological specimens.
If the subject withdraws from the study, any existing data will be rendered anonymous and
included in results. We will ask the participant to answer the final questionnaire if they are
willing to. Because this is a usefulness, feasibility and efficacy trial, even partial data could
provide us with useful results.    
5.17
Following the required data retention period, describe the procedures utilized to
protect subject confidentiality. (e.g., destruction of research records; removal of
identifiers; destruction of linkage code information; secured long-term retention)
Following the data retention period, the linkage code file will be deleted. Data will be
retained for a longer term using the security measures already outlined in section 5.15.
  

Section: Section 6 - Costs and Payments
     [reviewer notes¬] 
 
6.1
Will research subjects or their insurance providers be charged for any of the
procedures (e.g., screening procedures, research procedures, follow-up
procedures) performed for the purpose of this research study?
*  
No 
  
     [reviewer notes¬] 
6.2
Will subjects be compensated in any way for their participation in this research
study?
*  Yes
6.2.1
Describe the amount of payment or other remuneration offered for
complete participation in this research study.
200 dollars
6.2.2
Describe the amount and term of payment or other remuneration that will be
provided for partial completion of this research study.
20 dollars for enrolling (passing the phone screening and coming to the lab to be
consented) and being determined ineligible or withdrawing after enrolling
75 dollars for participating for 4 weeks
125 dollars for participating 8 weeks
200 dollars for completing all requirements of the study
 
  

Section: Section 7 - Qualifications and Source(s) of Support
     [reviewer notes¬] 
7.1
Summarize the qualifications and expertise of the principal investigator and listed
co-investigators to perform the procedures outlined in this research
study.               
Jon Pearlman, PhD is associate professor in the Department of Rehabilitation Science &
Technology at the University of Pittsburgh.  Dr. Pearlman earned his BS and MS in
mechanical engineering at the UC Berkeley and Cornell University, respectively.  Dr.
Pearlman completed his PhD work Rehabilitation Science and Technology at the University
of Pittsburgh in 2007, with an emphasis on assistive technology design and transfer to
developing countries.  Dr. Pearlman’s research interests are in the areas of participatory
action design, assistive technology transfer methods, and new product development. 
Jonathan Duvall, MS is a graduate student researcher in the Rehabilitation Science and
Technology Department at the University of Pittsburgh. He received a BS in Mechanical
Engineering and an MS in Rehabilitation Science and Technology from the University of
Pittsburgh. This study is a large portion of his dissertation work and he has been approved
by his committee to conduct this work.
Patricia Karg received a BS degree in Mechanical Engineering from Lehigh University, and
an MS degree in Biomedical Engineering from the University of Virginia. She has broad
experience performing clinical research in the area of assistive technology. She performs
clinical and laboratory evaluations of technology, maintains data and regulatory records.  
Beth Casey Gold, MS,RDN,LDN is a Registered Dietitian with extensive experience leading
online behavioral weight management groups. Beth earned her BS in Nutrition at Penn
State and her MS in Nutrition and Food Sciences at the University of Vermont where she
published on the effectiveness of a structured online behavioral weight loss program
compared to a commercially available program.
 
     [reviewer notes¬] 
7.2
Indicate all sources of support for this research study.
* 
Selections
Foundation: Upload a copy of the research plan that was submitted to the agency
 
If Federal support, provide the sponsor information:
 Federal sponsor Grant Title Grant number Awardee institution Federal grant application
 
For projects not supported by a federal grant, upload the research plan that was submitted
for funding:
Name
Modified Date
PVA project narrative 4/20/2017 1:02 PM
If Industry support, provide the sponsor information and level of support:

If Foundation support, provide the sponsor information:
Paralyzed Veterans of America
If Other support, provide the support information and level of support:
     [reviewer notes¬] 
 
7.3
Is this study funded in part or whole by a PHS Agency?
 *  No 
 
Does any investigator* involved in this study (select all that apply):
 
Name
A. Have equity in a publicly-traded entity that either sponsors** this research or
owns the technology being evaluated or developed that exceeds a 5% ownership
interest or a current value of $10,000?
B. Have equity in a non-publicly-traded entity that either sponsors this research or
owns the technology being evaluated or developed?
C. Receive salary, consulting fees, honoraria, royalties or other remuneration from an
entity that either sponsors this research or owns the technology being evaluated or
developed that is expected to exceed $10,000 during the past or next 12 months?
D. Have rights as either the author or inventor of intellectual property being
evaluated or developed in this research that is the subject of an issued patent
or has been optioned or licensed to an entity?
E. Have an officer or management position**** with a Licensed Start-up Company
overseen by the COI Committee that either sponsors this research or owns the
technology being evaluated or developed?
F. Receive compensation of any amount when the value of the compensation would be
affected by the outcome of this research, such as compensation that is explicitly
greater for a favorable outcome than for an unfavorable outcome or compensation in
the form of an equity interest in the entity that either sponsors this research or owns
the technology being evaluated or developed?
None of the above options apply and there are no other financial conflicts of interest in
the conduct of this research.
*Investigator means the PI, co-investigators, and any other member of the study team,
regardless of title, who participates in the design, conduct, or reporting of this research, as
well as his/her spouse, registered domestic partner, dependents, or other members of
his/her household. The PI is responsible for ensuring that s/he and all other
relevant members of the study team review the above questions describing
Significant Financial Interests. 
**through the provision of funds, drugs, devices, or other support for this research
****Such as serving on the Board of Directors or Board of Managers or a position that
carries a fiduciary responsibility to the company (e.g., CEO, CFO, CTO, or CMO).
7.3.1
Provide the name of the investigator(s) and describe the nature of the Significant
Financial Interest(s):
Jonathan Pearlman and Jonathan Duvall both are listed as inventors for the E-scale. A PCT

has been filed by the University of Pittsburgh and the technology has been licensed to a
start-up company called Nexaware. Neither inventors have equity in the company. Neither
Jonathan Pearlman or Jonathan Duvall have received more than $5,000 in royalties.
*
Name
Modified Date
  

Section: Supporting Documentation
     [reviewer notes¬] 
 
Supporting Documentation Section
References and Other Attachments
 
Additional documents:
Name
Modified Date
Version
3-day diary of
diet
6/24/2017
3:29 PM
0.01
Script for
Physician
6/27/2017
4:32 PM
0.02
System Usability
Scale
11/30/2017
4:38 PM
0.01
 
Please use the Add button to the left to upload additional
documents if needed.
     [reviewer notes¬] 
ClinicalTrials.gov is a registry and results database of publicly and privately supported
clinical studies of human participants conducted around the world.
"Applicable clinical trials" are required by federal law to be registered in ClinicalTrials.gov.
Applicable Clinical Trials (ACTs) are studies that meet the following criteria:
The study is an interventional study AND 
The study intervention is a drug, biologic, medical device, radiation or genetic AND
The Study is not Phase 0 or 1 AND
The study has at least one site in the United States or is conducted under an investigational
new drug application or investigational device exemption
NIH Policy
Effective January 18, 2017, revised NIH Policy requires that all clinical trials funded in whole or in
part by the NIH be registered and results information posted on ClinicalTrials.gov. 
As defined by the NIH, a clinical trial is:
A research study in which one or more human subjects are prospectively assigned to one or
more interventions (which may include placebo or other control) to evaluate the effects of
those interventions on health related biomedical or behavioral outcomes.
The NIH Policy extends beyond the Food and Drug Administration Amendment Act (FDAAA 801)
requirements in that it requires registration and results reporting of:
clinical trials of behavioral, surgical and other types of health and medical interventions
phase 1 studies of drugs and biological products
small feasibility studies of device products 
Failure to submit all required registration and results information requested on ClinicalTrials.gov can
jeopardize University grant funding, the future funding of the grantee and subject the University of
Pittsburgh to future monetary penalties.

In addition, to promote transparency of the clinical trials process, the International Committee of
Medical Journal Editors (ICMJE) has established a policy requiring the entry of clinical trials in a
public registry, such as ClinicalTrials.gov, prior to subject enrollment as a condition of consideration
for publication of the trial results.
* Based on the above information, will this study be registered in ClinicalTrials.gov?
Yes 
 
Who will serve as the Responsible Party? UPMC/Pitt Investigator or IND/IDE Pitt Sponsor 
Why are you registering your study? (Check all that apply)
It is strongly encouraged by the NIH
If you are not yet registered and need to establish an account for the PI or other research staff that
may need to access the record, please send an email to the  University of Pittsburgh PRS
administrator at ctgov@pitt.edu with the following information for each individual:
Full name
Telephone number
Pitt or UPMC email address
If you have any questions or concerns, please email us at ctgov@pitt.edu. 
To find out additional information about how to register your study go to:
https://www.clinicaltrials.gov/ct2/manage-recs/how-register