Applying Novel Technologies and Methods to Inform the Ontology of Self-Regulation: Aim 4
Phase: NA
Conditions: Smoking, Binge Eating, Behavior
Sponsor: Stanford University

 
Applying Novel Technologies and Methods to 
Self-Regulation: Behavior Change Tools for 
Smoking and Binge Eating 
NCT03687658 
September 30, 2021 
Russell A Poldrack, PhD, Principal Investigator 
Stanford University 
Stanford, California 94305 
1. 
PURPOSE OF THE STUDY 
a. 
Brief Summary 
 
This study aims to examine targets of self-regulatory function among two 
exemplar populations for which behavior plays a critical role in health outcomes: 
smokers and individuals who binge eat (BED). This is the fourth phase of a study (first 
phase is IRB #34926) that aims to identify putative mechanisms of behavior change to 
develop an overarching "ontology" of self-regulatory processes. This phase features a 
mobile interaction period to engage targets in these samples with self-regulation 
assessment and behavior change tools. 
b. 
Objectives 
This study aims to improve our understanding of self-regulation 
by integrating a diverse literature under one ontology. An ontology systematizes our 
knowledge, and provides a common language to discuss relationships between 
putative control processes. Additionally, health risk behavior characterized by self-
control deficits (e.g. non-adherence to medical regimens, poor impulse control) are 
destructive to persons and societies, making self- 
control a fruitful target for intervention. A systematic ontology 
of self-regulation will better define the 'nodes' and 'relationships' 
that interventions should act upon, thus increasing their efficacy. This fourth phase 
of this ongoing project attempts to intervene and improve self-regulation based 
upon a cell-phone based intervention.  
c. 
Rationale for Research in Humans 
This is a study of human brain function and behavior, and thus it is essential to use 
human subjects for the project.  

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2. 
STUDY PROCEDURES 
a. 
Procedures 
Study participation will include timely completion of the eligibility process, 
completion of an introductory session for signing a consent form and completing 
baseline surveys (see below), completion of 1 MRI session, completion of a 4-week 
mobile interaction period, and completion of 1 additional follow-up MRI session.  
Participants will be compensated in full at the end of the study period.  
Eligibility Process:  
The eligibility process consists of an online eligibility questionnaire, which is housed 
on the Stanford Research Electronic Data Capture (REDCAP) website.  
The questionnaire will have branching criteria that aligns with the inclusion and 
exclusion criteria. Potential participants are assigned 
a study identification number upon beginning the questionnaire. This number is not 
associated with any protected health information.  
A Waiver of Documentation is being requested because participants will be 
consenting on the online eligibility questionnaire without signing the consent form 
(only selecting yes/no options). In addition, a Waiver of Authorization for 
Recruitment is being collected due to the collection of personal health information 
on the online eligibility questionnaire (See Attachments for Waiver of 
Documentation and Waiver of Authorization for Recruitment).  
If eligible and willing to participate after completing the online eligibility 
questionnaire, potential participants will then be invited to participate in a study 
session at the CNI (Center for Cognitive and Neurobiological Imaging) at Stanford.  
Prior to the MRI session, subjects will be invited to attend Session 1 in person, 
lasting 30-60 minutes. This session is aimed at improving retention efforts for 
subjects planning on arriving to the MRI session, by developing an initial point of 
in-person contact. At this session, participants will first see a copy of a HIPAA 
embedded informed Consent form including project title, PI's contact information, 
brief descriptions about the study, a description on the risks and benefits, payment 
information and privacy/confidentiality. The researcher will verbally confirm that 
the participant has read through and understood the entirety of the consent form.  
During this session, participants may also be asked to show proof of vaccination for 
COVID-19. Proof of vaccination will not be retained by the study team.  
Participants will also fill out the screening questionnaire provided by CNI to check 
for contraindications (attached in attachments as CNI screening form). 
Two different researchers will look through and check the responses to the 
screening form.  
Prospective participants will have an option to decline or to take part in the study. 
The subject will be informed explicitly that they may opt out of participation of the 
experiment at any point without penalty.  

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After signing the consent form, subjects will be asked to complete certain 
questionnaire items.  
These include:  
Alcohol, Smoking and Drug Questionnaire: Subjects are presented with a 
questionnaire assessing smoking, drinking, marijuana and other drug habits. 
The questions for marijuana are taken from Cannabis Use Identification Test.  
The questions for other drugs are taken from the DAST-10.  
Reward-based Eating Drive-13 Scale Questionnaire: Subjects are presented with 
questions from the RED-13 scale prior to scan in order to capture individual 
differences in the severity of feeling and behaviors related to binge eating.  
This Questionnaire also includes questions about physical activity, drawn from the 
LCAT-2.2 scale.  
In addition to completion of tasks and questionnaires, subjects will 
be asked to fill out a demographic form prompting them for age, sex, weight, height, 
race, ethnicity, education level, relationship status, divorce count, years in a 
relationship, number of relationships, number of children, household income, debt, 
retirement account, whether they own or rent a house, traffic tickets, traffic 
accidents, past or current problems with gambling, caffeine intake, and legal 
troubles. These "real-world" questions will be related the constructs measured in 
the above tasks and questionnaires.  
Please see attachment [Baseline & Follow-Up Questions (Stanford IRB)_date] for 
full suite of questions asked to subjects, including 
their source. 
These items from questionnaires relate to personality and self-control, 
and any questions not answered during session 1 will be completed during the MRI 
session.  
This will conclude the Session 1.  
Subjects will then participate in 1 MRI session (1.5 hours of MRI scanning plus 1.25 
hours of practice and setup time) at the CNI in Jordan Hall. 
This may be on a separate date from the Session 1.  
Subjects will complete 5 tasks (see below) in the scanner.  
Prospective participants will have an option to decline or to take 
part in the study. The subject will be informed explicitly that they may opt out of 
participation of the experiment at any point without penalty.  
MRI SESSIONS  
Subjects will participate in MRI sessions in the CNI in Jordan Hall, where they will 
complete the tasks described below.  
Participants may practice the experimental tasks they will be performing in the 
scanner on a desktop or laptop computer in the observation room. 

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They will also complete the battery of Participants will be informed that they may 
leave if at any time they feel uncomfortable or realize they no longer wish to 
participate.  
Subject in our smoking subject group will be asked to abstain from smoking for 3 
hours before the start of the session (4 hours before the start of the scan and totaling 
5.75 hours of abstaining from smoking per scan session).  
b. 
Subjects in our Binge Eating group will be asked to fast for 3 hours before the start 
of the session (4 hours before the start of the scan and totaling 5.75 hours of fasting 
per scan session). All subjects will be asked to weigh themselves on a body weight 
scale at the CNI prior to entry.  
After entering the magnet room, participants will be given earplugs and/or 
headphones to wear. They will be instructed to lie on a table. They will be provided 
with foam padding and blankets for comfort while in the scanner. The table will 
then be slid into the scanner so that the head and upper body are inside the magnet 
tube.  
Anatomical Imaging: Conventional anatomical scans (images that show us the 
structures of the brain) will be taken during the MRI sessions.  
Functional Imaging: After that, high-speed functional MRI images will be obtained 
while the subjects complete a set of tasks (see 'TASKS' below) or lie at "rest" while 
performing no explicit task or watching a movie clip that may include images of 
smoking or palatable food stimuli.  
Participants will be in the MRI scanner for approximately 90 minutes and at all 
times will have access to a means with which they can immediately indicate their 
desire to terminate the session. They will be encouraged to terminate the session if 
they become uncomfortable.  
The study will use the 3T UHP system at CNI. The UHP shares a common software 
and hardware architecture to GE's FDA-approved Premier system but uses a 
higher-performance gradient coil and is not FDA approved for diagnostic use and is 
subject to the 21 CFR 812 investigational device(IDE) regulations as well as 21 CFR 
50 and 56. The system has been tested by GE according to UL606001-1 and also for 
compliance with IEC 60601-2-33 (ed 3.1) --meeting limits and guidelines for 
peripheral nerve stimulation, patient thermal, SAR limit, acoustic noise, 
flammability rating UL94-5VA for safety covers, hydrostatic pressure, electrical 
hazards, dielectric strength and pinch 
point. The MRI scans in this study will also utilize operational parameters within 
FDA guidelines for Nonsignificant Risk thus an Investigational Device Exemption 
(IDE) from FDA should not be necessary.  
TASKS  
Stop Signal Task: Subjects are presented with 4 "go" shapes (circle, triangle, 
diamond, square) and are instructed to respond to two shapes with one key press 
and the other two shapes with another key press. On each trial, subjects make a 
speeded choice response to the "go" stimulus, except on a subset of trials when an 

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additional "stop signal" occurs after the "go" stimulus. This instructs the subject to 
try to withhold responding on that trial.  
Conditional Motor Selective Stop Signal Task: Similar to the Stop Signal task 
except subjects stop to the stop signal only if they were going to make one go 
response on that trial (e.g., right hand response) but not if they were going to make 
the other response (e.g., left hand response).  
c. 
Delay Discounting Titration Task: Subjects must choose between sooner but smaller 
rewards versus larger but later rewards. The smaller reward will not always be 
immediate and the reward amounts will be chosen randomly from a uniform 
distribution of a given interval. This allows for the estimation of a subjects' discount 
rate and for the comparison of different model fits of discounting behavior.  
Regulation/Manipulation task: One each trial, subjects will be 
presented either a "now" cue or a "later" cue, then will see a stimulus from one of 
three classes, then rate the stimulus on their degree of craving. On "now" cue trials, 
subjects are directed to think about the immediate feelings associated with 
consuming that stimulus. On the "later" cue trials, subjects are directed to think 
about the long-term consequences associated with consuming that stimulus. The 
following are the three classes of stimuli: smoking-related (presented only to the 
smoking group), palatable food (presented only to the binge eating sample), or 
neutral stimuli 
(presented to both groups). Finally, on each trial, subject rate the 
stimulus for their current degree of craving.  
Movie Watching "task": Subjects will watch a small set of movie clips with 
embedded smoking and food stimuli.  
• Physiological Monitoring and Recording: Subjects may be asked to allow non-
invasive physiological measurements during other tasks. Eye movements may be 
tracked using a small camera. Physiological data including respiration, heart rate, 
and galvanic skin response may be monitored using the Biopac monitoring system. 
If tasks require spoken responses, the responses may be recorded using a 
microphone in the scanner.  
• Other Information: For subjects who have previously participated in studies in the 
Poldrack lab, information from other tasks will be available. 
This information may be added to the study record for this study. This information 
may include:  
o Questionnaires for screening 
o Physiological data including spontaneous eye blink rate 
o Imaging data from structural and functional MRI sessions  
MOBILE INTERACTION PERIOD:  
Participants will be asked to complete items in response to queries using mobile 
ecological momentary assessment (EMA); i.e., questions/questionnaires asked at a 
given time point outside of a laboratory setting via a mobile device. We will assess 
antecedent conditions prior to health risk behavior: smoking or binge eating among 

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our smoking and binge eating samples, respectively. These antecedent conditions 
include mood, companionship, location, and temptation. We will offer the resources 
of Laddr? (a science-based behavior change intervention delivered via an 
interactive, self-directed mobile platform) to individuals and assess the effect of this 
mobile intervention system on putative targets of self-regulatory function. Laddr 
will also be used to deliver the EMAs to participants. 
Participants will use their own smartphones.  
We will ask participants to respond to EMAs and to engage with the mobile 
intervention for 28 consecutive days. We will prompt them four times daily to 
inquire about health risk behavior and ask them to complete measures of self-
regulation and potentially important contexts. Please see the attachment [EMA 
Questions] for the list of actual questions asked.  
We will send the four prompts at random times within time windows 
(e.g., 8– 
11:30 AM, 11:30 AM–3 PM, 3–6:30 PM, 6:30–10 PM). The time windows may vary 
based on participants' waking hours, and we will program through 
the software at least an hour between prompts (e.g., if a participant 
receives a prompt at 11 AM, he/she cannot receive another prompt until 
12 PM). We will ask them to use Laddr daily to, at a minimum, update 
progress toward goals and complete various activities on the application 
that we expect will improve their self-regulation. 
Participants will be recommended priority therapy guides (binge 
eating for the binge eating sample; smoking for the smoking sample) and 
can also choose to engage with other guides, such as depression, 
anxiety, and substance use.  
Participants will also be asked to use devices that allow for 
objective measuring of behaviors of interest. We will ask participants 
in the smoking sample to provide carbon monoxide (CO) samples via a breath CO 
meter (iCO? Smokerlyzer?, Bedfont? Scientific Ltd.). The monitor measures breath 
CO in parts per million (ppm) based on the conversion of CO to CO2 over a 
catalytically active electrode. We will ask smoking participants to provide one CO 
sample in the same time window each day. Smoking participants will have a goal of 
smoking abstinence by the end of the study, as evidenced by a CO reading of less 
than 4 ppm. We will ask participants in the binge eating sample to wear a physical 
activity tracking device (Fitbit Flex 2?), which tracks 
steps, distance, calories burned, active minutes, hourly activity, stationary time, and 
sleep. 
Objective measures of eating are in a nascent phase, and all 
participants in the binge eating sample are overweight or obese, making physical 
activity a suitable behavior to measure. We will ask binge eating participants to 
wear the activity tracker for at least 12 hours 
per day. We will encourage participants to use a changing criterion design to set 
stepped goals, in which participants set a 7-day activity criterion goal and are 
encouraged to increase their criterion goals in each subsequent 7-day block if they 
achieve the goal on at least 4 of 

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the 7 days. We will ask Binge eaters to also self-report their activity 
for the day in Laddr.  
Please see the attachments [Fitbit Flex 2] and [ICO Smokerlyser] for 
a description of each of the devices used in measuring our behaviors of interest.  
Participants in the smoking sample may use nicotine replacement medications, and 
we will track which participants use these medications. Potential participants taking 
medications for psychiatric reasons 
will be excluded from both samples.  
After completion of the 4-week mobile interaction period, participants will return 
for a 2.75 hour follow-up neuroimaging session, consisting of around 1.25 hour of 
practice, setup and assessments outside the scanner, and around 1.5 hours of 
scanning. Participants will be compensated in full at the completion of this session.  
d. 
Procedure Risks 
None of the proposed procedures involve more than minimal risk.  
e. 
Use of Deception in the Study 
Deception will not be used.  
f. 
Use of Audio and Video Recordings 
Video recording may be used to record eye movements and pupil diameter, but only 
traces of these measures will be saved; no raw video will be 
saved.  
g. 
Alternative Procedures or Courses of Treatment 
N/A 
h. 
Will it be possible to continue the more (most) appropriate therapy for the 
participant(s) after the conclusion of the study? 
N/A 
i. 
Study Endpoint(s) 
N/A 
3. 
BACKGROUND  
a. 
Past Experimental and/or Clinical Findings 
Health risk behavior, including poor diet, physical inactivity, 
tobacco and other substance use, causes as much as 40% of the illness, suffering, 
and early death related to chronic diseases. Non-adherence to medical regimens is 
an important exemplar of the challenges in changing health risk behavior -- and is 
common, 
costly (due to increased utilization of healthcare services), and associated with poor 

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patient outcomes. This may be particularly evident among older adults who 
experience a disproportionate amount of the chronic disease burden in the U.S. 
Although an 
array of interventions have been shown to be effective in promoting health behavior 
change, much of this work has been "siloed" (focused on one disorder at a time).  
Additionally, interventions are typically intended to engage multiple mechanisms of 
behavior change, but the mechanisms by which they actually work are infrequently 
systematically examined. Because the need to alter health-related behavior is 
ubiquitous across medicine, understanding the extent to which the principles of 
effective health behavior change, and the mechanisms by which they work, are 
similar or differ across health conditions and settings is a critically important area 
of scientific inquiry.  
One promising domain of putative behavior change targets is that of self-control -- a 
person's ability to manage cognitive, motivational and emotional resources to act in 
accordance with his/her long-term goals. A systematic ontology of self-control will 
better define the 'nodes' and 'relationships' interventions should act upon, thus 
increasing their efficacy.  
  
b. 
Findings from Past Animal Experiments 
Because this work is focused on self-regulation in humans, there are no animal 
studies that are directly relevant.  
4. 
RADIOISOTOPES OR RADIATION MACHINES 
a. 
Standard of Care (SOC) Procedures 
Identify Week/Month of Study 
Name of Exam 
Identify if SOC or Research 
N/A 
N/A 
N/A 
b. 
Radioisotopes 
i. 
Radionuclide(s) and chemical form(s) 
N/A 
ii. 
Total number of times the radioisotope and activity will be administered (mCi) and 
the route of administration for a typical study participant 
N/A 
iii. 
If not FDA approved: dosimetry information and source documents (package insert, 
Medical Internal Radiation Dose [MIRD] calculation, and peer reviewed literature) 
N/A 
c. 
Radiation Machines – Diagnostic Procedures 
i. 
Examination description (well-established procedures) 

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N/A 
ii. 
Total number of times each procedure will be performed (typical study participant) 
N/A 
iii. 
Setup and techniques to support dose modeling 
N/A 
iv. 
FDA status of the machine and information on dose modeling (if procedure is not 
well-established) 
N/A 
d. 
Radiation Machines – Therapeutic Procedures 
i. 
Area treated, dose per fraction/number of fractions, performed as part of normal 
clinical management or due to research participation (well-established procedures) 
N/A 
ii. 
FDA status of the machine, basis for dosimetry, area treated, dose per fraction and 
number of fractions (if procedure is not well-established) 
N/A 
5. 
DEVICES USED IN THE STUDY 
a. 
Investigational Devices (Including Commercial Devices Used Off-Label) 
Investigational Device 1 
Name: 
Laddr Mobile Application 
Description: 
Laddr is a mobile phone-based behavioral tool addressing self-regulatory 
function in individuals via self-management tools and skills training 
modules.  
 
Significant Risk? (Y/N) 
N 
Rationale for Non-Significant Risk 
The device does not meet the definition of a significant risk device. The 
device is not intended as an implant, does not support or sustain human 
life, is not being used for the purposes of diagnosing, curing, mitigating, 
treating disease or preventing impairment of health, cannot cause 
significant harm to any subjects, does not  
appear on any FDA list of significant risk devices, and cannot cause any 
harm to subjects which could be life threatening, cause permanent 
impairment of body function, cause permanent damage to body structure, 
or necessitate medical or surgical intervention to preclude permanent 
impairment of a body function or preclude permanent damage to body 
structure.  
 
Investigational Device 2 
Name: 
3T-UHP 
Description: 
The 3T Ultra-High Performance (UHP) MRI scanner from GE is an 
upgrade to the 3T MR750 which was a commercial FDA- approved 
system. The UHP system utilizes many components from GE's 3T Signa 
Premier, including gradient drivers, power supply, transmit and receive 
system electronics, but uses a higher-performance gradient coil.  
Significant Risk? (Y/N) 
N 

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Rationale for Non-Significant Risk 
The 3T Ultra-High Performance (UHP) MRI scanner from GE is an 
upgrade to the 3T MR750 which was a commercial FDA-approved 
system. The UHP system utilizes many components from GE's 3T Signa 
Premier, including gradient drivers, power supply, transmit and receive 
system electronics, but uses a higher-performance gradient coil. The 3T 
UHP system is not FDA approved, and is subject to the 21 CFR 812 
investigational device(IDE) regulations as well as 21 CFR 50 and 56. 
The system has been tested by GE according to UL606001-1 and also for 
compliance with IEC 60601-2-33 (ed 3.1) -- meeting limits and 
guidelines for peripheral nerve stimulation, patient thermal, SAR limit, 
acoustic noise, flammability rating UL94-5VA for safety covers, 
hydrostatic pressure, electrical hazards, dielectric strength  
and pinch point. The MRI scans in this study will also utilize operational 
parameters within FDA guidelines for Nonsignificant Risk thus an 
Investigational Device Exemption (IDE) from FDA should not be 
necessary. In addition, the MR research being conducted requires highly 
specialized software that does not exist in the clinical MR market so it is 
designed and implemented by researchers at the CNI. Any such software 
will be considered investigational, will function as a non-significant risk 
device, and is subject to the 21 CFR 812 investigational device(IDE) 
regulations as well as 21 CFR 50 and 56. The investigational image 
acquisition software will conform to FDA guidelines for MR safety 
related to heating (SAR), peripheral nerve stimulation (dB/dt), and 
acoustic noise.  
 
 
b. 
IDE-Exempt Devices 
IND-Exempt Device 1 
Name: 
Fitbit Flex 2 
Description: 
The device is a fitness tracker meant to be worn around the wrist, and 
capable of tracking steps, distance, calories burned, and sleep.  
IND-Exempt Device 2 
Name: 
iCO Smokerlyzer 
Description: 
The device is a breath carbon monoxide (CO) monitor connected to a 
personal mobile device, allowing testing of CO levels in participants.  
 
6. 
DRUGS, BIOLOGICS, REAGENTS, OR CHEMICALS USED IN THE STUDY 
a. 
Investigational Drugs, Biologics, Reagents, or Chemicals 
Investigational Product 1 
Name: 
N/A 
b. 
Commercial Drugs, Biologics, Reagents, or Chemicals 
Commercial Product 1 
Name: 
N/A 
7. 
DISINFECTION PROCEDURES FOR MEDICAL EQUIPMENT USED ON BOTH HUMANS AND 
ANIMALS 
The bed/table and accessories that are used for the animals is different than the table humans use. 
Physiologic monitoring equipment is cleaned with a commercial disinfectant such as Roccal, 
Conflick,Sani-Wipes, or a 10% Bleach solution. All RF coils and positioning accessories are 
wrapped in plastic wrap or plastic bags for use with animals. Everything, even if it is animal use 

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only, is cleaned with the above disinfectants after every use even if they are wrapped in plastic. 
The Lucas Center is checked yearly by several groups at Stanford who approve animal research 
in human systems: Stanford Health & Safety. We are reviewed by: Stanford APLAC panel; 
USDA; NIH; and Aaalac."  
8. 
PARTICIPANT POPULATION 
a. 
Planned Enrollment 
We plan to recruit a local sample of 100 subjects; because of attrition, we may need to 
recruit up to 125-154 individuals in order to obtain 100 complete subjects. Sample will 
consist of 50 smokers and 50 individuals who binge eat (BED). These are two exemplar 
populations that putatively involve self-regulatory dysfunction.  
 
b. 
Age, Gender, and Ethnic Background 
Our experiments will not restrict participants based upon gender, racial, or ethnic background. 
We will restrict participants to an age range of 18-50 years.  
 
c. 
Vulnerable Populations 
Students may be enrolled in the proposed study, though they are not targeted specifically 
for recruitment.  
The rationale for including students is that they comprise a significant proportion of the 
local population and fall within the stated age range for our study. To protect these 
individuals, participation will not be made mandatory as a part of any academic work, 
and the PI will not recruit students from his own classes as subjects.  
 
d. 
Rationale for Exclusion of Certain Populations 
The present research will include women and minorities, though the research is not specifically 
targeting these groups. Children are excluded because their brains are still developing and thus 
including them would introduce unwanted variability in the study.  
 
e. 
Stanford Populations 
Volunteers will be recruited from Stanford campus and surrounding areas. Although 
enrollment will not be restricted to Stanford community members, based on past 
experience of other labs we anticipate that the participants will come from the Stanford 
community, including students and university personnel. All participants will provide 
informed consent and will receive equivalent compensation. No participants will be 
associated with the lab.  
 
f. 
Healthy Volunteers 
All participants will be healthy volunteers, with the rationale being that we aim to 
understand the brain bases cognitive and self-regulatory processes in the human brain.  

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Subjects are specifically being recruited for either meeting DSM criteria for Binge Eating 
Disorder, or falling under classification as heavy smokers (5+ cigarettes/day), and all 
recruitment language is written in a neutral but explicit way relevant to the goals of the 
study (please see attached language for recruitment).  
It is possible that, based on information gained during this study, the investigators may be 
required to report information to the appropriate authorities.  
The Protocol director and study research staff will monitor participant safety throughout 
the duration of the study, and follow all procedures outlined in the Stanford CNI's 
recommendations for incidental findings outlined here: 
https://cni.stanford.edu/wiki/Operations#Incidental_Findings.  
Subjects will be screened for lifetime history of major depression using the Stanford 
PHQ-8 scale, but will not be excluded on this basis.  
Standard MRI procedures are associated with no more than minimal risk to participants.  
 
g. 
Recruitment Details 
Subjects will be recruited from the local community utilizing several methods of 
recruitment.  
First, we will advertise our studies through approved paper flyers around the Stanford 
campus (see Attachments for Study Flyers). Minor editing changes may be made to 
recruitment materials to enhance clarity.  
These flyers may include the web address for the department-wide recruitment website.  
We will use the same language in our flyers in some of the following recruitment 
methods:  
The study will be posted on Sona, the online recruitment system used by the psychology 
department.  
We may advertise our studies in local newspapers (specifically, the Palo Alto Daily and 
the Palo Alto Weekly).  
Phone scripts may be used by personnel Sunjae Shim and/or Jaime Rios in order to 
contact potential subjects drawn from Dr. Bohon's prior studies, who have indicated they 
wanted to be contacted about future studies.  
We may advertise on our lab web site (www.poldracklab.org).  
We may advertise using online resources such as Craigslist.  
Additional recruitment methods include online ads that display our study logo and link on 
newsfeeds of individuals who meet our demographic and/or inclusion criteria; online 
postings (e.g., Craiglist, NextDoor); existing e-mail distribution lists (e.g., KMGZ sports 
station, Stanford Staffers, corporate wellness programs, local support groups); 
advertisements through Reddit and Google Adwords; email invitations to individuals 
from Dr. Bohon's prior studies who indicated they wanted to be contacted about future 
studies; email invitations sent by other Stanford PIs to individuals who indicated they 
wanted to learn more about future studies (other PIs would forward our recruitment 
materials on our behalf).  
We have also created a Facebook business page for our study, through which we have 
posted the language from the attached 'onlineadvertisements_aim4' files. Facebook does 
not allow advertisers to disable comments or likes on advertising posts, a potential 
avenue for participants to share the study. One of the potential risks of this is that patients 
may inadvertently post about their health conditions as relevant to the smoking or binge 

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eating studies. In order to avoid this, we will implement the solution detailed here 
(https://www.pcsteps.com/2273-disable-comments-on-a-facebook-page/), in order to 
automate our comment disabling. This approach entails listing commonly used words 
(such as 'to') as 'forbidden' through the 'page moderation' available on Facebook. Any 
comments not captured by this approach will be deleted manually by our account admin 
(Amy Chieng on our protocol) within no more than 24 hours of their submission.  
These methods also include posting and circulating recruitment flyers and posters at 
community and corporate organizations (e.g., Paint the Bay, Palo Alto Medical 
Foundation, Stanford Multicultural Fest, Be Well Fair, Apple events).  
Additional subjects will also be identified from records of subjects identified by local 
collaborators at Stanford (Dr. Bohon and Dr. Prochaska), as particularly suitable for our 
desired subject populations. (Please see Attachment for Recruiting from Existing 
Databases).  
We will use email contact as a potential method of recruitment, iso that we might contact 
lists of interested participants, such as the psych-subjects list maintained by the 
department.  
Individuals who are interested in participating in psych studies self-subscribe to the 
department's email list, and are free to unsubscribe at any time. Only registered 
experimenters in the department are permitted to post to the list, and it is carefully 
monitored by the department. This recruitment method is widely used in the department.  
h. 
Eligibility Criteria 
i. 
Inclusion Criteria 
Selection of participants will involve screening for suitability for fMRI, along with 
general health questionnaire. Screening survey [See Appendix item 'Screening 
Eligibility V(x) '] will also be administered online in order to determine eligibility for 
study.  
Follow-up questionnaire will be administered immediately before the scan session. 
Upon arrival for the scan session, if participants do not meet selection criteria 
(detailed below) they will be paid at a rate of $20/hour for their time but will 
discontinue participation in the study. If subjects do meet selection criteria they will 
then participate in the fMRI session.  
All potential subjects will also need to successfully complete the screening forms at 
the Stanford Center for Cognitive and Neurobiological Imaging (CNI). Those 
subjects who present no contraindications to being scanned will be allowed to 
participate.  
All participants must meet the following criteria:  
Inclusion criteria: 
- Age 18–50 years 
- Understand English sufficiently to provide informed consent 
- Use a smartphone operating system compatible with Laddr 
- Have received a COVID-19 vaccine, and completed the vaccine-specific waiting 
period for full immunity  

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Additional inclusion criteria for binge eating sample: 
- 27 ≤ BMI ≤ 40 kg/m2 
- Have binge eating disorder according to DSM-5 criteria  
- Non-smoking (defined as no cigarettes in past 12 months—this includes former and 
never smokers) - Confirmed interest in a physical activity intervention 
- Use a smartphone compatible with Fitbit  
Additional inclusion criteria for smoking sample: 
- Smoke 5 or more tobacco cigarettes/day for past year 
- 17 ≤ BMI < 27 kg/m2 
- Confirmed interest in a smoking quit attempt 
- Use a smartphone compatible with the iCO Smokerlyzer  
 
ii. 
Exclusion Criteria 
MRI specific exclusion criteria:  
- Volunteers will be excluded for any contraindications to MRI as identified on the 
CNI screening form: 
https://cni.stanford.edu/cniwiki/images/5/59/CNI_Screening_form.pdf  
Significant medical illness (both samples): 
Have had heart attack (MI), stroke, coronary heart disease, congestive heart failure, 
or angina  
Have had coronary artery bypass surgery or cardiac catheterization such as 
percutaneous transluminal coronary angioplasty (PTCA), cath or stent placement  
Have moderate to severe asthma, or chronic obstructive pulmonary disorder (also 
called emphysema or chronic bronchitis)  
Had cancer within the past 5 years (except non-melanoma skin cancer)  
Currently under medical care for digestive issues, gastrointestinal distress, abdominal 
pain, or diarrhea  
Had an organ transplant  
Have an immunodeficiency disorder  
NOTE: Ask about but don't exclude on diabetes  
Any current substance use disorder  
Will not exclude based on use of substances, but need to be sure they aren't 
intoxicated in scanner  
History of head trauma with loss of consciousness, cerebrovascular accident, 
seizures, neurosurgical intervention, or brain tumor  
History of mental disorder due to a medical condition  

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Lifetime history of major psychotic disorders (including schizophrenia and bipolar 
disorder)  
Current use of medication for psychiatric reasons (excluding for anxiety and 
depression)  
Current use of prescription pain medications (e.g., Vicodin, oxycodone)  
Current use of any medication for smoking (Exceptions: short-acting NRT (e.g., gum, 
lozenge, nasal spray, inhaler)) - (will screen out for Wellbutrin or varenicline)  
Current use of any medication for weight loss  
Have undergone weight-loss surgery (e.g., gastric bypass, lap band)  
Current nighttime shift work or obstructive sleep apnea  
Additional exclusion criteria for Binge Eating Sample:  
Compensatory behavior (e.g., purging, excessive exercise, fasting) as determined 
through Q14-19 of QEWP-5 (Please see appendix item 'Screening Survey')  
Lost weight in recent past (>10 pounds in past 6 months)  
Currently in a weight-loss program (e.g., Weight Watchers, Jenny Craig)  
Currently on a special diet for a serious health condition  
Additional Exclusion Criteria for Smoking Sample:  
Binge eating behavior according to QEWP-5 ("yes" to Qs 8 and 9 and for Q10, at 
least one episode per week for three months). (Please see appendix item 'Screening 
Survey')  
- Compensatory behavior (e.g., purging, excessive exercise, fasting) 
- Already excluded as part of the DSM-5 binge eating disorder criteria  
- Lost weight in recent past (>10 pounds in past 6 months)  
- Undergoing current treatment for binge eating with a clinician  
- Currently in a weight-loss program (e.g., Weight Watchers, Jenny Craig)  
- Will ask about, but won't exclude on, online/mobile app weight-loss programs as 
part of the screener  
- Currently on a special diet for a serious health condition  
-Nickel allergy (because the Fitbit includes nickel)  
Additional exclusion criteria for smoking sample:  
- Binge eating behavior according to QEWP-5 ("yes" to Qs 8 and 9 and for Q10, at 
least one episode per week for three months).  

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- QEWP-5 #8: During the past three months, did you ever eat in a short period of 
time (for example, a two-hour period) what most people would think was an 
unusually large amount of food? [yes or no]  
- QEWP-5 #9: During the times when you ate an unusually large amount of food, did 
you ever feel you could not stop eating or control what or how much you were 
eating? [yes or no]  
- QEWP-5 #10: During the past three months, how often, on average, did you have 
episodes like this? That is, eating large amounts of food plus the feeling that your 
eating was out of control? (There may have been some weeks when this did not 
happen. Just average those in.) [less than one episode per week, five response options 
for 1 or more episodes per week]  
i. 
Screening Procedures 
Interested potential participants will receive descriptions of the studies as well as a 
list of requirements for participation. Potential participants will be asked to confirm 
that they understand the requirements. Screening will be done primarily through an 
online screener via RedCap, please see attachment [Eligibilty Screening Questions 
V(x)] for list of screening questions.  
Subjects may also be contacted for screening via phone scripts. Scripts for these 
forms of contact are included as appendices. (See attachment Scripts for Phone 
Contact)  
Please note that participants will not provide PHI until after consent. 
Waiver of Authorization for Recruitment and Waiver of Documentation are 
attached.  
j. 
Participation in Multiple Protocols 
Subjects will be asked whether they have participated in additional protocols. In 
addition, we will check our database of subjects (stored in Redcap) to ensure that 
subjects are not run multiple times in the same protocol.  
k. 
Payments to Participants 
Up for $ 350 per participant for all baseline tasks, surveys, and neuroimaging 
(required to complete full battery of tasks, surveys, and neuroimaging to receive $ 
350). This full compensation schedule breaks down as follows:  
$20 for completion of a 30-minute introductory session with baseline surveys and 
consent form signing $61 for completion of the first neuroimaging session 
Up to $230 (see below for detail) for completion of the four-week EMA period: 
$.50 per EMA * 4 EMAs per day * 28 days = up to $56  
$10 bonus per week for completing minimum of 25 EMAS (~90% of 28 total EMAs 
in the seven-day period) * 4 weeks = up to $40  
$2 per day for Laddr activities (at least 5 minutes of engagement) * 28 days = up to 
$56  

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$2 per day for wearing the wrist sensor for a minimum of 12 hours per day and 
inputting activity data into Laddr (binge eating sample) or using the CO monitor 
daily and inputting CO reading into Laddr (smoking sample) * 28 days = up to $56  
$61 for completion of the second neuroimaging session  
Participants will be compensated after completion of the session. Participants will 
not be compensated for any time spent completing the online screening.  
This payment rate is commensurate with the compensation other fMRI labs in the 
department provide.  
Smoking only 
Participants may keep the carbon monoxide monitor, which is intended for use by a 
single person. The research team may deduct up to $10 from a participant's 
compensation for failure to return, or for damage to, the lightning-to-headphone 
jack adapter if they borrowed one. The research team may withhold all payment 
until the adapter has been returned.  
Binge eating only 
The research team may deduct up to $55 from a participant's compensation for 
failure to return, or for damage to, the wrist sensor and band, charging cable, or 
charging adapter. The research team may withhold all payment until the wrist 
sensor and band, charging cable, and charging adapter have been returned.  
The opportunity for compensation expires six months after the end of the 
participant's study period. Each participant who is unable to be reached (e.g., after 
three tries) for compensation will be notified of this expiration date. This expiration 
is implemented to account for the end of study funding from the National Institutes 
of Health.  
Finally, subjects may be compensated for travel expenses, up to $50, and offered the 
option of receiving a parking pass provided by the Stanford CNI for the Q parking 
locations.  
l. 
Costs to Participants 
No costs will be charged to the participant.  
m. 
Planned Duration of the Study 
This arm of the study will last from September, 2018 to August 2022. Each subject's 
participation will take around 5.5 hours and 28 days. Screening will take up to 30 
minutes. Each Session 1 will take approximately 30-60 minutes. Each MRI session 
will be approximately 90 minutes, plus 1-1.25 hour(s) of practice/setup time. The 
mobile interaction period will last for 28 days.  
9. 
RISKS 
a. 
Potential Risks 
i. 
Investigational devices 

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N/A 
ii. 
Investigational drugs 
N/A 
iii. 
Commercially available drugs, biologics, reagents or chemicals 
N/A 
iv. 
Procedures 
There are no known physical, psychological, social, or legal risks associated with the 
proposed studies, as we are excluding subjects with contraindications for MR studies 
(e.g., metallic implants such as pacemakers, surgical aneurysm clips, or known metal 
fragments embedded in the body). We do not anticipate any significant risks 
associated with performing the simple cognitive tasks also involved with these 
experiments.  
v. 
Radioisotopes/radiation-producing machines 
N/A 
vi. 
Physical well-being 
Risks from mobile sensing of physical activity (binge eating participants only): This 
project does not involve any risks beyond those ordinarily encountered in daily life or 
the performance of routine tests. Participants may experience slight initial discomfort 
while wearing the wrist sensors, such as minor skin irritations. As with any electrical 
device, the sensors can theoretically cause electric shocks. Electrical shocks can be a 
health concern with certain health conditions (e.g., heart conditions that require a 
pacemaker). Additionally, participants could have privacy concerns regarding mobile 
sensing.  
Risks from carbon monoxide monitor (smoking participants only): The carbon 
monoxide (CO) monitor requires participants to hold their breath for approximately 
15 seconds and then to exhale for 15–20 seconds, which may cause slight discomfort 
for some participants. Additionally, the CO monitor carries the risk of spreading 
illnesses.  
Risks from physical activity intervention (binge eating participants only): There may 
be physical health risks associated with increases in physical activity.  
vii. 
Psychological well-being 
Risks from smoking quit attempts (smoking participants only): There may be 
psychological discomfort experienced as a result of making a smoking quit attempt.  
viii. 
Economic well-being 
There are no known economic risks associated with the proposed studies.  
ix. 
Social well-being 

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There are no known social risks associated with the proposed studies.  
x. 
Overall evaluation of risk 
Low - innocuous procedures such as phlebotomy, urine or stool collection, no 
therapeutic agent, or safe therapeutic agent such as the use of an FDA approved drug 
or device.  
b. 
International Research Risk Procedures 
N/A 
c. 
Procedures to Minimize Risk 
Standard MR safety procedures are in place at the Stanford Center for Cognitive 
and Neurobiological Imaging (CNI). All study personnel will receive extensive 
training in MR safety guidelines. These MRI procedures have been associated with 
no known adverse effects since initiating fMRI investigation in 1994. In addition, all 
subjects will complete the CNI screening form prior to the scan and will not 
undergo the scan if there is the potential for any risk.  
Any incidence of complications, whether or not related to these procedures, will be 
reported immediately.  
Risks to students as potentially vulnerable individuals will be minimized by not 
requiring participation as a part of any academic requirements, and not recruiting 
directly from the investigator's courses.  
Please review our attached Data Sharing SOPs for a discussion of steps to minimize 
risks to confidentiality of identifiable information.  
d. 
Protection against risks from mobile sensing (binge eating participants only): 
Previous studies with wristband sensors have indicated that after a brief adjustment 
period, the majority of the participants adjusted to wearing the bands and did not 
find them to be intrusive or restraining. Although slight discomfort is possible from 
wearing the wrist sensors, Fitbit sensors have been used in over 600 studies. 
Therefore, we assess the severity of the discomfort and irritation of wearing the 
wrist sensors to be minimal. If irritation persists to a point where the participant no 
longer wishes to participate, any irritation is entirely reversible once the participant 
removes the wrist sensors.  
While electrical devices do introduce the risk of electric shocks, the probability of a 
participant experiencing even minor electrical shocks is negligible. High impedance 
circuitry is used to limit current flow, even in the case of external events (e.g., 
through physical breaking of the sensor board or shorting of the battery leads). All 
sensors in the wristbands are commonly used in mobile phones and other activity 
monitors and pose minimal risk to participants. We expect that the wrist sensors, 
which have precedent of prior use in a research study or have otherwise been 
designed for everyday wear, will elicit similar acceptability among the participants 
in this study.  

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Regarding privacy concerns, participants' contact information will be linked to 
their study data via a code. The key to this code will be available only to the 
research staff at Stanford, and will be secured separately from the rest of the study 
data that is transmitted to Fitabase. Participants will be informed of their rights to 
terminate their participation in the study at any time. Participants will also be 
informed of their rights to remove the wrist sensors if they so choose, if they do not 
wish to be tracked. Participants will be given a summary of the incentive structure, 
and will be informed how their participation will affect their final incentive 
payment.  
All personnel that will be present for the research activities will be essential 
personnel in the conduct of this research. All personnel who will interact with 
participants at Stanford are trained in human participants research. Moreover, all 
staff at Small Steps Labs LLC, which owns and operates Fitabase, will receive only 
coded data. No directly identifiable data will be provided to Small Steps Labs LLC 
staff, and the key linking participant codes to identifiers will not be shared under 
any circumstances.  
Study participants will be informed that this research is conducted with the use of 
Fitabase and that coded data, which will not directly identify them, will be 
maintained in a database owned and operated by Small Steps Labs LLC.  
Protection against risks from physical activity intervention (binge eating 
participants only): Participants will be encouraged to set physical activity goals in 
line with their current health and fitness status. Participants who have concerns 
about increasing their physical activity will be encouraged to contact a medical 
professional.  
Protection against risks from smoking quit attempts (smoking participants only): 
While participants may experience psychological discomfort from making a 
smoking quit attempt, this discomfort is not beyond what participants would 
ordinarily encounter in daily life (e.g., cravings, disappointment from a lack of 
success). Laddr is designed to support participants through a smoking quit attempt. 
Participants experiencing psychological discomfort beyond that encountered in 
ordinary life will be withdrawn from the study and referred to the appropriate 
resources.  
e. 
Study Conclusion 
Subjects are given a squeeze-ball that they can use to signal at any time to the 
experimenter to stop the MRI scan. If an individual asks to terminate the study 
during a scan, they will be removed from the scanner immediately. If they do not 
wish to re-enter the scanner to continue the study, then the study will be ended and 
they will be paid for their time.  
f. 
Data Safety Monitoring Plan (DSMC) 
i. 
Data and/or events subject to review 
N/A 

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ii. 
Person(s) responsible for Data and Safety Monitoring 
N/A 
iii. 
Frequency of DSMB meetings 
N/A 
iv. 
Specific triggers or stopping rules 
N/A 
v. 
DSMB Reporting 
N/A 
vi. 
Will the Protocol Director be the only monitoring entity? (Y/N) 
Y 
vii. 
Will a board, committee, or safety monitor be responsible for study monitoring? 
(Y/N) 
N 
g. 
Risks to Special Populations 
N/A 
10. 
BENEFITS 
Participants may learn self-regulation skills through the Laddr mobile application, 
which may have a positive impact on their smoking (in the smoking sample) or  
binge eating behavior (in the binge eating sample). Additionally, the information to 
be gained from their participation may benefit others in the future. Knowledge of  
brain function may have implications for our understanding of the diagnosis or 
treatment of CNS disease in the future.  
 
11. 
PRIVACY AND CONFIDENTIALITY 
All participant information and specimens are handled in compliance with the Health Insurance 
Portability and Accountability Act (HIPAA) and privacy policies of Stanford University, Stanford 
Health Care, and Stanford Children’s Health.