Noom Health for Weight Management
Phase: NA
Conditions: Weight Loss, Obesity
Sponsor: Icahn School of Medicine at Mount Sinai

Noom Health for Weight Management 
PI: Thomas B Hildebrandt, Psy.D. 
NCT04797169
Document Date: 9/1/2022

Noom Health for Weight Management
Protocol Number: STUDY-20-01299M
National Clinical Trial (NCT) Identified Number:  <Number, once assigned by 
CT.gov>
Principal Investigator: Thomas Hildebrandt, PsyD
Sponsor: <Noom, Inc>
Version Number:  v.<5.0>
01 September 2022
10.4
Effective Date: 9/1/2022
End Date:10/18/2022

NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans
CONFIDENTIALITY STATEMENT
This document is confidential communication. Acceptance of this document constitutes agreement by the 
recipient that no unpublished information contained herein will be published or disclosed without prior 
approval of the Principal Investigator or other participating study leadership and as consistent with the 
NIH terms of award. 
Effective Date: 9/1/2022
End Date:10/18/2022

NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans
Table of Contents
STATEMENT OF COMPLIANCE.......................................................................................................................................1
INVESTIGATOR’S SIGNATURE ........................................................................................................................................2
1
PROTOCOL SUMMARY......................................................................................................................................3
1.1
Synopsis..................................................................................................................................................3
1.2
Schema...................................................................................................................................................3
1.3
Schedule of Activities .............................................................................................................................6
2
INTRODUCTION.................................................................................................................................................7
2.1
Study Rationale ......................................................................................................................................7
2.2
Background ............................................................................................................................................7
2.3
Risk/Benefit Assessment........................................................................................................................7
2.3.1
Known Potential Risks ........................................................................................................7
2.3.2
Known Potential Benefits ...................................................................................................8
2.3.3
Assessment of Potential Risks and Benefits .......................................................................8
3
OBJECTIVES AND ENDPOINTS ...........................................................................................................................9
4
STUDY DESIGN ................................................................................................................................................12
4.1
Overall Design ......................................................................................................................................12
4.2
Scientific Rationale for Study Design....................................................................................................13
4.3
Justification for Intervention................................................................................................................13
4.4
End-of-Study Definition........................................................................................................................13
5
STUDY POPULATION .......................................................................................................................................13
5.1
Inclusion Criteria ..................................................................................................................................14
5.2
Exclusion Criteria..................................................................................................................................15
5.3
Lifestyle Considerations .......................................................................................................................16
5.4
Screen Failures .....................................................................................................................................16
5.5
Strategies for Recruitment and Retention ...........................................................................................17
6
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S)..................................................................18
6.1
Study Intervention(s) or Experimental Manipulation(s) Administration..............................................19
6.1.1
Study Intervention or Experimental Manipulation Description .......................................19
6.1.2
Administration and/or Dosing ..........................................................................................19
6.2
Fidelity..................................................................................................................................................19
6.2.1
Interventionist Training and Tracking...............................................................................19
6.3
Measures to Minimize Bias: Randomization and Blinding ...................................................................20
6.4
Study Intervention/Experimental Manipulation Adherence................................................................21
6.5
Concomitant Therapy...........................................................................................................................21
6.5.1
Rescue Therapy ................................................................................................................22
7
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL.............................................................................................................................22
7.1
Discontinuation of Study Intervention/Experimental Manipulation....................................................23
7.2
Participant Discontinuation/Withdrawal from the Study ....................................................................23
7.3
Lost to Follow-Up .................................................................................................................................24
8
STUDY ASSESSMENTS AND PROCEDURES.......................................................................................................25
8.1
Endpoint and Other Non-Safety Assessments .....................................................................................25
8.2
Safety Assessments..............................................................................................................................27
8.3
Adverse Events and Serious Adverse Events........................................................................................28
8.3.1
Definition of Adverse Events ............................................................................................28
8.3.2
Definition of Serious Adverse Events................................................................................29
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NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans
8.3.3
Classification of an Adverse Event....................................................................................29
8.3.4
Time Period and Frequency for Event Assessment and Follow-Up..................................31
8.3.5
Adverse Event Reporting ..................................................................................................33
8.3.6
Serious Adverse Event Reporting .....................................................................................33
8.3.7
Reporting Events to Participants ......................................................................................34
8.3.8
Events of Special Interest .................................................................................................34
8.3.9
Reporting of Pregnancy ....................................................................................................34
8.4
Unanticipated Problems.......................................................................................................................35
8.4.1
Definition of Unanticipated Problems..............................................................................35
8.4.2
Unanticipated Problems Reporting ..................................................................................36
8.4.3
Reporting Unanticipated Problems to Participants..........................................................37
9
STATISTICAL CONSIDERATIONS.......................................................................................................................37
9.1
Statistical Hypotheses ..........................................................................................................................37
9.2
Sample Size Determination..................................................................................................................38
9.3
Populations for Analyses......................................................................................................................39
9.4
Statistical Analyses...............................................................................................................................39
9.4.1
General Approach.............................................................................................................40
9.4.2
Analysis of the Primary Endpoint(s)..................................................................................40
9.4.3
Analysis of the Secondary Endpoint(s) .............................................................................41
9.4.4
Safety Analyses.................................................................................................................42
9.4.5
Baseline Descriptive Statistics ..........................................................................................42
9.4.6
Planned Interim Analyses .................................................................................................42
9.4.7
Sub-Group Analyses..........................................................................................................43
9.4.8
Tabulation of Individual Participant Data.........................................................................43
9.4.9
Exploratory Analyses ........................................................................................................44
10
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ......................................................44
10.1
Regulatory, Ethical, and Study Oversight Considerations ....................................................................44
10.1.1
Informed Consent Process................................................................................................44
10.1.2
Study Discontinuation and Closure...................................................................................45
10.1.3
Confidentiality and Privacy...............................................................................................46
10.1.4
Future Use of Stored Specimens and Data.......................................................................48
10.1.5
Key Roles and Study Governance .....................................................................................49
10.1.6
Safety Oversight................................................................................................................50
10.1.7
Clinical Monitoring ...........................................................................................................50
10.1.8
Quality Assurance and Quality Control.............................................................................52
10.1.9
Data Handling and Record Keeping ..................................................................................53
10.1.10
Protocol Deviations ..........................................................................................................56
10.1.11
Publication and Data Sharing Policy .................................................................................57
10.1.12
Conflict of Interest Policy..................................................................................................57
10.2
Additional Considerations....................................................................................................................58
10.3
Abbreviations and Special Terms .........................................................................................................58
10.4
Protocol Amendment History ..............................................................................................................60
11
REFERENCES....................................................................................................................................................61
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STATEMENT OF COMPLIANCE
The trial will be conducted in accordance with International Council on Harmonisation Good Clinical 
Practice (ICH GCP), applicable United States (US) Code of Federal Regulations (CFR), and the <specify NIH 
Institute or Center (IC) > Terms and Conditions of Award. The Principal Investigator will assure that no 
deviation from, or changes to the protocol will take place without prior agreement from the funding 
agency and documented approval from the Institutional Review Board (IRB), and the Investigational New 
Drug (IND) or Investigational Device Exemption (IDE) sponsor, if applicable, except where necessary to 
eliminate an immediate hazard(s) to the trial participants. All personnel involved in the conduct of this 
study have completed Human Subjects Protection and ICH GCP Training.
The protocol, informed consent form(s), recruitment materials, and all participant materials will be 
submitted to the IRB for review and approval. Approval of both the protocol and the consent form(s) must 
be obtained before any participant is consented. Any amendment to the protocol will require review and 
approval by the IRB before the changes are implemented to the study. All changes to the consent form(s) 
will be IRB approved; a determination will be made regarding whether a new consent needs to be 
obtained from participants who provided consent, using a previously approved consent form.
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INVESTIGATOR’S SIGNATURE
The signature below constitutes the approval of this protocol and provides the necessary assurances 
that this study will be conducted according to all stipulations of the protocol, including all statements 
regarding confidentiality, and according to local legal and regulatory requirements and applicable US 
federal regulations and ICH guidelines, as described in the Statement of Compliance above.
Principal Investigator or Clinical Site Investigator:
Signed:
Date:
Name: Thomas Hildebrandt
Title: Associate Professor
Investigator Contact Information
Affiliation: Icahn School of Medicine at Mount Sinai
Address: 53-55 E 96th St., New York, NY 10128
Telephone: 212-659-8673
Email: tom.hildebrandt@mssm.edu
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1
PROTOCOL SUMMARY
1.1
SYNOPSIS 
Title:
Noom Health for Weight Management
Study Description:
Overweight and obesity affect as many as one-third of the population 
of the United States. Excess weight represents a serious public health 
concern, as overweight and obesity are associated with an increased 
risk of medical sequelae (e.g., high blood pressure, sleep apnea, 
COVID-19, etc.). Although behavioral treatments for obesity are 
generally effective, reductions in weight are typically modest and 
largely not maintained over the long-term. This study will test a 
successful commercially available weight loss phone app (Noom 
Health) in comparison to a Digital Education program (Noom Digital 
Health) for weight loss, quality of life, psychosocial functioning, and 
self-reported health status. We will recruit 600 subjects and 
randomize them to receive Noom Health vs. Digital Control. 
Baseline measures will include demographics, psychosocial 
measures, height/weight,  weight loss history/practices, health care 
practices/utilization, and quality of life. We will conduct remote 
scheduled direct entry interview and self-report questionnaire data at 
8 time points (Screening/Baseline, 1 month, 4 months, 6 months, 12 
months, 18 months, 24 months, and 30 months). Weight data will be 
collected by video observed scale. Digital scales will be provided for 
those who do not have access.
Objectives:
Primary Objective: The goals of the study are to use the Noom 
smartphone platform to help individuals with weight loss, quality of life, 
psychosocial functioning, and self-reported health status.
Secondary Objectives: We will test the efficacy of this platform against 
a Digital Education program in a cohort of patients.
Endpoints:
We will conduct remote scheduled direct entry interview and self-report 
questionnaire data at 8 time points (Screening/Baseline, 1 month, 4 
months, 6 months, 12 months, 18 months, 24 months, and 30 months). 
Weight data will be collected by video observed scale. Digital scales 
will be provided for those who do not have access
Study Population:
Overweight and obese adults aged 18-60 years.
Phase or Stage:
Phase II trial. 
Description of 
Sites/Facilities Enrolling 
Participants:
The team at the Icahn School of Medicine at Mount Sinai (ISMMS) is 
responsible for recruitment, consenting, consulting on the coaching 
intervention, and data collection and analysis. Research procedures are 
expected to occur remotely with ISMMS staff.  
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Description of Study 
Intervention/Experimental 
Manipulation:
Participants will use the Noom app for 6 months of intervention and 6 
months of maintenance (12 months total). 
Study Duration:
3-5 years
Participant Duration:
30-32 months
1.2
SCHEMA 
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Flow Diagram (randomized controlled trial)
Pre-Screening
Visit 1
Visit 2 - 1 month
Visit 3 - 4 months 
Visit 4 - 6 months
Visit 5 - 12 months
Visit 6 - 18 months
Visit 7 - 24 months
Visit 8 - 30 months
Total N: 684
Pre-screen potential participants by inclusion and exclusion criteria; schedule Visit 1.
Conduct virtual informed consent process. Perform baseline assessments virtually.
Assessments: 24 hour recall interview, EDE-Q, Q-LES-Q-SF, IPAQ, Brief Self-Efficacy Scale 
for Healthy Eating, DASS, SF-36, PROMIS, Demographics and Smartphone Comfort
Assessments
Arm 2
N = 300 
Arm 1
N = 300 
Assessments: 24 hour recall interview, EDE-Q, Q-LES-Q-SF, IPAQ, Brief Self-Efficacy Scale 
for Healthy Eating, DASS, SF-36, PSQI, Demographics and Smartphone Comfort
Randomize (N=600)
Assessments
Assessments
Assessments
Assessments
Final Assessments
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1.3
SCHEDULE OF ACTIVITIES 
The schedule of activities (SOA) provided below outlines the expected activities for each research visit.  
Participants are expected to be enrolled in the study for 2.5 years and complete all research visits via a 
HIPAA compliant video platform (Zoom) and REDCap.
Pre-screening
(Pre-consent)
Visit 1
Day 1
Visit 2
Day 30 ± 42
Visit  3
 Day 121 ± 42
Visit  4
Day 182 ± 42
Visit  5
Day 365 ± 42
Visit  6
Day  547 ± 42
Visit  7
Day  
730 ± 
42
Visit  8
Day  912 ± 42
EMR Review Eligibility
X
Informed Consent
X
Demographics
X
Height, Weight,
X
X
X
X
X
X
X
X
Outcome Evaluation
Depression, Anxiety, Stress Scale
X
X
X
X
X
X
X
X
Quality of Life Questionnaire
X
X
X
X
X
X
X
X
ASA24
X
X
X
X
X
X
X
X
Eating Disorder Examination 
Questionnaire
X
X
X
X
X
X
X
X
International Physical Activity 
Questionnaire
X
X
X
X
X
X
X
X
PROMIS Sleep Impairment
X
X
X
X
X
X
X
X
Short Form Health Survey
X
X
X
X
X
X
X
X
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Brief Self-Efficacy Scale for 
Healthy Eating
X
X
X
X
X
X
X
X
Randomization
X
Control & Experimental 
Interventions – Noom App vs 
Digital Control
X
X
X
X
X
Adverse Events Reporting
X
X
X
X
X
X
X
X
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2
INTRODUCTION
2.1
STUDY RATIONALE 
The goals of the study are to use the Noom smartphone platform to help individuals with weight 
loss, quality of life, psychosocial functioning, and self-reported health status. In addition, we will test 
the efficacy of this platform against a Digital Education program in a cohort of patients.
We will conduct a large test (n=600) where participants are randomized to receive Noom Health vs. 
Digital Control (Noom Digital Health). Baseline measures will include demographics, psychosocial 
measures, height/weight, , weight loss history/practices, health care practices/utilization, and quality 
of life. We will conduct remote scheduled direct entry interview and self-report questionnaire data 
at 8 time points (Screening/Baseline, 1 month, 4 months, 6 months, 12 months, 18 months, 24 
months, and 30 months). Weight data will be collected by video observed scale. Digital scales will be 
provided for those who do not have access.
2.2
BACKGROUND 
Overweight and obesity have reached epidemic proportions in the United States. Excess weight 
represents a serious public health concern, as overweight and obesity are associated with an 
increased risk of medical sequelae (e.g., high blood pressure, sleep apnea, COVID-19, etc.). Although 
behavioral treatments for obesity are generally effective, reductions in weight are typically modest 
and largely not maintained over the long-term.
Behavioral weight loss programs are typically provided with weekly nutritional counseling because 
of the numerous required changes to diet and physical activity; however, this type of intervention is 
costly and requires the availability of trained professionals with advanced degrees. A smartphone 
app to translate behavioral weight loss principles into a digestible and manageable intervention 
helps to overcome limitations such as costs, availability of trained professionals, and time-burden 
and scalability that make behavioral weight loss less practical and available. The Noom platform 
improves the accessibility of expert guidance for individuals interested in weight loss and facilitates 
maintenance through low-burden smart phone engagement.
2.3
RISK/BENEFIT ASSESSMENT 
2.3.1
KNOWN POTENTIAL RISKS 

Anxiety related to eating or change in weight status

Emotional discomfort during assessments

Possible loss of confidentiality
2.3.2
KNOWN POTENTIAL BENEFITS 
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There are no anticipated direct benefits to participants. Some participants may improve their 
diet/exercise, and data from the study may help to identify individuals who benefit from a behavioral 
weight loss app in comparison to other interventions.
With increasing numbers of individuals with overweight and obesity, and few effective behavioral 
treatment options, understanding factors that influence outcomes could be broadly beneficial to 
society.
2.3.3
ASSESSMENT OF POTENTIAL RISKS AND BENEFITS 
Participants may feel some anxiety related to the lifestyle changes that the intervention asks of 
them. Noom coaches are trained in managing these difficult situations as part of a standardized 
Noom Coach Academy lead by licensed clinical psychologist (Andreas Michalaedes, PhD) who 
maintains the academy training and regulation. Participants are free to end their participation at any 
point in the study.
Participants will be told that they are free to not respond or to terminate involvement with the 
assessment at any time, with no adverse consequences. If a participant appears to be distressed 
during assessments, research staff will halt the interview and offer to proceed at another time. The 
interview will only recommence when and if the participant reports feeling capable of doing so. The 
interviews during the course of the study involve no specific risk or discomfort beyond those of a 
standard clinical interview. Interviews will be conducted by experienced and well- trained staff 
sensitive to these issues.
There is a slight risk that research records (questionnaires, consents) might be obtained by persons 
not authorized to do so. There is a slight risk that research data files might be compromised, and 
obtained or viewed by unauthorized persons. As described in the data storage section, we have 
secure databases that will store de-identified data. Only trained research personnel will have access 
to these files. Noom will have access to subjects' PHI including name, contact info, and 
demographics. However, Mount Sinai IT security has assessed the risk of potential PHI loss through 
previous similar work with Noom (IRB-16-01047).
3
OBJECTIVES AND ENDPOINTS  
OBJECTIVES
ENDPOINTS
JUSTIFICATION FOR ENDPOINTS
Primary
To test the comparative 
efficacy of Noom Health vs. 
Noom Digital Health for 
weight loss, quality of life, 
psychosocial functioning, and 
self-reported health status.
We will conduct remote 
scheduled direct entry 
interview and self-report 
questionnaire data at 8 
time points 
(Screening/Baseline, 1 
month, 4 months, 6 
months, 12 months, 18 
months, 24 months, and 30 
Hypothesis 1: Noom Health users will show 
6 month efficacy relative to Noom Digital 
Health for weight loss at post-intervention.  
Hypothesis 2: Noom Health users will show 
long-term (12 Month) efficacy relative to 
Noom Digital Health.
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OBJECTIVES
ENDPOINTS
JUSTIFICATION FOR ENDPOINTS
months). Weight data will 
be collected by video 
observed scale. Digital 
scales will be provided for 
those who do not have 
access. 
Secondary
To compare potential 
moderators of treatment 
response in Noom Health vs.  
Digital Health subjects.
We will conduct remote 
scheduled direct entry 
interview and self-report 
questionnaire data at 8 
time points 
(Screening/Baseline, 1 
month, 4 months, 6 
months, 12 months, 18 
months, 24 months, and 30 
months). Weight data will 
be collected by video 
observed scale. Digital 
scales will be provided for 
those who do not have 
access. 
Hypothesis 1: Clinical Profile (composite 
moderator) will show significant interaction 
with treatment condition, demonstrating 
that individuals with a more severe profile 
(older, less support, more health 
conditions, more psychosocial problems) 
will benefit more from Noom Health than 
Digital Control.
Hypothesis 2: Weight suppression (absolute 
difference between highest and current 
weight) will moderate efficacy of Noom 
Health vs. Digital Education.  
Tertiary/Exploratory 
To identify within treatment 
mechanisms of change 
among Noom Health group.
Hypothesis 1: Time series Bayesian belief 
network model of adherence will predict 
(a) study dropout, (b) successful weight 
loss, (c) quality of life.
Hypothesis 2: Regular eating will mediate 
treatment effects of weight loss over time.
Hypothesis 3: Self-efficacy of weight loss 
will mediate Noom Health vs.  Noom Digital 
Health effects at post treatment and 12 
month follow-up.  
4
STUDY DESIGN
4.1
OVERALL DESIGN
The study will: (a) test the Noom app in coach led groups with individuals interested in weight loss to 
determine if it significantly improves weight loss, quality of life, psychosocial functioning, and self-
reported health status compared to a control.
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We will use a randomized-controlled design comparing the Noom app administered in groups (6 
months) to Digital Control with 6 months active maintenance in both groups. The proposal allows for 
a critical test of effect of Noom on relevant outcomes in the population.
All participants will complete a brief survey indicating that they would like to be contacted and 
includes a study description and availability. Then they will complete informed consent via a HIPAA-
compliant videoconference (Zoom) and questionnaires on REDCap.  Eligible participants will be 
randomized to one of two groups for 6 months intervention and 6 months maintenance (12 months 
of intervention): (1) Noom app with coaching (Noom Health; n=300), or (2) Digital Control (Noom 
Digital Health; n=300). We anticipate screening 684 subject to reach our recruitment goal of 600.
Participants' procedures:

screening survey to determine eligibility and Baseline/Pre-intervention Zoom call

Assessments: 24 hour recall interview, EDE-Q, Q-LES-Q-SF, IPAQ, Brief Self-Efficacy Scale 
for Healthy Eating, DASS, SF-36, PROMIS, Demographics and Smartphone Comfort
Intervention:
Noom Health participants will use Noom for 6 months of intervention and 6 months of maintenance (12 
months total). Participants will use the app multiple times per day to log eating episodes (the number of 
episodes will vary by person). The features include diet, physical activity, and weight tracking, a social 
media group in the app, access to coaches, and personalized coach feedback. Coaches will interact with 
participants directly through the app.  Participants will be encouraged to use the app for 6 months after 
intervention to maintain weight loss, with goal to maintain weight.
Noom Digital Health participants will use a limited version of Noom for 6 months of intervention and 6 
months of maintenance (12 months total). The features include diet, physical activity, and weight 
tracking. Weight loss advice will be given once a week. Participants will use the app multiple times per 
day to log eating episodes (the number of episodes will vary by person). the app for 6 months after 
intervention to maintain weight loss, with goal to maintain weight.
Acceptability/Satisfaction assessments: During the intervention, we will send a 7-point Likert-type scale 
at monthly intervals Noom Health participants to assess satisfaction with the Noom app. For those in 
the Noom Digital Health condition, we will give a one question assessment at the same time points to 
indicate participants are still enrolled in research procedures.
Follow-up visits (1 month, 4 months, 6 months, 12 months, 18 months, 24 months, and 30 months): 24-
hour dietary recall interview, EDE-Q, Q-LES-Q-SF, IPAQ, Brief Self-Efficacy Scale for Healthy Eating, DASS, 
SF-36, PROMIS, Demographics and Smartphone Comfort.
4.2
SCIENTIFIC RATIONALE FOR STUDY DESIGN
We are using a parallel randomized controlled design with 12 month follow-up to determine the efficacy 
and short-term durability of the effects of Noom on weight and associated changes in psychosocial and 
health.  We chose an active control condition (Noom Digital Health) to control for proactive engagement 
in health related dietary and physical activity changes.  These efforts are driven by expert information and 
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our control condition provides this expert information, consistent with CDC guidelines for healthy lifestyle.  
It is designed to reflect readily available expert information on weight loss and management in the 
community and adapted into a digital format to control for delivery method.  
4.3
JUSTIFICATION FOR INTERVENTION  
Commercial and medical weight loss interventions typically vary from 3-6 months with maximal weight 
loss achieved for the majority of participants within the first 3-4 months and rarely reaching maximal 
weight loss after 6 months of active intervention.  Maintenance is an active process and requires a 
different set of skills and practices, so the Noom intervention builds on these behavioral weight loss and 
lifestyle intervention data to utilize expert coaching to increase uptake and contextualization of these 
skills in the individual’s natural environment through coaching led smartphone assisted behavioral 
interventions targeting diet, exercise, and lifestyle.  Observational data support 5-10% weight loss from 
the Noom app with adherence moderating this effect to a moderate degree.  Consequently, Noom offers 
a digital adaptation of existing and well established behavioral weight loss interventions and maximized 
the windows of time for weight loss and maintenance based on these data. 
4.4
END-OF-STUDY DEFINITION
A participant is considered to have completed the study if he or she has completed the baseline 
assessment, 6 months intervention, 6 months active maintenance and the 1-month, 4-month, 6-month, 
12-month, 18-month, 24-month, and 30-month follow-up assessments. 
The end of the study is defined as completion of the 30-month follow-up assessment shown in the 
Schedule of Activities (SoA), Section 1.3.
5
STUDY POPULATION
5.1
INCLUSION CRITERIA

Interested in the Noom platform

BMI > 27 kg/m2

Between the ages of 18 and 60 at entry to the study

Speak English
5.2
EXCLUSION CRITERIA

Contraindication to smartphone use (e.g., seizures from prior smartphone use, do not own a 
smartphone).
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
Acute suicide risk

Pregnancy

Current and planned breastfeeding*
Individuals who are pregnant should not participate in a medically unsupervised weight loss program due 
to the risks associated.
* Added after recruitment closed
5.3
LIFESTYLE CONSIDERATIONS
During this study, participants may be asked to make significant changes to their lifestyle in relation to 
food intake and physical activity as recommended by the Noom coaches.
5.4
SCREEN FAILURES
Formal withdrawal, removal of the Noom app, or failure to complete scheduled measures will constitute 
drop-out for the study.
5.5
STRATEGIES FOR RECRUITMENT AND RETENTION
Participants will be recruited from Noom and from the Center for Excellence for Eating and 
Weight Disorders Program (EWDP) at the Icahn School of Medicine at Mount Sinai
Noom. Participants will have signed up with Noom directly to hear about research studies or 
have viewed the ad on the Noom app. These ads will contain a recruitment link to direct the 
participants to the research team.
EWDP. Patients or providers calling the Center for Excellence for Eating and Weight Disorders 
Program (EWDP) at the Icahn School of Medicine at Mount Sinai requesting information about 
research options for weight loss treatment will be emailed the recruitment link. A description 
will be provided as well.  
Link. Upon clicking the recruitment link, participants will be directed to a 5-minute REDCap 
survey. The first page of the survey will include a description of the study.  The second page will 
include 3 questions which will help with the booking process of the Zoom consent.
PPHS Guidance. This recruitment process aligns with the PPHS guidance > Screening 
Guidelines > Section 1, page 1, indicating that basic screening can take place prior to informed 
consent if it’s part of the recruitment process. By incorporating this initial eligibility survey 
before the informed consent, we reduce burden for participants who are not eligible by lessening 
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the contacts with them to book a Zoom call, and by not conducting the 30-45 minute Zoom call. 
Additionally, we minimize risk to them by not collecting any identifiers other than email. By 
following PPHS guidance > Screening Guidelines > Section III, page 1, we adhere to consent 
process by having two different consent forms, one for screening and one for the full research 
study.  This process will allow us to follow the HIPAA guidelines indicating that we should only 
collect as minimal information as possible. 
Compensation will be $35 for the first assessment and $20 for each additional assessment. 
Additionally, in an effort to maintain retention, a lottery drawing will take place every 3 months 
for $50. Participants who win the lottery and also provided weight at their last follow-up will 
receive $100. For participants who are willing provide a social security number, they will be paid 
in the form of a check, otherwise it will be in the form of an Amazon gift card. The drawing will 
be done by the project manager in the EWDP office and the winner of the drawing will be 
notified by email. The winner will be chosen using random number generator 
https://g.co/kgs/J8o9Hy. The ID numbers of all participants still enrolled will be listed in an 
excel spreadsheet. In the number generator, a min and max number is entered. For this drawing, 
the min number entered will be “1” and the max will be the total number (count) of participants 
who are still enrolled. The number that appears will represent the row in the excel file and will 
determine the selected winner of that drawing. A purchase is not required for participants to be 
placed in the drawing. We are using a lottery to incentivize weight because it poses additional 
time and practical constraints for participants to complete.  Because this commitment can vary 
randomly depending on where in weight loss journey, environmental changes (scale no longer at 
home, uses gym scale), or timing (assessment scheduled for mid-day when scale not accessible), 
the lottery offers incentive for those unpredictable extra time-burdens that our participants have 
reported in the first year of the study.
6
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S)
6.1
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION
6.1.1
STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION
As approved in the prior Ideate protocol, participants will be randomized to one of the groups for 6 
months intervention and 6 months maintenance: (1) Noom app with coaching, administered in a group 
format (Noom Health; n=300), or (2) Noom Digital Health (n=300).
6.1.2
ADMINISTRATION AND/OR DOSING
All participants will use their assigned app for 6 months of intervention and 6 months of maintenance (12 
months total). Subjects will use the app multiple times per day to log eating episodes (the number of 
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episodes will vary by person). Participants will be encouraged to use the app for 6 months after 
intervention to maintain weight loss, with goal to maintain weight.
6.2
FIDELITY
6.2.1
INTERVENTIONIST TRAINING AND TRACKING
Noom Coaches will be trained to monitor the safety of their participants. Additionally, in the introductory 
material given to all participants, information about how to identify and report a crisis will be outlined. 
This is to safeguard participants in the event there is a problem with the facilitator. Since this is a non-
clinical population (obese individuals without serious psychopathology) and Noom has never had any 
incidents with their typical overweight population, we do not anticipate this will be a problem. In the 
event a Coach discovers one of their group members has a serious psychiatric condition (e.g., severe 
eating disorder, substance dependence), he/she will be instructed to alert Noom and Mt. Sinai 
immediately via a shared e-mail address (e.g., sinai@noom.com). These incidents will be dealt with on a 
case-by-case basis and the absolute minimal course of action will be to contact the identified participant 
with relevant psychoeducational material and/or information about where they can go to receive help.
6.3
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING
As indicated in the approved Ideate protocol, we will use a randomized-controlled design. Participants 
will not be blinded to condition.
6.4
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE
Both local and global adherence will be measured. Local adherence will be the percent of completed 
versus expected activities in each of the available categories (i.e., ((# completed/# expected) x 100%)), 
including: self-monitoring, activity levels, reading psychoeducational materials, problem solving, etc.). 
Global adherence will be measured with a similar calculation for virtual attendance/contact with 
scheduled coach check-ins.
6.5
CONCOMITANT THERAPY
N/A
6.5.1
RESCUE THERAPY
N/A
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7
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL
7.1
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION
All participants will be contacted to complete all follow-up assessments unless they indicate that they 
would like to be withdrawn from the study. Participants are instructed in the consent form to contact the 
research staff directly if they would like to withdraw.  Participants may indicate that they would like to 
withdraw from the intervention, but are still willing to complete future follow-up assessments. Contacts 
made to these participants will be assessment-related and not intervention-related. Depending on when 
the participant withdraws and under which circumstances would dictate the remaining procedures that 
they complete. Research staff will attempt to collect the reason for discontinuing at the time of 
withdrawal. 
7.2
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY
Participants are free to withdraw from participation in the study at any time upon request.
An investigator may discontinue a participant from the study for the following reasons:

The study is being stopped

Significant study intervention non-compliance

Lost-to-follow up; unable to contact participant

Any event, medical condition or situation occurs such that continued collection of follow-up  study 
data would not be in the best interest of the participant or might require an additional treatment 
that would confound the interpretation of the study

Currently breastfeeding or pregnant (withdraw from intervention, but will still complete follow-
up surveys) 
Should someone report that they are breastfeeding or pregnant, we will stop the intervention (aka 
withdraw from intervention). They will not receive any further intervention content. We will still ask if 
they’d be willing to complete surveys until the end of their 2.5-year participation as this would pose no 
harm the mother or fetus.  
The reason for participant discontinuation or withdrawal from the study will be recorded in the tracking 
form in REDCap. Participants who are randomized and subsequently withdraw or are discontinued from 
the study, will not be replaced.
7.3
LOST TO FOLLOW-UP
Participants will be considered lost to follow-up if they withdraw from the study by directly contacting our 
research team or if they don’t complete the follow-up assessments. Participants will be contacted 
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throughout the assessment window via phone, email, and the family/friend contact. If no contact is made 
during the assessment window, they will be deemed lost to follow-up. 
8
STUDY ASSESSMENTS AND PROCEDURES
8.1
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS
Noom Coaches will be trained to monitor the safety of their participants. Additionally, in the 
introductory material given to all participants, information about how to identify and report a crisis will 
be outlined. This is to safeguard participants in the event there is a problem with the facilitator. Since 
this is a non-clinical population (obese individuals without serious psychopathology) and Noom has 
never had any incidents with their typical overweight population, we do not anticipate this will be a 
problem. In the event a Coach discovers one of their group members has a serious psychiatric condition 
(e.g., severe eating disorder, substance dependence), he/she will be instructed to alert Noom and Mt. 
Sinai immediately via a shared e-mail address (e.g., sinai@noom.com). These incidents will be dealt with 
on a case-by-case basis and the absolute minimal course of action will be to contact the identified 
participant with relevant psychoeducational material and/or information about where they can go to 
receive help.
Within the context of the present study, Serious Adverse Events (SAEs) include any serious decline of 
psychological functioning (e.g., suicidal ideation, plan, or action) that requires immediate psychiatric 
intervention (e.g., inpatient hospitalization). This may occur while participants are in the assessment of 
follow-up components of the study. Important medical events that may not result in death, be life-
threatening, or require hospitalization may be considered serious adverse experiences when, based on 
appropriate medical judgement of the study physician, they may jeopardize the patient or subject and 
may require medical or surgical intervention to prevent one of the outcomes in this definition. The 
judgement of whether a particular AE meets the above criteria for an SAE for the proposed study will be 
determined by the PI. It will also be the PI’s responsibility to manage all SAEs and to make referrals for 
appropriate care as necessary.
8.2
SAFETY ASSESSMENTS
N/A. There are no formal safety assessments performed in this protocol. If an adverse event is reported 
to the research team, we will follow-up as needed depending on the severity of the event and relation to 
the study. 
8.3
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS
8.3.1
DEFINITION OF ADVERSE EVENTS
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The intervention in this trial is low risk and is not expected to result in adverse events. Expected risks they 
may occur include anxiety related to eating or change in weight status or emotional discomfort during 
assessments. An adverse event will be defined as any untoward medical occurrence related to the 
intervention.
8.3.2
DEFINITION OF SERIOUS ADVERSE EVENTS
A serious adverse event in this project will be defined as an adverse event that occurs during participation 
that is unanticipated, related to the research, and serious in nature (seriousness as defined by hhs.gov -- 
https://www.hhs.gov/ohrp/sites/default/files/ohrp/policy/advevntguid.pdf)
8.3.3
CLASSIFICATION OF AN ADVERSE EVENT
8.3.3.1
SEVERITY OF EVENT
Adverse events will be classified on the following categories by research staff. All events will be brought 
to the attention of the PI, who will also confirm severity. 
•
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities. 
•
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning.
•
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug 
therapy or other treatment. Severe events are usually potentially life-threatening or 
incapacitating.  Of note, the term “severe” does not necessarily equate to “serious”.]
8.3.3.2
RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION
Adverse events will be assessed to determine relation to the intervention. Determinations will be made 
by research staff. All events will be brought to the attention of the PI, who will also confirm relation to 
study.
•
Definitely Related – There is clear evidence to suggest a causal relationship, and other possible 
contributing factors can be ruled out. The clinical event, including an abnormal laboratory test 
result, occurs in a plausible time relationship to study procedures administration and cannot be 
explained by concurrent disease or other drugs or chemicals. The response to withdrawal of the 
study procedures should be clinically plausible. The event must be pharmacologically or 
phenomenologically definitive.
•
Probably Related – There is evidence to suggest a causal relationship, and the influence of other 
factors is unlikely. The clinical event, including an abnormal laboratory test result, occurs within a 
reasonable time after administration of the study procedures, is unlikely to be attributed to 
concurrent disease or other drugs or chemicals, and follows a clinically reasonable response on 
withdrawal. 
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•
Potentially Related – There is some evidence to suggest a causal relationship (e.g., the event 
occurred within a reasonable time after administration of study procedures). However, other 
factors may have contributed to the event (e.g., the participant’s clinical condition, other 
concomitant events). Although an AE may rate only as “possibly related” soon after discovery, it 
can be flagged as requiring more information and later be upgraded to “probably related” or 
“definitely related”, as appropriate.
•
Unlikely to be related – A clinical event, including an abnormal laboratory test result, whose 
temporal relationship to study procedures administration makes a causal relationship improbable 
(e.g., the event did not occur within a reasonable time after administration of the study 
procedures) and in which other drugs or chemicals or underlying disease provides plausible 
explanations (e.g., the participant’s clinical condition, other concomitant treatments).
•
Not Related – The AE is completely independent of study procedures administration, and/or 
evidence exists that the event is definitely related to another etiology. There must be an 
alternative, definitive etiology documented by the clinician.]
8.3.3.3
EXPECTEDNESS 
Research staff will be responsible for determining whether an adverse event is expected or unexpected. 
An AE will be considered unexpected if the nature, severity, or frequency of the event is not consistent 
with the risk information previously described for the study procedures. All events will be brought to the 
attention of the PI, who will also confirm expectedness.
8.3.4
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
research staff during the study.
All AEs, not otherwise precluded per the protocol, will be captured on the appropriate tracking form in 
REDCap. Information to be collected includes event description, time of onset, assessment of severity, 
relationship to study procedures, and time of resolution/stabilization of the event. All AEs occurring while 
on study will be documented appropriately regardless of relationship. All AEs will be followed to adequate 
resolution.
Any medical or psychiatric condition that is present at the time that the participant is screened will be 
considered as baseline and not reported as an AE. However, if the study participant’s condition 
deteriorates at any time during the study, it will be recorded as an AE. 
8.3.5
ADVERSE EVENT REPORTING 
As described in the prior Ideate protocol, there is no DSMB required for this project. All adverse events 
will be brought to the attention of the project manager immediately. The PI will be made aware of events 
within 24 hours. The IRB will be notified of non-serious events at the time of annual renewal. 
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8.3.6
SERIOUS ADVERSE EVENT REPORTING 
Serious adverse events will be brought to the attention of the project manager immediately. The PI will 
be made aware of events within 24 hours. The IRB will be notified of serious events within 2 business days 
and the funding agency will be notified of serious events within 5 business days.
8.3.7
REPORTING EVENTS TO PARTICIPANTS 
N/A
8.3.8
EVENTS OF SPECIAL INTEREST 
N/A
8.3.9
REPORTING OF PREGNANCY 
Participants reporting that they are pregnant will be withdrawn from the intervention, but may still 
complete the follow-up surveys.
8.4
UNANTICIPATED PROBLEMS
8.4.1
DEFINITION OF UNANTICIPATED PROBLEMS
This protocol uses the definition of Unanticipated Problems as defined by the Office for Human Research 
Protections (OHRP).  OHRP considers unanticipated problems involving risks to participants or others to 
include, in general, any incident, experience, or outcome that meets all of the following criteria:
•
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-
approved research protocol and informed consent document; and (b) the characteristics of the 
participant population being studied;
•
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and
•
Suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized.]
8.4.2
 UNANTICIPATED PROBLEMS REPORTING 
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UPs that are serious adverse events will be reported as indicated in section 8.3.4. > 1.1.3 and any other 
UP will be reported to the IRB and the funding agency as indicated in section 8.3.4. > 1.1.2. The investigator 
will report unanticipated problems to the IRB and will include the following information:
•
Protocol identifying information: protocol title and number, PI’s name, and the IRB project 
number
•
A detailed description of the event, incident, experience, or outcome 
•
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP
•
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP
8.4.3
REPORTING 
UNANTICIPATED 
PROBLEMS 
TO 
PARTICIPANTS 
N/A
9
STATISTICAL CONSIDERATIONS 
9.1
STATISTICAL HYPOTHESES

Primary Endpoint(s): 
Hypothesis 1: Noom Health users will show 6 month efficacy relative to Noom Digital Health for weight 
loss at post-intervention.  
Hypothesis 2: Noom Health users will show long-term (12 Month) efficacy relative to Noom Digital 
Health.

Secondary Endpoint(s):
Hypothesis 1: Clinical Profile (composite moderator) will show significant interaction with treatment 
condition, demonstrating that individuals with a more severe profile (older, less support, more health 
conditions, more psychosocial problems) will benefit more from Noom Health than Noom Digital Health.
Hypothesis 2: Weight suppression (absolute difference between highest and current weight) will 
moderate efficacy of Noom Health vs. Noom Digital Health.  
9.2
SAMPLE SIZE DETERMINATION
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Mt. Sinai will use piecewise latent growth curve models with treatment as primary indicator. Using 
Monte Carlo simulation studies with 10,000 draws and 6 time points and 2 growth processes, Mt. Sinai 
evaluated sample size needed to detect significant differences on each growth process (within 
treatment, post-treatment follow-up). Mt. Sinai also varied missing at random patterns of missing of 
data at 10%, 20% and 30% increasing linearly over each timepoint. The results indicate that with 30% 
missing data, mean difference in BMI change of 1 .2 (SD =4.5), Mt. Sinai is 85% powered to detect 
significant difference at 24 month follow-up with N = 600. The power increases substantially for within 
treatment BMI change .8 (SD =4.5), power = .942. For psychosocial outcomes, N=600 with same 
parameters indicated 82-90% power to find treatment effects at 24 months, assuming a .20 SD unit 
difference between groups. Within treatment, the same difference is powered 90-98%.
For Aim 2, Mt. Sinai assumed full information on all moderators and tested the interaction effect with a 
composite moderator profile of 12 indicators. The interaction between latent moderator (M) and 
treatment was powered at .93 and .85 with N=600, and 30% attrition for within treatment and follow-
up.
For Aim 3 power analyses were based on a 13-item adherence measure adapted from the Noom 
Monitor (Binge Eating) study and assumes network efficiency of .75. Mt. Sinai would examine the 
relationship between network entropy and the outcomes, with statistical power for the regression 
prediction at 100% for each outcome. Mediation model of weekly regular eating is a time series 
mediation model and assumes latent measure of meal-snack adherence will mediate changes in weight. 
The calculation is based on effect size goal of .25, .5, and .75. The results of simulations suggest that 
power for the smallest effect size (.25) is approximately .80 with 10% missing data or less and moderate 
correlations between time and change in regular eating (.3) and moderate correlation between regular 
eating and weight outcome (.3).
9.3
POPULATIONS FOR ANALYSES
All analyses will be intent to treat (include all randomized participants).   Sensitivity analyses will include 
examining sources of missing data and alternative parameter estimates under different assumptions of 
missing data (e.g., missing completely at random, missing at random, multipleimputation).
9.4
STATISTICAL ANALYSES
9.4.1
GENERAL APPROACH
We are using a latent growth curve model (piecewise) to model separate change processes assumed 
during weight loss and post intervention.  All models will be examined for goodness of fit, normality and 
linear (vs. Nonlinear) change.  Best fit models will be interpreted for primary effects.  
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9.4.2
ANALYSIS OF THE PRIMARY ENDPOINT(S)
Primary weight and psychosocial/health endpoints will be analyzed using the same piecewise linear 
growth curve model.  Validity of model will be examined via BIC, AIC, and RMSEA with the later below .05 
used as threshold for moving to interpretation of the model.  We will test simple linear models and build 
complexity (non-linear, robust model estimation) based on model fit and observation of outliers and 
potential subgroups.  Missing data will be assumed missing at random during initial model estimation and 
sensitivity analyses using (missing completely at random) tests to evaluate the impact of missing data.  
9.4.3
ANALYSIS OF THE SECONDARY ENDPOINT(S)
The same modeling approach will be used for secondary endpoints and moderator models will include 
first, estimation of latent factor based on demographic variability and the interaction of this latent variable 
and treatment estimated as formal hypothesis test.  
9.4.4
SAFETY ANALYSES
N/A
9.4.5
BASELINE DESCRIPTIVE STATISTICS
Baseline variables (demographics and anthropometrics) will be compared at baseline using t-tests and chi-
square to determine if pre-treatment bias exists in randomization.  
9.4.6
PLANNED INTERIM ANALYSES 
N/A—no interim analysis planned.
9.4.7
SUB-GROUP ANALYSES  
Our moderator analyses rely on empirically derived profiles (as opposed to p-hacking search for group 
difference) to maximize likelihood of identifying meaningful differences between relevant individuals.  
9.4.8
TABULATION OF INDIVIDUAL PARTICIPANT DATA
Data will be tabulated in person-period format.  
9.4.9
EXPLORATORY ANALYSES
We will utilize repeated measures Bayesian belief network to establish adherence within the Noom group 
and examine its changes to relationship over time.  BBNs are most often used to establish greatest 
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predictive value related to available data and tested against randomly sampled (80-20) develop and test 
data sets.  
Our Mediation model of weekly regular eating is a time series mediation model and assumes latent 
measure of meal-snack adherence will mediate changes in weight and included a time-varying set of 
latent variables that change in parallel to our primary outcome.  
10
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS
10.1.1 INFORMED CONSENT PROCESS
10.1.1.1 CONSENT/ASSENT 
AND 
OTHER 
INFORMATIONAL 
DOCUMENTS 
PROVIDED 
TO 
PARTICIPANTS
SOP HRP-090 Informed Consent Process for Research is being used. Interested individuals will be sent a 
pdf of the consent form to review before reviewing it with study staff. Informed consent and screening 
interviews will be conducted via a HIPAA-compliant videoconference (Zoom). A member of the study staff 
will review the study protocol and obtain written informed consent using the full-study e-consent form. 
Voluntary written informed consent will be completed prior to completing study procedures in 
accordance with the PPHS of Mount Sinai. Our consent documents will be submitted with the protocol.
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION
Prior to the consent call, interested individuals will be sent a REDCap link to the electronic version of the 
full-study consent form. Informed consent and screening interviews will be conducted via a HIPAA-
compliant videoconference (Zoom). A member of the study staff will review the study protocol and obtain 
written informed consent using the full-study e-consent form. Voluntary written informed consent will be 
completed prior to completing study procedures in accordance with the PPHS of Mount Sinai. The consent 
process includes a description of the remaining screening procedures and assessments, treatment, and 
other study requirements and will be obtained in a closed office with only members of the research group 
present. No reference to the potential subject's identity will be made outside of closed quarters. The 
consent form includes an explanation of study procedures, their time commitments, risks and benefits, 
alternatives to participation, the confidentiality of information, and the rights of research subject. 
Participants will be given the opportunity to have all their questions answered. Participants' 
understanding of the protocol will be examined by direct questioning prior to their signing the consent 
forms. The potential subject will provide their e- signature and name as well as the date of the consenting 
process on the e-consent form. After the subject submits the form, the study staff member obtaining the 
consent will provide their signature, name, and the consenting date on the signed e-consent form and 
send a copy of the form to the participant via an encrypted email. All study related questions from study 
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participants that a research staff member is unable to address will be referred to the Principal Investigator 
or other co-investigators. No further information will be gathered until participants have provided written, 
signed informed consent.
The consent form will explicitly notify participants that participation is voluntary, can be discontinued at 
any time and will not affect their medical care or status in the Mount Sinai Health System. Patients will be 
screened to ensure they do not meet criteria for exclusion.
10.1.2 STUDY DISCONTINUATION AND CLOSURE
As approved in prior Ideate protocol, if the benefit-risk analysis of this study changes, based on the 
number of SAEs related to study procedures, we will consult with the IRB and determine how to proceed 
(e.g., changes to the inclusion criteria, additional criteria for discontinuation of research participation, 
ending the trial prematurely).
10.1.3 CONFIDENTIALITY AND PRIVACY 
To protect confidentiality, the following precautions will be taken: (1) all questionnaire and interview data 
will use study identification numbers; (2) raw data will be kept in a locked file cabinet and will be available 
only to research staff; (3) electronically stored data will be coded and password protected in a secure 
database behind the Mount Sinai firewall.
The database containing participant data at Noom Inc. is hosted by Rackspace, and features a virtualized 
mySQL instance. These systems are accessible only via secured socket connections using 256-bit 
encryption, with a second layer of security to access the actual databases themselves. There is no 
protected health or identifiable information in the database, only a unique id. There is no public IP for the 
database. The database is managed, so that it is continually patched. It is on a closed VLAN, behind an 
industrial strength firewall. There is a pair of virtualized webservers behind a similar firewall, accepting 
the requests. Access is restricted to Artem Petakov, the designated database security officer for this study. 
The web server is similarly behind an industrial strength firewall, only accessible via SSL. Rackspace is one 
of the best providers in the industry, maintaining very high security standards, with policies in place to 
prevent unauthorized access to the systems.
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA 
Smartphone application data from each participant phone will be sent to the centralized secure database 
at Noom, Inc. that will solely contain data for study participants. The Noom application is HIPAA compliant, 
and all users will be provided with HIPAA Notice of Privacy Practices. The data will only be identified by a 
128-Bit number randomly generated for each participant and data will only be code-based. One electronic 
copy linking participant names and individualized identifier codes will be stored in a password-protected 
document on a computer at Noom, Inc. The server system where the data is stored requires an 
authorization token to log into the system, and a second authorization token to access the database. 
Artem Petakov, the Noom, Inc. CTO, is the only person who has access to both tokens.
The proposed study data will be used only for research purposes. Only trained and qualified research team 
members will have access to study data. To further reduce possible risk to participants, all paper data will 
be will be stored in locked rooms and electronic data on password-protected systems. Participants will be 
assigned a study code, which is the only identifier that will be used when labeling study data. In addition 
to promoting participant confidentiality, the above measures will also facilitate data sharing with other 
investigators in the future.
The data will be stored for 7 years following data analysis/publication, as per Mount Sinai policy.
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10.1.5 KEY ROLES AND STUDY GOVERNANCE
Principal Investigator
Medical Monitor or 
Independent Safety Monitor
Thomas Hildebrandt, PsyD
Name, degree, title
Icahn School of Medicine at Mount 
Sinai
Institution Name 
53-55 E 96th St.
New York, NY 10029
Address
(212) 659-8673
Phone Number
tom.hildebrandt@mssm.edu
Email
A description of the Data Monitoring Committee has been submitted along with the protocol.
10.1.6 SAFETY OVERSIGHT
As indicated in the previously approved protocol, Thomas Hildebrandt will serve as the Principal Monitor. 
Study data will be reviewed by the investigative team on a monthly basis. Reporting or resolution of any 
discovered issues will be the responsibility of the study PI. A description of the Data Monitoring 
Committee has been submitted along with the protocol.
10.1.7 CLINICAL MONITORING
10.1.810.1.8 N/A
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL
•
Dr. Tom Hildebrandt will conduct all data safety monitoring on a monthly basis with the 
investigative team.  As approved in the Ideate protocol, we will conduct monthly data audits to 
evaluate the quality of the data entered and to ensure missing data or data entry errors are 
avoided. This process involves reviewing individual case data, interview data, biometric data and 
laboratory data.
•
As approved in our previous proposal, independent audits will not be conducted.
10.1.7
Quality control (QC) procedures will be implemented as follows:
Informed consent --- Study staff will review both the documentation of the consenting process as well as 
a percentage of the completed consent documents.  This review will evaluate compliance with GCP, 
accuracy, and completeness.  Feedback will be provided to the study team to ensure proper consenting 
procedures are followed. 
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Source documents and the electronic data --- Data will be initially captured on source documents (see 
Section 10.1.9, Data Handling and Record Keeping) and will ultimately be entered into the study 
database.  To ensure accuracy site staff will compare a representative sample of source data against the 
database, targeting key data points in that review.
Intervention Fidelity — Consistent delivery of the study interventions will be monitored throughout the 
intervention phase of the study. Procedures for ensuring fidelity of intervention delivery are described in 
Section 6.2.1, Interventionist Training and Tracking. 
Protocol Deviations – The study team will review protocol deviations on an ongoing basis and will 
implement corrective actions when the quantity or nature of deviations are deemed to be at a level of 
concern.
Should independent monitoring become necessary, the PI will provide direct access to all trial related 
sites, source data/documents, and reports for the purpose of monitoring and auditing by the 
sponsor/funding agency, and inspection by local and regulatory authorities.
10.1.9 DATA HANDLING AND RECORD KEEPING 
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES 
Source Records:
1.
Measures of eating and activity:
a.
24 hour recall interview. Foods and beverages consumed during the 24-hour period before the 
assessment will be asked.
b.
Eating Disorder Examination Questionnaire (EDE-Q). EDE-Q measures dietary restraint, eating, 
shape, and weight concerns, loss of control eating episodes.
c.
International Physical Activity Questionnaire (IPAQ). The IPAQ is a brief self-report measure of 
time spent in an average week completing vigorous or moderate physical activity, walking, and 
sitting.
2.
Measures of Related Symptoms:
a.
Depression Anxiety Stress Scales (DASS). The DASS is a 42-item self-report measure of negative 
emotional states with subscales of depression, anxiety, and stress symptoms.
b.
Short Form-36 Health Survey (SF-36). The SF-36 is a 31-item self-report of health-related quality 
of life measure that generates two scores: The Mental Composite Score (MCS), and the Physical 
Composite Score (PCS).
c.
Brief Self-Efficacy Scale for Healthy Eating. The Brief Self-Efficacy Scale for Healthy Eating is a 12-
item self-report of self-efficacy with scales specific to physical activity, healthful eating and 
weight-loss.
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d.
PROMIS Sleep-Related Impairment is a self-report questionnaire that assesses sleep impairment 
over the last 7 days. The measure consists of 16 individual items and takes 2-5 minutes to 
complete.
e.
The Quality of Life, Enjoyment, and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) is a 16 
self-report assessment of overall enjoyment and satisfaction with physical health, mood, work, 
household and leisure activities, social and family relationships, daily functioning, sexual 
desire/interest/performance, economic status, vision, ability to get around physically, overall 
well-being, medications, and contentment.
3.
Noom App Data:
a.
Adherence: Both local and global adherence will be measured. Local adherence will be the percent 
of completed versus expected activities in each of the available categories (i.e., ((# completed/# 
expected) x 100%)), including: self-monitoring, activity levels, reading psychoeducational 
materials, problem solving, etc.). Global adherence will be measured with a similar calculation for 
virtual attendance/contact with scheduled coach check-ins.
b.
Attrition: Formal withdrawal, removal of the Noom app, or failure to complete schedules 
measures will constitute drop-out for the study.
c.
Compatibility: We will capture and categorize the type of problems encountered by in the course 
of the trial and their 'fixes' for individual's phones. Percentage of successful fixes will be our 
compatibility measure.
d.
Anthropometric Data: Participants will complete a measure of height and weight. As this 
information will be collected remotely, participants will be asked to use a secure Zoom meeting 
to complete the weight with a member of the research team viewing the scale.
Smartphone application data from each participant phone will be sent to the centralized secure database 
at Noom, Inc. that will solely contain data for study participants. The Noom application is HIPAA compliant, 
and all users will be provided with HIPAA Notice of Privacy Practices. The data will only be identified by a 
128-Bit number randomly generated for each participant and data will only be code-based. One electronic 
copy linking participant names and individualized identifier codes will be stored in a password-protected 
document on a computer at Noom, Inc. The server system where the data is stored requires an 
authorization token to log into the system, and a second authorization token to access the database. 
Artem Petakov, the Noom, Inc. CTO, is the only person who has access to both tokens.
The proposed study data will be used only for research purposes. Only trained and qualified research team 
members will have access to study data. To further reduce possible risk to participants, all paper data will 
be will be stored in locked rooms and electronic data on password-protected systems. Participants will 
be assigned a study code, which is the only identifier that will be used when labeling study data. In 
addition to promoting participant confidentiality, the above measures will also facilitate data sharing with 
other investigators in the future.
10.1.9.2 STUDY RECORDS RETENTION 
The data will be stored for 7 years following data analysis/publication, as per Mount Sinai policy.
10.1.10
PROTOCOL DEVIATIONS  
It will be the responsibility of the site investigator to use continuous vigilance to identify and report 
deviations within 7 working days of identification of the protocol deviation, or within 7 working days of 
the scheduled protocol-required activity. All deviations will be addressed in study source documents, 
reported to Noom, Inc Dr. Andreas Michaledels. Protocol deviations will be sent to the reviewing 
Institutional Review Board (IRB) per their policies. The site investigator will be responsible for knowing 
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and adhering to the reviewing IRB requirements. Further details about the handling of protocol deviations 
will be included in the MOP.] 
10.1.11
PUBLICATION AND DATA SHARING POLICY 
This data will be made available through permission from Noom, Inc.  All publication material will be 
managed by the investigative team and in accordance with contract.
10.1.12
CONFLICT OF INTEREST POLICY
The independence of this study from any actual or perceived influence, such as by the pharmaceutical 
industry, is critical. Therefore, any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. Furthermore, 
persons who have a perceived conflict of interest will be required to have such conflicts managed in a way 
that is appropriate to their participation in the design and conduct of this trial. The study leadership in 
conjunction with the Noom, Inc and conflict of interest office at Mount Sinai has established policies and 
procedures for all study group members to disclose all conflicts of interest and will establish a mechanism 
for the management of all reported dualities of interest.
10.2 ADDITIONAL CONSIDERATIONS
N/A
10.3 ABBREVIATIONS AND SPECIAL TERMS
AE
Adverse Event
ANCOVA
Analysis of Covariance
CFR
Code of Federal Regulations
CLIA
Clinical Laboratory Improvement Amendments
CMP
Clinical Monitoring Plan
COC
Certificate of Confidentiality
CONSORT
Consolidated Standards of Reporting Trials
CRF
Case Report Form
DCC
Data Coordinating Center
DHHS
Department of Health and Human Services
DSMB
Data Safety Monitoring Board
DRE
Disease-Related Event
EC
Ethics Committee
eCRF
Electronic Case Report Forms
FDA
Food and Drug Administration
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FDAAA
Food and Drug Administration Amendments Act of 2007
FFR
Federal Financial Report
GCP
Good Clinical Practice
GLP
Good Laboratory Practices
GMP
Good Manufacturing Practices
GWAS
Genome-Wide Association Studies
HIPAA
Health Insurance Portability and Accountability Act 
IB
Investigator’s Brochure
ICH
International Council on Harmonisation 
ICMJE
International Committee of Medical Journal Editors
IDE
Investigational Device Exemption
IND
Investigational New Drug Application
IRB
Institutional Review Board
ISM
Independent Safety Monitor
ITT
Intention-To-Treat
LSMEANS
Least-squares Means
MedDRA
Medical Dictionary for Regulatory Activities
MOP
Manual of Procedures
NCT
National Clinical Trial
NIH 
National Institutes of Health
NIH IC
NIH Institute or Center
OHRP
Office for Human Research Protections
PI
Principal Investigator
QA
Quality Assurance
QC
Quality Control
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
SMC
Safety Monitoring Committee
SOA
Schedule of Activities
SOC
System Organ Class
SOP
Standard Operating Procedure
UP
Unanticipated Problem
US
United States
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10.4 PROTOCOL AMENDMENT HISTORY
The table below is intended to capture changes of IRB-approved versions of the protocol, including a 
description of the change and rationale. A Summary of Changes table for the current amendment is 
located in the Protocol Title Page. 
Version
Date
Description of Change 
Brief Rationale
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11
REFERENCES 
Include a list of relevant literature and citations for all publications referenced in the text of the protocol.  
Use a consistent, standard, modern format, which might be dependent upon the required format for the 
anticipated journal for publication (e.g., N Engl J Med, JAMA, etc.).  The preferred format is International 
Committee of Medical Journal Editors (ICMJE). 
Examples:

Journal citation
Veronesi U, Maisonneuve P, Decensi A. Tamoxifen: an enduring star. J Natl Cancer Inst. 2007 Feb 
21;99(4):258-60.

Whole book citation
Belitz HD, Grosch W, Schieberle P. Food chemistry. 3rd rev. ed. Burghagen MM, translator. Berlin: 
Springer; 2004. 1070 p.

Chapter in a book citation
Riffenburgh RH. Statistics in medicine. 2nd ed. Amsterdam (Netherlands): Elsevier Academic 
Press; c2006. Chapter 24, Regression and correlation methods; p. 447-86.

Web Site citation
Complementary/Integrative Medicine [Internet]. Houston: University of Texas, M.D. Anderson 
Cancer Center; c2007 [cited 2007 Feb 21]. Available from: 
http://www.manderson.org/departments/CIMER/.

Electronic Mail citation
Backus, Joyce. Physician Internet search behavior: detailed study [Internet]. Message to: Karen 
Patrias. 2007 Mar 27 [cited 2007 Mar 28]. [2 paragraphs]

References to package insert, device labeling or investigational brochure
Cite date accessed, version number, and source of product information.
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