Evaluating a Digital Intervention for Binge Eating and Weight Management Among Adults With Food Insecurity
Phase: NA
Conditions: Binge Eating, Type 2 Diabetes, Food Insecurity
Sponsor: Northwestern University

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STUDY TITLE:
Evaluating a Digital Intervention for Binge Eating and Weight Management
among Adults with Food Insecurity
PRINCIPAL INVESTIGATOR:
Andrea Graham, PhD
Department of Medical Social Sciences
VERSION DATE:
June 14, 2024
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)
☒
This is funded by the American Diabetes Association to
a NIH-funded P30 Center at Northwestern University &
the University of Chicago, who administers the pilot
award to the study PI
IRB #: STU00219612-MOD0010 Approved by NU IRB for use on or after 6/14/2024

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1.0
Purpose of the study:
The purpose of this study is to (1) adapt the mobile intervention, FoodSteps, to
address food insecurity (i.e., tailor the intervention, offer financial support for
accessing food to facilitate implementing healthy behavior changes), and (2)
test its feasibility, acceptability, and preliminary efficacy to inform a future R01
clinical trial of FoodSteps among this subpopulation. The Specific Aims are to:
Aim 1: Determine the feasibility of delivering the FoodSteps intervention
among adults with food insecurity, recurrent binge eating, and diabetes.
Feasibility will be based on study recruitment and retention rates, retention to
treatment, and adherence documenting prescribed intervention strategies.
Aim 2: Assess the acceptability of FoodSteps by applying user-centered design
methodology via qualitative interviews and self-report surveys, which will
inform future intervention enhancements.
Aim 3. Derive estimates of the preliminary efficacy of FoodSteps on changes in
weight and binge eating from baseline to post-intervention. Efficacy estimates
will be used to power a future R01 trial.
Background / Literature Review / Rationale for the study:
Two in five U.S. adults have obesity,1 which is associated with morbidity,
mortality, and high healthcare costs.2-4 Up to 30% of adults with obesity engage
in binge eating,5 an eating disorder behavior characterized by eating a large
amount of food and experiencing a loss of control while eating.6 Binge eating
causes excess weight gain, undermines weight control treatment outcomes, and
confers risk for comorbidities including metabolic syndrome.7,8 Despite their
substantial overlap and tendency to persist in the absence of treatment, no
intervention sufficiently addresses both obesity and binge eating,9-11 which
results in a pressing clinical gap.
To fill these gaps, we created FoodSteps, the first intervention for both obesity
and binge eating, delivered by mobile device to increase scalability. In the first
trial of FoodSteps (K01 DK116925; PI Graham), we rigorously designed the
intervention with user input and tested its feasibility. Preliminary findings show
that FoodSteps is engaging with high rates of completion and adherence, unlike
most apps.12 But, FoodSteps has not been adapted for nor tested among a
subpopulation of people with binge eating, obesity, and food insecurity.
Food insecurity, defined as inadequate/inconsistent access to food required for a
healthy life,13 is increasingly being linked to binge eating.14 Only 9 people
(15%) who enrolled in the K01 clinical trial reported having food insecurity, as
recruitment was not designed to target this subpopulation. To inform a future
R01 clinical trial of FoodSteps among people with food insecurity, we need to
pilot test this intervention among a larger sample. Additionally, FoodSteps has
not been tested in people with weight-related health problems such as type 2
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diabetes mellitus, a clinically important extension given the prevalence (up to
20%) and negative impact of binge eating among people with diabetes.15,16
Therefore, the overarching goal of this study is to conduct a pilot test of the
FoodSteps intervention among adults with recurrent binge eating, Type 2
diabetes, and food insecurity to determine its feasibility, acceptability, and
preliminary efficacy among this population.
2.0
Enrollment Criteria:
Participants will be non-pregnant, English-speaking adults age ≥18 years with
recurrent binge eating (≥12 episodes in the past 3 months), type 2 diabetes (self-
reported as a current diagnosis), and food insecurity (≥2 on the 6-item Short
Form Food Security Survey Screener). 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. Participants will also need
to have sufficient capacity for calls and text messaging through their cellular
carrier plan, have a valid e-mail address so that they can receive study
information, and complete relevant study procedures (e.g., consent form,
REDCap link with questionnaires), and have a valid five-digit zip code.  
Participants will be excluded if they self-report a diagnosis for which the
study/intervention is not clinically indicated (e.g., psychosis, mania,
dissociation, cognitive impairment). Participants may be excluded if they are
currently working with a clinical professional to receive services for
management of weight/binge eating or started/recently changed dosage of a
medication for binge eating, weight loss, or diabetes.
3.0
Sample Size:
Up to 40 participants will be enrolled in the study.
4.0
Recruitment and Screening Methods:
Recruitment Methods: 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 (e.g. WIC clinics, IDHS
offices offering SNAP applications or mental health services, Greater Chicago
Food Depository food pantries), 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. Additionally, we will recruit
potentially eligible participants who have filled out an eligibility screener for a
concurrent study and who have consented to having their screener data shared
with other approved research projects by the PI. Across all recruitment
pathways, information/study advertising content will remain consistent with
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IRB-approved recruitment language.
Screening Methods: Interested individuals will complete an online screener
survey administered via REDCap to assess for potential eligibility. The online
screener will include questions about the individual’s contact information,
demographics, food security status, smartphone ownership, access to a scale,
current treatment utilization, mental and physical health concerns (e.g., type 2
diabetes), and interest/capacity to participate in study activities. Interested
individuals also will be asked to self-report their height, weight, and number of
episodes of binge eating over the past 3 months. “Helper text” may be added in
REDCap to questions that appear challenging to understand to improve reading
comprehension.
Individuals recruited from the concurrent study will complete a shortened
screener via REDCap which will only include questions about the individual’s
food security status (i.e., items not assessed on the other study’s screener); these
individuals’ responses to the other items from the concurrent study’s eligibility
screener will be copied to this study’s REDCap.
Potentially eligible individuals will then be invited to complete an assessment
to confirm eligibility. This assessment will occur via videoconference or
telephone call (e.g., via Zoom, CiscoJabber). First, participants will complete
informed consent. Consenting individuals then will complete the assessment,
which will include a semi-structured interview with a trained assessor to assess
for the number of binge episodes over the past three months and other eating
disorder pathology. Individuals will also be asked to complete surveys, which
will be sent as a REDCap link via email. Questionnaires will assess
participants’ demographics not captured at screening (e.g., marital status,
education level, employment status, income, insurance), height, weight, eating-
related symptoms, food security, and mood. Participants can skip any questions
as a part of the interviews or questionnaires and can stop their participation at
any time. “Helper text” may be added in REDCap to questions that appear
challenging to understand to improve reading comprehension.
Of those eligible, participants will be selected with a range of backgrounds to
ensure a diverse and representative sample of target users. Ineligible individuals
will be offered referral information for treatment.
5.0
Research Locations:
Research procedures will occur at the Center for Behavioral Intervention
Technologies (CBITs) lab space at Northwestern University and/or remotely
(e.g., via Zoom, telephone, CiscoJabber). CBITs has private offices and a
usability lab.
6.0
Multi-site Research (research that involves external collaborating institutions
and individuals):
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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 decision-making 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 ____
Eligible individuals will be invited to enroll in the pilot trial. Participants who
elect to enroll will be sent an electronic scale and will schedule an onboarding
call. This call will occur by telephone or an internet-based phone service (e.g.,
Google Hangouts/Voice, CiscoJabber, Zoom). During the onboarding call,
enrolled participants will provide their weight using the electronic scale and
onboard to the FoodSteps intervention. Participants will keep the electronic
scale from onboarding for use throughout the remainder of the study; they will
be allowed to keep the scale after the study ends. Within one month of
participants discontinuing or completing the 16-week trial, we will alert the
electronic scale contractor (BodyTrace) to request termination of data
transmissions from the participant’s scale to the research team. Each enrolled
participant will also receive a stipend of $10 per week (up to $160 total) to
support implementing healthy behavior changes during the intervention. The
stipend will be prorated and given to participants at the beginning of every
week of the intervention. If a participant chooses to withdraw from the
intervention before the end of the study, they will not continue to receive the
stipend. Additionally, to sustain participant engagement over the 16-week
study, enrolled participants may be sent variable promotional, study-branded
materials—and not extra compensation—such as a tote bag, sticker, and/or
water bottle (valued at ~$2-20) during the study period.
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Intervention: Enrolled participants will be offered access to the mobile
intervention, FoodSteps, with coaching for 16 weeks. All participants will
receive the intervention; there is no inactive control. 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 a website app on a smartphone or on a computer or tablet.
Participants can choose to 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 intervention will not include
anything that can identify them except for their email address, phone number,
and zip code.
Coaching: Each participant will be assigned a coach, who is trained and
supervised weekly by a 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, set expectations for
the coach-participant relationship, and make the participant aware that they can
request treatment referral information any time as well as explain how to
navigate to the intervention’s Resources page which includes treatment referral
information. 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, with potential for additional calls as needed. After
participants schedule their coaching call, they may receive emails and/or text
messages (up to 4) reminding them of their upcoming appointment. Participants
who have already consented into the study will not receive text message
reminders.
Study assessments will occur again at mid-intervention (8-weeks) and post-
intervention (16-weeks). Baseline (i.e., the eligibility assessment), mid-
intervention, and post-intervention assessments will include interviews and/or
questionnaires. After participants schedule their research assessments, they may
receive emails and/or text messages (up to 4) reminding them of their upcoming
appointment. Participants who have already consented into the study will not
receive text message reminders. Interviews and questionnaires will assess the
following topics: personal and demographic information, treatment and stipend
utilization, height, weight, number of binge episodes over the past three
months, eating-related symptoms, stress, shame, food security, and experiences
with technology. The following questionnaires will be administered via a
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REDCap survey link:
Measure
Timepoint
Baseline
Mid-intervention Post-intervention
Demographic Information
X
Eating Questionnaire
X
X
X
Stipend Questionnaire
X
CIA 3.0
X
X
X
CESDR-10
X
X
X
6-item FI Screener
X
X
System Usability Scale
X
X
Treatment Utilization
X
X
Perceived Stress Scale
X
X
X
Personal Feelings Questionnaire
X
X
X
Implementation Questionnaire (Baseline)
X
Implementation Questionnaire (Post-
Intervention)
X
Intervention use data (from start of intervention through 16-week post-
intervention) and weights from the electronic scale also will be automatically
collected.
Interviews will be conducted via Zoom video call or telephone by a trained
assessor and questionnaires will be e-mailed as a REDCap survey link to
participants. Height and weight will be self-reported as a part of the
questionnaires; at mid-intervention and post-intervention, participants also will
be asked to provide a weight using their electronic scale. Participants can
choose not to answer any questions as a part of the interviews or questionnaires
and can stop the assessments at any time. “Helper text” may be added in
REDCap to questions that appear challenging to understand to improve reading
comprehension.
Intervention use data will be downloaded monthly from the intervention and in
entirety at the end of the study by an approved research team member.
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 within the Research Electronic Data Capture (REDCap)
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program on a HIPAA-compliant server with secure access for approved study
staff.
9.0
Research with Vulnerable Populations
NA
10.0
Incomplete Disclosure or Deception:
NA
11.0
Consent Process:
Screening: Interested individuals will complete an online consent form prior to
beginning the online screening survey or the shortened screening survey. The
online consent form will describe the online screening survey in REDCap.
Eligible individuals who are invited to participate in the eligibility assessment
will be asked to complete an online consent form via REDCap prior to
beginning the assessment. A PDF copy of the consent form will be emailed to
participants prior to the assessment so they can review the form in advance.
Then during the assessment, 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. The
assessor will then provide the participant with the REDCap link so the
participant can e-sign the form. Individuals who do not consent to study
procedures will be unable to participate.
12.0
Waiver of Participant Signature on Consent Form:
N/A
13.0
Waivers and Alterations of Consent Information:
NA
14.0
Financial Compensation:
Compensation will be prorated in the study. Participants will receive increasing
amounts for each assessment they complete: $20 for baseline (eligibility), $25
for mid-intervention (8-weeks), and $30 for post-intervention (16-weeks). To
encourage participants to complete all assessments, they can earn an additional
$15 for completing all assessments. This means participants have potential to be
compensated $90 total for completing all study activities. Hyperwallet electronic
gift cards (e-gift cards) will be provided to participants. Hyperwallet e-gift cards
may be used anywhere Visa is accepted. Participants also will be allowed to keep
their electronic scale. Participants will not be compensated for completing the
intervention or communicating with their coach.
1.0
Audio/Video Recording/Photography
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Interview assessments will be audio and/or video recorded to assess reliability
of assessors in administration or for subsequent qualitative analyses.
After each session, audio and/or video files will be transcribed (e.g.,
automatically by Zoom, manually by an approved research member) and the
recordings and transcriptions will be uploaded to the FSM research files and
removed from the recording device. Additional edits may be made to the
transcription files by an approved research team member. All transcripts of the
recordings will be de-identified. Recordings and transcripts will be stored on
password protected computers and secure servers only accessible to approved
study staff.
15.0
Potential Benefits to Participants:
Participants may experience reductions in 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 trial.
16.0
Risks to Participants:
There are minimal risks associated with participating in the 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
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.
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(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. 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 questions the
participant has about this. There is also the remote possibility that
research records will be subpoenaed by a court of law. All 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 treatment referral
information. 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.
17.0
Provisions to Protect the Privacy and Confidentiality of Participants and the
Research Data:
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, will be obtained. Identifying information will be obtained with the
screen to allow for the study team to contact the potential participants to
schedule the eligibility assessment. Participants’ identifying information will be
kept private. All participants will receive a study ID to protect their identity
during assessments and for data analysis.
All self-report questionnaire 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. Research
interviews will occur by video or telephone call, and questionnaires will be e-
mailed as a link for participants to complete on their own. For these sessions,
participants will be encouraged prior to and on the day of to find a private space
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to complete the call and questionnaires, and not while driving. Participants
using the intervention will create a unique password to use with the
intervention. Passwords will only be known to participants.
Participant data that are exported from the mobile intervention will be 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 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
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 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. 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.
18.0
Data Monitoring Plan to Ensure the Safety of Participants:
Any participants who do not show symptom improvement by the end of the
intervention will be offered referral information for treatment. The principal
investigator will be responsible for assembling the 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 accrual and retention will be presented to the study team on a
monthly basis.  
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.
19.0
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.
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20.0
Qualifications of Research Team to Conduct the Research:
The study team has expertise spanning all areas required to successfully conduct
this study. Dr. Graham’s research program focuses on designing, optimizing,
and implementing digital interventions, primarily for eating disorders and
obesity. She has been working on trials of digital interventions for more than 12
years. Dr. Wildes is a renowned leader in the treatment of eating disorders and
obesity, specializing in evaluating mechanisms of aberrant eating pathology.
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