Impact of Online Ordering on Low-Income Adults' Food Security in Online Food Pantry Settings
Phase: NA
Conditions: Food Security
Sponsor: NYU Langone Health

Official Title: 
Impact of Online Ordering on Low-Income Adults' Food Security in 
Online Food Pantry Settings
NCT Number:
NCT05752721
Study Number:
22-01523 
Document Type:
Study Protocol and Statistical Analysis Plan
Date of the 
Document: 
 
September 14, 2023 

STUDY PROTOCOL 
Impact of Online Ordering on Low-Income 
Adults’ Food Security in Online Food Pantry 
Settings 
 
NYULH Study Number
s22-01523 
 
Principal Investigator 
Pasquale Rummo 
 
 
Protocol Version
September 7, 2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Number: s22-01523 
 
September 7, 2023 
2
Study Personnel
Principal Investigator
Pasquale Rummo
NYU Grossman School of Medicine 
Department of Population Health 
180 Madison Avenue, 3rd floor 
New York, New York 10016 
Email: Pasquale.Rummo@nyulangone.org
Phone: 646-501-3371 
Research Coordinator
Carla Seet 
NYU Grossman School of Medicine 
Department of Population Health 
180 Madison Avenue, 3rd floor 
New York, New York 10016 
Email: carla.seet@nyulangone.org
Phone: 646-501-3394 
 
 

Study Number: s22-01523 
 
September 7, 2023 
3
Synopsis 
Study Description
The specific aims of this proposal are to 1) ascertain whether the transition to online ordering 
at a choice-based food pantry network in New York City influences food security status 
among 386 food pantry clients and 2) determine whether there are differences in outcome 
by age group (18-61 vs. 62 years). 
To accomplish Aim 1, study team members will conduct a natural experiment with two 
conditions in food pantry sites within the Met Council Kosher Food Pantry Network. To 
accomplish Aim 2, we will test for potential interaction effects at the individual-level by adding 
an interaction term for age group. 
Overall, the research study will occur over 18 months (see timeline below). Year 1 will 
involve survey design and data collection. Year 2 will involve data analysis and development 
of dissemination materials. 
Table 1. 
Timeline 
 
 
Year 1 of grant 
Year 2 of grant 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
15 
16 
17 
18 
Design of 
survey, 
training 
RA, and 
IRB 
approval 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data 
collection 
 
 
 
X 
X 
X 
pause 
Online 
ordering 
transition 
pause 
X 
X 
X 
 
 
 
 
 
 
Data 
analysis 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
 
 
Write 
and 
dissemin
ate 
results 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
Objectives 

Study Number: s22-01523 
 
September 7, 2023 
4
Our primary objectives are to determine whether the transition to online ordering at a choice-
based food pantry network influences food security status among low-income adults and
determining whether there are differences in impact by age group. 
Endpoints 
The endpoint for Aim 1 for the intervention arm is the successful completion of the follow-up 
period, including food and nutrition security status, total fruits and vegetables selected per 
visit, total energy intake, intake of key food groups, and time to obtain food from food pantry 
per visit. 
The endpoint for Aim 2 is the completion of data analysis. 
Study Population 
The study population for Aim 1 is a sample of low-income adults aged 18 years..  
Accrual Ceiling
We require a total sample size of 193 participants per condition for Aim 1 (total n=386).  
Aim 2 will not involve participant enrollment.  
Phase 
Not applicable. 
Description of Sites/Facilities Enrolling Participants 
We propose to recruit participants from food pantry clients at food pantry sites within the Met 
Council Kosher Food Pantry Network, a network that contains 65 pantry partners and over 
200 community partners in NYC. Met Council procures and distributes kosher food to their 
network of kosher food pantries and provides ongoing support with reporting, pantry set up 
and maintenance, advocacy, and programming. The Network primarily serves immigrants, 
seniors living on fixed incomes, the un- and underemployed and anyone else in need in 
immigrant-dense neighborhoods. 
Study Duration 
The study will last 18 months, but data collection will specifically occur in 2 time periods, 
including months 4-6 and 10-12 in Year 1 of the study. 
Participant Duration 
The total participant duration will be approximately 30-50 minutes to complete the survey 
and record food selections for both data collection periods.  

Study Number: s22-01523 
 
September 7, 2023 
5
Schedule of Activities (SoA) 
During the baseline data collection period, all participants will complete a survey about their 
food and nutrition security, diet behaviors, and frequency of food pantry visits.  To finish, the 
Research Assistant will record their food selections from the current food pantry visit.  
During the follow-up data collection period, all participants will complete a survey about their 
food and nutrition security, diet behaviors, and frequency of food pantry visits. Participants in 
the control arm will record their food selections from their most recent food pantry visit and 
send them to the study team.  
End of Study Definition 
The end of the study is when we have disseminated our results. 
 

Study Number: s22-01523 
 
September 7, 2023 
6
1 – Statement of Compliance 
1.1 Statement of Compliance
This study will be conducted in accordance with the Code of Federal Regulations on the 
Protection of Human Subjects (45 CFR Part 46), any other applicable US government research 
regulations, and institutional research policies and procedures. The Principal Investigator will 
assure that no deviation from, or changes to the protocol will take place without prior agreement 
from the sponsor and documented approval from the Institutional Review Board (IRB), except 
where necessary to eliminate an immediate hazard(s) to the study participants. All personnel 
involved in the conduct of this study have completed Human Subjects Protection Training. 
 

Study Number: s22-01523 
 
September 7, 2023 
7
2 - Introduction 
2.1 Background
Compared to food secure adults, adults experiencing food insecurity have lower energy intake, 
lower intake of key nutrients, and poorer diet quality.1-5 Food insecurity is also associated with 
poor or fair health, underweight status, and chronic health issues, such as diabetes and 
hypertension.2-12 Malnutrition among low-income adults who use food pantries is also linked to a 
lack of housing, barriers to accessing health care and other social resources, unemployment, 
substance abuse, and domestic conflict.13  
In NYC, 1.5 million residents are food insecure, a 36% increase from before the COVID-19 
pandemic.14 Evidence from survey research suggests that food insecurity and hunger are also 
higher among immigrants (vs. non-immigrants) and older (vs. younger) adults in NYC, 
potentially due to higher rates of income inadequacy and fixed incomes, respectively.15-17 These 
disparities are likely to grow in the future given how population growth in NYC is driven by older 
adults, and how population growth of older adults is driven by growth in immigrant older adults.18
In the Parent Grant, we established how nutrition assistance programs, such as meal delivery 
programs and the Supplemental Nutrition Assistance Program (SNAP), address key barriers to 
healthy eating in low-income adults. Food pantries are also a key source of nutrition and healthy 
foods for low-income adults, especially for low-income older adults, who use food pantries as 
their primary source of food assistance.19,20 In NYC, approximately 1.4 million residents rely on 
food pantries for emergency food assistance each year, including one out of every five older 
adults.17 Previous studies show that visiting a food pantry mitigates food insecurity among food 
pantry clients,21-23 and may improve diet quality among food insecure clients.24,25 The use of 
food pantries may also mitigate chronic disease risk among food pantry clients, including 
diabetes and heart disease.21,26  
However, mistrust of emergency food resources may be disproportionately higher in immigrant 
(vs. non-immigrant) communities,27 potentially due to stigma, fear of interaction with government 
representatives (e.g. NYPD, ICE), and other factors.28 Evidence from qualitative research, for 
example, suggests that the stigma of waiting in public to be served reduces utilization and 
satisfaction of food pantries.29 This was corroborated by a recent review study noting how food 
pantry clients describe reasonable wait times and an “easy process” as a cornerstones of good 
customer service in food pantry settings.30 Thus, strategies to increase food pantry use may 
support food security and healthy eating behaviors among low-income adults, especially those 
designed to mitigating the high opportunity costs of waiting in line and stigma, such as digital 
ordering. 
In the Parent Grant, we are leveraging the rapid growth in online grocery shopping and 
expansion of retailers accepting SNAP benefits in online transactions. The recent shift to online 
ordering in some food pantries affords a similar opportunity to support food security and a 
healthy diet among low-income adults, which we aim to leverage in this Administrative 
Supplement. Online ordering is available in a small number of food pantries across the U.S., 
such as the Portland Open Bible Community Pantry in Portland, OR and The Open Door in 
Essex County, MA, largely due to increases in food insecurity and social distancing measures 
during the COVID-19 pandemic.31,32 Anecdotal evidence suggests online ordering has 
contributed to increased food pantry use, potentially due to reductions in wait times, reduced 
stigmatization, and increases in self-efficacy and self-sufficiency.33-37 Increases in food pantry, in 

Study Number: s22-01523 
 
September 7, 2023 
8
turn, may improve food pantry clients’ food security status and increase fruit and vegetable 
intake relative to a traditional distribution model,38,39 especially in combination with changes to 
food “pricing” (e.g., assigning foods with high nutritional value fewer points than less healthy 
food). To our knowledge, however, there have been no evaluations of the transition to online 
ordering in food pantries. 
 
2.2 Study Rationale 
The successful completion of the proposed research may highlight and support the 
development of a novel approach to improving food security and healthy food choices in a high-
need population. 
 
2.3 Potential Risks and Benefits  
2.3.1 Known Potential Risks 
There is a risk of breach of confidentiality. To reduce the likelihood of a breach of confidentiality, 
we will store the survey responses on Qualtrics, which is password protected and encrypted. 
We will collect names, phone numbers, email addresses, and mailing addresses in a secure 
REDCap form to facilitate data collection in the follow-up period, which will be conducted 
virtually, and to distribute gift cards. The REDCap data will not be linked to Qualtrics survey 
responses. The content of the participants’ responses to survey questions will pertain only to 
their food and nutrition security status, intake of key foods, and frequency of food pantry visits. 
We will not be asking for information that could place the participants at risk of criminal or civil 
liability or be damaging to the participants’ financial standing or employability. 
 
Participants may receive texting over mobile/cell phones and this method of communication 
may also result in a breach of their confidential information because text messages to 
mobile/cell phones are not encrypted. This method of communication will only be used with 
participants’ agreement/consent.  
 
Participants may become frustrated when completing the survey It will be made clear to 
participants that they are free to skip any questions they do not wish to answer or stop at any 
time.  
 
2.3.2 Known Potential Benefits 
There are no direct benefits to subjects. This study will provide evidence to be used in 
evaluating the effect of food pantries’ transitioning to online ordering on clients’ food selection. 
Met Council and other food pantries will be able to reference this information when deciding 
whether to transition their pantries to online ordering. 
 

Study Number: s22-01523 
 
September 7, 2023 
9
3 - Objectives and Endpoints 
3.1 Primary Objective 
Our primary objectives are to determine whether the transition to online ordering at a choice-
based food pantry network influences food security status among low-income adults and 
determining whether there are differences in impact by age group. 
3.2 Endpoints 
 
The endpoint for Aim 1, the intervention, is the successful completion of the follow-up period 
data collection, including food and nutrition security status, total fruits and vegetables selected 
per visit, diet behaviors, and time to obtain food from food pantry per visit. 
The endpoint for Aim 2 is the completion of data analysis. 
 

Study Number: s22-01523 
 
September 7, 2023 
10
4 - Study Design 
4.1 Overall Design
This research study includes two aims, though only Aim 1 involves human subjects. The 
duration of the study is 18 months. 
In Aim 1, study team members will recruit low-income adults aged 18 years. Participants will 
be recruited from a food pantry that is not scheduled to transition to online ordering (control) and 
a food pantry that is scheduled to transition to online ordering after the baseline data collection 
period (intervention). Participants in both arms will complete an in-person survey. Potential 
participants who are not able to take the survey in-person, will be offered the option to take the 
survey online. To assess potential changes in fruit and vegetable intake, we will administer the 
Behavioral Risk Factor Surveillance System (BRFSS) 6-item brief dietary assessment tool 
(questions 9-14 in the survey attached in Research Navigator).  A Research Assistant will 
record the food items they received in the relevant visit to the pantry. After the transition to 
online ordering at the intervention food pantry, participants will again complete the survey over 
the phone. The survey will be administered by a member of the study team using the Follow-Up 
Survey Guide. Participants in the control arm will record their food selections and send them to 
the study team during the phone call. Food selections for participants in the intervention arm will 
be accessible through the online ordering platform. The study team will then analyze the 
baseline and follow-up data for differences in outcomes between study conditions. 
 
In Aim 2, we will test for potential interaction effects at the individual-level by adding an 
interaction term for age group (18-
  
 
4.2 Scientific Rationale for Study Design 
 
The design and methods proposed will achieve robust and unbiased results because random 
assignment to an intervention group or control group in the context of a natural experiment 
minimizes bias. 
 
4.3 End of Study Definition 
 
The end of the study is when we have disseminated our results. 
 

Study Number: s22-01523 
 
September 7, 2023 
11
5 - Study Population 
5.1 Inclusion Criteria
In order to be eligible for participation in Aim 1 Control Arm of this study, an individual must 
meet all of the following criteria:  
 
1) aged 18 years or older 
2) have capacity and willingness to provide consent  
 
In order to be eligible for participation in Aim 1 Intervention Arm of this study, an individual 
must meet all of the following criteria:  
 
1) aged 18 years or older 
2) have capacity and willingness to provide consent  
 
5.2 Exclusion Criteria 
The exclusion criteria for both arms of Aim 1 include: 1) aged <18 years..  
 
5.3 Vulnerable Populations 
Adults who have used the food pantry are the target subject population because strategies to 
increase food pantry use may support food security and healthy eating behaviors among low-
income adults, especially those designed to mitigate the high opportunity costs of waiting in line 
and stigma, such as digital ordering. 
 
5.4 Lifestyle Considerations 
Participants in the intervention arm will have to transition with their food pantry to online ordering 
after the baseline data collection period regardless of their participation in this research study. 
The change will be brought on “naturally” by the food pantry (not the NYULH researchers or 
specifically as part of this research study). There will be no other restrictions during any other 
parts of the study pertaining to lifestyle and/or diet. 
 
5.5 Strategies for Recruitment and Retention 
For Aim 1, we will choose the food pantry recruiting sites with help from Met Council Kosher 
Food Pantry Network. We will aim to select a control site that is similar to the intervention site 
based on food pantry characteristics (e.g., number of food pantry clients per week, primary 
language(s) spoken) and community-level characteristics (e.g., neighborhood poverty level).  
 
IRB-approved NYULH study personnel will recruit participants in person at two Met Council food 
pantries and will obtain permission from the food pantries prior to in-person recruitment at their 

Study Number: s22-01523 
 
September 7, 2023 
12
facilities. We will have support from food pantry staff members in introducing the NYULH study 
to potential participants. The study personnel will be on-site at the food pantry to introduce the 
study to food pantry clients and answer questions. Food pantry staff will also be available to 
direct food pantry clients to the study personnel. The study team will provide the food pantry 
with a recruitment flyer to post and/or pass out informing clients of the study and directing them 
to scan a QR code for the consent form with more information about the study and access to the 
study team’s contact information. After scanning the QR code, clients will first see a short 
paragraph (“Pre-Consent QR Code Copy”) listing the eligibility requirements and explaining 
what the consent is, in addition to a note that they do not need to sign the form at that moment. 
After the short paragraph, they will be able to scroll down to view the consent.  
 
We will collect names, phone numbers, email addresses, and mailing addresses from 
participants in a secure REDCap form to facilitate the follow-up data collection, which will be 
conducted virtually, and to distribute gift cards. 
 
Screen failures include those who do not meet all of our inclusion criteria. Potential participants 
will be asked to answer one pre-screening question about their age to determine their eligibility. 
If they do not meet our inclusion criteria, these participants will be told by the Research 
Assistant, “Thank you for your time, but unfortunately, you are not eligible for this study.” We will 
immediately discard information from screen failures and from individuals that do not provide 
consent to take part in this study. Re-screening is not applicable. 
 
Prior to the follow-up period, the study team will provide the food pantry with a flyer and post-
card-sized handouts to remind participants of the upcoming follow-up surveys. 
 
Aim 2 will not involve any participant recruitment. 
 

Study Number: s22-01523 
 
September 7, 2023 
13
6 - Study Procedures
6.1 Aim 1 
 
Data collection in the baseline period will occur during the two to four month period prior to the 
intervention month (months t-2 to t-4), and data collection in the follow-up period will occur 
during the two-to-four-month period after the transition to digital ordering (months t+2 to t+4). 
The months immediately preceding (t-1) and following (t+1) the intervention month will be 
omitted to account for potential uncertainty in the implementation of online ordering and to allow 
for sufficient time for food pantry clients to return to their food pantry, respectively.  
 
For the baseline period/visit (in person), consent will take place in person at the food pantry and 
data collection will take place in person at the food pantry, with the option to take the survey 
online offered on a case-by-case basis. The following will occur for both arms: 
 
 
Participants will be asked to complete a survey about their food and nutrition security, 
diet behaviors, and frequency of food pantry visits. The survey will take about 10 
minutes to complete. Survey responses will be collected using Qualtrics. 
 
 
We will administer the Behavioral Risk Factor Surveillance System (BRFSS) 6-item brief 
dietary assessment tool to participants in both arms to assess potential changes in fruit 
and vegetable intake (questions 9-14 in the survey attached in Research Navigator).  
 
 
Participants will be given a card with an appointment time of their choosing that falls 
within the follow-up period, which will also include the phone number for an IRB-
approved NYULH study personnel that they can reach if they need to re-schedule.  
 
 
The food pantry items selected by participants will be documented in-person by the 
Research Assistant. It will take approximately 5 minutes for the Research Assistant to 
record the participants’ food selections. 
 
For the follow-up period/visit (virtual/phone): 
 
 
Intervention Arm 
 
o We will send follow-up reminders to participants via email and/or text, based on 
their preference.  
 
o Participants will be asked to complete a survey by phone about their food and 
nutrition security, diet behaviors, and frequency of food pantry visits. The survey 
will take approximately 20-25 minutes to complete. The survey will be 
administered by a member of the study team using the Follow-Up Survey Guide. 
 
o Data on participants’ food selections will be gathered from the online ordering 
system. This data will be provided to the study team by Met Council. Participants 
will not need to wait for the Research Assistant to record their selections. 
 

Study Number: s22-01523 
 
September 7, 2023 
14
 
Control Arm 
 
o We will send follow-up reminders to participants via email and/or text, based on 
their preference. 
 
o Participants will be asked to complete a survey by phone about their food and 
nutrition security, diet behaviors, and frequency of food pantry visits. The survey 
will take approximately 20-25 minutes to complete. The survey will be 
administered by a member of the study team using the Follow-Up Survey Guide. 
 
o Since the follow-up data collection occurs virtually and the study team will not be 
on site at the food pantry to record food selections, we will instruct participants to 
take a photo of their selections at their next food pantry visit and email or text the 
photo to the research team, using the information on the appointment card. It will 
take approximately 5 minutes for participants to record their food selections and 
send them to the study team. If participants do not remember to take the photo, 
we will assess their recall of their selections during the follow-up conversation. 
 
6.2 Aim 2 
 
We will test for potential interaction effects at the individual-level by adding an interaction term 
for age group (18-
analyses. No additional data will be collected for Aim 2.  
 
 

Study Number: s22-01523 
 
September 7, 2023 
15
7 - Participant Discontinuation/Withdrawal
7.1 Participant Discontinuation/Withdrawal from the Study 
The participants are allowed to withdraw from the study at any point with no penalty.
7.2 Lost to Follow-Up 
Not applicable. 
 

Study Number: s22-01523 
 
September 7, 2023 
16
8 - Statistical Considerations 
8.1 Statistical Hypotheses
In Aim 1, we will test the working hypotheses that 1) food security will improve (i.e. food security 
score will decrease) among participants visiting a food pantry that transition to online ordering in 
the follow-up period, but not among those in the control arm, and 2) participants visiting a food 
pantry that transitions to online ordering will also select more fruits and vegetables per visit, 
have higher fruit and vegetable intake, and spend less time accessing food pantries in the 
follow-up (vs. baseline) period compared to those in the control arm. 
For Aim 2, we hypothesize that improvements in food security due to online ordering will be 
larger for younger adults. 
 
8.2 Sample Size Considerations 
To calculate our sample size, we used estimates from a similar study that found that a food 
bank-delivered intervention (diabetes-appropriate food packages, text-based health education, 
and referrals to health care) resulted in a decrease in the mean food security score from 2.8 to 
2.3, or a 6.3% decrease in the percentage of participants with low or very low food security 
status.40 Based on this study, we assume the standard deviation of the food security score is 1.5 
and estimate that 155 participants in each condition (total n=310) will provide 90% power to 
detect a 0.5 difference in food security score between experimental and control conditions. To 
account for a potential attrition rate of 20% in the follow-up period, we plan to recruit a total 
sample size of 193 participants per condition (total n=386). 
 
8.3 Populations for Analyses 
The study population is a sample of adults aged 18 years.  
 
8.4 Statistical Analyses 
We will perform a linear regression to assess balance of demographic characteristics between 
conditions; because of the natural experiment design, these characteristics should be balanced. 
To assess differences in outcomes between study conditions, we will regress the outcome 
variable on indicator variables for the experimental conditions, with the control condition as the 
reference group; if necessary, we will also adjust for any respondent characteristics that may be 
unbalanced by condition. The design and methods proposed will achieve robust and unbiased 
results because random assignment to an intervention group or control group in the context of a 
natural experiment minimizes bias. 
We will also test for potential interaction effects at the individual-level by adding an interaction 
term for age group (18-
clients served are above 61 years of age, so we will have adequate variation to assess potential 
interactions by age group. For assessing differences in the frequency of food pantry visits per 
month at the food pantry-level, we will also add an interaction term for age group, which the 

Study Number: s22-01523 
 
September 7, 2023 
17
food pantry network measures as child (<18 years), adult (18-61 years), and older adult (
years). 
 
8.4.1 General Approach 
For Aim 1, we will examine differences in outcomes between study conditions, including food 
and nutrition security, intake of key foods, and frequency of food pantry visits. 
For Aim 2, we will examine differences in outcomes between adult (18-61 years) and older adult 
 
 
8.4.2 Analysis of the Primary Efficacy Endpoint(s) 
The primary outcome for Aim 1 is food security status. We will use the United States 
Department of Agriculture (USDA) six-item food security survey module to assess food security 
status, where the range of points is zero to six points, and higher points corresponds to lower 
food security.41 Food security status will be categorized according to USDA guidelines, including 
very low (5-6); low (2–4); and high or marginal (0-1) food security. We will perform a linear 
regression to assess balance of demographic characteristics between conditions; because of 
the natural experiment design, these characteristics should be balanced. To assess differences 
in outcomes between study conditions, we will regress the outcome variable on indicator 
variables for the experimental conditions, with the control condition as the reference group; if 
necessary, we will also adjust for any respondent characteristics that may be unbalanced by 
condition. 
The primary outcome for Aim 2 is the same as Aim 1 and measured using the same 
specifications. We will test for potential interaction effects at the individual-level by adding an 
interaction term for age group (18-
25% of clients served are above 61 years of age, so we will have adequate variation to assess 
potential interactions by age group. 
 
8.4.3 Analysis of the Secondary Endpoint(s) 
The secondary outcomes for Aim 1 include changes in: 1) total cup-equivalents of fruits and 
vegetables selected per visit; 2) intake of fruits and vegetables; 3) time to obtain food from food 
pantry per visit (minutes); and 4) individual-level frequency of food pantry visits per month (n). 
To capture a potential increase in new clients visiting the food pantry due to the transition to 
online ordering, we will also measure changes in the frequency of food pantry visits per month 
at the food pantry-level (n). 
The primary outcome for Aim 2 is the same as Aim 1 and measured using the same 
specifications, including number of fruits and vegetables selected per visit; total energy intake; 
intake of key food groups; time to obtain food from food pantry per visit; and individual-level and 
food pantry-level frequency of food pantry visits per month. For assessing differences in the 
frequency of food pantry visits per month at the food pantry-level, we will add an interaction term 
for age group, which the food pantry network measures as child (<18 years), adult (18-61 
years), and older adult (
). 

Study Number: s22-01523 
 
September 7, 2023 
18
8.4.4 Safety Analyses 
Not applicable. 
 
8.4.5 Baseline Descriptive Analyses  
Not applicable. 
 
8.4.6 Planned Interim Analyses  
Not applicable. 
 
8.4.7 Tabulation of Individual Participant Data 
Individual participant data will not be listed by measure and time point. Only aggregated data 
will be presented. 
 
8.4.8 Exploratory Analyses 
For Aim 1, we will examine differences in outcomes between study conditions, including food 
and nutrition security, intake of fruits and vegetables, and frequency of food pantry visits. We 
will perform a linear regression to assess balance of demographic characteristics between 
conditions; because of the natural experiment design, these characteristics should be balanced. 
To assess differences in outcomes between study conditions, we will regress the outcome 
variable on indicator variables for the experimental conditions, with the control condition as the 
reference group; if necessary, we will also adjust for any respondent characteristics that may be 
unbalanced by condition. The design and methods proposed will achieve robust and unbiased 
results because random assignment to an intervention group or control group in the context of a 
natural experiment minimizes bias. 
 
For Aim 2, we will examine differences in outcomes between adult (18-61 years) and older adult 
62 years) participants. We will test for potential interaction effects at the individual-level by 
adding an interaction term for age group (18-
average of 25% of clients served are above 61 years of age, so we will have adequate variation 
to assess potential interactions by age group. For assessing differences in the frequency of food 
pantry visits per month at the food pantry-level, we will also add an interaction term for age 
group, which the food pantry network measures as child (<18 years), adult (18-61 years), and 
older adult (
). 
 

Study Number: s22-01523 
 
September 7, 2023 
19
9 – Ethical Considerations 
9.1 Regulatory, Ethical, and Study Oversight Considerations
 
The Principal Investigator will ensure that this study is conducted in full conformity with 
Regulations for the Protection of Human Subjects of Research codified in 45 CFR Part 46.  
 
The protocol, study information sheet (with key information), application for waiver of 
documentation of consent, recruitment materials, and all participant materials will be submitted 
to the IRB for review and approval. Approval of both the protocol and the consent materials 
must be obtained before any participant is enrolled. Any amendment to the protocol will require 
review and approval by the IRB before the changes are implemented to the study. All changes 
to the consent form will be IRB approved; a determination will be made regarding whether 
previously consented participants need to be re-consented. 
 
9.2 Informed Consent Process 
 
9.2.1 Consent and Other Informational Documents Provided to Participants 
 
Consent materials describing in detail the study, study procedures, and risks will be given to the 
participant and documentation of informed consent is required prior to starting study. 
 
9.2.2 Consent Procedures and Documentation 
 
Aim 1: IRB-approved NYULH study personnel will obtain verbal informed consent from 
participants in a private space at the food pantry. Extensive discussion of risks and possible 
benefits of participation will be provided to potential participants. Potential participants will be 
given an IRB-approved study information sheet (with key information) and asked to review the 
document. The NYULH study personnel will explain the research study to potential participants 
and answer any questions that may arise. All participants will receive a verbal explanation in 
terms suited to their comprehension of the purposes, procedures, and potential risks of the 
study and of their rights as research participants. Potential participants will have the opportunity 
to carefully review the consent document and ask questions prior to consenting. Potential 
participants will also have the opportunity to discuss the study with their family or friends or think 
about it prior to agreeing to participate. Participants will give their verbal consent prior to any 
study procedures being done specifically for the study. Participants may withdraw consent at 
any time throughout the course of the study. The rights and welfare of the participants will be 
protected by emphasizing to them their use and access to the food pantry will not be adversely 
affected if they decline to participate in this study. 
 
The consent process, including the name of the individual obtaining consent, will be thoroughly 
documented in the subject’s research record. Any alteration to the standard consent process 

Study Number: s22-01523 
 
September 7, 2023 
20
(e.g. use of a translator, consent from a legally authorized representative, consent document 
presented orally, etc.) and the justification for such alteration will likewise be documented.  
Aim 2: NA 
9.3 Study Discontinuation and Closure 
The study will be terminated or temporarily suspended based on PI decision, IRB decision in the 
event of an Unanticipated Problem. If an unanticipated problem is recognized, data collection 
will stop and any corrective action or explanation that can be given to participants experiencing 
this issue will be administered. Then, a modification to rectify the issue will be submitted to the 
IRB (and details sent to the sponsor if applicable) and new methods to avoid the problem will be 
used going forward. The study team will work with the IRB to ensure that any problems 
participants experienced prior to the change are ethically addressed. The consent document 
also includes text that informs the participants they can call or email the Principal Investigator 
with any questions. We will also inform participants that any questions, concerns, suggestions, 
or complaints that have not been or cannot be addressed by the researcher, or if they wish to 
report research-related harm, they can contact the IRB. 
9.4 Participant and Data Confidentiality  
Participant confidentiality will be strictly held in trust by the participating investigators, their staff, 
and the sponsor(s) and their agents. No information concerning the study or the data will be 
released to any unauthorized third party without prior written approval of the sponsor. 
 
We will only collect names, phone numbers, email addresses, and mailing addresses from 
participants in a secure REDCap form during the baseline data collection period to facilitate 
follow-up data collection, which will be conducted virtually, and to distribute gift cards. Only the 
study team will have access to the data. PII will not be connected to Qualtrics survey responses. 
Extreme care will be taken to guarantee confidentiality of participants’ responses. 
 
To further protect the privacy of study participants, a Certificate of Confidentiality will be 
obtained from the NIH. This certificate protects identifiable research information from forced 
disclosure. It allows the investigator and others who have access to research records to refuse 
to disclose identifying information on research participation in any civil, criminal, administrative, 
legislative, or other proceeding, whether at the federal, state, or local level. By protecting 
researchers and institutions from being compelled to disclose information that would identify 
research participants, Certificates of Confidentiality help achieve the research objectives and 
promote participation in studies by helping assure confidentiality and privacy to participants. 
 

Study Number: s22-01523 
 
September 7, 2023 
21
9.5 Future Use of Stored Data 
Study data will be retained for the longer of 3 years after close out or 5 years after final 
reporting/publication. We are not be storing data beyond the current research study for future 
research and publications. These documents should be retained for a longer period, however, if 
required by local regulations. No records will be destroyed without the written consent of the 
sponsor, if applicable. It is the responsibility of the sponsor to inform the investigator when these 
documents no longer need to be retained. 
 
9.6 Study Oversight 
The research team will only ever have access to unique ID numbers for all participants, which 
will allow for linkage between participants’ survey responses, dietary assessment responses, 
and food selection data. 
 
9.7 Key Roles and Study Governance 
The Principal Investigator is Pasquale Rummo, PhD, MPH, NYU Grossman School of Medicine, 
Department of Population Health, 180 Madison Ave, Room 3-54, 646-501-3371, 
pasquale.rummo@nyulangone.org. The Research Coordinator is Carla Seet, MPH, NYU 
Grossman School of Medicine, Department of Population Health, 180 Madison Ave, 
carla.seet@nyulangone.org.  
The PI also has a Mentoring Committee. A K01 award from the NIH is a training grant, which 
requires training and mentorship from a team of mentors and co-mentors. The mentors and co-
mentors include Brian Elbel, PhD, MPH; Joshua Chodosh, MD, MSHS; Christina Roberto, PhD; 
Lorna Thorpe, PhD, MPH; and Andrea Troxel, ScD. The mentors and co-mentors are not a part 
of the study team and will not be engaged in human subjects research activities at any point 
including accessing research data. 
 
9.8 Quality Assurance and Quality Control 
Prior to enrolling participants, we will test the survey tool and the dietary assessment methods. 
The research team will also monitor the data collected from participants from the survey. 
 
9..9 Data Handling and Record Keeping 
 
9..9.1 Data Collection and Management Responsibilities  
 

Study Number: s22-01523 
 
September 7, 2023 
22
Data collection is the responsibility of the study staff at the site under the supervision of the PI. 
The PI is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the 
data reported.  
9.9.2 Study Records Retention 
Study documents will be retained for the longer of 3 years after close out or 5 years after final 
reporting/publication. These documents should be retained for a longer period, however, if 
required by local regulations. No records will be destroyed without the written consent of the 
sponsor, if applicable. It is the responsibility of the sponsor to inform the investigator when these 
documents no longer need to be retained. 
9.10 Protocol Deviations 
If a protocol deviation occurs, data collection will stop and any corrective action or explanation 
that can be given to participants experiencing this issue will be administered. Then, a 
modification to rectify the issue will be submitted to the IRB (and details sent to the sponsor if 
applicable) and new methods to avoid the problem will be used going forward. The study team 
will work with the IRB to ensure that any problems participants experienced prior to the change 
are ethically addressed. 
 
9.11 Publication and Data Sharing Policy 
The Principal Investigator, Pasquale Rummo, holds primary responsibility for publishing the 
study results. The plan is to generate at least one manuscript with work from this award and to 
submit at least one abstracts to conferences for oral or poster presentations. 
 
9.12 Conflict of Interest Policy 
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or 
financial gain greater than the minimum allowable by their institution, etc.) must have the conflict 
reviewed by the NYU Langone Conflict of Interest Committee with a Committee-sanctioned 
conflict management plan that has been reviewed and approved by the study sponsor prior to 
participation in this study.  All NYULH investigators will follow the applicable conflict of interest 
policies.
 
 

Study Number: s22-01523 
 
September 7, 2023 
23
10 – Study Finances 
10.1 Funding Source
NIH/NIA. 
 
10.2 Costs to Subjects 
The NYULH study team may communicate with participants by text during the follow-up data 
collection period if participants agree to communication by text. Participants will be responsible 
for all fees charged by their carrier’s service plan for text messaging. This research study and 
NYU Langone Health will not cover the cost related to any increased charges, data usage 
against plan limits or changes to data fees from the research texts.  
 
10.3 Subject Payment 
 
Aim 1: Participants will receive $30 for the baseline data collection period and $50 for the 
follow-up data collection period. Participants will receive a total of $80 if they complete both time 
periods. Incentives will be provided in gift card format and will be distributed in person after the 
baseline data collection and by email or mailing address, depending on the participant’s 
preference, after the follow-up data collection. 
 
 
We will adhere to NYULH Human Subjects Payment Policy. 
 
Aim 2: NA 
 
 
 

Study Number: s22-01523 
 
September 7, 2023 
24
11 – References 
1.
Andreyeva T, Tripp AS, Schwartz MB. Dietary Quality of Americans by Supplemental 
Nutrition Assistance Program Participation Status: A Systematic Review. Am J Prev 
Med. 2015;49(4):594-604. PMCID: PMC6022372. 
2. 
Bergmans RS, Palta M, Robert SA, Berger LM, Ehrenthal DB, Malecki KM. Associations 
between Food Security Status and Dietary Inflammatory Potential within Lower-Income 
Adults from the United States National Health and Nutrition Examination Survey, Cycles 
2007 to 2014. J Acad Nutr Diet. 2018;118(6):994-1005. PMCID: PMC5971121. 
3. 
Lee JS, Frongillo EA, Jr. Nutritional and health consequences are associated with food 
insecurity among U.S. elderly persons. J Nutr. 2001;131(5):1503-1509. PMID: 
11340107. 
4. 
Sahyoun N, Basiotis PP. Food insufficiency and the nutritional status of the elderly 
population. Family Economics and Nutrition Review. 2001;13(2):58-61. 
5. 
Ziliak JP, Haist M, Gundersen C. The causes, consequences, and future of senior 
hunger in America. Alexandria, VA: National Foundation to End Senior Hunger. 2008. 
6. 
Bhargava V, Lee JS, Jain R, Johnson MA, Brown A. Food insecurity is negatively 
associated with home health and out-of-pocket expenditures in older adults. J Nutr. 
2012;142(10):1888-1895. PMID: 22933748. 
7. 
Choi SK, Fram MS, Frongillo EA. Very Low Food Security in US Households Is 
Predicted by Complex Patterns of Health, Economics, and Service Participation. J Nutr. 
2017;147(10):1992-2000. PMID: 28855422. 
8. 
Jih J, Stijacic-Cenzer I, Seligman HK, Boscardin WJ, Nguyen TT, Ritchie CS. Chronic 
disease burden predicts food insecurity among older adults. Public Health Nutr. 
2018;21(9):1737-1742. PMCID: PMC6204426. 
9. 
Miller LMS, Tancredi DJ, Kaiser LL, Tseng JT. Midlife vulnerability and food insecurity: 
Findings from low-income adults in the US National Health Interview Survey. PLoS One. 
2020;15(7):e0233029. PMCID: PMC7357765. 
10. 
Seligman HK, Laraia BA, Kushel MB. Food insecurity is associated with chronic disease 
among low-income NHANES participants. J Nutr. 2010;140(2):304-310. PMCID: 
PMC2806885. 
11. 
Seligman HK, Schillinger D. Hunger and socioeconomic disparities in chronic disease. N 
Engl J Med. 2010;363(1):6-9. PMID: 20592297. 
12. 
Stuff JE, Casey PH, Szeto KL, et al. Household food insecurity is associated with adult 
health status. J Nutr. 2004;134(9):2330-2335. PMID: 15333724. 
13. 
An R, Wang J, Liu J, Shen J, Loehmer E, McCaffrey J. A systematic review of food 
pantry-based interventions in the USA. Public Health Nutr. 2019;22(9):1704-1716. PMID: 
30834852. 
14. 
Hunger in NYC. City Harvest. https://www.cityharvest.org/food-insecurity/. Accessed 
November 2021. 

Study Number: s22-01523 
 
September 7, 2023 
25
15. 
NYC Food Policy. 2019 Food Metrics Report.  
https://www1.nyc.gov/assets/foodpolicy/downloads/pdf/Food-Policy-Report-2019.pdf. 
Accessed November 2021. 
16.
Women’s Center for Education and Career Advancement. Overlooked & Undercounted 
2021: Struggling to Make Ends Meet in New York City. 
https://1giqgs400j4830k22r3m4wqg-wpengine.netdna-ssl.com/wp-
content/uploads/2021/10/NYC2021_Self_Sufficiency_Report.pdf. Accessed November 
2021. 
17. 
Perez-Jimenez A, Freudenberg N. CUNY Urban Food Policy Institute. Policy Brief: 
Expanding Food Benefits for Immigrants: Charting a Policy Agenda for New York City. 
2016. 
https://static1.squarespace.com/static/572d0fcc2b8dde9e10ab59d4/t/5829e01b5016e1a
4d8747ac3/1479139356230/Expanding+Food+Benefits+for+Immigrants+11.14.16.pdf. 
Accessed November 2021. 
18. 
Aging with Dignity: A Blueprint for Serving NYC’s Growing Senior Population. 2017. 
https://comptroller.nyc.gov/reports/aging-with-dignity-a-blueprint-for-serving-nycs-
growing-senior-population/. Accessed November 2021. 
19. 
Wolfe WS, Olson CM, Kendall A, Frongillo EA, Jr. Hunger and food insecurity in the 
elderly: its nature and measurement. J Aging Health. 1998;10(3):327-350. PMID: 
10342935. 
20. 
Wolfe WS, Olson CM, Kendall A, Frongillo Jr EA. Understanding food insecurity in the 
elderly: a conceptual framework. Journal of Nutrition Education. 1996;28(2):92-100. 
21. 
Eicher-Miller HA. A review of the food security, diet and health outcomes of food pantry 
clients and the potential for their improvement through food pantry interventions in the 
United States. Physiol Behav. 2020;220:112871. PMID: 32179054. 
22. 
Leonard T, Andrews D, Pruitt SL. Impact of changes in the frequency of food pantry 
utilization on client food security and well-being. Applied Economic Perspectives and 
Policy. 2021. 
23. 
Martin KS, Wu R, Wolff M, Colantonio AG, Grady J. A novel food pantry program: food 
security, self-sufficiency, and diet-quality outcomes. Am J Prev Med. 2013;45(5):569-
575. PMID: 24139769. 
24. 
Liu Y, Desmond NE, Wright BN, et al. Nutritional contributions of food pantries and other 
sources to the diets of rural, Midwestern food pantry users in the USA. Br J Nutr. 
2021;125(8):891-901. PMID: 32873361. 
25. 
Wright BN, Bailey RL, Craig BA, et al. Daily Dietary Intake Patterns Improve after 
Visiting a Food Pantry among Food-Insecure Rural Midwestern Adults. Nutrients. 
2018;10(5). PMCID: PMC5986463. 
26. 
Greer AE, Faber M, Smith G, Pendley S, Kamdar N. Objectively measured chronic 
disease risk among food pantry patrons. Public Health Nurs. 2021;38(5):920-925. PMID: 
34048076. 
27. 
Cooksey Stowers K, Marfo NYA, Gurganus EA, Gans KM, Kumanyika SK, Schwartz 
MB. The hunger-obesity paradox: Exploring food banking system characteristics and 

Study Number: s22-01523 
 
September 7, 2023 
26
obesity inequities among food-insecure pantry clients. PLoS One. 
2020;15(10):e0239778. PMCID: PMC7577435. 
28. 
Maynard M, Dean J, Rodriguez PI, Sriranganathan G, Qutub M, Kirkpatrick SI. The 
experience of food insecurity among immigrants: a scoping review. Journal of 
International Migration Integration. 2019;20(2):375-417. 
29. 
Greenwald HP, Zajfen V. Food Insecurity and Food Resource Utilization in an Urban 
Immigrant Community. J Immigr Minor Health. 2017;19(1):179-186. PMID: 26691739. 
30. 
Caspi CE, Davey C, Barsness CB, et al. Needs and Preferences Among Food Pantry 
Clients. Prev Chronic Dis. 2021;18:E29. PMCID: PMC8021143. 
31. 
Bryniarski A. 2021. Food pantries are increasingly providing an Instacart-style shopping 
experience. The Counter. https://thecounter.org/food-pantries-instacart-style-shopping-
experience-covid-19/. Accessed November, 2021. 
32. 
Bradford TA. 2021. Food pantry launches online ordering system. Salem News. 
https://www.salemnews.com/news/local_news/food-pantry-launches-online-ordering-
system/article_5628bf7c-7a60-5593-951c-6c4545f9a708.html. Accessed November, 
2021. 
33. 
Potter B, Potter M L. 2021. Digital choice: How our SMALL Pantry made it happen. Food 
Bank News. https://foodbanknews.org/digital-choice-how-our-small-pantry-made-it-
happen/. Accessed November, 2021. 
34. 
Digital Food Pantry Cuts Wait Times, Costs. 2019. Food Bank News. 
https://foodbanknews.org/digital-food-pantry-cuts-wait-times-costs/. Accessed 
November, 2021. 
35. 
Holt R. 2021. Online Ordering System At Food Pantry Helps Create More Choices, 
Eliminate Returns. CBS Boston. https://boston.cbslocal.com/2021/09/13/the-open-door-
online-ordering-system-food-pantry-choice-returns/. Accessed November, 2021. 
36. 
Pick A, Romirowsky K, Roth-Kahn A. 2019. Innovative Approaches to Combating 
Hunger: How two Jewish federations are leveraging technology and data to decrease 
hunger and increase dignity in their communities. https://cdn.fedweb.org/fed-
42/2892/paper-2-innovativeapproachestocombatinghunger.pdf. Accessed November, 
2021. 
37. 
Unruh J. 2021. Modern food pantries keep up with challenges of today’s food insecurity. 
WGN-TV. https://wgntv.com/feedingamerica/modern-food-pantries-keep-up-with-
challenges-of-todays-food-insecurity/. Accessed November, 2021. 
38. 
Martin K, Shuckerow M, O'Rourke C, Schmitz A. Changing the conversation about 
hunger: the process of developing Freshplace. Prog Community Health Partnersh. 
2012;6(4):429-434. PMID: 23221287. 
39. 
Martin KS, Colantonio AG, Picho K, Boyle KE. Self-efficacy is associated with increased 
food security in novel food pantry program. SSM Popul Health. 2016;2:62-67. PMCID: 
PMC5757945/ 
40. 
Cheyne K, Smith M, Felter EM, et al. Food Bank-Based Diabetes Prevention 
Intervention to Address Food Security, Dietary Intake, and Physical Activity in a Food-

Study Number: s22-01523 
 
September 7, 2023 
27
Insecure Cohort at High Risk for Diabetes. Prev Chronic Dis. 2020;17:E04. PMCID: 
PMC6977780. 
41.  
USDA Economic Research Service. Six-Item Short Form of the Food Security Survey 
Module. 2012. https://www.ers.usda.gov/media/8282/short2012.pdf. Accessed 
November 2021.