Testing Intervention Strategies for Addressing Obesity and Binge Eating
Phase: NA
Conditions: Obesity, Binge Eating
Sponsor: Northwestern University

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STUDY TITLE: 
Testing Intervention Strategies for Addressing Obesity and Binge Eating
PRINCIPAL INVESTIGATOR:
Andrea Graham, PhD
Department of Medical Social Sciences
VERSION DATE:
February 14, 2022
Indicate Vulnerable 
Population(s) to be Enrolled
☒ Children 
☐ Cognitively Impaired Adults  
☐ Pregnant Women (IF the research activities will affect   
the pregnancy or the fetus)
☐ Prisoners (or other detained/paroled individuals) 
International Research 
(check this box if you will 
collect data from 
individuals located outside 
the United States)
☐
Research involving external 
collaborators (some 
research activities will be 
carried out by individuals 
not employed by 
Northwestern or NU 
affiliates)
☐
Research has U.S. Federal 
government funding (e.g., 
NIH, NSF, other federal 
agencies/departments)
☒
IRB #: STU00208056-MOD0030 Approved by NU IRB for use on or after 2/19/2022

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1.0
Purpose of the study:
The purpose of this study is to design a mobile intervention that targets obesity 
and binge eating. Two studies will be conducted with adults with obesity (BMI 
≥30) and recurrent binge eating (≥12 binge episodes in the past 3 months). The 
first study will employ a user-centered design approach to design a 16-session 
guided self-help, mobile intervention and conduct usability testing to inform 
intervention refinements prior to a pilot trial. The second study will involve a 
randomized pilot trial that will determine the feasibility of delivering the 
intervention protocol and generate preliminary data on the effect of the 
intervention on changes in weight and binge eating at 16 weeks (post-
intervention) and 3 months post-intervention (follow-up). Additional design 
sessions (as part of Study 1) will be conducted with adolescents (ages 13-17 
years) with elevated weight status (BMI≥75th percentile for age and sex) and 
who endorse loss of control eating or overeating (≥3 loss of control and/or 
overeating episodes in the past 3 months). The specific aims and hypotheses of 
this research are to:  
Aim 1: Employ a user-centered design approach to design a mobile 
intervention that targets obesity and binge eating and conduct usability 
testing to inform intervention refinements prior to the pilot trial.
Hypothesis 1: Quantitative and qualitative data from usability testing will 
inform intervention refinements prior to the pilot.
Aim 2: Conduct a randomized pilot trial of the mobile intervention that 
targets obesity and binge eating, using a 23 full factorial design, to (2a) 
determine the feasibility of delivering the intervention, and (2b) derive 
estimates of the effect of 3 intervention components on changes in weight 
and binge eating at post-intervention and follow-up to inform a future R01 
trial.
Hypothesis 2: Feasibility will be based on study recruitment and retention rates, 
acceptability, retention to treatment, and compliance documenting prescribed 
strategies. Effect sizes estimates will be used to power a R01 trial.
Exploratory Aim 3: Explore if intervention components interact to change 
weight and binge eating at post-intervention and follow-up.
Hypothesis 3: The factorial design will enable me to test if the effect of a 
component is moderated by another component, to ensure the optimized 
intervention retains components that directly or indirectly impact outcomes.
Background / Literature Review / Rationale for the study:
Obesity affects one third of US adults.1 Obesity is associated with medical and 
psychosocial morbidities, impaired quality of life, increased mortality, and high 
health care costs.2-8 Up to 30% of treatment-seeking adults with obesity engage 
in binge eating,9-11 an eating disorder behavior characterized by eating a large 
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amount of food and experiencing loss of control.12 More than 75% of people 
with recurrent binge eating also have overweight or obesity.13 First-line 
interventions are face-to-face treatments for obesity or binge eating,14-16 but 
face-to-face treatment cannot reach all people in need.17-19 
A novel solution to tackle comorbid obesity and binge eating entails designing 
a new intervention and delivery approach. First, an intervention needs to target 
both weight and binge eating. No existing behavioral weight loss (BWL) or 
psychological treatment resolves both conditions,20-23 likely because these 
treatments fail to address factors that drive both weight change and binge 
eating. Second, an intervention needs to be efficient yet potent. Retention rates 
show patients drop out of psychological treatment when weight loss is a focus 
only after binge eating resolves.23 Identifying the “active ingredients” of 
psychological treatments that reduce binge eating in the context of BWL will 
help to optimize an intervention for efficiency while preserving its potency. 
Third, an intervention needs to be scalable to large populations of users. In 
contrast to face-to-face treatment, mobile interventions hold promise for 
increasing access to care,17-19 and have efficacy for reducing weight24,25 or binge 
eating.26-29 
The mobile intervention will target dietary intake and physical activity, which 
impact weight. These are key targets of BWL interventions.30,31  Three 
additional targets—which are the intervention component “ingredients” under 
investigation in this study—are key treatment targets to address binge eating in 
psychological interventions, but are not components of BWL. Overvaluation of 
weight and shape refers to concerns about weight or appearance, which can 
result in excess attention to weight/shape relative to other areas of one’s life. 
For cognitive-behavioral therapy (CBT), this is the core psychopathology of 
eating disorders,32 and it is associated with increased impairment among those 
with binge eating.33,34 Weight/shape concerns can be exacerbated by weight 
gain, lead to unhealthy weight control practices and binge eating, and increase 
negative affect. Unhealthy weight control practices are behaviors that occur in 
response to weight/shape concerns, such as restrictive dieting, eliminating 
particular foods, or skipping meals. These behaviors can increase binge eating 
through dysregulated appetite and elevated hunger, drive negative affect, and 
lead to inappropriate and unsuccessful attempts to lose weight. This construct is 
a core target in CBT.32 Negative affect is characterized by low mood/depression 
or emotional distress, and mediates the relation between interpersonal problems 
and binge eating.35-37 Negative affect also can affect dietary intake and physical 
activity. No study has (a) tested an intervention that targets all three 
components within BWL, or (b) determined which components are the active 
ingredients for improving weight and binge eating.
2.0
Enrollment Criteria:
Participants will be non-pregnant, English-speaking adults age ≥18 years with 
obesity (BMI ≥30) and recurrent binge eating (≥12 episodes in the past 3 
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months). Adolescent participants (ages 13-17 years) will have elevated weight 
status (defined as BMI≥75th percentile for age and sex) and endorse ≥3 loss of 
control eating and/or overeating episodes in the past 3 months. Individuals will 
be eligible if they indicate they want to lose weight, are willing to use a mobile 
application (“app”), and have a Smartphone with Internet access and capacity 
for calls and text messaging. Participants enrolled after July 2020 will be 
required to have a valid e-mail address so they can receive study information 
and complete any relevant study procedures (e.g., consent form, REDCap link 
with questionnaires). Teens will only need to endorse willingness to use an app 
so as to reflect future app intervention users. Participants enrolled in the Study 
2 randomized pilot trial will be required to have access to a scale for weight 
verification purposes (i.e., to take a photo and upload it into REDCap survey). 
Participants in Study 2 will be excluded if they self-report a diagnosis for which 
the study/intervention is not clinically indicated (e.g., schizophrenia/psychotic 
use disorders, bipolar disorder/manic depression/mania, dissociative disorder, 
dementia or cognitive impairment), are currently working with a clinical 
professional to receive services for management of weight or binge eating, or 
started or recently changed dosage for a medication for weight loss or binge 
eating.
To mimic Study 1 design activities that occur in person, any remote design and 
usability testing sessions, including field trial assessments, among adults will 
require participants reside in the Chicagoland area, confirmed based on the first 
three digits of their zip code. 
For the Study 2 randomized pilot trial, participants will not be required to live 
in the Chicagoland area, but will be required to have a valid five-digit zip code. 
3.0
Sample Size:
In total, up to 122 participants will be included.
Study 1 All Activities: 25 participants will complete a needs assessment, up to 
10 participants will complete design and usability testing sessions, and up to 5 
participants will complete the field trial. Up to 10 adolescents will invited to 
complete design sessions. 
Study 2 Randomized Pilot Trial: Up to 96 participants will be enrolled into 
the trial. The pilot trial was not powered for hypothesis testing, as the goal of 
the pilot is to inform a R01 trial of an optimized intervention. This goal will be 
achieved by evaluating feasibility and generating effect sizes of each 
component on changes in outcomes.39-41 The effect sizes will inform which 
components to retain in the optimized intervention and be used to power a 
subsequent trial. However, a power calculation was run to determine the effect 
size this pilot trial will be powered to detect. Using intent-to-treat analyses with 
n=36/group for tests of each component (Aim 2b), assuming 80% power, 5% 
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alpha, and a two-sided test, there is power to detect main effects of d=0.67. This 
effect is in the range of past trials of digital BWL and CBT.26-29,42-47 It is 
acknowledged that this is a large effect; however, because the primary purpose 
of this research is for training and to collect pilot data, increasing the sample 
size could decrease feasibility and threaten these two goals. As such, a smaller 
N to maintain appropriate scope was prioritized. 
4.0
Recruitment and Screening Methods:
Recruitment Methods, Study 1 Needs Assessment: Participants will be 
recruited from potentially eligible individuals who have consented on dscout to 
complete screens and be considered for qualitative research projects (i.e., 
“missions”). 
Recruitment Methods, Study 1 Design & Usability Testing (including the 
Field Trial) and Study 2 Randomized Pilot Trial: Participants will be 
recruited from clinics at Northwestern University (e.g., Center for Lifestyle 
Medicine) and the University of Chicago (e.g., Eating Disorders Program, 
Center for Surgical Treatment of Obesity) and the community via flyers, media 
(including online social media such as Facebook, Instagram, Reddit, and 
Craigslist), newsletters, referrals, and word of mouth. We also will recruit 
participants using ResearchMatch and The New Normal, which are free 
participant recruitment online platforms that are accessible to researchers at 
participating institutions including Northwestern University, and 
Northwestern’s StudyTracker. Across all recruitment method platforms, 
information/study advertising content will remain consistent with IRB-
approved recruitment language.
Screening Methods, Study 1 Needs Assessment: For the Study 1 needs 
assessment, screening will involve recruiting and consenting individuals, and 
inviting interested individuals who consented to complete a screener via an 
application. The application includes open-ended questions, multiple choice 
questions, and uploading a 30-second video describing the impact that binge 
eating and weight has on their lives. The multiple choice questions assess for 
eligibility criteria, information about the impact of weight and binge eating, and 
demographic information. 
Screening Methods, Study 1 Design & Usability Testing (including the 
Field Trial): A research assistant will conduct a telephone screen with 
interested participants to determine their eligibility for participation. The 
telephone screen will be conducted using a work telephone or CiscoJabber, a 3rd 
party vendor contracted through Northwestern that is accessible to 
Northwestern staff and faculty (with NU credentials) and allows them to make 
phone calls that appear as their work phone number. Interested individuals will 
be asked to complete a verbal consent form prior to completing the telephone 
screen. A copy of the verbal consent form will be emailed to participants (who 
have a working email address) prior to (when possible), during, or following 
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the telephone screener. For adolescent participants, verbal assent and parental 
consent will be obtained prior to completing the telephone screen. This will 
occur at the start of the call prior to conducting the telephone screen, or will be 
done on a separate call beforehand as needed for scheduling purposes between 
parent and teen.   
The screener will include questions about contact information (i.e., email, 
phone), personal information (i.e., age, gender, race, ethnicity, height, weight), 
episodes of binge eating or overeating (as relevant), and other relevant 
questions pertaining to the particular study activities (e.g., availability for 
participation). During any remote procedures, adult participants will also be 
asked to provide their zip code (i.e., to confirm whether they reside in the 
Chicagoland area). 
Participants’ responses to the telephone screen will be directly entered into the 
Research Electronic Data Capture program (REDCap) by an approved research 
team member. Individuals who are not eligible will be offered referral 
information for treatment. Of those eligible, participants will be selected with a 
range of backgrounds to ensure a diverse and representative sample of target 
users.
Screening Methods, Study 2 Randomized Pilot Trial: Interested individuals 
will complete an online screener survey administered via REDCap survey to 
assess for potential eligibility. 
The online screener will include questions about the individual’s contact 
information, demographics, smartphone and email ownership, access to a scale 
for weight verification purposes, current treatment utilization, and availability 
to participate in study activities. Interested individuals will be asked to self-
report their height, weight, and episodes of binge eating over the past 3 months. 
Participants’ responses to the online screener will be captured in REDCap. 
Potentially eligible individuals will then be invited to complete a baseline 
assessment to confirm study eligibility. The assessment will include an 
interview and surveys. This assessment will occur in person or via 
videoconference call (Zoom). For the interview, a trained assessor will 
administer a semi-structured interview to assess for the number of binge 
episodes over the past 28 days and other eating disorder pathology. More 
detailed information about the screening consent process can be found in 
Section 11.   
Ineligible individuals who provide a working email address will be offered 
referral information for treatment.
5.0
Research Locations:
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The Study 1 needs assessment will be conducted using the secure dscout 
platform. 
For all other study 1 and study 2 activities, research procedures will occur at the 
Center for Behavioral Intervention Technologies (CBITs) lab space at 
Northwestern University. CBITs has private offices (for research assessments) 
and a usability lab (for usability testing). However, during any remote work 
requirements, study activities will be conducted by video call via Zoom (a 
videoconferencing software that is accessible to Northwestern University 
faculty and staff using their NU credentials) and/or by telephone or an internet-
based phone service (e.g., Zoom, Google Hangouts/Voice, CiscoJabber). 
Participants and research team members will have the option to conduct any 
study activities remotely or in-person. 
6.0
Multi-site Research (research that involves external collaborating 
institutions and individuals): 
NA 
7.0
International Research (where data collection will occur outside 
the United States and U.S. territories)
NA
8.0
Procedures Involved:
Please check the boxes for all applicable data collection procedures you plan to 
use:
☒One-on-one interviews
☒Focus Groups
☒Questionnaires/surveys
☐Analysis of secondary data (medical record data, educational records, 
government or private sector datasets, etc.)
☐Ethnographic observation
☐Physiological measurements (e.g., EEG, EKG, MRI)
☐Biospecimen collection (saliva samples, blood draws, hair samples, etc.)
☐Mobile applications/data collection devices (e.g., Fitbits, actigraphs, etc.)
☐Behavioral decisionmaking tasks (e.g., puzzles, interactive games, etc.)
☐Physical activities such as walking and other forms of exercise
☒Other procedures (briefly list types of procedures here if not covered by the 
check-boxes above): ____Measure height and weight ____
Study 1 Needs Assessment: We will conduct a needs assessment with 25 
individuals via the secure dscout platform. Dscout is a service that facilitates 
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conducting qualitative research, through which you can recruit participants 
from >100,000 consented “scouts,” conduct a qualitative research study (called 
a “mission”), and tag and export data for qualitative analysis. The needs 
assessment will take approximately one month to complete. Eligible scouts (n = 
25) will enroll in a 9-part mission. The mission asks participants to help us 
understand ways to help individuals lose weight and reduce episodes of binge 
eating, in order to design tools that can help people achieve these goals. First, 
participants will share how things have been going when it comes to their binge 
eating and weight (Part 1). Then, they will share moments when binge eating 
and weight impact them as they go about their daily life (Part 2). Third, 
participants will share things that help them or could help them manage their 
binge eating and weight (Parts 3-4). In the final parts, participants will rate their 
experiences and interests using a variety of techniques that have helped people 
work on these problems (Parts 5-7), practice implementing one of the 
techniques over the course of one week (Part 8), and then reflect on the 
experience (Part 9). Each part involves multiple choice questions, open-ended 
questions, uploading a 60-second video, and/or uploading a photograph. For 
Parts 2, 3, & 8, participants are asked to submit up to 4 entries. Given the 
potentially sensitive nature of this topic, participants will be encouraged to 
complete the parts in a private, comfortable setting. They can skip any 
questions they do not feel comfortable answering. 
De-identified written transcripts from the Study 1 needs assessment interviews 
will be analyzed using Dedoose, a qualitative data analysis software. Dedoose 
has been widely used for qualitative analyses, and it conforms to the data 
security and protection standards ISO 27001 and SOC 2 Type 2. Dedoose also 
participates in and is certified in compliance with the EU-US Privacy Shield 
Framework with respect to data transfers to the U.S. More details about 
Dedoose are described here: https://www.dedoose.com/about/security.
All data will be stored in FSM research files on password protected computers 
on secure servers.
Study 1 Design & Usability Testing (Not Including the Field Trial): Up to 
10 adult participants and up to 10 adolescent participants will participate in one 
or more individual or small group design and usability testing sessions. For 
adult participants, each session will last up to two hours. For adolescent 
participants, sessions will last up to one hour. Adult participants will be invited 
to complete up to 3 design sessions and may be invited to participate in 
additional sessions. We expect each session will take place a few days or weeks 
apart, based on participant availability. Adolescent participants will be invited 
to complete 1 design session. For adult participants, study procedures will occur 
in a private room, or be conducted remotely during any remote work 
requirements. Upon return to work, design and usability testing sessions will 
have the option to be conducted remotely or in person. For adolescent 
participants, all procedures will be remote. 
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Sessions will be conducted in-person or by video call on Zoom. During these 
sessions, participants will work with members of the research team to explore 
what components of a mobile app intervention would most effectively support 
management of weight and binge eating. Each of these sessions will involve 
activities such as one-on-one or group discussions, drawing, visualizing, and/or 
interacting with paper or digital (i.e., on a computer, tablet, or smartphone) 
prototypes of a mobile app intervention. For adolescent participants, only 
individual sessions will be conducted. 
Afterwards, adult participants will complete questionnaires and height and 
weight measurements. Adolescent participants will not be asked to complete 
questionnaires. Height and weight will be measured by an approved research 
member or self-reported as a part of the questionnaires. Procedures for in-
person height/weight measurements include up to three measurements if needed 
to resolve any measurement discrepancies, and the average will be used. 
Questionnaires will be completed on paper or via REDCap on a computer. For 
remote sessions, a REDCap link will be e-mailed after the videoconference call 
has ended. Questionnaires will assess participants’ demographic information 
(e.g., age, marital status, education level, employment status, income, 
insurance), eating-related cognitions, behaviors, and impairment, as well as 
their impressions of and experiences with the technology. To improve reading 
comprehension in the questionnaires, “helper text” may be added in REDCap to 
questions that appear challenging to understand. For example, if a question asks 
“How many times per month on average over the past 3 months have you 
experienced X”, helper text may be added such as, “If you experienced this 1 
time EACH MONTH for the past the 3 months, you would choose answer "1". 
Participants can skip any questions as a part of the interviews or questionnaires, 
and can stop the sessions at any time. 
All data will be stored in FSM research files on password protected computers 
on secure servers, or in REDCap on a HIPAA-compliant server with secure 
access for approved study staff.
Study 1 Field Trial: Up to 5 participants will be invited to complete a single-
arm usability field trial of the intervention over 4 weeks to ensure it works. 
Before, during, and after the field trial, qualitative and quantitative data will be 
collected. 
Before beginning the intervention (at baseline), participants will be invited to 
complete an interview in-person or by video call with an assessor, followed by 
questionnaires administered via REDCap. Questionnaires will assess 
participants’ demographic information (e.g., marital status, education level, 
employment status, income, insurance), height, weight, eating-related 
cognitions and impairment, food security, eating and physical activity 
behaviors, social support for diet and exercise, and mood. Throughout the 4-
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week intervention, participants will be provided a log to track any usability 
problems they uncover and prompted to complete weekly self-report usability 
questionnaires. At post-intervention, participants will be invited to complete the 
same questionnaires as they did at baseline, except for the one on 
demographics, and to provide feedback on their impressions of and experiences 
of the technology through a semi-structured interview and two questionnaires. 
To improve reading comprehension in the questionnaires, “helper text” may be 
added in REDCap to questions that appear challenging to understand. 
Participants can skip any questions as a part of the interviews or questionnaires 
and can stop the sessions at any time. 
All data will be stored in FSM research files on password protected computers 
on secure servers, or in REDCap on a HIPAA-compliant server with secure 
access for approved study staff.
Study 2 Randomized Pilot Trial: Study 2 will use a 23 full factorial trial 
design48,49 to test the effect of 3 binary components that are delivered in a 
mobile intervention. All participants (up to 96) will receive the intervention for 
16 weeks; there is no inactive placebo. Individuals also will be randomized to 1 
of 8 experimental conditions (see Table 4, below). As shown in the Table, 
everyone will receive “weight loss” and up to 3 additional components (content 
areas) based on their randomization assignment. Participants’ experimental 
condition will be masked to them.
Potentially-eligible individuals will be invited to complete a baseline 
assessment. First, participants will complete informed consent. Consenting 
individuals then will complete the baseline assessment, which will include a 
semi-structured interview with a trained assessor, followed by questionnaires 
administered via REDCap to confirm eligibility. Following the session, 
participants will be emailed their eligibility status. Ineligible individuals will be 
notified via e-mail that they are ineligible and offered referral information for 
treatment. Eligible individuals will be notified via e-mail that they are eligible 
and will be invited to enroll in the pilot trial. Enrolled participants will be 
randomly assigned to 1 of 8 experimental conditions; randomization will be 
performed using a computerized random-number generator to assign 
participants to an experimental condition with an 8:1 ratio. Enrolled participants 
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will then be contacted by a member of the research team to schedule a call with 
their Coach to begin the intervention. The call will occur by telephone or an 
internet-based phone service (e.g., Google Hangouts/Voice, CiscoJabber, 
Zoom).
Intervention: Participants will be offered access to the mobile 
intervention, FoodSteps, with coaching for 16 weeks. Participants can 
continue using the intervention after the 16 weeks of coaching ends. The 
intervention is focused on addressing binge eating and weight management, 
with recommended weekly modules for participants to complete. 
Participants will access the intervention by creating a personal password 
known only to the participant. FoodSteps can be accessed as an app on a 
smartphone or as a website on a smartphone or computer. Participants can 
use or not use the intervention and still be enrolled in the study. The 
intervention and data are hosted on a secure, encrypted server. The 
information that participants enter into the app will not include anything 
that can identify them except for their email address, phone number, and 
zip code, and will not include the information they provide in the study 
assessments.
Coaching: Each participant will be assigned a coach, trained and 
supervised weekly by a licensed clinical psychologist. Coaching follows a 
low-intensity model aimed at encouraging participants to use the 
intervention and practice skills in their daily lives, as well as provide some 
technical support as needed. Coaches will use messaging such as text or e-
mail to communicate with participants through a password-protected 
website on a secure server. Coaching will begin with an initial ~30-minute 
phone call to establish goals and build rapport, ensure the participant can 
access the intervention, and set expectations for the coach-participant 
relationship. Thereafter, participants will receive ~1-2 messages per week 
from their coach to offer encouragement, reinforce app use, and check-in 
on progress or challenges. Coaches also will aim to respond to participant-
initiated messages within 1 working business day. An optional ~10-minute 
call at week 8 (mid-way through the intervention) will be offered to 
participants to check in on their progress.   
Study assessments will occur at the following intervals: baseline, mid-
intervention (5-weeks and 10-weeks), post-intervention (16 weeks) and follow-
up (3-months post-intervention). Baseline, post-intervention, and follow-up 
assessments will include interviews and questionnaires; mid-treatment 
assessments will only include questionnaires. Interviews and questionnaires 
will assess the following topics: personal and demographic information, 
treatment utilization, height, weight, number of binge episodes over the past 28 
days, eating-related, cognitions, behaviors, and impairment, food security, 
eating and physical activity behaviors, social support for diet and exercise, 
mood, and experiences with technology. Intervention use data (from start of 
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intervention through 3-month follow-up) also will be automatically collected. 
Study procedures will be conducted remotely during remote work requirements. 
Upon return to work, participants and researchers will have the option conduct 
these activities remotely or in-person.
For in-person procedures, interviews and questionnaires will be conducted in a 
private room at CBITs. Height and weight will be measured by an approved 
research member. Procedures for in-person height/weight measurements 
include up to three measurements if needed to resolve any measurement 
discrepancies, and the average will be used. For remote procedures, interviews 
will be conducted using Zoom video call and questionnaires will be e-mailed as 
a REDCap link to participants after the call ends. For remote procedures, height 
and weight will be self-reported as a part of the questionnaires; participants also 
will be asked to upload a photo of their weight on a scale to verify their weight. 
If needed (e.g., due to social distancing guidelines), participants will be 
presented the option to participate in assessments remotely if they started the 
baseline in-person, and vice versa. 
As noted, questionnaires will be delivered via REDCap survey and interviews 
will be administered by a trained assessor. Participants can choose not to 
answer any questions as a part of the interviews or questionnaires and can stop 
the assessments at any time. To improve reading comprehension in the 
questionnaires, “helper text” may be added in REDCap to questions that appear 
challenging to understand. As Study 2 is a clinical trial, the study will be 
registered in Clinicaltrials.gov within 21 days of the first enrolled participant 
beginning the study.
Intervention use data will be downloaded monthly from the intervention and in 
entirety at the end of the study by an approved member of the research team. 
Following the study, all intervention use data will be removed from the 
intervention host server. All data will be stored in FSM research files on 
password protected computers on secure servers, or the Research Electronic 
Data Capture program on a HIPAA-compliant server with secure access for 
approved study staff.
 
9.0
Research with Vulnerable Populations
Study 1 design sessions with adolescents (ages 13-17 years) involves research 
with vulnerable populations (i.e., individuals ≤17 years old). Additional 
safeguards for conducting research with this population include using an assent 
form with developmentally tailored language. We will be conducting a shortened 
design session (i.e., maximum one hour) and eliminated the use of questionnaires 
to reduce burden on the adolescent participant. Consent/assent will be conducted 
in the presence of a parent, but the screening questions and design sessions will be 
conducted only with the adolescents so they feel comfortable discussing the 
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potentially sensitive topic of eating and weight. These topics also are appropriate 
to discuss without parents as they are not about safety-related issues. The purpose 
of the design sessions is to understand participants’ interests in and preferences 
for a technology-based intervention; therefore, questions are appropriate to 
adolescents since they are consumers of technology. Because session prompts 
include the potentially sensitive topic of eating and weight, adolescents will be 
reminded all questions are optional and can stop any time. 
10.0
Incomplete Disclosure or Deception:
NA 
11.0
Consent Process: 
Individuals who meet eligibility criteria will be invited to participate in one of 
the two studies. 
Study 1 Needs Assessment: Online consent with a waiver of documentation of 
informed consent will be obtained. More specifically, scouts on dscout will 
complete an online consent form after reviewing recruitment materials, prior to 
completing the screen. Individuals who do not consent to the research or who 
do not answer this question will be unable to complete the screen. Individuals 
will be informed they can save a copy of the consent form from the application. 
Study 1 Design & Usability Testing (including the Field Trial): Prior to 
administering a telephone screener to determine eligibility for the study, verbal 
consent from adults and consent/assent from parents/adolescents will be 
obtained by telephone. To address privacy considerations for the screener, 
participants will be encouraged to find a private, quiet location for the call, and 
not to complete the call while driving. If the telephone screen is conducted 
during any remote work requirements, an approved research team member will 
conduct the screen using CiscoJabber, and participants also will be informed 
that CiscoJabber is not HIPAA compliant. 
Eligible adult individuals who are invited to participate in the main study 
procedures will be asked to provide written informed consent or verbal 
informed consent (i.e., in which an approved member of the research team will 
sign to confirm that the participant has consented) prior to beginning study 
procedures. Verbal consent will be obtained if a session is conducted remotely 
over video call. A copy of the consent form will be emailed to participants prior 
to the session and/or provided at the session. Eligible adolescents and their 
parents will be asked to provide verbal informed assent/consent respectively 
prior to beginning study procedures. This will occur at the start of the design 
session prior to conducting the design session activities, or on a separate 
telephone or Zoom call beforehand as needed for scheduling purposes between 
parent and teen.
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Written informed consent will occur in a private room at CBITs. To address 
privacy considerations for remote procedures, participants will be notified prior 
to, as well as on the day of the call, that they are encouraged to find a private, 
quiet location for the session, and not to complete the study while driving. 
Participants also will be informed about the use of Zoom and that it is not 
HIPAA compliant. For Study 1 design sessions among adults, informed consent 
(i.e., written or verbal) may be conducted in a group or individual format 
depending on the number of participants. 
An approved member of the research team will explain the study and 
procedures, and participants will be allowed as long as needed to review the 
consent form and ask any questions they may have. Individuals who do not 
consent to study procedures will be unable to participate. 
Study 2 Randomized Pilot Trial:
Interested individuals will complete an online consent form prior to beginning 
the online screening survey. The online consent form will describe the online 
screening survey in REDCap and a brief description about how a subsequent 
baseline assessment will be used to confirm their eligibility for the pilot trial. 
For all interested individuals who complete the online screener, a PDF copy of 
the consent form will be available for download. 
Based on the online screener, potentially eligible individuals who are invited to 
participate in the baseline assessment will be asked to provide informed consent 
prior to beginning the baseline assessment. 
For remotely-conducted baseline assessments, verbal informed consent will be 
obtained over video call on Zoom. A copy of the consent form will be emailed 
to individuals prior to or after the session. A research team member will sign to 
confirm that the individual has consented to participate in the pilot trial and 
study procedures. To address privacy considerations for remote procedures, 
individuals will be notified prior to, as well as on the day of the call, that they 
are encouraged to find a private, quiet location for the call, and not to complete 
the call while driving. Individuals also will be informed about the use of Zoom 
and that it is not HIPAA compliant and involves minimal risk of breach of 
confidentiality.
For in-person baseline assessments, written informed consent will be obtained 
at the start of the session. A copy of the consent form will be provided in-
person or e-mailed to individuals prior to or after the session. The individual 
will sign to confirm they have consented to participate in the pilot trial and 
study procedures. To address privacy considerations for in-person procedures, 
all assessments will take place in a private room at CBITs. 
For all baseline assessments, an approved member of the research team will 
explain the study and procedures, and participants will be allowed as long as 
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needed to review the consent form and ask any questions they may have. 
Individuals who do not consent to trial enrollment at baseline will be unable to 
participate. 
12.0
Waiver of Participant Signature on Consent Form:
For any Study 1 and 2 remotely conducted research procedures, participants will 
be asked to provide verbal consent instead of in-person written consent, because 
asking participants to provide in-person written consent during remotely 
conducted study procedures is not feasible.
13.0
Waivers and Alterations of Consent Information:
NA
14.0
Financial Compensation:
Study 1 All Activities: Participants completing the needs assessment will 
receive $100 each. Adult and adolescents participants who complete design 
sessions in the laboratory or remotely will receive $20 for each design session 
completed. Participants who complete the 4-week single arm usability field trial 
will receive $50. 
There will be no prorating for compensation in Study 1. For remote procedures, 
electronic gift cards (e-gift cards) will be provided to participants. For in-person 
procedures, parking reimbursement will be provided in the form of a parking 
ticket for participants that drive to the lab and park in the nearby garage (Erie 
and Huron garages). This information and directions to the lab will be provided 
to all participants as an option beforehand. 
Study 2 Randomized Pilot Trial: Compensation will be prorated in Study 2. 
Participants will receive increasing amounts for each assessment they complete: 
$10 for baseline; $15 for mid-intervention at 5 weeks; $15 for mid-intervention 
at 10 weeks; $20 for post-intervention (16-weeks); $30 for 3-month follow-up. 
To encourage participants to complete all assessments, they can earn an 
additional $10 for completing all assessments. This means participants have 
potential to be compensated $100 total for completing all study activities. 
Payment will be provided in the form of a gift card in-person or as an e-gift 
card for remote assessments. Participants will not be compensated for 
completing the intervention or communicating with their coach. 
For in-person procedures, parking reimbursement will be provided in the form 
of a parking ticket for participants who drive to the lab and park in the nearby 
garage (Erie and Huron garages). This information and directions to the lab will 
be provided to all participants as an option beforehand. 
15.0
Audio/Video Recording/Photography
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Study 1 All Activities: Study 1 will involve audio- and/or video-recording 
(e.g., using a “think aloud” strategy during design sessions to describe reactions 
while using the intervention). Photographs or screenshots of artifacts (e.g., 
drawings from design sessions) may be taken as well. 
During remote procedures for design and usability testing sessions, the audio 
and/or video recording feature in Zoom will be used to record participants. 
After each in-person session, audio and/or video files will be manually 
transcribed by an approved research member and transcriptions will be 
uploaded to the FSM research files. After each remote session, audio and/or 
video files will be automatically transcribed in Zoom, and additional edits may 
be made to the transcription file by an approved research member. Then, the 
video recording and transcription will be uploaded to the secure FSM research 
files and removed from Zoom if transcribed there. All transcripts of the 
recordings will be de-identified. Recordings and transcripts will only be 
accessible to approved study staff.
 
Study 2 Randomized Pilot Trial: Interview assessments will be audio-
recorded to assess reliability of assessors in administration or for subsequent 
qualitative analyses. Recordings will be stored on password protected 
computers and secure servers accessible only to approved study staff. During 
remote procedures, we will use Zoom to audio record and transcribe interviews. 
After each remote session, recordings and transcription files will be moved to 
the secure FSM research files and removed from Zoom. Additional edits may 
be made to the transcription files by an approved research team member. 
During in-person procedures, an approved research team member will manually 
transcribe recordings, and transcriptions will subsequently be uploaded to the 
FSM research files and removed from the recording device. All transcripts of 
the recordings will be de-identified. Recordings and transcripts will only be 
accessible to approved study staff.
16.0
Potential Benefits to Participants: 
Study 1 All Activities: There may be no direct benefits in terms of changes in 
participants’ weight and frequency of binge eating. However, participants may 
benefit from knowing that their feedback is helping to design an intervention 
that may improve the precision and efficacy of care for individuals with 
obesity/elevated weight status and binge eating/overeating. Individuals 
participating in field trial may benefit from the knowledge gained from using 
the intervention in real-world settings. All participants will be provided with 
referral information for treatment following the design and usability testing 
sessions, including the field trial.
Study 2 Randomized Pilot Trial: Participants may experience reductions in 
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weight and binge eating, as well as improvements in core psychopathology (i.e., 
overvaluation of weight and shape, unhealthy weight control practices, and 
negative affect). These changes have potential to reduce the onset or 
maintenance of medical problems and total health care service use and costs 
associated with obesity and binge eating. Participants may also benefit from 
knowing that their use of the intervention and feedback will help inform 
improvements to the intervention that may improve the precision and efficacy 
of care for individuals with obesity and binge eating. All participants will be 
provided with referral information for treatment following the pilot trial.
17.0
Risks to Participants:
Study 1 All Activities: There are no high-risk or hazardous aspects of design or 
usability testing or of the proposed intervention. There is potential for 
participants to feel bored or possibly distressed during the design and usability 
testing sessions given the potentially sensitive nature of discussing of eating 
and weight-related topics. Participants can choose not to answer any questions 
within the questionnaires or during the interview. 
Individuals completing the 4-week field trial will be informed in advance that 
the goal of the field trial is to confirm the intervention works when deployed 
and not to change clinical outcomes (although these data will be assessed as 
practice for the Study 2 randomized pilot trial). As such, it is possible that 
participants will experience no change or worsening of symptoms. Participants 
completing design and usability testing sessions, including the field trial, will 
be offered referral information for treatment. If any participant appears to be in 
crisis during the usability testing, appropriate action will be taken based on an 
established crisis assessment protocol. 
For remotely conducted design and usability testing procedures, there is the 
potential for breach of confidentiality or loss of data due to the use of 
CiscoJabber and Zoom, which are both 3rd party vendors contracted with 
Northwestern that require NU credentials to use but are not HIPAA-compliant.
Study 2 Randomized Pilot Trial: There are minimal risks associated with 
participating in this study. Potential risks that might exist fall into the following 
four categories: (a) risks associated with the intervention; (b) risks associated 
with study assessments; (c) risks associated with potential loss of 
confidentiality; and (d) risks of worsening symptoms. 
(a) Risks associated with the intervention: Digital mental and behavioral 
health interventions have not been shown to cause any harm. All 
intervention activities are optional, and participants can discontinue 
using the intervention at any time, while still participating in the study. 
(b) Risks associated with study assessments: Study assessments include 
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questions about eating disorder behaviors and other mental and 
emotional problems that may make study participants experience 
discomfort or anxiety. All participant responses to assessment questions 
are voluntary; they are told that they can decline to answer any 
questions that they choose or stop the assessment. The instruments and 
methodologies used throughout the study are well tested and are not 
known to cause problems or distress on the behalf of the participants. 
(c) Risks associated with potential loss of confidentiality. Every possible 
measure will be taken to minimize the potential risk of loss of 
confidentiality. For use of the intervention, transmissions are protected 
using a Transport Security Layer and communication occurs within a 
secure messaging platform; however, there is the possibility that others 
may see the participant’s open webpage or smartphone. There is also the 
possibility that databases may be hacked. For remote procedures, there 
is the potential risk of breach of confidentiality or loss of identifying 
information due to the use of Zoom (a 3rd party vendor contracted with 
Northwestern that requires NU credentials to use but is not HIPAA-
compliant) and internet-based phone services (e.g., Zoom, Google 
Hangouts/Voice, CiscoJabber). A research team member will explain all 
risks involved with the study during the consent process and answer any 
question about this. There is also the remote possibility that research 
records will be subpoenaed by a court of law. All of these potential 
losses of confidentiality will be disclosed in the consent documents. 
(d) Risks of worsening symptoms: There is potential for participants to 
show no change or worsening in binge eating or weight. It is not 
believed that the risk of these or other adverse outcomes are increased as 
a function of being enrolled in this study. If a participant does not show 
symptom improvement following the intervention or at the follow-up 
assessment, this individual will be offered referral information for in-
person treatment. Individuals also may request this information at any 
point during the active intervention period. If any participant appears to 
be in crisis during the intervention or assessments, appropriate action 
will be taken based on an established crisis assessment protocol. 
18.0
Provisions to Protect the Privacy and Confidentiality of 
Participants and the Research Data:
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For both studies, the overall risks for study participation are minimal, and any 
possible risk will be minimized as much as possible. Personal identifiers, 
namely via video/audio recordings and photographs, will be obtained during the 
needs assessment using the secure dscout server and during the design sessions. 
Identifying information will be obtained with the screen to allow for the study 
team to contact the potential participants to schedule the design and usability 
testing sessions, including field trial assessments, (Study 1) or pilot trial 
baseline assessment (Study 2), as well as to confirm residence in the 
Chicagoland area for relevant sub-studies. Participants’ identifying information 
will be kept private. All participants will receive a study ID to protect their 
identity during assessments and for data analysis. 
For Study 1 design and usability testing and Study 2 randomized pilot trial, data 
collection will occur using a REDCap survey. REDCap is a secure, web-based 
data collection and management software program that will be accessible to 
only approved study members. Remotely-conducted telephone screens will be 
conducted using CiscoJabber and participants’ responses will be inputted 
directly into REDCap by an approved research team member. In-person 
research assessments will occur in private rooms to protect the anonymity of 
the participant and any written data (e.g., from questionnaires completed on 
paper and/or from height/weight measurements) will be inputted into REDCap. 
Remotely-conducted research interviews will occur by video call on Zoom and 
questionnaires will be e-mailed as a link for participants to complete on their 
own after the call has ended. For these sessions, participants will be encouraged 
prior to and on the day of to find a private space to complete the call and 
questionnaires, and not while driving. Participants and researchers will be 
encouraged to avoid indicating any identifying information during the session. 
For participants using the intervention during the field trial (Study 1) or pilot 
trial (Study 2), participants will create a unique password to use with the 
intervention. Passwords will only be known to participants. Initial onboarding 
calls will occur via telephone or internet-based phone services (e.g., Google 
Hangouts/Voice, CiscoJabber, Zoom). Participants will be provided with the 
contact information of the study staff. If any participant appears to be in crisis 
during the intervention or assessments, appropriate action will be taken based 
on an established crisis assessment protocol. If a participant does not show 
symptom improvement following the intervention or (for Study 2 only) at the 3-
month follow-up assessment, this individual will be offered referral information 
for in-person treatment. Any adverse event will be reported promptly to the 
mentorship team, the NIH, and the IRB. 
Participant data that are exported from the mobile intervention will uploaded to 
the secure, password-protected FSM research servers. Following the study, all 
intervention use data will be removed from the intervention host platform. All 
other study-related records (e.g., consent forms, payment materials, study 
assessment data) will be stored for at least 3 years following the end of the 
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study in locked file cabinets, on secure, password-protected servers, and/or 
password-protected file or software program(s) (e.g., REDCap, StudyTracker). 
Only approved study staff will have access to a password-protected file or 
software program(s) (e.g., REDCap) that link participants with their study IDs 
and usernames. Among individuals who complete the verbal consent, data 
collected from the telephone or online screeners will be retained for research 
purposes in the event that information needs to be reported (e.g., for research 
publications) comparing differences between eligible and non-eligible 
participants. Screener and questionnaire data collection will occur through 
REDCap surveys. Audio and/or video recordings will be kept on secure, 
password-protected files (i.e., FSM research files) and removed from the audio 
recording device after they are uploaded.
For analyses of qualitative data (e.g., from the Study 1 needs assessment), de-
identified data from participants’ transcripts will be uploaded and analyzed 
using Dedoose, described in Section 8.0: Procedures.  
19.0
Data Monitoring Plan to Ensure the Safety of Participants:
As this research is being conducted via a NIH career development award, the 
mentorship team (i.e., 3 faculty members at Northwestern University and 2 
faculty members at the University of Chicago) will serve as a data and safety 
monitoring committee. 
The data safety and monitoring plan for the randomized pilot trial includes 
close monitoring by the principal investigator and mentorship team. Any 
adverse event will be reported promptly to the NIH and to the IRB. For Study 1, 
all participants completing usability testing, including the field trial, will be 
offered referral information for in-person treatment. For Study 2, participants 
who do not show symptom improvement by the end of the intervention or 
follow-up period will be offered referral information for in-person services. The 
principal investigator will be responsible for assembling data safety and 
monitoring data and producing data safety and monitoring reports. Information 
will be documented on each participant who drops out of the study. Results of 
participant retention will be presented to the mentorship team on an annual 
basis. 
For both studies, significant adverse events are not anticipated because usability 
testing and the intervention follow standard practice guidelines. For Study 2, 
there is the potential for lack of improvement or worsening of symptoms. To 
ensure participant safety, the principal investigator will keep a log of any issues 
perceived to be related to testing or the intervention or that might require 
further assessment or attention. Any potentially adverse events will be 
evaluated by the principal investigator within 72 hours. Serious adverse events 
will be promptly reported to the IRB at Northwestern University and to the 
NIH; all other adverse events will be included in the annual report to the NIH.
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No standards have been established to suggest an expected adverse event rate; 
thus, adverse event discontinuation rules have not been established. Rather, data 
will be collected on events and these data will be presented to the mentorship 
team, the IRB, and the NIH. Because no guidelines exist to determine when 
usability testing or the trial should be discontinued, the principal investigator 
will rely on the mentorship team’s professional judgment to justify 
discontinuation.
20.0
Long-term Data and Specimen Storage and Sharing:
Data generated from this project may be shared with other investigators who 
provide a proposal with a strong research question and appropriate rationale and 
analytic plan. In such a case, data would be de-identified as per HIPAA 
regulations to protect the confidentiality of participants, and the investigators 
would work closely together to ensure high quality output and meet all 
compliance regulations of participating institutions.
21.0
Qualifications of Research Team to Conduct the Research:
I, the principal investigator, am a licensed clinical psychologist and health 
services researcher. This research project is a natural extension of my prior 
research. I have shown that people with overweight or obesity experience 
problematic eating behaviors50-53 and that eating disorder pathology is highest 
among young adults with overweight/obesity compared to under- or normal 
weight.54 I have co-authored papers that link overvaluation of weight/shape, 
unhealthy weight control practices, and negative affect.55-60 I have collaborated 
on studies that demonstrate the efficacy of digital interventions using BWL61,62 
and CBT approaches,63,64 including showing improvements in overvaluation of 
weight/shape, unhealthy weight control behaviors, and negative affect in 
women with eating pathology.64 My work indicates that a CBT-based online 
intervention for eating disorder pathology benefits from coaching,63 and I have 
served as a coach for digital interventions in previous NIH-funded trials (e.g., 
R01 MH081125, R01 MH100455). I anticipate success recruiting my sample as 
I have worked on teams to enroll >1,000 people into studies of digital 
tools.61,62,64-66 
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