Supplementing Evidence-based Commercial Weight Management Program With Inhibitory Control Training: a Pilot Study
Phase: NA
Conditions: Overweight and Obesity
Sponsor: Cedars-Sinai Medical Center

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Supplementing evidence-based commercial weight management program with inhibitory 
control training: A pilot study 
 
NCT04747886 
 
STUDY00001164 
 
June 15, 2022 
 
Sarah-Jeanne Salvy, PhD 
 
Cedars-Sinai Research Center 
 
 
 

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TABLE OF CONTENTS  
 
PROTOCOL Summary .................................................................................................................. 3 
General Information ................................................................................................................... 3 
1.0 BACKGROUND, RATIONALE .................................................................................................. 3 
2.0 STUDY OBJECTIVES ............................................................................................................... 5 
3.0 Study Population .................................................................................................................. 6 
3.1 Selection of the Study Population ................................................................................ 6 
3.2 Inclusion Criteria ........................................................................................................... 6 
3.3 Exclusion Criteria........................................................................................................... 6 
3.4 Subject Screening and Enrollment ................................................................................ 6 
3.5 Subject Recruitment ..................................................................................................... 7 
4.0 STUDY DESIGN AND METHODS ............................................................................................ 7 
4.1 Overview of Study Design and Procedures ................................................................... 7 
4.2 Study Arms .................................................................................................................... 7 
4.3 Measurements .............................................................................................................. 7 
5.0 DATA COLLECTION and MANAGEMENT ............................................................................. 11 
5.1 Data Procurement ....................................................................................................... 11 
5.2 Time Period of data under review .............................................................................. 11 
5.3 Variables collected ...................................................................................................... 11 
5.4 Source documents ...................................................................................................... 12 
5.5 Data Collection and Storage ....................................................................................... 12 
5.6 Confidentiality and Security of Data ........................................................................... 12 
6.0 DATA AND SAFETY MONITORING ....................................................................................... 13 
6.1 Data and Safety Monitoring Plan ................................................................................ 13 
6.2 Quality Control and Quality Assurance ....................................................................... 13 
7.0 STATISTICAL CONSIDERATIONS .......................................................................................... 13 
7.1 Study Outcome Measures........................................................................................... 13 
7.2 Sample Considerations ............................................................................................... 14 
7.3 Statistical Analyses ...................................................................................................... 14 
8.0 REFERENCES........................................................................................................................ 15 

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PROTOCOL SUMMARY  
 
Purpose and Knowledge to be 
Gained 
 
This two-arm pilot study will be used to estimate the effect 
size in weight loss of supplementing the WW (formerly 
Weight Watchers) online program with gamified inhibitory 
control training (PolyRules!) among adults with overweight 
or obesity.  
Research Procedures 
 
• Participants (n=30) will be randomly assigned to one of 
two study arms: (1) WW (formerly weight watchers) only 
or (2) WW + Gamified inhibitory control training 
(PolyRules!). 
• All participants will complete demographic, medical 
history questionnaires and cognitive assessment battery 
at baseline/enrollment and after completing the 3-month 
intervention protocol.  
• All interactions with PolyRules! and WW will be passively 
recorded to monitor frequency of interaction with WW 
and PolyRules!  
• As compensation for completing all study procedures, 
participants will receive a $30 gift card. 
Subject Population 
• Adults (aged 18 and over) 
Duration 
• 12 months  
 
GENERAL INFORMATION  
 
CSMC Co-Investigators  
Arash Asher, MD 
Jun Gong, MD 
Biostatistics 
Marcio Diniz, PhD 
Sponsor/Funder 
This study will be Internally funded 
Institutional Commitment to Dr. Salvy 
Collaborating Institutions 
Involved in the Research 
None 
 
1.0 BACKGROUND, RATIONALE  
Evidence-based weight management programs are effective when individuals adhere to 
treatment recommendations.4 However, a majority of individuals are unable to engage and/or 
sustain a healthy diet5-8 because of the interaction between powerful biological drives and 
omnipresent obesogenic environmental factors.31  
A promising framework to address weight management challenges is premised on the reality that 
environmental cues can never be fully eliminated or prevented, so it may be valuable for 

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individuals to strengthen their self-regulatory control in order to inhibit their impulses when 
confronted with temptations. In this view, self-control is like a muscle, and although it fatigues, 
people can be trained to increase its strength.1-3 This is consistent with Dr. Salvy’s4,5 and others’ 
findings linking deficits in executive functioning and obesity,6-15 and with the use of impulse 
control training to regulate food-related impulsivity.16-19 Interventions based on the “Go/No-Go 
task,” a paradigm for studying and training inhibitory control by challenging subjects to withhold 
impulsive responses, are particularly promising.18 Go/No-Go training has been shown to increase 
short-term eating regulation and produce modest weight-loss.18,19 However, previous studies 
include key limitations: limited dosage or training duration, exposure to a small set of stimuli and 
lack of tailoring to participants’ proficiency. Furthermore, Go/No-Go impulse control programs 
primarily target single processes involved in inhibiting or suppressing motor responses rather 
than cognitive processes involved in inhibiting cue-response mappings. Resisting food cues not 
only requires inhibition of impulsive behaviors, but also inhibition of the reinforcing food task 
set.20 The efficacy of these interventions in improving daily self-regulation is also controversial, 
with some broad claims based on thin, and often irrelevant, scientific evidence.21-24  
To address the rigor of previous research, we draw upon recent developments in cognitive 
training with promising functional improvements in several areas (ADHD,25 chemo brain,26 age-
related cognitive decline,27 dyslexia,28 schizophrenia,29 sensory deficits,30 brain injury,31 in 
promoting mental fitness27). Novel inhibitory control training (PolyRules!) incorporates stimuli 
and task structures previously applied in visual perceptual learning and working memory 
training.32,33 PolyRules! adjusts to the users’ impulse control proficiency,34-36 and gains have been 
found to generalize to other tasks37-40 and transfer beyond the training context to complex 
activities.33,41-43  Poly Rules! incorporates four guiding principles of gamification44-47  to reinforce 
interactions with the app and promote adherence. Gamification, if applied properly, may 
promote positive behavioral health changes such as weight loss.  
In a recent pilot study, we documented the acceptability and feasibility of PolyRules! training 
among middle-age adults (M age 59±9.4) who were receiving care at Cedars-Sinai Medical 
Center. We met our enrollment target (n=40) within three hours of emailing the study flyer. This 
enthusiastic response speaks to the need fulfilled by the proposed lifestyle and cognitive 
intervention 
components. 
Over 
85% 
of 
respondents had attempted to lose weight in 
the last 5 years and 58% had tried to lose 
weight 5-10+ times. A majority of respondent 
(79%) said they knew what to eat but struggled 
keeping a healthy weight and adhering to 
healthy dietary recommendations. Over 90% of 
respondents reported that difficulty in resisting 
tempting foods and self-motivation were 
barriers to behavior change and weight loss. All 
components received mean scores >4 (1 = not 
at all useful, 5 = very useful) in terms of their 
usefulness in increasing adherence to dietary 
recommendations (Figure 1). All participants 
0
10
20
30
40
50
60
70
80
90
100
Access to
coach
Remote
delivery
Online
tracking
Cognitive
training
Likely
Extremely likely
Fig 1. Proportion (%) of respondents (n=40) likely or 
extremely likely to participate if components were 
offered. 

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reported they would be likely or extremely likely to participate in an intervention combining 
inhibitory control training and weight management if it was offered. 
A subset of ten participants further completed 
10 days of PolyRules! training. All participants 
completed the daily 30-min training sessions and 
increased in proficiency over the 10-day training. 
Figure 2 illustrates average improvement (••••) in 
inhibitory control, as well as participants with 
minimal (ID09) and steep (ID03) gains in 
performance over the 10 training sessions. 
Participants described the training as meditative, 
with the right balance of simplicity in navigating 
the app and cognitive challenge (e.g., “I can feel 
my brain working”; “It’s simple but challenging”; 
“Your brain is engaged”). All participants enjoyed PolyRules! and asked if they could continue 
using the app. Most frequently cited immediate perceived benefits from using the app were in 
terms of improved focus, attention and memory (“I paid more attention than I normally would”; 
“I was able to recall the details about what I read, and this is not how I normally am”) and in 
terms of overall thinking and cognition (“The app is making me smarter!”; “I feel more alert”; “I’m 
sharper”).  
This formative work supports the appeal and feasibility of gamified inhibitory control training as 
a stand-alone component. Additional data is needed to document inhibitory control training in 
combination to evidence-based weight management program. The proposed two-arm pilot study 
aims to estimate the effect size in weight loss of supplementing the WW (formerly Weight 
Watchers) online program with gamified inhibitory control training (PolyRules!) among adults 
with overweight or obesity. WW is a commercially available structured behavioral weight 
management program focusing on diet, physical activity and mindset skills. WW was selected for 
this study because it is the most used commercial program, and the #1 doctor recommended 
program based on a 2019 survey by Kantar Health of 500 doctors who recommend weight loss 
programs to patients.48-52  
 
2.0 STUDY OBJECTIVES  
 
2.1 Primary objective:  To estimate the effect size in weight loss of supplementing the WW 
(formerly Weight Watchers) online program with gamified inhibitory control training (PolyRules!) 
among adults with overweight or obesity.  
 
2.2 Secondary objectives: To explore whether inhibitory control training confers any benefits in 
terms of diet quality, physical activity or cognitive functioning in the early stages of a weight 
management program. 
 
Time per item (seconds) 
0
0.5
1
1.5
2
2.5
1
2
3
4
5
6
7
8
9
10
Fig 2. Improved inhibitory control over 10-day 
training. 
ID03 = Steepest improvement 
ID09 = Minimal improvement 
•••• = Average (n=10) 

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3.0 STUDY POPULATION  
 
 
3.1 SELECTION OF THE STUDY POPULATION 
 
Healthy adults (>18 years-old) will be recruited from Cedars-Sinai Medical Center and the 
general population. 
 
3.2 INCLUSION CRITERIA 
 
Individuals will be eligible to participate if they meet any of the following criteria: 
1) 18 years of age or older 
2) Read, write, and speak English with acceptable visual acuity 
3) BMI between 25-39.9 kg/m2 
 
3.3 EXCLUSION CRITERIA  
 
Individuals will not be eligible to participate if they meet any of the following criteria: 
1) Currently enrolled in weight loss interventions or undergoing bariatric surgery 
2) Pregnant women 
3) Individuals with severe cognitive delays or visual/hearing impairment 
 
3.4 SUBJECT SCREENING AND ENROLLMENT 
 
• Study advertisements (flyers, online posting) will instruct interested individuals to 
contact the study research coordinators via email, phone or text message for more 
information.  
• Individuals who contact the study team will be screened over the phone or provided 
a REDCap link containing the screening questions. After the screening questions are 
completed, the study team will review the information and follow up with 
individuals over the phone, email or via text to inform them if they are eligible for 
the study and explain the consenting process. 
• Electronic consent (eIC) will be obtained using DocuSign. The study coordinator will 
email the electronic consent to potential participants and then schedule a time to 
review it over the phone, MS Teams or other video-conferencing software. During 
this time individuals will have the opportunity to ask questions and discontinue if 
they are no longer interested in the study.  If they want to enroll in the study, the 
coordinator will email the consent (via DocuSign portal) with the signature fields 
highlighted to indicate a signature is required. Signature capture can be performed 
by a stylus and signature pad, mouse, signing with a finger on a touch screen, or by 
typing a name in an e-signature. When the document is signed electronically 
DocuSign can send a PDF of the eIC to the study team, which will be reviewed by the 

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coordinator. Once the eIC is complete, a copy will be emailed to the participants, 
and it will be stored in a Box folder.  
 
3.5 SUBJECT RECRUITMENT 
 
• Participants will be recruited from Cedars-Sinai and through community outreach 
with flyers posted around the community and distributed at community events. The 
study will also be posted online on Craigslist and on Cedars’ internal online 
newsletter, the Bridge. Interested individuals will be instructed to contact the study 
team via email, phone, or text message for more information.  
 
4.0 STUDY DESIGN AND METHODS 
 
 
4.1 OVERVIEW OF STUDY DESIGN AND PROCEDURES 
 
Participants (n=30) will be randomly assigned to one of two arms: (1) WW (formerly 
weight watchers) only or (2) WW + Gamified inhibitory control training (PolyRules!). All 
participants will complete demographic, medical history questionnaires and cognitive 
assessment battery at baseline/enrollment and after completing the 3-month 
intervention protocol. As compensation for completing all study procedures, participants 
will receive a $30 gift card.  
 
 
4.2 STUDY ARMS 
 
WW (all participants; n = 30): All participants will receive pre-loaded computer tablets and 3-
month access to the WW digital program. WW is a structured behavioral weight management 
program that focuses on diet, physical activity and mindset skills. The dietary approach is 
based on creating an energy deficit diet to produce weight loss while also being attentive 
to the quality of the calories. Specifically, the WW program assigns SmartPoints values to 
foods based on calories, sugar, saturated fat and protein. In addition, particular foods are 
assigned a points value of zero (0) to encourage a healthier eating pattern (e.g. fruits, 
vegetables, non-fat yogurt, fish). Upon sign-up, an individualized SmartPoints budget 
consisting of a daily SmartPoints target and weekly SmartPoints allowance is calculated 
based on height, weight, age and sex. The fitness component assigns FitPoints values to 
physical activities based on the type, duration, intensity and the participant’s body 
weight. Participants receive 24/7 access to coaches, automatic enrollment in a rewards 
program based on behaviors, weekly emails motivating lifestyle changes and a closed 
social network for WW members. 
 
WW + PolyRules! (50% of participants, n = 15): Participants assigned to the WW+ 
Polyrules arm will receive access to the WW online program (as described above) and to 
the PolyRules! app for three months. Participants will be trained on how to use PolyRules! 
via Zoom or Team Meeting platforms. Participants will be asked to engage in daily 

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cognitive training using the PolyRules! app for three months. They will be instructed to 
start with 20-min of daily cognitive training and to progressively increase their training 
time to 30-min. All interactions with PolyRules! will be passively recorded to monitor 
whether participants engage in cognitive training. 
 
4.3 MEASUREMENTS 
 
Demographics 
 
Participants will complete a questionnaire surveying: date of birth, sex, ethnicity, 
socioeconomic status (SES: education level, household income, marital status, 
employment status), household composition (multigenerational, single, married, 
cohabitating, children) and medical history. 
 
Shared weight, dietary and physical activity data 
 
As part of the WW experience, participants are instructed to track their weight, daily food 
intake and physical activity via the WW mobile app or online website. As a secondary 
objective, we will explore weight loss, dietary intake and physical activity over the course 
of the study and across study arms.   
 
Cognitive Functioning 
 
As a secondary objective, we will explore changes in attention, inhibitory control and 
working memory over the course of the study across study arms.   
 
Executive Functioning 
 
The Behavior Rating Inventory of Executive Function®- Adult Version (BRIEF-A) is a 
standardized measure of executive functions or self-regulation in everyday environment. 
The BRIEF-A assesses nine nonoverlapping theoretically and empirically derived clinical 
scales: Inhibit, Self-Monitor, Plan/Organize, Shift, Initiate, Task Monitor, Emotional 
Control, Working Memory, and Organization of Materials. BRIEF-A is available in English 
and Spanish and can be computer-administered.  
 
Attention and Inhibitory Control Tasks 
 
 
The Cancellation Task is a timed, tablet-based test of selective attention and inhibitory 
control, akin to D2 (Brickenkamp & Zilmer, 1998). There are two versions that can be used 
interchangeably: Cancellation Letters and Cancellation Pictures. Cancellation - Letters 
resembles the D2 in that it consists of similar stimuli: characters “d” and “p” with one to 
four dashes, arranged either individually or in pairs above or below the letters. For Letters, 
the participant must scan the items from left to right and select all “d”s with two dashes 

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(targets). In Cancellation - Pictures, letters are replaced with pictures of dogs and 
monkeys, some of which are rotated along the vertical axis or are presented upside down. 
For Pictures, the participant must select the upright dog (tail on the left) and the upside-
down monkey (tail on right) separately in single blocks and together in a mixed block.  
 
The Countermanding task is a relatively fast and easy task that is appropriate for all age 
levels, including children. The participant is instructed to tap on one of two green buttons 
in response to a visual stimulus - a picture of a dog or a monkey. For dogs, the participant 
must tap on the button that is on the same side of the screen (congruent trial); however, 
when the participant sees a monkey, they must tap on the button that is on the opposite 
side (incongruent trial). Note that the visual stimuli appear on the left or on the right 
interchangeably. On incongruent trials, the participant must inhibit a prepotent response 
to respond on the same side as the visual stimulus. There are 3 blocks of trials, each 
preceded by a practice session. The stimuli are presented on the screen until the 
participant responds, with an upper time limit of 15 seconds. Accuracy is typically very 
high in this task thus the main dependent measure is reaction time for correct responses 
on congruent and incongruent trials.   
 
Working Memory Tasks 
 
In the N-Back task, participants are presented with a consecutive stream of pictures, and 
the objective is to tap on the pictures that match those presented N items earlier. Higher 
levels of N levels increase WM load and make the task more difficult. All participants 
complete 1-back (Figure 4), 2-back, and 3-back (in that order). Before each level starts, 
there is a practice session consisting of 10 trials during which performance feedback is 
provided. The test phase for each N-level consists of 30 trials with 9 targets. Progression 
to 4-back (and beyond) is allowed if the participant made no more than 2 errors on the 
previous level. Stimuli are presented for 2500 ms (participant can respond during this 
period) with an ISI of 500 ms.  
 
In the Letter-Number task, participants are presented with a mixed order of letters and 
numbers, which they must remember and sort them numerically and alphabetically. For 
example, the sequence ‘H8T3K5’ would be sorted into ‘358’ and ‘HKT’. The mixed orders 
of letter and numbers ranges from 2 to 15. After a short tutorial, the participant practices 
the task and must get three out of the five trials correct to proceed to the test. The Letter 
Number Task is split into two parts: The first is a method of limits to find the participants 
threshold, whereas the second provides additional trials around that threshold. 
Characters that could be confused with other letters or numbers are excluded (0, I, O, U, 
X). Moreover, a given sequence does not include any of the characters in the previous 
trial and it does not contain consecutive numbers and letters.   
 
Visuo-spatial working memory will be measured with a modified Corsi Tasks, a collection 
of 4 types of tasks (i.e. classic - blocks, simple, complex, sequencing) that are customizable 

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where an experimenter can select which task mode, stimulus type, and algorithm they 
want to use. In all versions of the task, the participant is shown instructions and then 
practices the task. Corsi Blocks Classic: The participant first completes Corsi Blocks 
Forward (tap in same order), followed by Corsi Blocks Reverse (tap in reverse order). The 
Corsi Blocks Forward task is split into two parts: the first is a method of limits to find the 
participants threshold, whereas the second provides additional trials around that 
threshold. Complex Corsi: Combines Simple Corsi with a secondary sorting task in 
between each trial. In the sorting task, the participant must drag a dog to a bone or a 
monkey to a banana. The location of the bone and banana are randomized to prevent 
mnemonic strategies like chunking.  
 
Exit Interview  
 
Table 1 outlines questions asked during the exit interview across study arms.  
 
Table 1. Interview questions across study arms. 
 
WW 
only 
WW + 
PolyRules! 
1. What prompted you to participate in the study? 
x 
x 
2. What are the top 3 things that you liked about WW? 
x 
x 
3. Describe any concerns you had regarding WW? 
x 
x 
4. Can you tell me about some changes (good or bad) you have 
experiences since you have started WW? 
x 
x 
5. Would you continue using WW if available? 
x 
x 
6. What are the top 3 things that you liked about PolyRules!? 
 
x 
7. Describe any concerns you had regarding PolyRules!? 
 
x 
8. Do you feel cognitive training helped you with your weight 
loss? 
 
x 
9. Can you tell me about some changes (good or bad) you have 
experienced since you have started using PolyRules!? 
 
x 
10. Would you continue using PolyRules! if available 
 
x 
11. Would you be interested in participating in a larger study 
testing the benefits of combining cognitive training and WW 
x 
x 
12. Is there anything else you would like to share about the study 
x 
x 
 
 
 
 
 
 
 
 
 

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Schedule of Procedures 
Procedures 
Enrollment 
Intervention 
Post-Intervention 
Informed Consent (DocuSign) 
X 
 
 
Baseline assessment 
X 
 
 
Randomization 
X 
 
 
Equipment/software/application set-
up and training 
 
X 
 
Intervention:  
- 
WW only group 
- 
WW + PolyRules! group 
 
X 
 
Post-intervention assessment 
 
 
X 
Exit interview 
 
 
X 
Equipment Return  
 
 
X 
Compensation 
 
 
X 
 
 
 
5.0 DATA COLLECTION and MANAGEMENT 
 
 
5.1 DATA PROCUREMENT 
 
This study utilizes primary data collection. Data will be collected from participants 
enrolled in the study. 
 
 
5.2 TIME PERIOD OF DATA UNDER REVIEW  
 
Questionnaire data will be collected at baseline / enrollment and after the 3-month 
intervention protocol. Frequency of PolyRules! use and interactions with the WW 
program will be passively recorded on the PolyRules! and WW platforms. Participant data 
will be included in the analysis if at least three valid days of interactions with the WW 
program and PolyRules! use (if applicable) are available. De-identified data will be kept 
for 5 years and then destroyed. 
 
5.3 VARIABLES COLLECTED  
 
• Demographics: date of birth, sex, ethnicity, socioeconomic status (SES: education 
level, household income, marital status, employment status), household 
composition (multigenerational, single, married, cohabitating, children) and 
medical history 

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• Weight, dietary and physical activity data. Participants’ reported/tracked weight, 
food intake and physical activity data via the WW mobile app or online website.  
• Executive functioning as measured by the Behavior Rating Inventory of Executive 
Function®- Adult Version (BRIEF-A) 
• Cognitive functioning: inhibitory control, attention, verbal working memory tasks, 
visuo-spatial working memory tasks, and working memory capacity tasks 
 
5.4 SOURCE DOCUMENTS 
 
• All data will be stored electronically in secure servers at Cedars-Sinai, with the 
exception of (1) WW shared weight, dietary and physical activity stored on the 
HIPPA -compliant WW platform and PolyRules! app usage data which will be stored 
on a HIPPA-compliant Amazon Web Services Server that is under the University of 
California business use agreement with Amazon.  
• The surveys/questionnaires administered will be electronically based in REDCap, 
which is a survey platform on a Cedars-approved, secure network. The participant 
will be identifiable by a participant number which is linked to the participant in a 
separate, electronically secured location.  
• The code list linking participant responses to their identity will be kept in a separate, 
electronically secured location. After analysis is complete, this list will be destroyed. 
• Participants will be informed that audio recordings of semi-structured interviews 
will be kept until the completion of the study. Audio recordings will be transcribed 
and analyzed as soon as possible by the study team. After transcription has been 
completed, the audio recordings will be destroyed. 
• Deidentified study data will be kept for 5 years after the study is completed. At the 
conclusion of the study, all study data will be destroyed. 
 
5.5 DATA COLLECTION AND STORAGE  
 
• Participants’ consent forms will be stored in a password protected folder in Box, 
which is located in secure servers at Cedars-Sinai.  
• A unique participant number will be used for all the data so that it can be traced 
back to the consent form should the participant wish to withdraw.  
• Information on participants’ demographics data will be stored in REDCap separate 
from the participant’s identifying information.    
• Audio data (from semi-structured interviews) will be securely stored in a Box folder. 
Access to audio data will be strictly monitored and limited to study staff. All audio 
data will be transcribed and analyzed at the earliest opportunity. After transcription, 
the audio files will be destroyed. 
 
5.6 CONFIDENTIALITY AND SECURITY OF DATA 
 

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• All data will be stored electronically in secure servers.  
• A unique participant number will be used for all the data so that it can be traced 
back to the consent form should the participant wish to withdraw. The unique 
participant number will be kept in a REDCap database which will be separate from 
the data and consent documents. 
• Information on participants’ demographics data will be stored in REDCap separate 
from the participant’s identifying information.    
• Only IRB approved study staff and the PI will have access to the data collected. 
Personal and sensitive data will be stored for 5 years and will be destroyed after this 
time by the PI. 
 
6.0 
DATA AND SAFETY MONITORING 
6.1 DATA AND SAFETY MONITORING PLAN 
 
• All data will be stored electronically in secure servers (REDCap, Amazon Web 
Services) 
• The Box folder containing the consent forms will be password protected. 
• The audio recordings stored in a Box folder will also be password protected. 
• The PI will be responsible for data and safety monitoring for this study. 
• Any deviations from the research protocol or unexpected problems will be reported 
promptly to the Cedars-Sinai IRB. 
 
 
6.2 QUALITY CONTROL AND QUALITY ASSURANCE 
 
Principles underlying our approach to quality control include:  
• Standardization of measurements 
• Use of clear and specific protocols for all study activities including training for data 
collection and processing 
• Validation and verification of data management procedures by using software 
capable of checking for out-of-range values and other sources of outliers 
• Implementation of a data cleaning protocol 
• Confidentiality will be strictly maintained during all data management 
• The research team will follow aforementioned schemes to collect and manage study 
data by maintaining consistent quality and security of the study observations.  
 
7.0 STATISTICAL CONSIDERATIONS  
 
7.1 STUDY OUTCOME MEASURES 
 

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The primary objective of this study is to estimate the effect size in weight loss of 
supplementing the WW online program with gamified inhibitory control training 
(PolyRules!) among adults with overweight or obesity.  
 
As a secondary objective, we will explore changes in dietary intake, physical activity, 
attention, inhibitory control and working memory over the course of study across study 
arms.   
 
Primary endpoints 
• Weight loss from baseline to 3 months. 
 
Secondary endpoints 
• As a secondary objective, we will explore dietary intake, physical activity, 
attention, inhibitory control and working memory over the course of the study 
and across study arms. We acknowledge that we are not powered to detect 
between-group difference on these outcomes. However, inasmuch as participants 
assigned to the WW only group do not engage in inhibitory control training, we 
expect no change in attention, inhibitory control and working memory over the 
course of the study among participants randomized to WW only.  
 
• Qualitative outcomes measures will include participant’s satisfaction with WW 
and 
PolyRules! 
(if 
applicable) 
and 
perceived 
benefits. 
Perceived 
satisfaction/dissatisfaction and preferred features of the WW and PolyRules! app 
will be qualitatively assessed and data obtained in semi-structured interviews will 
be summarized.  
 
 
7.2 SAMPLE CONSIDERATIONS 
 
• Sample size was defined based on available funding such that we expect drop-
out over 3 months given the study is longitudinal. Therefore, a sample size of 30 
will provide us a reasonable sample size to estimate the effect size. 
 
 
7.3 STATISTICAL ANALYSES 
 
Descriptive analysis will be presented with mean ± standard deviation for quantitative 
variables, and frequency (percentages) for qualitative variables. A 95% confidence 
interval for the difference in weight loss between WW and WW + PolyRules! will be 
calculated. Cognitive test scores (inhibitory control, attention, verbal working memory 
tasks, visuo-spatial working memory tasks, and working memory capacity tasks),  
executive function, and physical activity questionnaires will be scored and summarized 
(Mean and SD) by group and used to inform the design of a larger randomized controlled 
trial. Calculations will be performed using R-package, version 4.0.53 

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7.4 REFERENCES 
 
1. 
Baumeister RF. Ego depletion and self-regulation failure: a resource model of self-
control. Alcohol Clin Exp Res. 2003;27(2):281-284. 
2. 
Baumeister RF. Self-regulation, ego depletion, and inhibition. Neuropsychologia. 
2014;65:313-319. 
3. 
Baumeister RF, Bratslavsky E, Muraven M, Tice DM. Ego depletion: is the active self a 
limited resource? J Pers Soc Psychol. 1998;74(5):1252-1265. 
4. 
Davis C, Salvy SJ, Wee CP, Vidmar A. Executive Function and Eating Addiction Qualities in 
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Vidmar AP, Wee CP, Salvy SJ. Food Addiction, Executive Dysfunction and Mood in 
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Yang Y, Shields GS, Guo C, Liu Y. Executive function performance in obesity and 
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Wyckoff EP, Evans BC, Manasse SM, Butryn ML, Forman EM. Executive functioning and 
dietary intake: Neurocognitive correlates of fruit, vegetable, and saturated fat intake in 
adults with obesity. Appetite. 2017;111:79-85. 
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Rodrigue C, Ouellette AS, Lemieux S, Tchernof A, Biertho L, Begin C. Executive 
functioning and psychological symptoms in food addiction: a study among individuals 
with severe obesity. Eat Weight Disord. 2018;23(4):469-478. 
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Pearce AL, Leonhardt CA, Vaidya CJ. Executive and Reward-Related Function in Pediatric 
Obesity: A Meta-Analysis. Child Obes. 2018;14(5):265-279. 
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Mora-Gonzalez J, Esteban-Cornejo I, Cadenas-Sanchez C, et al. Physical Fitness, Physical 
Activity, and the Executive Function in Children with Overweight and Obesity. J Pediatr. 
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Miller AL, Lee HJ, Lumeng JC. Obesity-associated biomarkers and executive function in 
children. Pediatr Res. 2015;77(1-2):143-147. 
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Gowey MA, Lim CS, Dutton GR, Silverstein JH, Dumont-Driscoll MC, Janicke DM. 
Executive Function and Dysregulated Eating Behaviors in Pediatric Obesity. J Pediatr 
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Eichen DM, Matheson BE, Liang J, Strong DR, Rhee K, Boutelle KN. The relationship 
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Blume M, Schmidt R, Hilbert A. Executive Functioning in Obesity, Food Addiction, and 
Binge-Eating Disorder. Nutrients. 2018;11(1). 
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Galindo Munoz JS, Morillas-Ruiz JM, Gomez Gallego M, et al. Cognitive Training Therapy 
Improves the Effect of Hypocaloric Treatment on Subjects with Overweight/Obesity: A 
Randomised Clinical Trial. Nutrients. 2019;11(4). 
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Lawrence NS, O'Sullivan J, Parslow D, et al. Training response inhibition to food is 
associated with weight loss and reduced energy intake. Appetite. 2015;95:17-28. 
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Veling H, van Koningsbruggen GM, Aarts H, Stroebe W. Targeting impulsive processes of 
eating behavior via the internet. Effects on body weight. Appetite. 2014;78:102-109. 
20. 
Steenbergen L, Colzato LS. Overweight and Cognitive Performance: High Body Mass 
Index Is Associated with Impairment in Reactive Control during Task Switching. Front 
Nutr. 2017;4:51. 
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Shipstead Z, Redick TS, Engle RW. Is working memory training effective? Psychol Bull. 
2012;138(4):628-654. 
22. 
Simons DJ, Boot WR, Charness N, et al. Do "Brain-Training" Programs Work? Psychol Sci 
Public Interest. 2016;17(3):103-186. 
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cognition? Front Psychol. 2011;2:226. 
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2010;465(7299):775-778. 
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Klingberg T, Fernell E, Olesen PJ, et al. Computerized training of working memory in 
children with ADHD--a randomized, controlled trial. J Am Acad Child Adolesc Psychiatry. 
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Franceschini S, Gori S, Ruffino M, Viola S, Molteni M, Facoetti A. Action video games 
make dyslexic children read better. Curr Biol. 2013;23(6):462-466. 
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training normalizes auditory sensory gating in schizophrenia: a randomized trial. Biol 
Psychiatry. 2011;69(5):465-471. 
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Huxlin KR, Martin T, Kelly K, et al. Perceptual relearning of complex visual motion after 
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Miyake A, Friedman NP. The Nature and Organization of Individual Differences in 
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through perceptual learning. Curr Biol. 2014;24(4):R146-147. 
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CONSENT FORM FOR RESEARCH
 Title:  SUPPLEMENTING EVIDENCE-BASED COMMERCIAL WEIGHT MANAGEMENT PROGRAM WITH 
INHIBITORY CONTROL TRAINING: A PILOT STUDY
STUDY SUPPORT PROVIDED BY: CEDARS-SINAI MEDICAL CENTER
PRINCIPAL INVESTIGATOR: SARAH-JEANNE SALVY, PHD
CSMC CO-INVESTIGATORS: ARASH ASHER, MD, PHD, JUN GONG, MD,  AND MARCIO DINIZ, PHD
STUDY CONTACT PHONE NUMBER AT CSMC: 310-423-2062 (24 HOURS)
We are seeking your consent to take part in this research study. Your participation in this research 
is voluntary. If you choose to participate, you can stop at any time. Please consider the following 
summary, along with the more detailed information provided throughout this consent form.
1.
WHAT IS THE PURPOSE OF THIS RESEARCH STUDY?
The purpose of this pilot study is to explore the benefits of supplementing the WW (formerly 
Weight Watchers) online program with a cognitive training game (PolyRules!) among adults with 
overweight or obesity.
You are being asked to take part in this research study because you showed interest in the study 
and are 18 years old or older. 
The study will enroll up to 30 people total.
2.
WHAT WILL HAPPEN DURING THE STUDY?
This section provides a general overview of what will happen during your participation in the 
study. Information included below should be considered before deciding to participate. Research-
related procedures are those performed solely for the research. They would not be performed if 
you did not take part in the study. 
Overview of study:

If you agree to participate in the study, you will be randomly assigned (like flipping a coin) 
to one of two groups: 
Group 1: WW (formerly Weight Watchers) only
Group 2: WW + Cognitive training game (PolyRules!)
CSMC IRB No: STUDY00001164
CSMC Date Effective: 1/15/2021


You will be asked to complete demographic, and medical history questionnaires and a 
computer-administered cognitive test at baseline/enrollment and after completing the 
three-month intervention protocol (described below). 

After the three-month intervention, you will be asked to participate in a one-on-one 
interview (conducted remotely) to share your experience in the study.

As compensation for completing all study procedures, you will receive a $30 gift card. 
Description of Study Arms:
If you agree to participate you will be randomly placed into one of the two groups. The study team 
has no control over which intervention you receive. 
Group 1: WW ((50% of participants, n = 15): Participants assigned to the WW arm will 
receive pre-loaded computer tablets and 3-month access to the WW digital program. The computer 
tablets will need to be returned to study staff after the intervention is completed. Participants will 
be provided a prepaid return box to mail the computer tablets to study staff. WW is a structured 
behavioral weight management program that focuses on diet, physical activity and mindset skills. 
The dietary approach is based on creating an energy deficit diet to produce weight loss while also 
being attentive to the quality of the calories. Specifically, the WW program assigns SmartPoints 
values to foods based on calories, sugar, saturated fat and protein. In addition, particular foods are 
assigned a points value of zero (0) to encourage a healthier eating pattern (e.g. fruits, vegetables, 
non-fat yogurt, fish). Upon sign-up, an individualized SmartPoints budget consisting of a daily 
SmartPoints target and weekly SmartPoints allowance is calculated based on height, weight, age 
and sex. The fitness component assigns FitPoints values to physical activities based on the type, 
duration, intensity and the participant’s body weight. Participants receive 24/7 access to coaches, 
automatic enrollment in a rewards program based on behaviors, weekly emails motivating lifestyle 
changes and a closed social network, in which WW members can interact with other members (if 
they choose to) via the WW app.
Group 2: WW + PolyRules! (50% of participants, n = 15): Participants assigned to the WW+ 
Polyrules! arm will receive access to the WW online program (as described above) and to the 
PolyRules! app for three months. Participants will be trained on how to use PolyRules! via Zoom 
or Team Meeting platforms. Participants will be asked to engage in daily cognitive training using 
the PolyRules! app for three months. They will be instructed to start with 20-min of daily cognitive 
training and to progressively increase their training time to 30-min. All interactions with 
PolyRules! will be passively recorded to monitor whether participants engage in cognitive training.
Semi-Structured Interview: After you complete the three-week intervention, you will be asked 
to take part in a one-on-one interview (conducted remotely over Zoom or Team Meeting) to obtain 
your feedback regarding your experience with the study. This interview will be audio recorded for 
accuracy and transcription purposes. Audio recordings will be confidential, and we will do our 
best to make sure that your identity is kept private, but we cannot guarantee total privacy. The 
audio files will be accessed only by verified members of the study team and will be kept until they 
have been analyzed. After analysis and completion of the study, all audio recordings will be 
destroyed.
CSMC IRB No: STUDY00001164
CSMC Date Effective: 1/15/2021

How long will you be in the study?
You will be in the study for approximately 12 months. This will involve 2 e-visits 
(baseline/enrollment, at completion of the intervention) 3 months apart and several interactions 
with the research staff throughout the study duration. Additionally, you will be asked to participate 
in a semi-structured interview to share your experience in the study.
Schedule of Procedures
Procedures
Enrollment
Intervention
Post-Intervention
Informed Consent (DocuSign)
X
Baseline assessment
X
Randomization
X
Equipment/software/application set-up 
and training
X
Intervention: 
-
WW only group
-
WW + PolyRules! group
X
Post-intervention assessment
X
Exit interview
X
Equipment Return via Prepaid Box
X
Compensation
X
3.
WHAT ARE THE POSSIBLE RISKS?
This section describes the possible risks and/or discomforts we anticipate you could experience 
that are related to the study procedures.
Although risks and discomfort are unlikely in this study, you may feel uncomfortable answering 
some of the questions. You do not have to answer any questions if you are not comfortable and 
can withdraw from the study at any time. 
This research involves the potential risk of accidental release of confidential information.  We will 
do our best to make sure that the personal information collected as part of this study is kept private. 
However, we cannot guarantee total privacy. Data will be stored in password-protected files 
accessible only to the investigators and staff under their supervision. In the database, only an ID 
code number will identify subjects. If information from this study is published or presented at 
scientific meetings, your name and other identifiable personal information will not be used.
Other risks include disclosure of your IP address when connecting the study provided your iPad to 
the internet. An IP address is a unique identifying number used to identify computers/devices 
connected to the Internet. An IP address might be static (i.e., always refer to one institution's 
server), dynamic (assigned upon connection), or pooled (a group of servers share one or more IP 
CSMC IRB No: STUDY00001164
CSMC Date Effective: 1/15/2021

addresses). IP addresses represent a form of potentially indirect identifying information such as 
city geolocation. An IP address is less of a threat to confidentiality than handwriting, fingerprints, 
postal-addresses, email addresses, handwritten signatures, or being observed completing a paper 
survey. We will not collect or use your IP address for any research purposes.
4.
ARE THERE BENEFITS IN TAKING PART IN THE STUDY?
If you agree to take part in this research study, there may or may not be direct medical benefit to 
you.  The possible benefits of taking part in the research study are improvements in cognitive 
functioning and/or physical activity. You may also enjoy the gamified cognitive training and 
physical activity regimen. However, no benefit is guaranteed. 
5.
WHY WOULD MY PARTICIPATION BE STOPPED?
Your participation in this study may be stopped at any time by the researcher without your consent 
for any reason, including:

The study is stopped or suspended;

Funding for the study is reduced, stopped or withdrawn;

If it is in your best interest;

You do not consent to continue in the study after being told of changes in the research 
that may affect you;

You do not follow the study procedures.
6.
ARE THERE ANY OTHER OPTIONS?
Your participation is voluntary, so you have the right to decline to participate or to withdraw 
from this research study at any time without any penalty or loss of benefits to which you would 
be entitled outside of the study.  Choosing not to participate will not affect the care you receive 
at Cedars-Sinai Health System.
7.
WILL MY INFORMATION BE KEPT CONFIDENTIAL?
We will do our best to make sure that the personal information collected as part of this study is 
kept private. However, we cannot guarantee total privacy. A copy of your research consent and 
authorization forms may be filed in your electronic medical record at CSMC. Your personal 
information may be given out if required by law. If information from this study is published or 
presented at scientific meetings, your name and other identifiable personal information will not be 
used. Organizations that may look at and/or copy your medical records for research oversight, 
quality assurance, and data analysis include: accrediting agencies, government and regulatory 
groups (such as Food and Drug Administration (FDA), Office for Human Research Protections 
(OHRP), etc.), safety monitors, companies that sponsor the study, and authorized representatives 
of the sponsor. 
8.
WHAT IF I BECOME ILL OR INJURED BECAUSE OF TAKING PART IN 
THIS STUDY?
You will not be in danger of any illness or injury from this research study.  However, should you 
believe that you are ill or have been injured as a result of your participation, please contact the 
study team at the phone number listed on page 1 of this consent form.
CSMC IRB No: STUDY00001164
CSMC Date Effective: 1/15/2021

9.
FINANCIAL CONSIDERATIONS
Costs of Participation
There will be no cost for you to participate in this study. However, if you elect to receive text 
message notifications or communications, standard text rates may apply that will not be covered 
by the study.
Compensation for Participating
You will be paid a $30 gift card for participating in the entirety of the research study at the end 
of the study. 
You may be required to complete a W-9 Form (tax form where you provide your Social Security 
Number) in order to receive payment. The W-9 Form will be maintained by our accounting 
department at Cedars-Sinai. Although any amount of payment may be reportable (check with a tax 
professional if you have questions about your obligations), if total payment by Cedars-Sinai is 
$600 or more in a calendar year, a 1099 Form will be filed with the IRS in accordance with federal 
tax law.
If you are a Cedars-Sinai employee, you should provide your employee identification number to 
the research team so that your payment can be appropriately processed through Payroll.  For your 
own protection and to comply with tax laws, your payment for participation will be reported to the 
IRS together with other compensation you receive from Cedars-Sinai.
Financial Interest in the Research
The PI and institution have no potential financial conflict of interest with respect to this study.
10.
WHAT IF I HAVE QUESTIONS OR PROBLEMS?
Please contact the investigator listed on the first page of this form for questions or concerns about 
the research.  If you have questions, problems, or concerns that you want to discuss with someone 
who is not associated with this study, or want to offer suggestions or feedback, please contact:
Cedars-Sinai Human Research Protection Program (HRPP)
Phone: (310) 423-3783
Email: ResearchConcerns@cshs.org
The Cedars-Sinai HRPP has been established to protect the rights and welfare of research 
participants.  You may also contact the Cedars-Sinai HRPP if you want to offer input or obtain 
information regarding the study.
11.
CONSENT PROVISIONS 
If you sign this form below, it means that:  
CSMC IRB No: STUDY00001164
CSMC Date Effective: 1/15/2021

(1) You have taken the time to carefully read and understand the information presented in 
this informed consent form; you should discuss it with others, and if appropriate seek a 
second opinion to make an informed decision;
(2) The information concerning the research study and its involved procedures has been fully 
explained to you and your questions have been answered to your satisfaction; 
(3) You have received and understand all of the information you desire regarding your 
participation in the research study; 
(4) You have considered the potential risks, any anticipated benefits and alternatives (and 
their relative risks and benefits) of participation;
(5) You are voluntarily agreeing to participate in this research study;
(6) You understand that by consenting to participate in the research, you are not giving up any 
of your legal rights; 
(7) You understand that you have the right to be informed of significant new findings related 
to this research study which may affect your willingness to continue participating in this 
study; and
(8) You have been provided with a copy of the “Experimental Subject’s Bill of Rights”, if 
applicable to this research study, and have been provided with an opportunity to ask 
questions regarding the Bill of Rights.
You will receive a signed and dated copy of this form and the Experimental Subject’s Bill of 
Rights.
CSMC IRB No: STUDY00001164
CSMC Date Effective: 1/15/2021

SIGNATURE PAGE
Consent Form for Research 
SIGNATURE BY THE PARTICIPANT: I hereby agree to participate in the research study 
described to me during the informed consent process and described in this informed consent 
form.  You will be given a signed copy of this form.
Name of Participant (Print)
Signature
Date Signed
Optional Contact for Future Research Studies: I hereby give permission to Dr. Sarah-Jeanne 
Salvy’s research team to contact me about future research studies.
Name of Participant (Print)
Signature
Date Signed
SIGNATURE BY THE INVESTIGATOR: I attest that all the elements of informed consent 
described in this form have been discussed fully in non-technical terms with the participant.  I 
further attest that all questions asked by the participant were answered to the best of my 
knowledge.   
Name of Investigator (Print)
Signature
Date Signed
CSMC IRB No: STUDY00001164
CSMC Date Effective: 1/15/2021

APPENDIX: EXPERIMENTAL SUBJECT’S BILL OF RIGHTS
In accordance with California Health and Safety Code 24172, any person who is required to 
consent to participate as a subject in a research study involving a medical experiment or who is 
requested to consent on behalf of another has the right to:
1.
Be informed of the nature and purpose of the experiment.
2.
Be given an explanation of the procedures to be followed in the medical experiment, and 
any drug or device to be utilized.
3.
Be given a description of any attendant discomforts and risks to the subject reasonably to 
be expected from the experiment.
4.
Be given an explanation of any benefits to the subject reasonably to be expected from the 
experiment, if applicable.
5.
Be given a disclosure of any appropriate alternative procedures, drugs or devices that 
might be advantageous to the subject, and their relative risks and benefits.
6.
Be informed of the avenues of medical treatment, if any, available to the subject after the 
experiment if complications should arise.
7.
Be given an opportunity to ask any questions concerning the experiment or the procedure 
involved.
8.
Be instructed that consent to participate in the medical experiment may be withdrawn at 
any time and the subject may discontinue participation in the medical experiment without 
prejudice.
9.
Be given a copy of any signed and dated written consent form used in relation to the 
experiment.
10.
Be given the opportunity to decide to consent or not to consent to a medical experiment 
without the intervention of any element of force, fraud, deceit, duress, coercion, or undue 
influence on the subject’s decision.
CSMC IRB No: STUDY00001164
CSMC Date Effective: 1/15/2021