CTSI Pilot: Improving Adherence to a Diabetic Diet With a Grocery Shopping Intervention
Phase: NA
Conditions: Diabetes Mellitus, Type 2, Diet, Healthy, Pre-diabetes
Sponsor: State University of New York at Buffalo

 
 
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CTSI Pilot: Improving Adherence to a Diabetic Diet 
NCT 04051008 
Study Protocol and Statistical Analysis Plan 
Document date: 5-4-2020 
 
 
 

 
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IRB Version: 1/23/19 
Complete Research Protocol (HRP-503) 
 
Table of Contents 
Template Instructions ....................................................................................................... 3 
1.0 
Study Summary ...................................................................................................... 10 
2.0 
Objectives* ............................................................................................................ 12 
3.0 
Scientific Endpoints* ............................................................................................. 12 
4.0 
Background* .......................................................................................................... 13 
5.0 
Study Design* ........................................................................................................ 14 
6.0 
Study Intervention/Investigational Agent .............................................................. 15 
7.0 
Local Number of Subjects ..................................................................................... 16 
8.0 
Inclusion and Exclusion Criteria* .......................................................................... 20 
9.0 
Vulnerable Populations* ........................................................................................ 22 
10.0 Eligibility Screening* ............................................................................................ 23 
11.0 Recruitment Methods ............................................................................................. 24 
12.0 Procedures Involved*............................................................................................. 28 
13.0 Study Timelines* ................................................................................................... 31 
14.0 Setting .................................................................................................................... 32 
15.0 Community-Based Participatory Research ............................................................ 33 
16.0 Resources and Qualifications ................................................................................. 33 
17.0 Other Approvals ..................................................................................................... 34 
18.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 34 
19.0 Data Management and Analysis* .......................................................................... 36 
20.0 Confidentiality* ..................................................................................................... 37 
A. 
Confidentiality of Study Data ......................................................................... 37 
B. 
Confidentiality of Study Specimens ................................................................ 38 
21.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 39 
22.0 Withdrawal of Subjects* ........................................................................................ 40 
23.0 Risks to Subjects* .................................................................................................. 41 
24.0 Potential Benefits to Subjects* .............................................................................. 42 
25.0 Compensation for Research-Related Injury ........................................................... 42 
26.0 Economic Burden to Subjects ................................................................................ 42 
27.0 Compensation for Participation ............................................................................. 43 
28.0 Consent Process ..................................................................................................... 44 
29.0 Waiver or Alteration of Consent Process ............................................................... 48 
30.0 Process to Document Consent ............................................................................... 49 
31.0 Multi-Site Research (Multisite/Multicenter Only)*............................................... 49 
32.0 Banking Data or Specimens for Future Use* ........................................................ 51 
 
 
 

 
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IRB Version: 1/23/19 
Template Instructions 
Sections that do not apply: 
• In several sections, the addition of checkboxes for Not Applicable have been 
added to the template as responses.   
o If an N/A checkbox is present, select the appropriate justification 
from the list.   
o If an N/A checkbox is not present, or if none of the existing 
checkboxes apply to your study, you must write in your own 
justification. 
• In addition: 
o For research where the only study procedures are records/chart 
review:  Sections 19, 20, 22, 23, 24, 25, 31, and 32 do not apply. 
o For exempt research:  Sections 31 and 32 do not apply. 
 
Studies with multiple participant groups: 
 
• If this study involves multiple participant groups (e.g. parents and children), 
provide information in applicable sections for each participant group. Clearly 
label responses when they differ.  For example: 
Response Example 
Intervention Group:  
Control Group: 
Formatting: 
• Do not remove template instructions or section headings when they do not apply 
to your study. 
If you are pasting information from other documents using the “Merge Formatting” 
Paste option will maintain the formatting of the response boxes. 
Amendments: 
• When making modifications or revisions to this and other documents, use the 
Track Changes function in Microsoft Word. 
• Update the version date or number on Page 3. 
 
 

 
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PROTOCOL TITLE: 
Include the full protocol title. 
Response:  
Improving adherence to a diabetic diet with a grocery shopping intervention 
PRINCIPAL INVESTIGATOR: 
Name 
Department 
Telephone Number 
Email Address 
Response:  
Stephanie Anzman-Frasca, PhD 
Pediatrics, Division of Behavioral Medicine 
(716) 829-6692 
safrasca@buffalo.edu 
VERSION NUMBER/DATE: 
Include the version number and date of this protocol. 
Response 11 – 05/04/2020 (final version) 
All changes from the original protocol and Clinicaltrials.gov registration were 
minimal and are detailed herein. 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
3/28/19 
Changes made in response to clarifications 
requested: unbolded payment on recruitment 
postcard, removed date from HIPAA form and 
added detail on how this information is 
confirmed, unchecked pregnant women in 
section 6.3, checked box in 7.1, provided 
further detail on recruitment/social media, 
indicated waiver of consent requested, with 
justification, clarified voluntary nature of 
participating in consent document 
Yes 
2 
4/11/19 
Changes made in response to clarifications 
requested: recommended statement added to 
consent, formatting of protocol template was 
checked/updated as requested, NA was added 
to 6.1 and 6.2, additional details on social 
media use were added, the term de-identified 
was changed to coded throughout, requested 
Yes 

 
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modifications were made to the HIPAA form, 
and recruitment postcard was checked/edited as 
requested.  
3 
6/28/19 
We have made the following changes: receipts 
will be collected for the household; 
modifications to inclusion criteria – participant 
needs to do 75% of the grocery shopping for 
household and needs to complete at least 75% 
of grocery shopping at Wegman’s/Tops; 
changed number of recipes cards provided (3 
per week). We also made a few minor 
additions/changes to questionnaire/interview: 
asking how long they were in the store 
shopping; whether they use insulin; how they 
liked the recipes from the study; whether they 
follow a special diet; and a question about their 
liking of several possible recipes. We also 
modified our food frequency questionnaire (to 
ask about the past month rather than year given 
the time frame of our study) and added a 
receipt form to allow participants to clarify 
what the items on their receipts are. All of 
these changes are included in the modification 
in tracked changes (in this protocol/the relevant 
attachments). 
 
4 
7/24/19 
We made minor changes after internal 
feasibility testing of the protocol. These 
include: removing part of our baseline 
questionnaire (corresponding changes are 
tracked in the protocol and study 
script/questionnaire attachments) and minor 
changes to the script/receipt form to streamline 
procedures, now asking questions about who 
the purchased food items are for on the receipt 
forms rather than the phone interview. We also 
specify our stratification factors in the 
protocol. All of these changes are included in 
the modification in tracked changes (in this 
protocol/the relevant attachments) 
 
5 
9/16/19 
We have changed the consent procedure to 
include written consent consistent with SOP 
and full HIPAA authorization after challenges 
acquiring participant medical information from 
clinicians. All of these changes are included in 
this modification in tracked changes (in this 
protocol/the relevant attachments). 
 
 
 

 
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6  
9/30/2019 
We have made the following changes: adding 
pre-diabetes/type II diabetes eligibility criteria 
to the front of the recruitment materials (flyer, 
postcard, and Facebook advertisement) to make 
this criteria more visible for interested 
individuals; modifying our eligibility script to 
align with the SOP consent/HIPAA form; 
expanding recruitment as described herein 
(collaborating with partners within our 
department, at Independent Health Foundation, 
I2B2 and ResearchMatch; adding an additional 
mode of communication with physicians’ 
offices (fax via eFax.com, to maintain 
confidentiality because or lab does not have a 
private fax machine); adding an option for 
participants to receive study documents via 
postal mail if that is their preference. We have 
also made minor changes to eligibility criteria 
where participants must shop at 
Tops/Wegmans at least 50% of the time 
(instead of 75% of the time). A number of 
interested participants were deemed ineligible 
solely because of this criterion, leading the 
study team to review the inclusion criteria and 
their purposes. While it is important that 
participants shop at these stores regularly, the 
selection of the specific cutoff was somewhat 
arbitrary, and upon revisiting, the study team 
felt that a cutoff of 50% or more would still 
capture the majority of the household’s 
shopping and would facilitate greater 
participation without affecting the rigor of the 
study. An additional option was added to the 
screener document to encompass this change in 
eligibility criteria. We have also added a 
question to the screener document asking 
participants if they have recently participated in 
(or are currently in) any other research studies 
and to explain the nature of each study. 
Additionally, we have changed our enrollment 
procedures to allow participants to self-report 
and start the study before confirming their 
diabetes status with a physician. This decision 
was made because of feasibility concerns; a 
number of eligible participants have not been 
able to enroll in the study as a direct result of 
 

 
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extended delays in communication between 
study staff and physician’s offices; this change 
will allow for faster turnover and study 
progress, while still allowing for the 
confirmation of diabetes status later in the 
study. All of these changes are included in the 
modification in tracked changes (in this 
protocol/the relevant attachments) 
7 
11/5/2019 
We have made the following changes: Addition 
of a joint recruitment postcard and flyer to be 
used by our study as well as two other studies 
recruiting similar populations within the 
Division of Behavioral Medicine 
(STUDY00002659 and STUDY00003608) so 
that we may efficiently direct participants to 
the study that might suit them. We have also 
created a shared online questionnaire that will 
be used solely to direct participants to the IRB-
approved online screening questionnaire for the 
aforementioned studies. No personally 
identifiable information will be collected on 
this survey; it is completely anonymous. All of 
these changes are included in the modification 
in tracked changes (in this protocol/the relevant 
attachments) 
 
 
 
8 
12/10/2019  
We have made the following changes: Given 
the remote nature of this study (all participant 
contact takes place via phone, email, or postal 
mail), we have elected to expand our 
recruitment efforts past the Buffalo area to 
include the greater Northeastern US, where 
Tops and Wegmans stores are located. For this 
reason, we have added an additional question 
to the screener asking potential participants to 
input their home zip code; this will help us 
determine whether the participant is within the 
specified distance to Tops and/or Wegmans 
stores, and if they are eligible to receive 
Instacart delivery services in their area. We 
have also edited the protocol to specify that 
recruitment will extend beyond the Buffalo 
area to include the Northeastern US. All of 
these changes are included in the modification 
in tracked changes (in this protocol/the relevant 
attachments) 
 

 
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9 
02/20/2020 
We have made the following changes: We plan 
to collaborate with the UB contracted media-
buying agency Fahlgren Mortine (FM) for 
study recruitment. FM has created a 
customized media plan specific to our study 
objectives, and we have developed a new 
recruitment material for digital display 
advertising. This has been adapted from 
previously approved material to better suit a 
digital display platform, and a user-friendly 
vanity link has been created to direct interested 
individuals to our screening survey (which 
remains unchanged). All of these changes are 
included in the modification in tracked changes 
(in this protocol/the relevant attachments) 
 
10 
03/12/2020 
We have made the following changes to the 
protocol in response to the COVID-19 
pandemic: We will allow study team members 
to work remotely on UBs secure VPN as a 
preventative measure to limit person contact. 
The study team has been instructed to maintain 
confidentiality as in the lab setting and to 
perform study tasks in a private space in 
accordance with laboratory emergency 
procedures. 
 
11 
05/04/2020 
We have made the following changes: We have 
modified our definition of “at risk for diabetes” 
after learning that few individuals have a 
formal prediabetes diagnosis. We are still 
interested in recruiting individuals with type 2 
diabetes and type 2 diabetes risk, but now, 
instead of defining this as type 2 diabetes or 
prediabetes diagnosis, we are defining it as 
type 2 diabetes diagnosis OR at risk for type 2 
diabetes based on a diagnosis of prediabetes or 
meeting criteria for increased risk of 
developing type 2 diabetes based on the 
American Diabetes Association Type 2 
Diabetes Risk Test (described further herein). 
This affects the questions we ask on our 
screening questionnaire and the wording of 
some of our materials; uploaded attachments 
have been included and described in the 
modification submission. We have also 
extended our study timeline and prepared 
additional language and measures in response 
Yes 

 
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to the COVID19 pandemic; these include 
tempering the language about in-person 
grocery shopping for the control group, so that 
it doesn’t feel like it is required if not preferred 
in the context of COVID-19, and adding 
changes in daily life, perceived stress and 
loneliness measures within our baseline and 
post surveys. Additionally, we added 
newspapers and periodicals, and the Clinical 
and Translational Sciences Institute (CTSI) 
Community Liaison and Buffalo Research 
Registry (BRR) to our recruitment methods to 
aid in the recruitment of participants from the 
greater Buffalo community. We also changed 
the mention of added sugar to sugar and/or 
added sugar throughout the protocol, as we do 
plan to examine at least one of these, but 
realized in beginning our data entry processes 
that examination of added sugar in particular 
may be difficult with the current nutritional 
software/analysis plan.  
FUNDING: 
Indicate any funding for this proposal. This should match the Funding Sources 
page in Click IRB. 
Response:  
This research is being funded by the Clinical and Translational Science 
Institute. 
GRANT APPLICABILITY: 
Indicate whether this protocol is funded by a grant (e.g. NIH, foundation grant).  
For a grant with multiple aims, indicate which aims are covered by this research 
proposal. 
NOTE: This question does not apply to studies funded by a sponsor contract. 
Include a copy of the grant proposal with your submission.     
Response:  
Response: A grant proposal to fund this work was submitted to the CTSI in 
December 2018 and has been funded with a start date of 4/1/2019 (pending IRB 
approval). The grant is attached. 

 
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RESEARCH REPOSITORY: 
Indicate where the research files will be kept, including when the study has been 
closed.  The repository should include, at minimum, copies of IRB 
correspondence (approval, determination letters) as well as signed consent 
documents.  This documentation should be maintained for 3 years after the study 
has been closed.   
Response:  
Location: Child Health and Behavior Lab, Division of Behavioral Medicine 
Address: 151 Farber Hall 
Department: Pediatrics 
1.0 Study Summary 
 
Study Title 
Improving adherence to a diabetic diet with a grocery 
shopping intervention 
Study Design 
This study has an experimental design. Participants will be 
randomly assigned to 1 of 2 interventions or a control group 
in which they will shop in-person as usual. Stratification 
factors will be sex and diabetes status: diabetic vs. at risk for 
type 2 diabetes, defined as a diagnosis of prediabetes or 
meeting criteria for increased risk of developing type 2 
diabetes in accordance with the American Diabetes 
Association Type 2 Diabetes Risk Test. In all groups, recipe 
cards that follow the evidence-based DASH diet will be 
provided; recipes correspond to dietary recommendations for 
patients with type 2 diabetes or at increased risk of 
developing type 2 diabetes. The Online intervention will 
utilize online grocery shopping (shopping at a local grocery 
store via Instacart) to promote healthier purchasing, 
removing visceral factors that can lead to impulse purchases 
in stores. The Defaults intervention will augment this 
intervention, showing participants a default cart when they 
log into their accounts. They will be told that their cart has 
been filled with items that conform to a diet for diabetes 
prevention, management, and overall health and can be used 
to make the recipes from the provided recipe cards, and that 
they may modify it as they like.  
At baseline, all participants will complete a survey online or 
via phone and then will grocery shop in-person as usual. 
Participants will then be randomized and receive further 
instructions. For the next 3 weeks, they will receive recipe 
cards and shop in accordance with their assigned study 
group. The following week (post), they will shop using their 
preferred mode (in-person or online) and complete a survey 
again. Household receipt data will be collected throughout 

 
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the study. The baseline period will also serve as a run-in 
period, and participants who do not comply with study 
guidelines for baseline procedures (including guidelines for 
receipt submission) will not be randomized for further 
participation. Primary analyses will examine intervention 
effects on grocery purchases, with additional analyses on 
spending and dietary intake. The study is designed, so that 
all participant interactions will occur remotely: online, via 
phone, or through paper mail (study materials may be sent 
via paper mail if it is the participants preference, and 
Clincards for participant payment will initially be sent via 
mail as is standard, using participant addresses as already 
collected on the consent form).  
Primary Objective 
The goal of this study is to test novel approaches informed 
by behavioral economics to promote healthier grocery 
shopping among adults with type 2 diabetes or at an 
increased risk of developing type 2 diabetes. 
Secondary 
Objective(s) 
The specific aims are: (1) to test effects of Online and 
Defaults grocery shopping interventions on the grocery 
purchases of adults with type 2 diabetes or at risk of 
developing type 2 diabetes and (2) to explore effects of the 
Online and Defaults interventions on participants’ spending 
during grocery shopping. We will also explore effects on 
dietary intake. 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
There will be two interventions in this study. The first 
intervention is the Online intervention, which will utilize 
online grocery shopping (shopping at a local grocery store 
via Instacart) to promote healthier purchasing, removing 
visceral factors that can lead to impulse purchases in stores. 
The second intervention, the Defaults intervention, will 
augment the Online intervention, showing participants a 
default cart when they log into their accounts. They will be 
told that their cart has been filled with items that conform to 
a diet appropriate for diabetes prevention, management, and 
overall health and can be used to make the recipes from the 
provided recipe cards, and that they may modify their carts 
as they like. 
IND/IDE #  
 
Study Population 
Adults diagnosed with type 2 diabetes or at increased risk of 
developing type 2 diabetes, defined as a diagnosis of 
prediabetes or meeting criteria for increased risk of 
developing type 2 diabetes in accordance with the American 
Diabetes Association Type 2 Diabetes Risk Test 
Sample Size 
Up to 100 

 
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Study Duration for 
individual 
participants 
An individual subject’s participation in the study will take 
place over about 6 weeks. 
Study Specific 
Abbreviations/ 
Definitions  
 
2.0 Objectives* 
2.1 Describe the purpose, specific aims, or objectives of this research. 
Response:  
The goal of this study is to test novel approaches informed by behavioral 
economics to promote healthier grocery shopping among adults diagnosed with 
type 2 diabetes or at increased risk of developing type 2 diabetes, defined as a 
diagnosis of prediabetes or meeting criteria for increased risk of developing type 2 
diabetes as determined by the American Diabetes Association Type 2 Diabetes 
Risk Test. The specific aims are: (1) to test effects of Online and Defaults grocery 
shopping interventions on participants’ grocery purchases and (2) to explore 
effects of the Online and Defaults interventions on participants’ spending during 
grocery shopping. 
2.2 
State the hypotheses to be tested, if applicable. 
NOTE:  A hypothesis is a specific, testable prediction about what you expect to 
happen in your study that corresponds with your above listed objectives. 
Response:  
It is hypothesized that (1a) purchases made by adults in the Defaults group will be 
lower in calories, carbohydrates, and sugar (total sugar and/or added sugar) and 
higher in nutritional quality (DASH diet score) at post-test versus other study 
groups, (1b) adults in the Defaults group will show the greatest increases in 
nutritional quality versus other study groups, (1c) the Online group will have 
intermediary results between Defaults and Controls, and (2) there will be no 
difference in total dollars depicted on receipts across study groups during the 
intervention period (i.e., the costs of online shopping will be offset by effects of 
the Online and Default interventions). 
3.0 Scientific Endpoints* 
 
2.1    Describe the scientific endpoint(s), the main result or occurrence under 
study.   
 
NOTE:  Scientific endpoints are outcomes defined before the study begins to determine 
whether the objectives of the study have been met and to draw conclusions from the data.  
Include primary and secondary endpoints.  Some example endpoints are:  reduction of 
symptoms, improvement in quality of life, or survival.  Your response should not be a 
date.   
Response: 

 
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The primary endpoint is to determine whether there are group differences in 
grocery purchases among adults randomized to the Online or Defaults 
interventions or control group. Primary analyses will examine differences in the 
study groups’ grocery purchases, including total calories, carbohydrates, and 
sugar (total sugar and/or added sugar), and overall nutritional quality of foods and 
beverages purchased at post-test and throughout the study period. 
4.0 Background* 
4.1 Provide the scientific or scholarly background, rationale, and significance 
of the research based on the existing literature and how it will contribute to 
existing knowledge.  Describe any gaps in current knowledge.  Include 
relevant preliminary findings or prior research by the investigator.  
Response:  
Millions of deaths are caused by diabetes, and impacts on health 
expenditures are staggering, with $727 billion spent in 2017. Dietary 
approaches are recommended for weight control and diabetes prevention 
and management, but modern environments, characterized by plentiful, 
unhealthy foods, pose challenges to selecting a healthy diet. Modifications 
to the food environment can address these barriers by making healthier 
choices more automatic and reducing the need for self-control. 
Behavioral economics offers a framework for modifying the food 
environment to encourage individuals with diabetes to select foods that 
align with diabetic diet goals. The standard dietary approach to diabetes 
involves educating people in a clinical setting but does not prepare them to 
make purchasing decisions under normal conditions. Decision-making is 
affected by visceral factors, including hunger and strong emotions, which 
can lead to impulse purchasing. Rather than expecting humans to behave 
rationally, behavioral economics aims to make the healthy choice the easy 
choice. For example, people tend to accept default options rather than 
requesting alternatives, offering the potential to encourage healthier 
behaviors by positioning them as automatic defaults. 
Such strategies have been applied effectively in many domains (e.g., organ 
donation; Johnson & Goldstein, 2003) but have seldom been used to 
promote health during grocery shopping, which is the leading source of 
sugar-sweetened beverages and nutrient-poor foods (An & Maurer, 2016). 
One recent study randomized undergraduates to grocery shop online, 
receiving either: 1) nutrition education, 2) a financial incentive for 
selecting healthy foods, or 3) a default shopping cart with healthy foods, 
which they could alter as desired. The default group chose healthier foods 
than education controls, with no effect of incentives. This study supports 
the promise of defaults to encourage healthier purchases when grocery 
shopping and highlights a need for ecologically-valid studies in 
populations with diet-related diseases. The present study will fill this gap 
by testing online grocery shopping and defaults as potential mechanisms 

 
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to promote adherence to a diabetic diet among adults with diabetes or at 
risk of developing diabetes. 
These strategies have translational significance as they could be 
incorporated into clinical treatment: e.g., by “prescribing” online grocery 
shopping if the Online intervention is efficacious, and/or working with 
dieticians to generate default carts catering to different lifestyles and 
disseminating this information in clinical settings and/or via partnerships 
with grocery stores. As such, the proposed interventions have the potential 
to improve dietary intake, glucose regulation, weight, and medication 
needs among diabetic patients. The study team has the substantive 
expertise needed to examine this question, including a history of 
behavioral economics, diabetes, grocery shopping/retail, and community-
based research (e.g., Anzman-Frasca et al., 2018; Epstein & Saelens, 
2000; Leone et al., 2018). 
4.2 Include complete citations or references.  
Response:  
American Diabetes Association. (2020). 2. Classification and Diagnosis of 
Diabetes: Standards of Medical Care in Diabetes - 2020. Diabetes Care, 
43(Supplement 1), S14-S31. 
An, R., & Maurer, G. (2016). Consumption of sugar-sweetened beverages and 
discretionary foods among US adults by purchase location. European 
Journal of Clinical Nutrition, 70, 1396-1400. 
Anzman-Frasca, S., Braun, A. C., Ehrenberg, S., Epstein, L. H., Gampp, A., 
Leone, L. A., … Tauriello, S. (2018). Effects of a randomized intervention 
promoting healthy children’s meals on children’s ordering and dietary 
intake in a quick-service restaurant. Physiology & Behavior, 192, 109-117. 
Epstein, L. H., & Saelens, B. E. (2000). Behavioral economics of obesity: Food 
intake and energy expenditure. In W. K. Bickel & R. E. Vuchinich (Eds.), 
Reframing health behavior change with behavioral economics (pp. 295-
314). Mahwah, NJ: Lawrence Erlbaum Associates.   
Johnson, E. J., & Goldstein, D. (2003). Do defaults save lives? Science, 
302(5649), 1338-1339. 
Leone, L. A., Tripicchio, G. L., Haynes-Maslow, L., McGuirt, J., Grady Smith, J. 
S., Armstrong-Brown, J., … Ammerman, A. (2018). Cluster randomized 
controlled trial of a mobile market intervention to increase fruit and 
vegetable intake among adults in lower-income communities in North 
Carolina. International Journal of Behavioral Nutrition and Physical 
Activity, 15(1), 1-11. 
5.0 Study Design* 
5.1 Describe and explain the study design (e.g. case-control, cross-sectional, 
ethnographic, experimental, interventional, longitudinal, observational). 

 
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Response:  
This study has an experimental design. Participants will be randomly assigned to 
1 of 2 interventions or a control group in which they will shop in-person as usual. 
Stratification factors will be sex and diabetes status: type 2 diabetic vs. at risk for 
type 2 diabetes, defined as a diagnosis of prediabetes or meeting criteria for 
increased risk of developing type 2 diabetes as determined by the American 
Diabetes Association Type 2 Diabetes Risk Test. In all groups, recipe cards that 
follow the evidence-based DASH diet and correspond to dietary 
recommendations for diabetic patients will be provided. The Online intervention 
will utilize online grocery shopping (shopping at a local grocery store via 
Instacart) to promote healthier purchasing, removing visceral factors that can lead 
to impulse purchases in stores. The Defaults intervention will augment this 
intervention, showing participants a default cart when they log into their accounts. 
They will be told that their cart has been filled with items that conform to a diet 
appropriate for diabetes prevention, management, and overall health and can be 
used to make the recipes from the provided recipe cards, and that they may 
modify it as they like.  
At baseline, all participants will complete a survey online or via phone and then 
will grocery shop in-person as usual. Participants will then be randomized and 
receive further instructions. For the next 3 weeks, they will receive recipe cards 
and shop in accordance with their assigned study group. The following week 
(post), they will shop using the method of their choice (in-person, online) and 
complete a survey again. Household receipt data will be collected throughout the 
study. The baseline period will also serve as a run-in period, and participants who 
do not comply with study guidelines for baseline procedures (including guidelines 
for receipt submission) will not be randomized for further participation. Primary 
analyses will examine intervention effects on grocery purchases, with additional 
analyses on spending and dietary intake. All participant interactions will occur 
online or via phone. 
6.0 
Study Intervention/Investigational Agent 
1.1 Description: Describe the study intervention and/or investigational 
agent (e.g., drug, device) that is being evaluated. 
Response:  
This study does not involve drugs or devices; however, there will be two 
interventions in this study. The first intervention is the Online intervention, which 
will utilize online grocery shopping (shopping at a local grocery store via 
Instacart) to promote healthier purchasing, removing visceral factors that can lead 
to impulse purchases in stores. The second intervention, the Defaults intervention, 
will augment the Online intervention, showing participants a default cart when 
they log into their accounts. They will be told that their cart has been filled with 
items that conform to a diet appropriate for diabetes prevention, management, and 
overall health and can be used to make the recipes from the provided recipe cards, 
and that they may modify their cart as they like. 

 
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6.1 Drug/Device Handling: If the research involves drugs or device, 
describe your plans to store, handle, and administer those drugs or 
devices so that they will be used only on subjects and be used only by 
authorized investigators. 
• 
If the control of the drugs or devices used in this protocol will 
be accomplished by following an established, approved 
organizational SOP (e.g., Research Pharmacy SOP for the 
Control of Investigational Drugs, etc.), please reference that 
SOP in this section. 
Response:  
N/A, this study does not involve drugs or devices.  
6.2 If the drug is investigational (has an IND) or the device has an IDE 
or a claim of abbreviated IDE (non-significant risk device), include 
the following information: 
• 
Identify the holder of the IND/IDE/Abbreviated IDE. 
• 
Explain procedures followed to comply with sponsor 
requirements for FDA regulated research for the following: 
 
Applicable to: 
FDA Regulation 
IND Studies 
IDE studies 
Abbreviated 
IDE studies 
21 CFR 11 
X 
X 
 
21 CFR 54 
X 
X 
 
21 CFR 210 
X 
 
 
21 CFR 211 
X 
 
 
21 CFR 312 
X 
 
 
21 CFR 812 
 
X 
X 
21 CFR 820 
 
X 
 
Response:  
N/A, this study does not involve drugs or devices.  
7.0 Local Number of Subjects 
7.1 Indicate the total number of subjects that will be enrolled or records that 
will be reviewed locally. 
Response:  
We will enroll up to 100 adults with type 2 diabetes or at increased risk of 
developing type 2 diabetes in this study.  
7.2 If applicable, indicate how many subjects you expect to screen to reach your 
target sample (i.e. your screen failure rate).  
Response:  

 
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Given that approximately 14% of the US population has diabetes, and an 
estimated 34% of US adults has prediabetes, we anticipate that about 208 adults 
would need to be screened in order to identify 100 eligible adults. 
7.3 Justify the feasibility of recruiting the proposed number of eligible subjects 
within the anticipated recruitment period. For example, how many potential 
subjects do you have access to? What percentage of those potential subjects 
do you need to recruit? 
Response:  
Participants will be recruited during 2019-2020 from the Northeastern United 
States via one or more of the following methods. Participants will be recruited via 
advertisements in print and social media, mailings, newspapers and periodicals, 
flyers in clinics and other community locations, and attendance at community 
events and clinics. Prior research by study team members has led to relationships 
with area clinics that will facilitate recruitment of diabetic patients. With regards 
to social media, the study will be advertised on our lab’s and our Division’s 
Facebook and Twitter pages (UB Child Health and Behavior Lab, UB Division of 
Behavioral Medicine). The information will also be posted on our lab’s website 
(http://ubhablab.weebly.com/). The attached recruitment advertisement and/or 
postcard will be uploaded/linked to these sites. These are public pages that 
potential participants can view (and “like”/follow in the case of Facebook and 
Twitter) of their own free will. No information will be collected from participants 
by the researchers via these sites. The potential participants will be able to read 
the text on the recruitment postcard and decide whether to contact the study team 
for more information using the contact information provided and/or whether to 
access and fill out the study screener, with screening information collected on a 
different platform (e.g. Survey Monkey) and protected as indicated herein.  
The study will also utilize the University at Buffalo’s Clinical and Translational 
Sciences Institute (CTSI) for recruitment assistance and consultation. The CTSI’s 
Recruitment and Community Engagement Team provides resources and guidance 
to link our study with community partners to reach populations of interest. These 
resources include the Buffalo Research Registry (BRR) and Conventus Research 
Table. The BRR is a voluntary research registry which can connect researchers to 
community members who have completed a health profile and are interested in 
participating in research. These community members have agreed to be contacted 
about potential research opportunities based on their self-reported information. 
The BRR’s Community Recruitment Liaison (CRL) will complete the process of 
sorting BRR data to reflect the inclusion and exclusion criteria for the study, and 
may reach out to potentially eligible participants in the BRR to provide 
information about the study. The CRL will then provide the study team with the 
name and contact information of interested participants. No recorded health 
information will be shared from BRR data. 
 
We will collaborate with the UB contracted media-buying agency Fahlgren 
Mortine (FM) for the purposes of study recruitment. FM services include media 

 
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planning, placement, management of assets, and creative support specific to study 
objectives. For the purposes of our study, FM will utilize a digital pharmacy 
network to display recruitment advertisements on digital screens in three 
pharmacies in Erie and Niagara counties. These advertisements will be adapted 
from our standard recruitment materials to better suit the digital display platform. 
This advertisement will be used for print and digital media platforms where 
limited text is appropriate (e.g. newspaper advertisements, social media). These 
advertisements will be shown in public spaces that potential participants can view 
of their own free will. The potential participants will be able to access the link on 
the advertisement to decide whether to contact the study team for more 
information and/or whether to access and fill out the study screener, with 
screening information collected on a different platform and protected (e.g. Survey 
Monkey) as indicated herein. 
We will also utilize ResearchMatch, a not-for-profit, free recruitment initiative 
that is supported by a National Institutes of Health (NIH) Clinical and 
Translational Science Award Program grant.  ResearchMatch identifies 
participants from a pool of registered study volunteers that fit within specified 
demographic filters and will email a de-identified group of eligible participants.  
ResearchMatch volunteers are individuals who have self-registered their interest 
to be contacted about participating in research studies that may be a good match 
for them. Recruitment access to ResearchMatch requires evidence of having IRB 
approval and only lasts as long as the IRB-study approval. The expiration date of 
recruitment access will mirror the expiration date of the study. After a researcher 
has been granted recruitment access, they are able to search for appropriate 
matches amongst the non-identifiable ResearchMatch volunteer pool by entering 
the study’s criteria into the ResearchMatch search builder. Search criteria will be 
adults living within 20 miles of a TOPS and/or Wegmans. This process will yield 
a list of potential matches, and these individuals will be contacted with the IRB-
approved recruitment content in an initial recruitment message via a secure 
ResearchMatch system. These potential matches will then have the option to reply 
yes, no, or no response. 
 
In addition, we will share study information with individuals from several 
databases; first, we will access the contact information from a database of 
potentially interested participants maintained by our department. Our 
department’s centralized database includes hundreds of individuals with 
prediabetes or type II diabetes who indicated interest but did not participate in 
prior studies. In addition, there are several similar but smaller databases 
maintained by individual labs within our department. These labs also conduct 
studies with type II diabetic and/or prediabetic patients, and maintain a list of 
individuals who were interested in participating, but did not meet the eligibility 
criteria for the given study. We plan to collaborate with these labs, sharing 
information about our study with these potential participants who indicated an 
interest in hearing about other study opportunities, and also sharing information 
about these colleagues’ studies with individuals who were interested in, but not 

 
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eligible for, the present study. Two other IRB-approved studies within the 
Division of Behavioral Medicine, STUDY00002659 and STUDY00003608, are 
recruiting pre-diabetic and type II diabetic participants. To minimize the 
likelihood participants screen for multiple projects in the lab, and in order to 
efficiently direct participants to the study that might suit them, a shared online 
(Qualtrics) questionnaire will be used that asks participants questions about their 
height and weight, diabetes/prediabetes status, if they are taking medications for 
blood glucose management, hypertension, or high cholesterol, if they are 
interested in weight loss, if they shop at local grocery stores, and if they are on 
public assistance. No personally-identifiable information will be collected on this 
survey; it is completely anonymous and it will only be used to direct participants 
to the IRB-approved online screening questionnaire for the aforementioned 
studies. Research staff within the Division of Behavioral Medicine have used the 
database successfully for multiple years for recruitment purposes, and we feel 
confident that we can recruit the required number of subjects from this database 
and our online and community based efforts. Additionally, Dr. Anzman-Frasca 
has experience conducting research within and recruiting from community 
settings and has recruited similarly-sized samples within similar time frames. 
 
We will also utilize the I2B2 dashboard, a secure, HIPAA compliant database 
maintained by the Institute for Healthcare Informatics within the University at 
Buffalo. In addition, we have previously collaborated with Independent Health 
Foundation on research, and our colleagues there have indicated their willingness 
to share information about this study in two ways: 1) with contacts from their 
database, and 2) via the Brook app. With regard to the latter, our colleagues at 
Independent Health Foundation are collaborating with Brook 
(https://www.brook.health/), encouraging Independent Health members who are 
diabetic to download the app to help track and manage their diabetes. Study 
information can be sent to these individuals via the app. Similar to our outreach 
via the other methods described above, potential participants who receive study 
information through these avenues will be able to read the recruitment text and 
decide whether to contact the study team for more information using the 
information provided and/or whether to access and fill out the study screener, 
with screening information collected on a different platform (e.g. Survey 
Monkey) and protected as indicated herein.   
 
Efforts will be made to recruit low-income individuals (e.g., by mailing 
recruitment postcards to low-income census tracts of Buffalo and/or connecting 
with clinic locations in these tracts). Even though we are excluding SNAP/WIC 
recipients as mentioned above, there are low-income individuals who do not meet 
eligibility criteria for these programs or who do not sign up for these programs 
despite eligibility. Participants will provide informed consent prior to 
participation. 
 

 
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8.0 Inclusion and Exclusion Criteria* 
8.1 Describe the criteria that define who will be included in your final study 
sample.  
NOTE:  This may be done in bullet point fashion. 
Response:  
• Must be at least 18 years old 
• Must have been diagnosed with prediabetes or type 2 diabetes, or meet 
criteria for increased risk of developing type 2 diabetes as determined by 
the American Diabetes Association Type 2 Diabetes Risk Test 
o The American Diabetes Association Type 2 Diabetes Risk Test 
takes the factors below into account with the following scoring 
system; a total score of 5 points or higher indicates an increased 
risk of developing type 2 diabetes 
Criteria  
Scoring  
Age  
Less than 40 years = 0 points  
40-49 years = 1 point 
50-59 years = 2 points 
60 years and older = 3 points 
Gender  
Man = 1 point 
Woman = 0 points 
For women: previous or 
current diagnosis of 
gestational diabetes  
Yes = 1 point 
No = 0 points 
Family history of diabetes 
Yes = 1 point 
No = 0 points 
Previous or current diagnosis 
of high blood pressure 
Yes = 1 point 
No = 0 points 
Level of physical activity  
Physically active = 0 points 
Not physically active = 1 point 
Weight Status  
BMI < 24.9 = 0 points 
BMI of 24.9 – 29.8 = 1 point 
BMI of 29.9 – 39.8 = 2 points 

 
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BMI > 39.9 = 3 points 
• Must report shopping in-person at Tops and/or Wegmans stores at least 
weekly, and at least 50% of the grocery shopping for the household must 
be done at Tops and/or Wegmans 
• Must do at least 75% of the grocery shopping for the household 
• Must speak English 
8.2 Describe the criteria that define who will be excluded from your final study 
sample.   
NOTE:  This may be done in bullet point fashion.  
Response:   
We will exclude anyone who: 
• Is under 18 years of age 
• Has not been diagnosed with prediabetes or type 2 diabetes, or does not 
meet criteria for increased risk of developing type 2 diabetes as 
determined by the American Diabetes Association Type 2 Diabetes Risk 
Test 
• Does not report shopping in-person at Tops and/or Wegmans stores at 
least weekly 
• Does not live in a household in which at least 50% of groceries come from 
Tops and/or Wegmans 
• Does not do at least 75% of the grocery shopping for the household 
• Does not speak English 
• Receives SNAP or WIC benefits (an exclusion criterion for this study due 
to incompatibility of EBT cards with the Instacart platform at this time) 
• Has dietary restrictions or preferences that would not allow them to 
reasonably partake in the study (i.e. they would not be willing or able to 
buy/eat many of the staple foods included in default carts/recipe cards) 
• Has recently participated, or is currently participating, in studies that may 
affect shopping habits and/or eating behavior  
8.3 Indicate specifically whether you will include any of the following special 
populations in your study using the checkboxes below.   
 
NOTE:  Members of special populations may not be targeted for enrollment in 
your study unless you indicate this in your inclusion criteria. 
Response:   
☐ 
Adults unable to consent 
☐ 
Individuals who are not yet adults (infants, children, teenagers) 

 
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☐ 
Pregnant women 
☐ 
Prisoners 
 
8.4 Indicate whether you will include non-English speaking individuals in your 
study.  Provide justification if you will exclude non-English speaking 
individuals.  
In order to meet one of the primary ethical principles of equitable selection 
of subjects, non-English speaking individuals may not be routinely excluded 
from research as a matter of convenience. 
In cases where the research is of therapeutic intent or is designed to 
investigate areas that would necessarily require certain populations who 
may not speak English, the researcher is required to make efforts to recruit 
and include non-English speaking individuals.  However, there are studies 
in which it would be reasonable to limit subjects to those who speak 
English.  Some examples include pilot studies, small unfunded studies with 
validated instruments not available in other languages, studies with 
numerous questionnaires, and some non-therapeutic studies which offer no 
direct benefit. 
Response:  
We will not include non-English speakers given the pilot nature of the study. 
9.0 Vulnerable Populations* 
If the research involves special populations that are considered vulnerable, 
describe the safeguards included to protect their rights and welfare.   
NOTE: You should refer to the appropriate checklists, referenced below, to ensure you 
have provided adequate detail regarding safeguards and protections. You do not, 
however, need to provide these checklists to the IRB. 
9.1 For research that involves pregnant women, safeguards include: 
NOTE CHECKLIST: Pregnant Women (HRP-412) 
Response: 
  
☒ 
N/A:  This research does not involve pregnant women. 
9.2 For research that involves neonates of uncertain viability or non-viable 
neonates, safeguards include: 
NOTE CHECKLISTS: Non-Viable Neonates (HRP-413), or Neonates of Uncertain 
Viability (HRP-414) 
Response:  
 
☒ 
N/A:  This research does not involve non-viable neonates or neonates of 
uncertain viability. 

 
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9.3 
For research that involves prisoners, safeguards include: 
NOTE CHECKLIST: Prisoners (HRP-415) 
Response:  
 
☒ 
N/A:  This research does not involve prisoners. 
9.4 For research that involves persons who have not attained the legal age for 
consent to treatments or procedures involved in the research (“children”), 
safeguards include:   
NOTE CHECKLIST: Children (HRP-416) 
Response:  
 
☒ 
N/A:  This research does not involve persons who have not attained the 
legal age for consent to treatments or procedures (“children”). 
9.5 For research that involves cognitively impaired adults, safeguards include: 
NOTE CHECKLIST: Cognitively Impaired Adults (HRP-417) 
Response:  
 
☒ 
N/A:  This research does not involve cognitively impaired adults. 
9.6 Consider if other specifically targeted populations such as students, 
employees of a specific firm, or educationally or economically 
disadvantaged persons are vulnerable.  Provide information regarding 
their safeguards and protections, including safeguards to eliminate 
coercion or undue influence. 
Response:  
A portion of our sample may be of a lower socioeconomic status, including of a 
lower level of education. We will take care to ensure we give each potential 
participant a thorough explanation of the study and what it entails prior to 
consent, that we answer any questions they may have, and that measures are at an 
appropriate reading level. 
10.0 
Eligibility Screening* 
10.1 Describe screening procedures for determining subjects’ eligibility.  
Screening refers to determining if prospective participants meet inclusion and 
exclusion criteria.  
Include all relevant screening documents with your submission (e.g. screening 
protocol, script, questionnaire).  
Response: 
Potential subjects will be screened online or over the phone for eligibility [See 
attachment – Screener]. If it is determined that they meet all eligibility criteria 
based on their self-report, the consent document will be provided to the 
participant, and the participant will have the opportunity to review it and ask 

 
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study staff any questions. Then, interested participants will indicate their interest 
in participating and will complete consent and HIPAA forms consistent with SOP 
(see attached Consent, HIPAA Form), so that their diabetes/prediabetes diagnosis, 
or specific health characteristics that increase their risk for developing type 2 
diabetes in accordance with the American Diabetes Association Type 2 Diabetes 
Risk Test, can be confirmed by their physician (and so their mailing address can 
be obtained for mailing of their Clincard if they are eligible for the study and 
decide to sign up). Participants will progress to the next phase of the study while 
study staff seek confirmation of diabetes status with physicians via HIPAA 
authorizations.  
☐ 
N/A:  There is no screening as part of this protocol. 
11.0 
Recruitment Methods 
☐ 
N/A:  This is a records review only, and subjects will not be 
recruited.  NOTE:  If you select this option, please make sure that 
all records review procedures and inclusion/exclusion screening 
are adequately described in other sections. 
11.1 Describe when, where, and how potential subjects will be recruited.  
NOTE:  Recruitment refers to how you are identifying potential participants and 
introducing them to the study.  Include specific methods you will use (e.g. 
searching charts for specific ICD code numbers, Research Participant Groups, 
posted advertisements, etc.). 
Response:  
Participants will be recruited during 2019-2020 from the Northeastern United 
States via one or more of the following methods. Participants will be recruited via 
advertisements in print and social media, mailings, newspapers and periodicals, 
flyers in clinics and other community locations, and attendance at community 
events and in clinics. Prior research by study team members has led to 
relationships with area clinics that will facilitate recruitment of diabetic patients. 
With regards to social media, the study will be advertised on our lab’s and our 
Division’s Facebook and Twitter pages (UB Child Health and Behavior Lab, UB 
Division of Behavioral Medicine). The information will also be posted on our 
lab’s website (http://ubhablab.weebly.com/). The attached recruitment postcard 
will be uploaded/linked to these sites. These are public pages that potential 
participants can view (and “like”/follow in the case of Facebook and Twitter) of 
their own free will. No information will be collected from participants by the 
researchers via these sites. The potential participants will be able to read the text 
on the recruitment postcard and decide whether to contact the study team for more 
information using the contact information provided and/or whether to access and 
fill out the study screener, with screening information collected on a different 
platform and protected as indicated herein.  
The study will also utilize the University at Buffalo’s Clinical and Translational 
Sciences Institute (CTSI) for recruitment assistance and consultation. The CTSI’s 
Recruitment and Community Engagement Team provides resources and guidance 

 
Page 25 of 52 
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to link our study with community partners to reach populations of interest. These 
resources include the Buffalo Research Registry (BRR) and Conventus Research 
Table. The BRR is a voluntary research registry which can connect researchers to 
community members who have completed a health profile and are interested in 
participating in research. These community members have agreed to be contacted 
about potential research opportunities based on their self-reported information. 
The BRR’s Community Recruitment Liaison (CRL) will complete the process of 
sorting BRR data to reflect the inclusion and exclusion criteria for the study, and 
may reach out to potentially eligible participants in the BRR to provide 
information about the study. The CRL will then provide the study team with the 
name and contact information of interested participants. No recorded health 
information will be shared from BRR data. 
 
We will collaborate with the UB contracted media-buying agency Fahlgren 
Mortine (FM) for the purposes of study recruitment. FM services include media 
planning, placement, management of assets, and creative support specific to study 
objectives. For the purposes of our study, FM will utilize a digital pharmacy 
network to display recruitment advertisements on digital screens in three 
pharmacies in Erie and Niagara counties. These advertisements will be adapted 
from our standard recruitment materials to better suit the digital display platform. 
This advertisement will be used for print and digital media platforms where 
limited text is appropriate (e.g. newspaper advertisements, social media).  These 
advertisements will be shown in public spaces that potential participants can view 
of their own free will. The potential participants will be able to access the link on 
the advertisement to decide whether to contact the study team for more 
information and/or whether to access and fill out the study screener, with 
screening information collected on a different platform and protected (e.g. Survey 
Monkey) as indicated herein. 
 
We will also utilize ResearchMatch, a not-for-profit, free recruitment initiative 
that is supported by a National Institutes of Health (NIH) Clinical and 
Translational Science Award Program grant.  ResearchMatch identifies 
participants from a pool of registered study volunteers that fit within specified 
demographic filters and will email a de-identified group of eligible participants.  
ResearchMatch volunteers are individuals who have self-registered their interest 
to be contacted about participating in research studies that may be a good match 
for them. Recruitment access to ResearchMatch requires evidence of having IRB 
approval and only lasts as long as the IRB-study approval. The expiration date of 
recruitment access will mirror the expiration date of the study. After a researcher 
has been granted recruitment access, they are able to search for appropriate 
matches amongst the non-identifiable ResearchMatch volunteer pool by entering 
the study’s criteria into the ResearchMatch search builder. Search criteria will be 
adults living within 20 miles of a TOPS and/or Wegmans. This process will yield 
a list of potential matches, and these individuals will be contacted with the IRB-
approved recruitment content in an initial recruitment message via a secure 

 
Page 26 of 52 
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ResearchMatch system. These potential matches will then have the option to reply 
yes, no, or no response. 
 
In addition, we will share study information with individuals from several 
databases; first, we will access the contact information from a database of 
potentially interested participants maintained by our department. Our 
department’s centralized database includes hundreds of individuals with 
prediabetes or type II diabetes who indicated interest but did not participate in 
prior studies. In addition, there are several similar but smaller databases 
maintained by individual labs within our department. These labs also conduct 
studies with type II diabetic and/or prediabetic patients, and maintain a list of 
individuals who were interested in participating, but did not meet the eligibility 
criteria for the given study. We plan to collaborate with these labs, sharing 
information about our study with these potential participants who indicated an 
interest in hearing about other study opportunities, and also sharing information 
about these colleagues’ studies with individuals who were interested in, but not 
eligible for, the present study. Two other IRB-approved studies within the 
Division of Behavioral Medicine, STUDY00002659 and STUDY00003608, are 
recruiting pre-diabetic and type II diabetic participants. To minimize the 
likelihood participants screen for multiple projects in the lab, and in order to 
efficiently direct participants to the study that might suit them, a shared online 
(Qualtrics) questionnaire will be used that asks participants questions about their 
height and weight, diabetes/prediabetes status, if they are taking medications for 
blood glucose management, hypertension, or high cholesterol, if they are 
interested in weight loss, if they shop at local grocery stores, and if they are on 
public assistance. No personally-identifiable information will be collected on this 
survey; it is completely anonymous and it will only be used to direct participants 
to the IRB-approved online screening questionnaire for the aforementioned 
studies. 
 
We will also utilize the I2B2 dashboard, a secure, HIPAA compliant database 
maintained by the Institute for Healthcare Informatics within the University at 
Buffalo. In addition, we have previously collaborated with Independent Health 
Foundation on research, and our colleagues there have indicated their willingness 
to share information about this study in two ways: 1) with contacts from their 
database, and 2) via the Brook app. With regard to the latter, our colleagues at 
Independent Health Foundation are collaborating with Brook 
(https://www.brook.health/), encouraging Independent Health members who are 
diabetic to download the app to help track and manage their diabetes. Study 
information can be sent to these individuals via the app. Similar to our outreach 
via the other methods described above, potential participants who receive study 
information through these avenues will be able to read the recruitment text and 
decide whether to contact the study team for more information using the 
information provided and/or whether to access and fill out the study screener, 

 
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with screening information collected on a different platform and protected as 
indicated herein.   
 
Efforts will be made to recruit low-income individuals (e.g., by mailing 
recruitment postcards to low-income census tracts of Buffalo and/or connecting 
with clinic locations in these tracts). Even though we are excluding SNAP/WIC 
recipients as mentioned above, there are low-income individuals who do not meet 
eligibility criteria for these programs or who do not sign up for these programs 
despite eligibility. Participants will provide informed consent prior to 
participation. 
11.2 Describe how you will protect the privacy interests of prospective subjects 
during the recruitment process.   
NOTE:  Privacy refers to an individual’s right to control access to him or herself.   
Response:  
We will not contact anyone who has requested to be removed from our Division’s 
database of contact information. We will keep all recruitment and screening 
information confidential. 
11.3 Identify any materials that will be used to recruit subjects.  
NOTE:  Examples include scripts for telephone calls, in person announcements / 
presentations, email invitations.  
For advertisements, include the final copy of printed advertisements with your 
submission. When advertisements are taped for broadcast, attach the final 
audio/video tape.  NOTE:  You may submit the wording of the advertisement prior 
to taping to ensure there will be no IRB-required revisions, provided the IRB also 
reviews and approves the final version. 
 Response:  
For recruitment, materials will include advertisements in print and on social 
media, mailings, newspapers and periodicals, and flyers in clinics and other 
community locations. These materials are attached (see recruitment flyer and 
postcard). 
As mentioned, with regards to social media, the study will be advertised on our 
lab and our Division’s Facebook and Twitter pages (UB Child Health and 
Behavior Lab, UB Division of Behavioral Medicine). The information will also 
be posted on our lab’s website (http://ubhablab.weebly.com/). We will upload/link 
the attached recruitment postcard as our advertisement on these sites. These 
public sites are accessed by potential participants via their own free will. No 
information will be collected from participants by the researchers via these sites. 
The participants instead will be able to read the recruitment text and decide 
whether to contact the study team for more information using the contact 
information provided and/or whether to access and fill out the study screener. 
Information completed during the screening is on a separate website and is stored 
securely and not viewable to anyone besides the study staff.   

 
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We will collaborate with the UB contracted media-buying agency Fahlgren 
Mortine (FM) for the purposes of study recruitment. FM services include media 
planning, placement, management of assets, and creative support specific to study 
objectives. For the purposes of our study, FM will utilize a digital pharmacy 
network to display recruitment advertisements on digital screens in three 
pharmacies in Erie and Niagara counties. These advertisements will be adapted 
from our standard recruitment materials to better suit the digital display platform. 
This advertisement will be used for print and digital media platforms where 
limited text is appropriate (e.g. newspaper advertisements, social media).  These 
advertisements will be shown in public spaces that potential participants can view 
of their own free will. The potential participants will be able to access the link on 
the advertisement to decide whether to contact the study team for more 
information and/or whether to access and fill out the study screener, with 
screening information collected on a different platform and protected (e.g. Survey 
Monkey) as indicated herein. 
 
12.0 
Procedures Involved* 
12.1 Provide a description of all research procedures or activities being 
performed and when they are performed once a subject is screened and 
determined to be eligible. Provide as much detail as possible.   
NOTE:  This should serve as a blueprint for your study and include enough detail 
so that another investigator could pick up your protocol and replicate the research.  
For studies that have multiple or complex visits or procedures, consider the 
addition of a schedule of events table in in your response. 
Response:  
The proposed study will occur during 2019-2020 with data collection occurring 
for about 17 months. Recruitment and data collection will occur on a rolling basis, 
with individual participants’ involvement being for about 6 weeks. All data will 
be collected online or via phone.  
Following completion of initial screening, participants will complete consent 
procedures and a HIPAA form for their physician to confirm their 
diabetes/prediabetes diagnosis, or specific health characteristics that increase their 
risk of developing type 2 diabetes in accordance with the American Diabetes 
Association Type 2 Diabetes Risk Test [see Consent and HIPAA form]. 
Physicians will be contacted using their modality of choice; this may include 
phone, email, fax via efax.com, or in-person communication). Participants will be 
mailed their Clincard for participant payment and move on to baseline 
procedures: a questionnaire [See attachment: Questionnaires], a baseline shopping 
trip and receipt submission, and a brief phone interview with questions about their 
shopping trip [See attachment: Phone interview]. Any participant who does not 
follow guidelines for baseline procedures will not proceed to randomization (but 
will be compensated for their time, as detailed below).  

 
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Participants’ baseline shopping trips will be in-person at their usual grocery store. 
Following their baseline shopping trip, participants will submit a photograph of 
their household receipts via email and of a receipt information form (attached). 
Study staff will contact participants to remind them about this if photographs are 
not received within the time frame discussed during consent procedures. When 
the photos are received, study staff will mail participants their Clincards to be 
used for participant payments and will contact participants via phone to ask 
follow-up questions and share with participants their assigned study group [See 
attachment: Phone interview]. 
Participants will be randomized in blocks to the Online, Defaults, or Control 
group, stratifying by diabetes status (diabetes vs. increased risk for developing 
type 2 diabetes). Study staff will consult a pre-populated spreadsheet in order to 
determine the study group of each participant. Participants in the Online and 
Defaults groups will receive instructions on how to access an online grocery 
shopping account on Instacart (www.instacart.com). Instacart is a platform 
through which customers can grocery shop online and have their groceries 
delivered within a designated window. Many leading grocery retailers offer 
grocery shopping via Instacart, including Tops and Wegmans, both of which are 
based in Western New York; there are approximately 250  locations of these 
chains throughout the Northeastern United States, including but not limited to: 
New York, New Jersey, Pennsylvania, and Massachusetts.   
Accounts will be set up for the participants by study staff, with shared access. 
Participants will enter their credit/debit card information and purchase their own 
groceries, to enhance ecological validity. Only the last 4 digits of the participant’s 
credit or debit card number will be visible to study staff when accessing the 
account to download receipt data (Online and Defaults groups) and populate the 
default cart (Defaults group). During the 3 weeks that follow randomization, 
Control group participants will be asked to shop as they normally would, in-
person at Tops or Wegmans. Those in Online and Defaults groups will be asked 
to shop as they normally would but using their grocery store’s Instacart platform. 
In addition, the Defaults group will be told that their cart will be pre-filled with 
items that conform to adiet appropriate for diabetes management, prevention, and 
overall health. The items will correspond to the DASH diet. All participants will 
receive 3 DASH-diet friendly recipe cards each week, and the items in the 
Defaults group’s carts will correspond to the recipes. The default cart will be 
populated by study staff after study group assignment and will be re-populated to 
prepare for the next purchase each time the participant completes a shopping trip. 
During the post-test week, all participants will be asked to shop using the method 
of their choice (in-person, online); no default carts or recipe cards will be given. 
At post-test participants will also complete a Food Frequency Questionnaire as 
well as an Exit Questionnaire (see attachment: Questionnaires). 
Based on inclusion criteria, we expect each participant to shop at least once 
during each of the three intervention weeks; participants can shop more than once 
per week if this is what they typically do. Either way, they will be instructed to 
continue to submit their receipts from all household grocery shopping at 

 
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Tops/Wegmans via email as done at baseline. Participants will be prompted 
weekly, reminding them to shop as they normally would and to ask whether the 
household has completed any shopping trips without submitting receipts. 
Participants will also be asked about foods purchased from other locales during 
phone interviews following submission of receipts each week (See attachment: 
Phone interview). Although receipts are downloadable from Instacart in the 
intervention groups and weeks, we will collect these receipts from participants as 
well, for consistency and as an indicator of the extent to which the number of 
submitted receipts corresponds to the number of actual receipts, to further inform 
feasibility for subsequent larger-scale work. 
12.2 Describe what data will be collected.   
NOTE:  For studies with multiple data collection points or long-term follow up, 
consider the addition of a schedule or table in your response. 
Response:  
Data to be collected include:  
*Confirmation of diabetes status or diabetes risk status (see attachments: Consent 
and HIPAA Form) 
*Demographic questions collected at baseline (see attachment: Questionnaires) 
*Changes in daily routine, perceived stress and loneliness questions at baseline 
(see attachment: Questionnaires)  
*Calories, carbohydrates, sugar (total sugar and/or added sugar), and food groups 
each week of the 5-week shopping period, from receipts (see additional details 
below) 
*Information on which purchased items will be consumed by the participant and 
information about foods acquired from other sources besides the target grocery 
store that week (administered after each shopping trip, see attachment: Phone 
interview) 
*Dollars spent on groceries at each time point, from receipts (each week) 
*Dietary intake from a Food Frequency Questionnaire (see details below and 
attachment: Questionnaires; collected at post-test) 
*Exit questionnaire (completed at the end of the study; see attachment: 
Questionnaires) 
Additional details: 
Calories, carbohydrates, sugar (total sugar and/or added sugar), and food groups 
will be generated from each of the five weeks of receipt data using Nutritionist 
Pro software. Each item on the receipt, as well as the item quantity and weight, 
will be entered into the software following procedures from Hollis-Hansen et al. 
(Hollis-Hansen, Seidman, O’Donnell, & Epstein, 2018). Standard values from the 
USDA will be entered in the case of any missing information as done previously. 
Nutritional quality will be examined using the DASH diet scores based on the 
amount of 8 food types encouraged or discouraged by the DASH diet (e.g., fruits, 

 
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vegetables, sweetened beverages). Methods previously used to calculate DASH 
diet scores from intake data will be adapted for use in this context.  
The food frequency questionnaire is used to calculate nutrient intake. It is a 
structured self-administered questionnaire with pre-specified response options. 
12.3 List any instruments or measurement tools used to collect data 
(e.g. questionnaire, interview guide, validated instrument, data collection 
form).   
 
Include copies of these documents with your submission. 
Response:  
• Baseline demographic questionnaire – (see attachment: Questionnaires) 
• Food frequency questionnaire (to be completed at post-test) – (see 
attachment: Questionnaires)  
• Food receipt collection instructions (see attachment: Receipt collection) 
• Food receipt form (see attachment: Receipt collection) 
• Exit survey – (see attachment: Questionnaires) 
• Consent and HIPAA form  
12.4 Describe any source records that will be used to collect data about subjects 
(e.g. school records, electronic medical records). 
Response:  
N/A, no source records will be used to collect data about subjects. 
12.5 Indicate whether or not individual subject results, such as results of 
investigational diagnostic tests, genetic tests, or incidental findings will be 
shared with subjects or others (e.g., the subject’s primary care physician) 
and if so, describe how these will be shared. 
Response:  
N/A, no individual subject results will be shared with subjects or others. 
12.6 Indicate whether or not study results will be shared with subjects or others, 
and if so, describe how these will be shared. 
Response:  
No, study results will not be shared with subjects or others besides publication of 
study results in scientific journals and accompanying write-ups (e.g., conference 
presentations, press releases to promote published articles). All such publications 
will feature data in aggregate and no identifying information. 
13.0 
Study Timelines* 
13.1 Describe the anticipated duration needed to enroll all study subjects. 
Response:  

 
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It is anticipated that recruitment for this study will take approximately 18 months. 
Recruitment will begin in Summer 2019, pending IRB approval. 
13.2 Describe the duration of an individual subject’s participation in the study. 
Include length of study visits, and overall study follow-up time. 
Response:  
An individual subject’s participation in the study will take place over about 6 
weeks. 
13.3 Describe the estimated duration for the investigators to complete this study 
(i.e. all data is collected and all analyses have been completed). 
Response:  
The proposed study will take place over approximately 2 years. 
14.0 
Setting 
14.1 Describe all facilities/sites where you will be conducting research 
procedures.  Include a description of the security and privacy of the 
facilities (e.g. locked facility, limited access, privacy barriers).  Facility, 
department, and type of room are relevant.  Do not abbreviate facility 
names.   
NOTE:  Examples of acceptable response may be:  “A classroom setting in the 
Department of Psychology equipped with a computer with relevant survey 
administration software,” “The angiogram suite at Buffalo General Medical 
Center, a fully accredited tertiary care institution within New York State with 
badge access,” or, “Community Center meeting hall.” 
Response:  
Research will be conducted in the Division of Behavioral Medicine Laboratory 
located in 151 Farber Hall, or remotely using UB’s secure VPN in accordance 
with laboratory emergency procedures. 151 Farber Hall is secured suite with 
multiple private rooms. For this study, all participant contact will be remote 
(online or phone), and study staff will utilize computer/phone stations within 151 
Farber Hall for these contacts. The study team may receive some additional office 
space in Farber Hall over the next 1-2 years. If study staff are seated in these 
offices, participant contact could take place in these additional offices within 
Farber Hall. These locations would have the same security features as the 151 
Farber Hall location (door able to be closed and locked to ensure security and a 
private space for speaking with participants, computers password-protected, files 
saved on secure server, etc.). 
14.2 For research conducted outside of UB and its affiliates, describe: 
• Site-specific regulations or customs affecting the research 
• Local scientific and ethical review structure 
NOTE:  This question is referring to UB affiliated research taking place outside 
UB, i.e. research conducted in the community, school-based research, 

 
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international research, etc.  It is not referring to multi-site research.  UB affiliated 
institutions include Kaleida Health, ECMC, and Roswell Park Cancer Institute.   
Response:  
 
☒ 
N/A:  This study is not conducted outside of UB or its affiliates. 
15.0 
Community-Based Participatory Research 
15.1 Describe involvement of the community in the design and conduct of the 
research.  
NOTE:  Community-Based Participatory Research (CBPR) is a collaborative 
approach to research that equitably involves all partners in the research process 
and recognizes the unique strengths that each brings.  CBPR begins with a 
research topic of importance to the community, has the aim of combining 
knowledge with action and achieving social change to improve health outcomes 
and eliminate health disparities. 
Response:  
 
☒ 
N/A:  This study does not utilize CBPR. 
15.2 
Describe the composition and involvement of a community advisory 
board. 
Response:  
 
☒ 
N/A:  This study does not have a community advisory board. 
16.0 
Resources and Qualifications 
16.1 Describe the qualifications (e.g., education, training, experience, expertise, 
or certifications) of the Principal Investigator and staff to perform the 
research.  When applicable describe their knowledge of the local study sites, 
culture, and society.  Provide enough information to convince the IRB that 
you have qualified staff for the proposed research.  
NOTE:  If you specify a person by name, a change to that person will require prior 
approval by the IRB.  If you specify a person by role (e.g., coordinator, research 
assistant, co-investigator, or pharmacist), a change to that person will not usually 
require prior approval by the IRB, provided that the person meets the 
qualifications described to fulfill their roles. 
Response:  
All faculty, staff, and students on this protocol have completed CITI training. 
Additionally, all staff and research assistants working with human subjects in the 
Child Health and Behavior Lab undergo a Background Check.  
Dr. Stephanie Anzman-Frasca (PI) and Drs. Leonard Epstein and Leone (co-Is) 
have extensive experience in behavioral and/or community research. Student 

 
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Research Assistants Kelseanna Hollis-Hansen, Sara Tauriello, and Eunice Mak 
have prior experience collecting data from children and with community outreach. 
Describe other resources available to conduct the research.  
16.2 Describe the time and effort that the Principal Investigator and research 
staff will devote to conducting and completing the research. 
NOTE:  Examples include the percentage of Full Time Equivalents (FTE), hours 
per week.  The question will elicit whether there are appropriate resources to 
conduct the research. 
Response:  
It is planned for the PI to devote about 5-15% effort to this study while it is taking 
place, with more effort anticipated at the beginning and end of the project. It is 
expected that study staff and students will spend about 5-20 hours per week on 
this project, depending on their particular role. 
16.3 Describe the availability of medical or psychological resources that subjects 
might need as a result of anticipated consequences of the human research, if 
applicable. 
NOTE:  One example includes: on-call availability of a counselor or psychologist 
for a study that screens subjects for depression. 
Response:  
We do not anticipate that subjects will need medical or psychological resources as 
a result of the study.  
16.4 Describe your process to ensure that all persons assisting with the research 
are adequately informed about the protocol, the research procedures, and 
their duties and functions. 
Response:  
All personnel working on the project are required to complete the CITI training as 
required by the IRB. Additionally, all study staff will be trained on data collection 
procedures by senior team members (the PI, graduate students working on the 
project, and/or Eunice Mak, a senior undergraduate student with substantial 
research experience). The PI will provide initial training and continued oversight 
when students assume any leadership roles on the study. 
17.0 
Other Approvals 
17.1 Describe any approvals that will be obtained prior to commencing the 
research (e.g., school, external site, funding agency, laboratory, radiation 
safety, or biosafety). 
Response:  
 
☒ 
N/A:  This study does not require any other approvals. 
18.0 
Provisions to Protect the Privacy Interests of Subjects 

 
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18.1 Describe how you will protect subjects’ privacy interests during the course 
of this research. 
NOTE:  Privacy refers to an individual’s right to control access to him or herself.  
Privacy applies to the person.  Confidentiality refers to how data collected about 
individuals for the research will be protected by the researcher from release.  
Confidentiality applies to the data.   
Examples of appropriate responses include:  “participant only meets with a study 
coordinator in a classroom setting where no one can overhear”, or “the 
participant is reminded that they are free to refuse to answer any questions that 
they do not feel comfortable answering.”   
Response:  
The recruitment procedures described in this protocol make use of posted flyers 
web postings, and secure databases of interested potential participants – methods 
approved by previous IRB committees. With regards to public postings, 
participants may call the laboratory or complete the online screening 
questionnaire of their own free will, and thus are controlling access to their 
privacy.  
Other participants will be recruited using secure databases of interested 
participants maintained by the Division of Behavioral Medicine, Independent 
Health, the Center for Translational Sciences Institute (CTSI) and I2B2.Potential 
participants have signed up for these databases of their own free will. All 
recruitment details will be kept confidential and private. During the initial phone 
or online screening, data will be collected in the secure laboratory environment 
and will be recorded within password-protected files, to which only select staff 
have access. All information will be treated in strict confidence to the extent 
provided by the law.  
All study data will be stored on a secure password-protected server, UBBox, 
and/or external hard drive locked in a cabinet in a secure room (151 Farber). Only 
the PI and members of the research staff will have access to the data. Personally 
identifiable information will be stored separately from coded data. A file linking 
participant identities with participant ID numbers will be stored separately from 
these data sources and will be password-protected and accessible only by the PI 
and senior Child Health and Behavior Lab staff. Participants’ identities will not be 
linked with any published results. 
Participants will be told they have the right to refuse to answer any question that 
makes them uncomfortable and to stop participating in the study at any time 
should they so choose. 
18.2 Indicate how the research team is permitted to access any sources of 
information about the subjects.   
NOTE:  Examples of appropriate responses include:  school permission for review 
of records, consent of the subject, HIPAA waiver.  This question does apply to 
records reviews. 
Response:  

 
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Participants will indicate their consent after reviewing consent forms and having 
the chance to ask the study team any questions. A HIPAA authorization will be 
completed before the research team can access medical information about 
participants’ diabetes status and/or diabetes risk status (See attachment: Consent 
and HIPAA form). Then, HIPAA forms will be used to collect information 
needed to access information about participants’ diabetes status and/or diabetes 
risk status. Physicians will be contacted using their modality of choice; this may 
include phone, email, fax, or in-person communication.  
19.0 
Data Management and Analysis* 
19.1 Describe the data analysis plan, including any statistical procedures.  This 
section applies to both quantitative and qualitative analysis.  
Response:  
Linear mixed models will be used to test effects of the interventions on total 
calories, carbohydrates, sugar (total sugar and/or added sugar), and nutritional 
quality of grocery purchases, with study group, time, and their interaction as 
factors. Primary comparisons will be between-groups comparisons of these 
variables at post-test. We will also examine whether these variables differ overall 
by study group and whether changes in these variables differ by study group. We 
will conduct each analysis once for the total cart and then again examining these 
variables relative to household size and for items that the respondent indicated 
they would be consuming. We will conduct parallel analyses with total dollars 
spent each week and with DASH diet scores as outcomes to examine effects on 
spending and intake. We will also explore whether effects differ for participants 
with prediabetes vs. diabetes and whether results change when adjusting for food 
purchases beyond the target stores. Finally, we will test for relationships between 
purchases (calories, carbohydrates, and sugar (total sugar and/or added sugar)) 
and intake (DASH diet scores). We will also explore whether results differ when 
considering shopping trips completed by the participant only (vs. all trips for the 
household). 
19.2 If applicable, provide a power analysis.   
NOTE:  This may not apply to certain types of studies, including chart/records 
reviews, survey studies, or observational studies.  This question is asked to elicit 
whether the investigator has an adequate sample size to achieve the study 
objectives and justify a conclusion.  
Response:  
To estimate the sample size needed for this study, effect sizes from the most 
similar existing study were used: a proof-of-principle study examining the effects 
of defaults, incentives, and education strategies on healthfulness of grocery 
purchases among undergraduate students (Coffino & Hormes, 2018, Obesity). 
Based on the observed differences in calories purchased at post-test between 
defaults and education control groups (Cohen’s d=0.96), 15 participants would be 
needed for the primary comparison in the present study, with alpha=.05 and 
power=.80. We repeated this analysis using the difference between controls and 

 
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the prior study’s intermediary group (incentives; Cohen’s d=0.44) to conduct a 
more conservative sample size calculation, given our interest in detecting effects 
on purchasing between our intermediary group (Online) and the other groups. 
This calculation yielded a sample size of 54. We increased this to account for 
participants lost during the run-in period (i.e. failure to confirm diabetes 
diagnosis, failure to complete baseline procedures) as well as participants lost due 
to attrition, with a plan to enroll up to 100 participants.  
 
19.3 Describe any procedures that will be used for quality control of collected 
data. 
Response:  
Some data will be entered directly by participants (online questionnaires). All 
other study data will be entered by trained staff: study staff will enter participant 
responses into online forms while phone screening/phone interviews are 
completed. Study staff will also enter information from receipts into 
NutritionistPro (e.g., nutrition information) and Microsoft Excel (e.g., dollars 
spent) for analysis of study aims. Entered data will be double entered and/or 
checked for quality control. 
20.0 
Confidentiality* 
 
A. Confidentiality of Study Data 
 
Describe the local procedures for maintenance of confidentiality of study data 
and any records that will be reviewed for data collection.   
 
20.1 
A.  Where and how will all data and records be stored?  Include 
information about:  password protection, encryption, physical controls, 
authorization of access, and separation of identifiers and data, as applicable.  
Include physical (e.g. paper) and electronic files. 
Response:  
All electronic study data will be stored on a secure server (the S drive within the 
School of Medicine and Biomedical Sciences), UBBox, and/or external hard drive 
locked in a cabinet in a secure room (151 Farber). Any paper forms will be stored 
in a locked file cabinet in 151 Farber. Only the PI and members of the research 
staff will have access to the data. Personally identifiable information (e.g., 
HIPAA forms/addresses) will be stored separately from coded data. A file linking 
participant identities with participant ID numbers will be stored separately from 
these data sources and will be password-protected and accessible only by the PI 
and senior Child Health and Behavior Lab staff. Participants’ identities will not be 
associated with any published results.  
Only study staff associated with the project will have access to the data. 
Identifiable data and any links to identifiable data will be kept in the 
aforementioned secure locations for up to ten years after the study, at which point 

 
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they will be destroyed. At that point, the coded data will be de-identified, and 
such data will be kept indefinitely. 
No information will be collected from social media sites. Any participants who 
see recruitment materials on these websites will be directed to connect with the 
researchers via phone, email, or screener survey, and any information exchanged 
from there will be protected as described herein. Potential participants will view 
these advertisements on public pages/sites of their own free will, and should they 
decide to comment on the post, they will do that of their own free will, with this 
information not used by the research team in any way. 
20.2 
A.  How long will the data be stored? 
Response:  
Identifiable data and any links to identifiable data will be stored for up to ten 
years following study completion, after which the data will be destroyed. Upon 
destruction of identifiable data, coded data will be de-identified and then retained 
indefinitely. 
20.3 
A.  Who will have access to the data? 
Response:  
Only study staff working on the project will have access to the data. 
20.4 
A.  Who is responsible for receipt or transmission of the data? 
Response:  
Dr. Anzman-Frasca is responsible. 
20.5 
A.  How will the data be transported? 
Response: 
Data will not be transported locally; it will remain at the local site. 
B. Confidentiality of Study Specimens 
 
Describe the local procedures for maintenance of confidentiality of study 
specimens.   
 
☒ 
N/A:  No specimens will be collected or analyzed in this research.   
(Skip to Section 19.0) 
 
20.6 
B.  Where and how will all specimens be stored?  Include information 
about:  physical controls, authorization of access, and labeling of specimens, as 
applicable.   
Response:  
 
20.7 
B.  How long will the specimens be stored? 

 
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Response:  
 
20.8 
B.  Who will have access to the specimens? 
Response:  
 
20.9 
B.  Who is responsible for receipt or transmission of the specimens? 
Response:  
 
20.10 B.  How will the specimens be transported? 
Response: 
 
 
21.0 
Provisions to Monitor the Data to Ensure the Safety of 
Subjects* 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records review 
procedures only.  This section does not apply. 
 
NOTE:  Minimal risk studies may be required to monitor subject safety if the research 
procedures include procedures that present unique risks to subjects that require 
monitoring.  Some examples include:  exercising to exertion, or instruments that elicit 
suicidality or substance abuse behavior.  In such cases, N/A is not an acceptable 
response. 
 
21.1 Describe the plan to periodically evaluate the data collected regarding both 
harms and benefits to determine whether subjects remain safe. 
Response:  
Since the proposed study poses no greater than minimal risk to participants, a 
DSMB is not necessary. The Principal Investigator, Stephanie Anzman-Frasca, 
will be responsible for ensuring data integrity and safety monitoring of human 
subjects who are involved in the research. 
21.2 Describe what data are reviewed, including safety data, untoward events, 
and efficacy data. 
Response:  
Data will be checked to make sure that: 
A. All study data are coded with a unique participant ID.  
B. All electronic data are stored securely on password-protected server, UBBox, 
and/or external hard drive locked in a cabinet in a secure room (151 Farber).  
C. When the results of the study are presented and/or published, no individual 

 
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participant will be identifiable. Demographic data will only be presented in 
aggregate. Identifiable data will be retained for up to ten years. 
21.3 Describe any safety endpoints. 
Response:  
Since this study involves less than minimal risk, there are no safety endpoints. 
21.4 Describe how the safety information will be collected (e.g., with case report 
forms, at study visits, by telephone calls with participants). 
Response:  
N/A, this study involves less than minimal risk so safety information will not be 
collected. 
21.5 Describe the frequency of safety data collection. 
Response:  
N/A, this study involves less than minimal risk so there will be no safety data 
collection. 
21.6 Describe who will review the safety data. 
Response:  
N/A, this study involves less than minimal risk so no one will review safety data. 
21.7 Describe the frequency or periodicity of review of cumulative safety data. 
Response:  
N/A, this study involves less than minimal risk so there will be no revision of 
safety data. 
21.8 Describe the statistical tests for analyzing the safety data to determine 
whether harm is occurring. 
Response:  
N/A, this study involves less than minimal risk, so there will be no statistical tests 
for safety data. 
21.9 Describe any conditions that trigger an immediate suspension of the 
research. 
Response:  
N/A, this study involves less than minimal risk so there will be no stopping 
criteria. 
22.0 
Withdrawal of Subjects* 
☐ 
N/A:  This study is not enrolling subjects.  This section does not apply. 
 
22.1 Describe anticipated circumstances under which subjects may be withdrawn 
from the research without their consent. 

 
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Response:  
Participants who do not comply with study guidelines at baseline (including 
guidelines for receipt submission) will not be randomized for further participation 
and withdrawn from the research. Participants also have the ability to stop 
participating at any time if they so choose. 
22.2 Describe any procedures for orderly termination.   
NOTE:  Examples may include return of study drug, exit interview with clinician.  
Include whether additional follow up is recommended for safety reasons for 
physical or emotional health. 
Response:  
Participants will be debriefed about the nature of the study and the reason for their 
removal. 
22.3 Describe procedures that will be followed when subjects withdraw from the 
research, including retention of already collected data, and partial 
withdrawal from procedures with continued data collection, as applicable. 
Response:  
Participants can withdraw from the research at any time. If participants withdraw, 
no further data will be collected, but any information that had been provided may 
be retained and analyzed. 
23.0 
Risks to Subjects* 
23.1 List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related to their participation in the research. 
Consider physical, psychological, social, legal, and economic risks.  Include 
a description of the probability, magnitude, duration, and reversibility of the 
risks.  
NOTE:  Breach of confidentiality is always a risk for identifiable subject data. 
Response:  
There is no greater than minimal physical, psychological, social, or legal risks 
associated with participating in the study. 
23.2 Describe procedures performed to lessen the probability or magnitude of 
risks, including procedures being performed to monitor subjects for safety. 
Response:  
We do not anticipate participants reaching high or prolonged levels of distress as 
a result of participating in this study. 
23.3 If applicable, indicate which procedures may have risks to the subjects that 
are currently unforeseeable. 
Response:  
N/A, there are no currently unforeseeable risks to subjects. 

 
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23.4 If applicable, indicate which research procedures may have risks to an 
embryo or fetus should the subject be or become pregnant. 
Response:  
Pregnant women are not the focus of this study, but it is possible that one of the 
participants could be pregnant. The participant’s roles in this study are to grocery 
shop, submit photographs of receipts, and complete questionnaires. Therefore, 
there are no risks to an embryo or fetus beyond those in everyday life. 
23.5 If applicable, describe risks to others who are not subjects. 
Response:  
There are no risks to others who are not subjects. 
24.0 
Potential Benefits to Subjects* 
24.1 Describe the potential benefits that individual subjects may experience by 
taking part in the research.  Include the probability, magnitude, and 
duration of the potential benefits.  Indicate if there is no direct benefit.   
NOTE:  Compensation cannot be stated as a benefit. 
Response:  
Potential benefits include: participants being more likely to choose healthy 
options later on after exposure to the recipe cards provided to all groups or to our 
interventions (Defaults and Online groups). 
25.0 
Compensation for Research-Related Injury 
☒ 
N/A:  The research procedures for this study do not present risk of 
research related injury (e.g. survey studies, records review studies).  This 
section does not apply.   
25.1 
If the research procedures carry a risk of research related injury, 
describe the available compensation to subjects in the event that such 
injury should occur.   
Response: 
 
25.2 
Provide a copy of contract language, if any, relevant to compensation for 
research related injury. 
NOTE:  If the contract is not yet approved at the time of this submission, submit the 
current version here.  If the contract is later approved with different language 
regarding research related injury, you must modify your response here and 
submit an amendment to the IRB for review and approval. 
Response:  
 
26.0 
Economic Burden to Subjects 

 
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26.1 
Describe any costs that subjects may be responsible for because of 
participation in the research.   
NOTE:  Some examples include transportation or parking. 
Response:  
Subjects will pay for their own groceries as they would normally do. Participant 
payments (detailed further below) account for the additional costs of shopping 
online during the 3 intervention weeks. Therefore, subjects should not be 
responsible for any new/added costs as a result of participation in the study. 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records review 
procedures only.  This section does not apply. 
27.0 
Compensation for Participation 
27.1 
Describe the amount and timing of any compensation to subjects, 
including monetary, course credit, or gift card compensation. 
Response:  
All participants will receive up to $75 for their participation in the study, with $20 
provided after completing baseline measures ($20), $10 after each intervention 
measure, and another $25 provided after post-test. Participants will be paid as 
they complete study tasks using Clincard. Clincards will be provided after all 
screening procedures are completed, and eligibility (and interest in participating) 
has been determined. Payments during intervention weeks will also include 
reimbursements for typical costs of online shopping in Online and Defaults 
groups, given that these participants typically shop in-person but are being asked 
to shop online as part of the study. The typical cost of online shopping was 
estimated by applying Instacart service fees (5% of purchase) and data on average 
mark-ups on Wegmans items purchased via Instacart (~15% of purchase) to 
weekly grocery shopping amounts estimated using the USDA’s official food plans 
(moderate-cost plan for a given family size: 
https://www.cnpp.usda.gov/sites/default/files/CostofFoodMar2019.pdf). We also 
added the estimated cost of delivery ($5.99) to the estimates. The payment to 
subsidize costs of online shopping will be calculated in this manner for each 
participant based on their family size. For example, for a 19-50-year-old single 
female participant, the USDA’s moderate cost plan estimates $59.60 in weekly 
food expenditures. Calculating the costs of online shopping indicated above 
(service fees, item mark-ups, and delivery) at this budget, we will provide an 
additional $53.73 to this participant over the course of the study ($17.91 per 
intervention week). For a family of two adults, this estimate changes to $103.47 
or $34.49 per intervention week. As with other study payments, these payments 
will be provided to participants via Clincard provided they complete the study 
activities of the week. 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records 
review procedures only.  This section does not apply. 

 
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☐ 
N/A:  There is no compensation for participation.  This section 
does not apply. 
28.0 
Consent Process 
28.1 Indicate whether you will be obtaining consent.   
NOTE:  This does not refer to consent documentation, but rather whether you will 
be obtaining permission from subjects to participate in a research study.   
Consent documentation is addressed in Section 27.0. 
☒ 
Yes 
(If yes, Provide responses to each question in this Section) 
☐ 
No 
(If no, Skip to Section 27.0) 
 
28.2 Describe where the consent process will take place.  Include steps to 
maximize subjects’ privacy. 
Response:  
The study is designed, so that all study contact will be remote (online, phone, or 
paper mail), allowing participants to complete consent from the private location of 
their choosing (such as their own home). The initial screening questionnaire can 
be done via phone or via online survey; in both cases, information will be 
recorded using online survey software and stored in password-protected files. If a 
prospective participant consents to the information from the phone screen being 
stored, there is a button to click that indicates that they have been asked and 
agreed.  
If the prospective participant meets the criteria gathered from the initial screen 
and is interested, they will move on to the consent process. Study information will 
be provided electronically, with opportunities for potential participants to ask 
study staff any questions they may have and then indicate their consent to 
participate electronically if interested. After consent is obtained, participants will 
move onto the other steps of the study described herein, with all study data stored 
securely within the team’s research offices in Farber Hall and/or on a secure 
electronic platform (password-protected server, UBBox). 
28.3 Describe how you will ensure that subjects are provided with a sufficient 
period of time to consider taking part in the research study.   
NOTE:  It is always a requirement that a prospective subject is given sufficient 
time to have their questions answered and consider their participation.  See “SOP: 
Informed Consent Process for Research (HRP-090)” Sections 5.5 and 5.6. 
Response:  
Participants will be able to take as much time as they need to read and understand 
the consent documents, and ask any questions. 
28.4 Describe any process to ensure ongoing consent, defined as a subject’s 
willingness to continue participation for the duration of the research study.   
Response:  

 
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Subjects will only consent once to participating in the study. 
28.5 Indicate whether you will be following “SOP: Informed Consent Process for 
Research (HRP-090).” Pay particular attention to Sections 5.4-5.9. If not, 
or if there are any exceptions or additional details to what is covered in the 
SOP, describe: 
• 
The role of the individuals listed in the application who are involved in 
the consent process 
• 
The time that will be devoted to the consent discussion 
• 
Steps that will be taken to minimize the possibility of coercion or 
undue influence 
• 
Steps that will be taken to ensure the subjects’ understanding 
Response:  
☒ 
We have reviewed and will be following “SOP: Informed Consent Process 
for Research (HRP-090).” 
 
Non-English Speaking Subjects  
☒ 
N/A:  This study will not enroll Non-English speaking subjects.   
(Skip to Section 26.8) 
28.6 Indicate which language(s) other than English are likely to be 
spoken/understood by your prospective study population or their legally 
authorized representatives. 
 
NOTE: The response to this Section should correspond with your response to 
Section 6.4 of this protocol. 
Response:  
 
28.7 If subjects who do not speak English will be enrolled, describe the process 
to ensure that the oral and written information provided to those subjects 
will be in that language, how you will ensure that subjects are provided with 
a sufficient period of time to consider taking part in the research study, and 
any process to ensure ongoing consent. Indicate the language that will be 
used by those obtaining consent.  
NOTE:  Guidance is provided on “SOP:  Informed Consent Process for Research 
(HRP-090).” 
Response:  
 
 
Cognitively Impaired Adults 

 
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☒ 
N/A:  This study will not enroll cognitively impaired adults.   
(Skip to Section 26.9) 
28.8   Describe the process to determine whether an individual is capable of 
consent.  
Response:  
 
 
Adults Unable to Consent 
☒ 
N/A:  This study will not enroll adults unable to consent.  
(Skip to Section 26.13) 
When a person is not capable of consent due to cognitive impairment, a legally 
authorized representative should be used to provide consent (Sections 26.9 and 
26.10) and, where possible, assent of the individual should also be solicited 
(Sections 26.11 and 26.12). 
28.9  Describe how you will identify a Legally Authorized Representative (LAR).  
Indicate that you have reviewed the “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013)” for research in New 
York State.  
NOTE:  Examples of acceptable response includes: verifying the electronic 
medical record to determine if an LAR is recorded. 
Response:  
 
☐ 
We have reviewed and will be following “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013).”  
28.10 For research conducted outside of New York State, provide information 
that describes which individuals are authorized under applicable law to 
consent on behalf of a prospective subject to their participation in the 
research. One method of obtaining this information is to have a legal 
counsel or authority review your protocol along with the definition of 
“legally authorized representative” in “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013).” 
Response:  
 
28.11 Describe the process for assent of the adults: 
• 
Indicate whether assent will be obtained from all, some, or none of the 
subjects.  If some, indicate which adults will be required to assent 
and which will not. 
Response:  

 
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• 
If assent will not be obtained from some or all subjects, provide an 
explanation of why not. 
Response:  
 
28.12 Describe whether assent of the adult subjects will be documented and the 
process to document assent.   
NOTE:  The IRB allows the person obtaining assent to document assent on the 
consent document using the “Template Consent Document (HRP-502)” Signature 
Block for Assent of Adults who are Legally Unable to Consent. 
Response:  
 
 
Subjects who are not yet Adults (Infants, Children, and Teenagers) 
☒ 
N/A:  This study will not enroll subjects who are not yet adults.   
(Skip to Section 27.0) 
28.13 Describe the criteria that will be used to determine whether a prospective 
subject has not attained the legal age for consent to treatments or 
procedures involved in the research under the applicable law of the 
jurisdiction in which the research will be conducted (e.g., individuals under 
the age of 18 years).  For research conducted in NYS, review “SOP: 
Legally Authorized Representatives, Children, and Guardians (HRP-013)” 
to be aware of which individuals in the state meet the definition of 
“children.”  
NOTE:  Examples of acceptable responses include: verification via electronic 
medical record, driver’s license or state-issued ID, screening questionnaire. 
Response:  
 
28.14For research conducted outside of New York State, provide information 
that describes which persons have not attained the legal age for consent to 
treatments or procedures involved the research, under the applicable law of 
the jurisdiction in which research will be conducted.  One method of 
obtaining this information is to have a legal counsel or authority review 
your protocol along the definition of “children” in “SOP: Legally 
Authorized Representatives, Children, and Guardians (HRP-013).” 
Response:  
 
28.15 Describe whether parental permission will be obtained from: 

 
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Response:  
☐  One parent even if the other parent is alive, known, competent, reasonably 
available, and shares legal responsibility for the care and custody of the 
child. 
☐ 
Both parents unless one parent is deceased, unknown, incompetent, or not 
reasonably available, or when only one parent has legal responsibility for 
the care and custody of the child. 
☐ 
Parent permission will not be obtained.  A waiver of parent permission is 
being requested. 
NOTE:  The requirement for parent permission is a protocol-specific determination 
made by the IRB based on the risk level of the research.  For guidance, review the 
“CHECKLIST: Children (HRP-416).”  
28.16Describe whether permission will be obtained from individuals other than 
parents, and if so, who will be allowed to provide permission.  Describe 
your procedure for determining an individual’s authority to consent to the 
child’s general medical care. 
Response:  
 
28.17 Indicate whether assent will be obtained from all, some, or none of the 
children.  If assent will be obtained from some children, indicate which 
children will be required to assent. 
Response:  
 
28.18 When assent of children is obtained, describe how it will be documented. 
Response:  
 
29.0 
Waiver or Alteration of Consent Process 
Consent will not be obtained, required information will not be disclosed, or the 
research involves deception. 
☐ 
N/A:  A waiver or alteration of consent is not being requested. 
29.1 If the research involves a waiver or alteration of the consent process, please 
review the “CHECKLIST: Waiver or Alteration of Consent Process (HRP-
410)” to ensure that you have provided sufficient information for the IRB to 
make the determination that a waiver or alteration can be granted.   
NOTE:  For records review studies, the first set of criteria on the “CHECKLIST: 
Waiver or Alteration of Consent Process (HRP-410)” applies.  
Response:  

 
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We are requesting a waiver of consent for the screening survey as described herein. 
Participants will access the screening survey of their own free will and indicate that they 
wish to proceed with the questions after hearing the description of the study. Because our 
screening interactions are all via phone and online, the research could not practicably be 
carried out without the waiver. 
29.2 If the research involves a waiver of the consent process for planned 
emergency research, please review the “CHECKLIST: Waiver of Consent 
for Emergency Research (HRP-419)” to ensure you have provided sufficient 
information for the IRB to make these determinations.  Provide any 
additional information necessary here: 
Response:  
This research does not involve a waiver for planned emergency research. 
30.0 
Process to Document Consent 
☐ 
N/A:  A Waiver of Consent is being requested.   
(Skip to Section 29.0) 
30.1 Indicate whether you will be following “SOP: Written Documentation of 
Consent (HRP-091).” If not or if there are any exceptions, describe whether 
and how consent of the subject will be obtained including whether or not it 
will be documented in writing.   
NOTE:  If your research presents no more than minimal risk of harm to subjects 
and involves no procedures for which written documentation of consent is normally 
required outside of the research context, the IRB will generally waive the 
requirement to obtain written documentation of consent.  This is sometimes 
referred to as ‘verbal consent.’  Review “CHECKLIST: Waiver of Written 
Documentation of Consent (HRP-411)” to ensure that you have provided sufficient 
information.  
If you will document consent in writing, attach a consent document with your 
submission.  You may use “TEMPLATE CONSENT DOCUMENT (HRP-
502)”.  If you will obtain consent, but not document consent in writing, attach the 
script of the information to be provided orally or in writing (i.e. consent script or 
Information Sheet).   
Response:  
☒ 
We will be following “SOP:  Written Documentation of Consent” 
(HRP-091). 
31.0 
Multi-Site Research (Multisite/Multicenter Only)* 
☒ 
N/A:  This study is not an investigator-initiated multi-site study.  This 
section does not apply. 
 
31.1 
Indicate the total number of subjects that will be enrolled or records that 
will be reviewed across all sites. 
Response:  

 
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31.2 If this is a multi-site study where you are the lead investigator, describe the 
processes to ensure communication among sites, such as the following. See 
“WORKSHEET: Communication and Responsibilities (HRP-830).”: 
• 
All sites have the most current version of the IRB documents, including 
the protocol, consent document, and HIPAA authorization. 
• 
All required approvals have been obtained at each site (including 
approval by the site’s IRB of record). 
• 
All modifications have been communicated to sites, and approved 
(including approval by the site’s IRB of record) before the 
modification is implemented. 
• 
All engaged participating sites will safeguard data as required by 
local information security policies. 
• 
All local site investigators conduct the study appropriately in 
accordance with applicable federal regulations and local laws. 
• 
All non-compliance with the study protocol or applicable requirements 
will be reported in accordance with local policy. 
Response:  
 
31.3 Describe the method for communicating to engaged participating sites (see 
“WORKSHEET: Communication and Responsibilities (HRP-830)”): 
• 
Problems (inclusive of reportable events) 
• 
Interim results 
• 
Study closure 
Response:  
 
31.4 
If this is a multicenter study where you are a participating 
site/investigator, describe the local procedures for maintenance of 
confidentiality. (See “WORKSHEET: Communication and 
Responsibilities (HRP-830).”) 
• 
Where and how data or specimens will be stored locally? 
• 
How long the data or specimens will be stored locally? 
• 
Who will have access to the data or specimens locally? 
• 
Who is responsible for receipt or transmission of the data or 
specimens locally? 
• 
How data and specimens will be transported locally? 
Response:  
 

 
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31.5 
If this is a multicenter study and subjects will be recruited by methods not 
under the control of the local site (e.g., call centers, national 
advertisements) describe those methods.  Local recruitment methods are 
described elsewheres in the protocol. 
• 
Describe when, where, and how potential subjects will be 
recruited. 
• 
Describe the methods that will be used to identify potential 
subjects. 
• 
Describe materials that will be used to recruit subjects. (Attach 
copies of these documents with the application. For 
advertisements, attach the final copy of printed advertisements. 
When advertisements are taped for broadcast, attach the final 
audio/video tape. You may submit the wording of the 
advertisement prior to taping to preclude re-taping because of 
inappropriate wording, provided the IRB reviews the final 
audio/video tape.) 
Response:  
 
32.0 
Banking Data or Specimens for Future Use* 
☒ 
N/A:  This study is not banking data or specimens for future use or 
research outside the scope of the present protocol.  This section does not 
apply. 
32.1 If data or specimens will be banked (stored) for future use, that is, use or 
research outside of the scope of the present protocol, describe where the 
data/specimens will be stored, how long they will be stored, how the 
data/specimens will be accessed, and who will have access to the 
data/specimens.  
NOTE:  Your response here must be consistent with your response at the “What 
happens if I say yes, I want to be in this research?” Section of the Template 
Consent Document (HRP-502). 
Response:  
 
32.2 List the data to be stored or associated with each specimen. 
Response:  
 
32.3 Describe the procedures to release banked data or specimens for future 
uses, including: the process to request a release, approvals required for 
release, who can obtain data or specimens, and the data to be provided with 
specimens. 
Response:  

 
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