A Multilevel Intervention in the Hunger Relief Network to Improve Diet Among Adults Experiencing Food Insecurity
Phase: NA
Conditions: Food Selection
Sponsor: University of Connecticut

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NCT03421106 
 
A Multilevel Intervention in the Hunger Relief Network to Improve Diet Among Adults 
Experiencing Food Insecurity (SuperShelf) 
 
Date: November 10, 2020 
 
 

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Instructions for Completing the IRB-1 Study Protocol Form 
 
IRB-1 Study Protocol 
 
 
Protocol Version # and/or Date:  Version 2, 11/10/20 
 
 
Study Protocol Title: A multicomponent intervention in the hunger relief network to improve diet 
among adults experiencing food insecurity 
 
 
Clinical Trial/GCP Training  
 
Is this a research study in which one or more human subjects are prospectively assigned1 to one or more 
biomedical or behavioral interventions2 (which may include placebo or other control) to evaluate the 
effects of those interventions on health-related biomedical or behavioral outcomes3 (i.e a clinical trial)?     
Indicate “yes,” “no,” or “N/A” in the space immediately below. 
 
Yes 
 
Is the study fully or partially funded by the NIH?    Indicate “yes,” “no,” or “N/A” in the space 
immediately below. 
 
Yes 
 
Have the required key personnel completed Good Clinical Practice (GCP) Training?    Indicate “yes,” 
“no,” or “N/A” in the space immediately below.  (Note that IRB approval will not be given for NIH 
funded clinical trials until all required key personnel complete the GCP training.) 
 
Yes 
 
 
 
 
 
 
1The term “prospectively assigned” refers to a pre-defined process (e.g., randomization) specified in an approved protocol that 
stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or 
other control) of a clinical trial. 
2An intervention is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more 
health-related biomedical or behavioral processes and/or endpoints.  Examples include:  drugs/small molecules/compounds; 
biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies 
to change health-related behavior (e.g., diet, cognitive/behavioral therapy, exercise, development of new habits); treatment 
strategies; prevention strategies; and, diagnostic strategies. 
3 3.Health-related biomedical or behavioral outcome is defined as the pre-specified goal(s) or condition(s) that reflect the effect 
of one or more interventions on human subjects’ biomedical or behavioral status or quality of life.  Examples include:  positive or 
negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or 
negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading 
comprehension and /or information retention, behavioral intervention for psychiatric symptoms); positive or negative changes to 
disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life. 

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Research Plan 
 
Purpose/Introduction:  [State the reason for the study, the research hypothesis, and the goals of the 
proposed study as related to the research question(s).  Provide a clear and succinct summary description 
of the background information that led to the plan for this project. Provide references as appropriate and, 
when applicable, previous work in animal and/or human studies.  Provide previous UConn protocol 
number, if applicable.] 
 
The proposed study is an evaluation of a 1-year, group-randomized intervention in 8 intervention and 
8 control food pantries (called food shelves in Minnesota). The study aims to improve the health of 
low-income adults experiencing food insecurity. The study will enroll a cohort of clients at baseline 
and follow them for 1 year to assess changes in overall diet quality. The intervention targets the 
supply of nutritious foods through food pantry sourcing changes and capacity-building. It also targets 
healthy food demand using behavioral economics. This 5 year study is NIH funded. NIH study aims 
are as follows: 
 
Aim 1 (primary outcome): To evaluate the impact of the intervention on clients’ overall diet quality. 
We will follow a cohort of clients for 1 year to assess change in diet quality (measured by Healthy 
Eating Index, or HEI). H1: Pre/post changes in HEI will show a greater positive change among 
intervention clients compared with controls. 
 
Aim 2: To evaluate the impact of the intervention on the following additional client outcomes: 
2a: Self-reported cardiovascular (CV) health. In the cohort described in Aim 1, CV health will be 
assessed by the American Heart Association’s Life’s Simple 7 (LS7) scores. H2a: Pre/post changes in 
LS7 scores will show a greater positive change among intervention clients compared with controls. 
2b: Nutritional quality of food selected. We will perform pre/post client cart assessments to 
measure the nutritional quality of foods selected by clients at their food pantry visit, as measured by 
HEI scores, in a repeated cross-sectional study H2b: On average, HEI scores among clients at 
intervention food pantries will be higher after the intervention compared with controls. 
 
Aim 3: To evaluate the impact of the intervention on the nutritional quality of food offered at food 
pantries, measured by a pre/post Food Assortment Scoring Tool (FAST). H3: Pre/post FAST scores 
will show a greater positive change among intervention food pantries (n = 8) compared with controls 
(n = 8). 
 
Aim 4: To measure implementation of policies and practices that promote a nutrition-focused hunger 
relief network, as assessed by pre/post surveys and key informant interviews with hunger relief 
agency staff. 
 
Exploratory aim: To evaluate the cultural appropriateness of food shelf foods and services as 
measured by: (1) the availability of culturally-specific food, and (2) client satisfaction assessed by 
pre/post surveys. 
 
Outcomes:  
 
Primary Endpoint/Event/Outcome: The primary outcome is change in overall diet quality scores 
among clients, as measured by the USDA’s Healthy Eating Index (HEI). A cohort of clients will take 
two 24 hour recalls at each time point to measure overall dietary quality. 
 

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Secondary Endpoint(s)/Event(s)/Outcome(s): Secondary outcomes include: change in cardiovascular 
(CV) health as measured by the American Heart Association’s Life’s Simple 7 (LS7) scores collected 
vis participant survey; change in the nutritional quality of food selected by clients at their food shelf 
visit as measured by HEI; change in the nutritional quality of food offered at food pantries as 
measured by HEI during environmental assessments; implementation of policies and practices that 
promote a nutrition-focused hunger relief network, qualitatively assessed through key informant 
interviews; and cultural appropriateness of food shelf foods and services as measured by the 
availability of culturally-specific food, and client satisfaction assessed by pre/post surveys. 
 
Significance of Research Question/Purpose:  
 
In 2014, an estimated 14% of U.S. households experienced food insecurity (i.e., they lacked access to 
enough food for an active, healthy life for all household members).1 Food insecurity 
disproportionately affects low-income, African-American and Hispanic households,1 and immigrant 
and refugee families.2 Those who are food insecure are more likely to demonstrate poor dietary 
outcomes,3 resulting in a disproportionate burden of chronic conditions affecting low-income and 
minority groups.3 Food insecurity has been linked to cardiovascular disease and its risk factors.4–7 
Food pantry clients have demonstrated poor nutritional outcomes,8–11 and dissatisfaction with the 
quality of food offered.12,13 Unlike most food assistance programs (e.g., the National School Lunch 
Program), there are currently no standards for the nutritional quality of food shelf food offerings.14 
The hunger relief network has both supply-side issues that constrain what is offered to clients, and 
demand-side issues moving healthy food through the system in a timely way.14–17 Few interventions 
have been equipped to address both challenges, but small-scale efforts have shown promise. 
Meanwhile, local and national hunger relief agencies have suggested promising practices to promote 
a healthy and culturally appropriate food shelf, and to “nudge” clients towards healthier food 
selection,18–20  but most of these efforts have not been systematically adopted or rigorously evaluated. 
Coordinated efforts are needed to address both food shelf environment and client behaviors.  
 
Preliminary Data:  
We completed a pilot study testing the effect of the intervention in two food pantries. This study 
examined he nutritional quality of foods available at the pantries and the foods selected by adults 
visiting food pantries using the HEI. The intervention (SuperShelf) was implemented in two food 
pantries (Sites A and B), with two other pantries (Sites C and D) serving as a control for pantry 
outcomes. The intervention aimed to increase the amount and variety of healthy foods (supply), as 
well as the appeal of healthy foods (demand) using behavioral economics strategies. Assessments 
included baseline and 4-month follow-up client surveys, client cart inventories, pantry inventories and 
environmental assessments. A fidelity score (range 0-100) was assigned to each intervention pantry to 
measure the degree of implementation. HEI was generated for each client cart and pantry. The study 
was conducted among clients visiting the two intervention pantries before (n= 71) and after (n =70) 
the intervention. Results demonstrated that fidelity scores differed by intervention site (Site A=82, 
Site B=51). At Site A, in adjusted models, client cart HEI scores increased on average by 11·8 points 
(P<0·0001), whereas there was no change at Site B. HEI pantry environment scores increased in 
intervention pantries (Site A=8 points, Site B=19 points) and decreased slightly in control pantries 
(Site C=-4 points, Site D=-3 points). Data suggest that when implemented as intended, SuperShelf 
has the potential to improve the nutritional quality of foods available to and selected by pantry clients. 
The current study will expand the evaluation to include additional outcomes, including client dietary 
intake. 
 

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For EACH Participant Population State the Number of Participants to be Enrolled and Screened 
and/or the number of participant records reviewed (including, HIPAA covered health records and 
FERPA covered school records), if applicable:  [State the total number of participants/records to be 
enrolled and, if enrolling more than one participant population, describe the total enrollment for each.  
Tip:  consider attrition and the number of participants who may fail screening.  Use of a range may 
provide flexibility. Note that the range must be justified in the Justification of Sample Size section 
below.]   
 
We have enrolled 504 adult clients at food pantries.All participants draw from the same population 
but they were enrolled in two groups with different study activities.  
The original target sample size was 544, but UMN IRB approval was granted in May 22, 2018 to 
increase the sample size to 589 in case attrition was higher than expected. However, due to COVID-
19, we completed enrollment in March 2020 with 504 participants and will not be enrolling more 
participants.  
1. The first group (Sample A), consists of a cohort followed over one year. Recruitment of 
Sample A is complete. A total of 317 were enrolled; at this time, 214 have completed pre/post 
measures including the primary outcome, and a small number of participants continue to be 
followed. The remainder are lost-to follow up or did not complete primary outcomes 
measures. We will be adequately powered with 176 participants completing pre/post primary 
outcome measures. 
 
2. The second group (Sample B), consists of a cross-sectional sample with no identifiable data 
collected for the study, to collect a secondary outcome measure. Recruitment of Sample B 
stopped early due to COVID-19. We collected data 272 clients at 16 sites at pre-assessment 
(17 per site) 187 clients at 11 sites at post-assessment. However, post-assessment data could 
not be completed at the final 5 sites after March 2020 for two reasons: 1) Food pantries in 
Minnesota stopped offering client choice shopping for food at the start of the COVID-19 
pandemic, thus we could not assess what foods clients selected at their visit (the primary 
purpose of the measure), and 2) UMN’s “sunrise plan” for human subjects research studies 
has so far not included community-based studies without a clear clinical treatment benefit for 
participants, due to the unpredictability of community environments. As it is unclear when 
these conditions necessary for data collection will change during the study period, we are 
proceeding with the study analysis without these data  As participants are not followed over 
time, there is no consideration of attrition. 
 
Justification of Sample Size:  [For qualitative and pilot studies, describe how the proposed sample size is 
appropriate for achieving the anticipated results.  For quantitative studies, provide a power analysis that 
includes effect size, power and level of significance with references for how the sample size was 
determined.  Explain the rate of attrition and possible number who fail the screening, with references as 
appropriate.] 
 
Power Analysis:  
 
Healthy Eating Index (HEI). For the outcome of change in overall diet HEI scores (the primary 
outcome), power is computed based on the t-test at the individual client level, but sample size is 
inflated for the group randomization design by a factor of 1+(m-1)*ICC where m is the average 
cluster size and ICC is the intracluster correlation. A SD of 14.4 is based on change in individual total 
diet HEI scores from the PI’s pilot study of 43 food shelf clients21 assuming that individual total diet 
variability is a better reflection of the variability in client selection than the variability across food 

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pantries. We anticipate an ICC for HEI scores of 0.05 based on the same data. 21  Under these 
assumptions and using a two-sided type I error rate of 5%, this study would have 80% power to detect 
a mean difference in 7.5 HEI points between intervention and control. With a originally planned 
average cluster size m of 11 and number of clusters k of 16, we require at least 176 participants with 
pre/post measures, or at least 272 enrolled to account for 30% attrition. We have surpassed this 
number for our primary outcome. This calculation also yields more than adequate power to detect the 
same mean difference in the HEI of food selected at the visit based on actual the standard deviation in 
our baseline sample (secondary outcome), for which we  collected two repeated-sectional samples 
(with the second sample of 187 collected at post-assessment),.   
 
Enrollment of UConn Students and/or Employees:  [Will UConn students be enrolled?  If so, describe 
if these students include those who any key research personnel teaches, or for whom any key research 
personnel has responsibility.  Will UConn employees be enrolled?  If so, describe if these employees 
report to any key personnel.  For each group, explain why this population is necessary to the study.  Tip:  
convenience is not sufficient justification.] 
 
N/A 
 
Enrollment of Key Personnel, Spouses or Dependents/Relatives:  Will study key personnel, spouses of 
key personnel, or dependents/relatives of any key personnel be enrolled in the study?  If so, describe and 
provide justification.   
 
N/A 
 
For EACH Participant Population Describe Screening Procedures, if applicable:  [Describe when 
participants will be screened and how this will occur.  Include copies of all screening forms and related 
documents.  Describe procedures to notify participants of the screening result, if applicable.  Provide a 
copy of the screening instrument.]   
 
. No screening of additional participants will take place. 
 
 
Anticipated Study Time Frame:  [Describe the estimated time frame of the study from anticipated start 
to anticipated finish.  If the study will occur in more than phase include these in the time frame.  Use of a 
table is often helpful.] 
 
The total study period is five years (April 2017 to March 2022). Participants in Sample A, which 
assesses the primary outcome, are followed up with after 1 year. Study participants were enrolled 
from Jan 2018 to March 2020. Below is a visual representation of the originally planned study and its 
timeline. The intervention and evaluation occur in two waves (4 intervention and 4 control food 
pantries in year 2, 4 intervention and 4 control food pantries in year 3). 
 
 
 

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Design, Procedures, Materials and Methods:  [Describe the study design, including the sequence ll 
study procedures.  Experimental procedures should be clearly described and labeled as such.  If the study 
uses control or experimental groups, or different treatment arms, clearly describe what participation will 
be like for each of the groups or study arms.  Tip:  describe procedures in the order conducted, where they 
will be conducted and how long they will take to complete.  The IRB strongly suggests that investigators 
incorporate flexibility into the study design to accommodate anticipated events (i.e. explain how missed 
study appointments can be made up by participants). If this study offers treatment for the participants’ 
condition, complete the Treatment Study Supplemental Form (IRB-1C) and attach it to this application 
for review.  Use of a table is often helpful here.   
 
 
Design Overview: The intervention is an environmental-level intervention at 16 food pantries. 
Participants are exposed to the intervention through their normal pattern of visits to the food pantry 
(determined by the participant). It is a group-randomized study in which 8 pantries are randomly 
assigned to the intervention (“transformation”) and 8 are randomly assigned to the control (“delayed 
transformation”) arm. The intervention will be implemented over one year and will occur in two 
waves (4 intervention and 4 control food pantries in year 2, 4 intervention and 4 control food pantries 
in year 3). Clients will be recruited from intervention and control food pantries, and measures will be 
conducted before and after the intervention.  The final period of the study focuses on dissemination of 
our findings. 
 
Food pantry intervention (“transformation”) activities: At the food pantry level, activities support 
the goal of increasing the nutritional quality of foods available to clients to make the healthy choice 

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the easy choice. Food pantries will receive ongoing visits from trained UMN Extension educators, 
supervised by the study’s Community Outreach Coordinator, who work with food pantry managers to 
increase the supply of healthy food through sourcing and the appeal and the appeal of healthy food 
through behavioral economics. This occurs over a period of months. Food pantries “transform into a 
SuperShelf” according to the 6 steps outlined below.  
 
Pantries were selected via a request for applications to food pantries in the state of Minnesota. Food 
pantries will applied either via paper or online by responding to a brief list of questions to evaluated 
capacity to complete intervention and evaluation activities.  
More information is available at www.SuperShelfmn.org
 
 
Control sites. Control food pantries (“delayed transformation sites”) do not receive any intervention 
until completion of the evaluation. After evaluation measures are complete, they receive support from 
UMN Extension and the study Community Outreach Coordinator in transforming to be a SuperShelf.  
 
Quality Improvement Survey: A needs assessment was conducted in 2017 in the form of a 
statewide survey of clients at food pantries throughout the state of Minnesota. This survey was 
created by community partners and resulted in an aggregated report of client preferences in 
Minnesota. Food pantries were asked to give an anonymous 16-question survey to a convenience 
sample of 25 clients, with questions about frequency food pantry use and most requested types of 
food. No participant identifiers were collected. In 2019 the survey was repeated at the request of 
community partners for the purposes of surveillance. 
 
Data collected at the Food Pantry 
 
Inventory. Food pantry inventory is assessed by research data collectors in a single “snapshot” 
measure during the client data collection period. The measures include only food available for clients 
to choose at their visit, and thus excludes back-stock. Inventory is conducted when the pantry was 
closed to clients, but stocked as it typically would be for clients. Data collectors record the item 
details for each product, including the item name, brand, net product weight, the exact count of the 

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product, and special nutritional notes on the label (e.g., reduced sodium, reduced fat). For pre-
packaged items, data were obtained from package labels. Non-packaged items like produce were 
weighed with the container weight (e.g., bin, cart) subtracted. From the inventory, a Healthy Eating 
Score is created. 
 
Food Assortment Scoring Tool (FAST). Over 5 consecutive days, pantry staff and volunteers food 
pantries sort and weigh the food that moved onto the shelves from storage areas into 13 categories of 
food.  The resulting data is used to calculate a FAST score of the nutritional quality of food available 
to clients, to be compared with the inventory HEI score (gold standard), since FAST has not yet been 
validated to assess change over a long period time. 
 
Manager survey. At the time of pre and post data collection, managers complete a survey with 
questions about food pantry operations and the organization, not about the manager. This includes 
food distribution practices, food pantry policies, staffing patterns, and food sourcing.  
 
Note that data collection at the food pantry level may still be conducted if it can be done safely during 
the study period. 
 
Previously completed participant activities  
 
The schema for Sample A and Sample B, including the activities, is presented below.  
 
 
 
We recruited a group of participants (n=317) to participate as a longitudinal cohort. This is referred to 
as Sample A. Participants were approached at their food pantry visit at one of the 16 food pantries in 
the study after selecting their food. After obtaining informed consent, participants completed the 
study activities below. Participants earned up to $45 for completing all measures. Activities included: 
 
1. Completing a Pre survey (similar to the Post survey described in detail below) asking about 
demographic information, Life's Simple 7, food pantry usage and pantry satisfaction 
questions 
 
Sample B (n = 187) 
• Survey 
• Cart Measure 
• Two 24-hour recalls  
 
Sample A Post (n =at least 176) 
• Survey  
• Two 24-hour recalls 
Becomes 
longitudinal 
cohort  
  Pre intervention                                          Post intervention 
Client Activities Schema 
Sample A Pre (n  = 317) 
• Survey  
• Cart Measure 

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2. Completing a contact information and availability to enable us to follow up with them  
3. Allowing research staff to record (by photograph) the food they had selected at their visit  
4. Completing up to two 24-hour dietary recalls over the phone in approximately the subsequent 
month following the food pantry visit 
 
Key informant interviews. For Wave 1 sites, we also completed 32 interviews at pre and post with 
food pantry managers (n=16) and volunteers (n=16) to assess food pantry intervention 
implementation processes, challenges, and successes.  
 
Sample B activities. We could not collect client food selection data during the post-assessment in 
Sample A. Doing so would not be practical because researchers will not be with them during a food 
pantry visit; indeed, Sample A clients may not even be using the food pantry at the post-assessment 
time. Instead, to assess change in client food selection at the pantry, we needed a Sample B for a 
repeated cross-sectional design (two samples). Thus, we recruited a second set of non-cohort 
participants for whom no identifying data is collected and no follow-up is needed. The subjects in 
Sample B were be given an incentive in the form of a prepaid debit card for $15. Activities included 
the following: 
 
1. Taing a shortened version of the survey that includes demographics, and food pantry usage 
and satisfaction  
2. Allowing research staff to record (by photograph) the food they selected at their visit 
 
Recruitment process for Sample B: Recruitment took place at the food pantry during clients’ 
visits. After they selected their food (to avoid influencing choice), all clients over age 18 were 
approached by data collectors to gauge interest in the study.  
 
Subjects were told that they are being invited to participate in a research study to evaluate the 
impact of food pantry changes on the food that is selected and consumed by clients. They were 
told all of what will be asked of them to do, including allowing us to record their selections from 
the food pantry for that day and taking a survey. They were told that for their participation they 
will receive an incentive based on their completion of the activities. Potential participants will be 
notified that participation is completely voluntary and confidential.  
If they are interested and eligible, research staff had a consent conversation with the participant. 
Study staff walked through the consent document, including discussing the background 
information of the study, study tasks that participants will be asked to complete, risks and benefits 
of the study, compensation for completing study tasks, confidentiality, and the voluntary nature of 
the study. We obtained documented written consent. 
 
Assessments and recruitment documents were offered in English, Spanish, and Somali by 
bilingual data collectors who are deployed to pantries based on the expected population of clients. 
Because the study recruits from all parts of Minnesota include many rural sites, many food 
pantries have few non-English speakers; the vast majority of participants have been English 
speakers.  
 
Sample B survey procedures. The survey took approximately 15 minutes. Participants took the 
survey through an online REDCap form at the food shelf with the data collector available to 
answer questions. Participants could also choose to have the data collector administer the survey 
verbally, or take the survey on a paper copy if they prefer. 
 

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Client cart procedures. After clients select food from their pantry visit, and while they completed 
the survey, staff took photographs food selected at the visit. Pre-packaged items are photographed 
to capture the product name, brand, size, quantity, special nutritional notes on the label (e.g., 
reduced sodium, reduced fat) and, for grain items, whether the first ingredient was a whole grain. 
Non-packaged items like produce are photographed on a scale with its weight displayed. 
Following the pantry visit, photograph data are entered into a nutrient database.  
 
Ongoing participant activities 
 
Sample A activities. At post-assessment, we ask participants in Sample A to conduct the following 
activities, for which they receive up to $45 for completing all measures. 
 
1. Take the Post survey online, over the phone, or by mail ($15) 
2. Complete two 24 hour diet recalls. ($15 per recall) 
 
Follow-up with Sample A: Participants can take the survey online via a REDCap link, over the 
phone with a data collector, or by mail. At follow up, participants are mailed a notification that 
we will be contacting them soon. Data collectors follow up by calling participants. When 
participants cannot be reached by phone, participants are emailed the survey by REDCap and 
mailed a hard copy of the survey. We also send a text reminder. Due to the transient nature of the 
study population, we will use a broad range of strategies to re-engage with participants at the time 
of follow-up. In particular, if it is determined that the phone number originally provided by the 
participant are not valid (e.g. incorrect number, disconnected service, etc.) we will employ the 
other methods for reconnecting with the participant, not exceeding 3 points of contact with these 
methods. Potential methods include: social media (e.g. SuperShelf’s FaceBook page), 
WhitePages, and web-based phone/messaging services (e.g. WhatsApp, Viber) and LexisNexis. 
In our work with food pantry clients to date, we have found that many participants are interested 
in continuing to participate at follow-up, but delay completing activities due to the many 
competing priorities in their daily lives. For the final month of retention data collection in each 
Wave, participants will be given a “last chance” to participate, with an extra $10 offered for 
completing the follow-up survey. This was successful in increasing follow-up during Wave 1. 
 
Sample A survey procedures: Once participants have been contacted, they complete a survey that 
takes approximately 20 minutes. This can be completed on the phone with data collectors, though 
an online link, or by mail.  No participants in Sample A completed the survey in Somali; 
therefore, follow-up will be done using English and Spanish surveys only. Upon completion of 
the survey, they are contacted by the Nutrition Coordinating Center at the University of 
Minnesota to complete two dietary recalls.  
 
24 hour dietary recall procedures: Once the survey is complete, clients are contacted by phone to 
obtain two unannounced dietary recalls though the Nutrition Coordinating Center (NCC) at the 
University of Minnesota (http://www.ncc.umn.edu/). Each dietary recall takes approximately 20-
30 minutes to complete. The 24-hour dietary recalls are collected using Nutrition Data System for 
Research (NDSR), a computer-based software application developed at NCC that facilitates the 
collection of recalls in a standardized fashion.22,23 Dietary intake data gathered by interview is 
governed by a multiple-pass interview approach. Participants are assisted by a Food Amounts 
Booklet that helps in estimating quantities consumed. Five distinct passes provide multiple 
opportunities for the participant to recall food intake. The first pass involves obtaining from the 
participant a listing of all foods and beverages consumed in the previous 24 hours. This listing is 
reviewed with the participant for completeness and correctness (second pass). The interviewer 
then collects detailed information about each reported food and beverage, including the amount 

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consumed and method of preparation (third pass). In the optional fourth pass, the interviewer then 
probes for commonly forgotten foods. Finally, the detailed information is reviewed for 
completeness and correctness (fifth pass). The complete protocol for dietary recalls is attached. 
 
 
 
[Describe study procedures for use of interviews or focus groups if applicable.  Include details 
such as how long each procedure will take to complete, who will be asked to participate in these 
procedures and where these procedures will be conducted.  Provide copies of interview and focus 
group questions/topic areas.] 
 
NA . No additional interviews or focus groups will take place. 
 
 [If the study includes measures, survey instruments and questionnaires (including the collection 
of demographic data), identify each and, if available, provide references for the measures.  
Describe what they intend to measure (relate to purpose/hypothesis) and their psychometric 
properties (e.g., reliability and validity).  Identify any that were specifically created for the study 
and attach a copy for IRB review.] 
 
Measures 
 
Healthy Eating Index. Data from pantry inventory, client carts, and 24-hour dietary recalls are 
used create three sets of Healthy Eating Index-2015 (HEI) scores. The HEI is a validated tool 
developed by the National Cancer Institute and the USDA in which a higher HEI score 
indicates better alignment with the Dietary Guidelines for Americans.24,25 The HEI is 
calculated using nutrient density, so it can measure the diet quality of any amount or 
assortment of foods.26  
 
Survey Measures. Complete surveys are found in the attached documentation. Note that in 
measures, food pantries are referred to using the more common term food shelf in Minnesota.  
 
The Sample A post-survey assesses the following: food pantry use, frequency and duration, 
food pantry satisfaction with food and service, amount of food received at food pantry, 
household size and age composition, employment, SNAP and WIC participation, Hunger 
Vital Sign (food insecurity), Life’s Simple 7, and global self-rated health, and cancer 
screening behaviors. The survey takes approximately 20 minutes to complete. 
 
Sample B survey assesses the following: food pantry use, frequency and duration, food pantry 
satisfaction with food and service, amount of food received at food pantry, household size 
and age composition, employment, SNAP and WIC participation, Hunger Vital Sign (food 
insecurity), global self-rated health, and demographics (age category, race, language, and 
education status). It also asks two open ended questions: What else is important for us to ask 
about in our research? And “Help us understand your story. Why is the food shelf important 
to you?” The survey takes approximately 15 minutes to complete. 
 
Most questions were created for the survey and are not scales (i.e., do not have psychometric 
properties). Well-establish measures include the following: 
-Hunger Vital Sign: This 2-item food insecurity screener has demonstrated sensitivity of 97% 
and specificity of 83% for identifying food insecurity.27 
-Global self-rated health has demonstrated strong predictive validity for a range of health 
outcomes. 28–30  

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-Life’s Simple 7: . This score represents a summary of 7 components associated with health, 
including total cholesterol, blood pressure, fasting glucose, physical activity, healthy diet, 
smoking, and body mass index, all captured through self-report. For health data that is not 
always known, LS7 prompts for other information – for example, if blood glucose is not 
known, LS7 asks whether participants have Type I or II diabetes or currently take 
medications to manage glucose. LS7 was developed by the American Heart Association in 
2010 to set national 2020 goals for CV health promotion. Higher LS7 scores have been 
associated with lower lifetime occurrence of chronic diseases including diabetes. Scores are 
based a scale of 0-14, with each of the 7 items scored as 0 (poor), 1 (intermediate), or 2 
(ideal). 31–33 
 
[If applicable, describe the use of audiotape and/or videotape, provide justification for use and 
indicate if this is a requirement of participation.]  
 
 
 
NA 
 
[If the study involves use of deception or incomplete disclosure, explain the reason why this is 
necessary to answer the research question(s).  Complete the alteration of consent section below]   
  
NA 
 
[Describe opportunities provided to participants to ask questions in order for them to make an 
informed decision regarding participation.]    
 
No additional participants will be recruited. Participants had the opportunity to ask questions 
about the study before being consented by study staff. Study staff walked through the consent 
document, including discussing the background information of the study, study tasks that 
participants were asked to complete, risks and benefits of the study, compensation for 
completing study tasks, confidentiality, the voluntary nature of the study, and study staff as 
well as IRB contact information. Subjects will consent for themselves. 
Questions such as the following were be asked to assess the subject’s understanding of 
participation in the study. 
• What questions do you have regarding what we are asking you to do? 
• What concerns about this process do you have? 
 
 
Data Analysis:  [For all studies, specify the analytic techniques the researcher will use to answer the 
study questions. Indicate the statistical procedures (e.g. specific descriptive or inferential tests) that will 
be used and why the procedures are appropriate. For qualitative data, specify the proposed analytic 
approaches.] 
 
Data Analysis Plan:  
Primary outcome (HEI). To examine change in overall diet, we will use mixed-model linear 
regression models with fixed effects for treatment group, baseline client- and food pantry-level 
covariates, and a random effect for food pantry (to account for correlation within food pantries) to 
assess intervention effect on mean change. Change will be calculated as post-intervention score minus 
pre-intervention score in client-level overall diet HEI score. We will specify a correlation structure for 
the random effect appropriate for longitudinal data (e.g. autoregressive, Toeplitz or compound 

Page 14 of 25 
 
symmetry). Pre and post-intervention component scores and change scores will be calculated for the 
HEI subcomponents for descriptive purposes. We will also proceed with a sensitivity analysis of the 
11 sites where data was collected pre-COVID, as dietary habits may be different during COVID-19, 
for which we are powered to detect an effect size of 8.15 points. 
Secondary and exploratory outcomes. For food selected at the visit, we will compare post 
intervention HEI scores between intervention and control groups, adjusted for clustering within the 
food pantry (random effects) and adjusted for food pantry-level baseline HEI bag check scores and 
relevant covariates (client and food pantry level). HEI subcomponent scores will be calculated for 
descriptive purposes. We will proceed with analysis of HEI bag check scores for the 11 sites in which 
we have complete pre/post data, for which we are powered to detect and effect size of 7.27 points. 
Change in CV health scores (Life’s Simple 7) and satisfaction scores will be analyzed using models 
described above.  
Inclusion/Exclusion Criteria:  [List ALL inclusion and exclusion criteria.  Any proposed exclusion 
criterion based on gender (women of childbearing potential), age, or race must include justification for the 
exclusion.] 
 
Inclusion Criteria: Any adult who comes to a participating food pantry on a day in which data 
collection is taking place will be able to participate in the study, as long as they do not fit our 
exclusion criteria. This group, based on the demographic of adults who participate in food pantries’ 
services will include groups with socioeconomic disadvantage. Only one adult per household may 
participate. We will enroll clients who speak English, Spanish or Somali. Participants must have 
access to a phone. 
 
Exclusion Criteria:  
• Under the age of 18 
• Mentally incapable of providing informed consent 
• Food pantry clients that do not speak English, Spanish or Somali. 
 
[Describe the conditions under which participants may be removed from the study, i.e., 
noncompliance with study rules, study termination, etc.] 
 
Withdrawal Circumstances: Participants will be withdrawn if it is determined that they were 
ineligible at the time of enrollment; for example, if two participants from the same household 
mistakenly enroll, the second to enroll will be withdrawn. 
 
Withdrawal Procedures: When participants withdraw we will not continue to collect data.  
 
Termination Procedures: NA 
 
Potential Harms/Risks and Inconveniences:  [Describe the potential risks to participants (and 
secondary participants, if applicable) and steps taken to minimize risks for each participant population.   
Assess the likelihood of the risk occurring and, if it were to occur, the seriousness to the participant.  
Types of risks to consider include, but are not limited to: physical, psychological, social, legal, 
employment, and financial.    
 
[Describe any anticipated inconveniences the participants may experience (such as:  their time, 
abstention from food, etc.).] 
 
This study presents minimal risk. There is slight risk that participants may feel 
uncomfortable responding to some of the survey questions, including the food insecurity 

Page 15 of 25 
 
questions, and questions related to food pantry usage, or questions related to their dietary 
intake during the 24 hour diet recall. To minimize the risk of discomfort, all questions have a 
“prefer not to answer” options. Staff administering dietary recalls are trained to prompt in a 
way that minimizes participant discomfort, for example, asking “when is the first time you 
ate or drank in the morning?” instead of “what did you eat for breakfast?” 
 
Benefits:  [Describe anticipated benefits to the individual participants.  If test results will be provided, 
describe and explain procedures to help participants understand the results.  If individual participants may 
not benefit directly, state so here.  Do not include compensation or earned course credits in this section.] 
 
There is no direct benefit to individual participants.  
 
[Describe anticipated benefits to society (i.e., added knowledge to the field of study) or a specific 
class of individuals (i.e., athletes or autistic children).] 
 
This study will contribute an understanding of interventions that address diet-related 
outcomes among food insecure populations. This is a population at a high risk of poor 
diet and chronic disease. Until recently, food pantries were an uncommon and 
overlooked setting for research. This study is one of few large-scale rigorously 
evaluated interventions in food pantries.  
 
 
Risk/Benefit Analysis:  [Describe the ratio of risks to benefits.  Risks to research participants should be 
justified by the anticipated benefits to the participants or society.  Provide your assessment of anticipated 
risks to participants and steps taken to minimize these risks, balanced against anticipated benefits to the 
individual or to society.] 
 
The risk to individual participants is minimal, whereas the potential benefit is the identification of an 
evidence-based intervention to address a food insecure population. Food insecurity has been 
identified as growing problem, particularly in the post-pandemic (COVID-19) era, and very little 
research has identified effective strategies to improve the nutritional quality of food clients can 
receive. The research transforms the food pantries that participants are likely to visit to make them 
more client-centered; thus the broader study could be beneficial to participants, though this benefit 
would be experienced whether or not the individual completes our study measures.  
 
Economic Considerations:  [Describe any costs to the participants or amount and method of 
compensation provided.  Describe how you arrived at the amount and the plan for compensation; if it will 
be prorated, please provide the breakdown. Experimental or extra course credit should be considered an 
economic consideration and included in this section.  Indicate when participants will receive 
compensation.] 
Payment: Incentives will be given in prepaid debit cards, ClinCards, which are a secure and safe way 
to administer research participant incentives. As we will be providing incentives to participants in 
increments based on their completion of study activities that we will not be present for (over the 
phone 24 hour recalls), using prepaid, reloadable debit cards makes the most sense, so participants 
can receive their incentive in more timely manner, and gift cards do not have to be sent in the mail.  
Subjects in Sample A received the ClinCard at their first visit, and then additional incentives are 
added as participants complete study activities. New ClinCards can be mailed if participants misplace 
empty cards. Compensation levels is determined based on study activity completion.  When 
participants are given the ClinCards, they will be walked through the features of ClinCards:  
• 
Worldwide acceptance of card. 

Page 16 of 25 
 
• 
Protection against fraud with MasterCard Zero Liability. 
• 
No bank account required for recipients of cards. 
• 
24/7 customer service. 
• 
Card can be used as a PIN based transaction, with signature point of sale, or for cash 
withdrawal at a bank or ATM. 
• 
There will be a fee charged to the cardholder if an ATM is used to withdraw cash, if the card 
has no activity for three months, or if transactions are made in foreign currencies. 
• 
Participants should track the amount on the card and tell a cashier how much is left on the 
card if they plan to use it for an amount over the amount left on the card 
• 
Balance of card can be checked at myclincard.com 
 
1. For Sample A, they may receive up to $45 for completing all post-assesment activities, after 
having received up to $45 during the pre-assessment. This includes the survey ($15) and up to 
two 24-hour dietary recalls ($15 each) 
2. The compensation for Sample B is $15, also paid by ClinCard. 
 
 
Data Safety Monitoring:  [This is a prospective plan set up by the study investigators to assure that 
adverse events occurring during studies are identified, evaluated, and communicated to the IRB in a 
timely manner.  Although the investigators initially propose a Data Safety Monitoring Plan (DSMP), the 
IRB must approve the plan and may require revision of the plan.  A DSMP is required for all human 
studies at the University of Connecticut except for studies reviewed under the Exempt Criteria.  For 
studies that present more than minimal risk to participants, the IRB will review and determine on a case-
by-case basis whether a data safety monitoring board is most appropriate.  Please refer to the IRB’s policy 
regarding data safety monitoring before completing this section - http://research.uconn.edu/policies-
procedures.  
 
Issues that should be addressed in the DSMP include the following: 
1. Frequency of the monitoring. 
2. Who will conduct the monitoring (Under UConn policy a student cannot be the sole person 
responsible for monitoring the data and safety of the protocol procedures?) 
3. What data will be monitored (include compliance with approved IRB protocol? 
4. How the data will be evaluated for problems? 
5. What actions will be taken upon the occurrence of specific events or end points? 
6. Who will communicate to the IRB and how will communication will occur? 
7. Describe procedures to inform the sponsor. 
 
Sample response to issues listed above for minimal risk/slight increase over minimal risk – “Survey 
results will be monitored by the PI in conjunction with the student investigator once every two weeks 
(items 1, 2 and 3).  Survey responses will be reviewed to monitor for clarity (i.e., the same question is 
skipped by 5 or more participants).  In that case, the question will be revised and an amendment will be 
submitted to the IRB (items 4, 5 and 6).” 
 
A copy of our DSMP is included in this application. Because the intervention and evaluation 
activities are low risk, the data safety monitoring plan for this trial focuses on close monitoring of 
recruitment, retention, and safety by the principal investigator (PI) in conjunction with a Safety 
Officer. A Safety Officer was considered to be appropriate for this study (rather than a full Data 
Safety and Monitoring Board) as the study was not high-risk and did not involve a highly vulnerable 
patient population. The Safety Officer will fulfill many of the roles of a DSMP. Participant safety 
problems identified by the PI or Safety Officer will be promptly reported to NHLBI and to the IRB at 
the University of Minnesota. The ongoing safety officer for this trial is Jerica Berge, PhD, Professor 

Page 17 of 25 
 
in the Department of Family Medicine and Community Health at the University of Minnesota. Dr. 
Berge has substantial experience leading NIH-funded behavioral intervention studies and has a strong 
understanding of the types of risks associated with behavioral interventions involving environmental 
changes and dietary measurements.  She has served on other DSMBs for randomized studies. 
 
As Safety Officer, Dr. Berge will: 
• 
Review recruitment reports (quarterly) from the start of recruitment at the end of Year 1 to the 
end of recruitment in year 4. This includes assuring that participants meet gender, racial/ethnic 
and SES diversity. While we do not expect large deviations from our quarterly recruitment goal, 
Dr. Berge will help the research team to consider alternate recruitment strategies to ensure that 
diversity recruitment goals are met. 
• 
Review retention reports (quarterly) beginning six months after the start of recruitment, until data 
collection is completed in year 4. This includes assuring that there is no unexpected loss-to-
follow-up, and that the rate of loss-to-follow-up is not differential across the intervention and 
control groups. While some loss-to-follow up is expected, Dr. Berge will help the research ream 
to consider retention strategies to endure that retention goals are met, and that retention is 
adequate across interventions and controls.  
• 
Monitor Unexpected Problems/Adverse Events and the adequacy of reporting of such events 
(quarterly) 
• 
After each report review or at any other time, suggest other corrective action, trigger of an ad hoc 
review, or trigger of a stopping rule, that should be communicated to the study investigator, the 
University of Minnesota IRB, and the NHLBI.    
 
The project manager is responsible for assembling the data and producing the recruitment and 
retention reports outlined in this plan, as well as, assuring that copies of these reports are sent to the 
principal investigator and Safety Officer, which are reviewed by the PI. Reports contain, at a 
minimum, the following: 
1. Study summary and issues or problems 
2. Changes to protocols or consent procedures 
3. Recruitment and Retention 
a. Total recruitment status  
b. Recruitment by gender, ethnicity, and race 
c. Completion of study components for enrolled participants  
d. Participant retention by intervention vs. control (6 months post, 1 year post for both 
waves) 
4. Safety assessment  
a. Unanticipated problems/Adverse Events/Serious Adverse Events and reporting of 
events 
 
Beyond the review of the Safety Officer, issues of recruitment will be discussed at weekly research 
team meetings as the need emerges. The research team will also discuss issues relating to the study 
protocol, consent procedures, in-home visits and observations, intervention visits, overall data quality, 
and data analysis as needed during their weekly meetings. 
 
Data Management: 
Data management systems in this project include the design of online interface, data entry forms, 
supervising the collection and processing of all data, training and certification of data collection and 
entry personnel, and designing and implementing all quality control procedures. All of these activities 
will be accomplished under the supervision of Data Manager with consultation from the study’s 
analyst. REDCap is the primary means of collecting data for the study. The Data Manager for the 
study is the University of Minnesota’s REDCap Administrator, who has developed a data entry 

Page 18 of 25 
 
interface using the web-based data capture software, which is hosted on the secure network 
maintained by the University of Minnesota Academic Health Center. The Data Manager will manage 
the assembly of all the client data into one complete dataset: merge 24-hour recall data from the 
NDSR and match client survey data.  The Data Manager will produce the study codebooks.  
 
 
Data Security:  
Digital data for this project will be stored on REDcap. REDcap is a secure database housed on secure 
servers operated by the University of Minnesota Academic Health Center's Information Systems 
group (AHC-IS). Access to the database by username and password will require specific permission 
from the principal investigator and the data manager. 
 
REDCap uses a MySQL database via a secure web interface with data checks used during data entry 
to ensure data quality. REDCap includes a complete suite of features to support HIPAA compliance, 
including a full audit trail, user-based privileges, and integration with the institutional LDAP server. 
The MySQL database and the web server will both be housed on secure servers operated by the 
University of Minnesota Academic Health Centers Information Systems group (AHC-IS). The servers 
are in a physically secure location on campus and are backed up nightly, with the backups stored in 
accordance with the AHC-IS retention schedule of daily, weekly, and monthly tapes retained for 
1month, 3 months, and 6 months, respectively. Weekly backup tapes are stored offsite. The AHC-IS 
servers provide a stable, secure, well-maintained, and high-capacity data storage environment, and 
both REDCap and MySQL are widely-used, powerful, reliable, well-supported systems. Access to the 
study's data in REDCap will be restricted to the members of the study team by username and 
password. Additional protection of identifying information will be maintained by restricting 
identifiers only to those who need to see them. Any paper surveys, the 24-hour recall database, and 
the client cart data will have a participant number ID only, but will not itself contain any identifiable 
information for the client 
 
Beyond REDCap survey data, all other electronic data will be stored on Box Secure Storage. These 
data are de-identified and include 24-hour dietary recall data, client cart data, and key informant 
interview transcripts. It also includes all other data that is not human subjects data on the food 
pantries (inventory, FAST data, pantry photos, statewide client survey data).  
 
Data that is collected on paper will be stored in a locked carrying case while onsite at the food pantry. 
The paper copies will be brought back to the office entered into REDcap and stored in locked cabinets 
of the Project Manager's locked office. 
 
Privacy/Confidentiality Part 1:  [Explain how the privacy interests of participants will be maintained 
during the study (note that privacy pertains to the individual not to the data).  Describe how data will 
be coded.  Do not use the any potentially identifiable information such as initials of participants as part of 
the code.  Explain how long data will be kept in an identifiable format and how long de-identified data 
will be retained.  Explain how long the master key or audio or video recordings obtained, will be kept.  
Consider whether keeping de-identified data will be retained indefinitely and whether participants may be 
contacted for a follow-up study (explain procedures to retain identifiable contact data is kept.] 
 
Provisions to Protect the Privacy Interests of Participants:  
In this minimal risk study, study activities will take place in a private space at the food pantry. No 
data on participation or individual client responses will be disclosed to the food pantry, and the food 
pantry will not be involved in any way in attempts to follow up with participants.  Any data reported 
to the food pantry will be reported in aggregate.  
 

Page 19 of 25 
 
Unique Study IDs are assigned to participants with numerical codes based on the food pantry they 
were recruited from. The codes do not contain any information about the individual themselves such 
as initials.  Those Study IDs are used in place of identifiers outside of a single form in REDCap. 
Participant identifiers are not saved to any devices. The link between identifiers and codes will be 
maintained for 5 years, at which point identifiable data will be deleted. De-identified data will be 
maintained indefinitely for future data analysis.  
 
For Sample B, we do not collect any identifiers because we do not need to follow up with these 
participants. It is necessary to maintain identifiers for Sample A because we will be collecting data at 
two time points.  We will need the phone numbers of participants to call to administer post data 
collection (two 24 hour recalls, and a survey) and to send text messages as reminders. We need their 
email addresses to send reminders and to maintain updated telephone numbers. Postal address are 
needed to send the post survey as option for participants to complete it on a hard copy if requested (vs 
online). Participant contact information will not be used for any other purposes. 
 
Although photographs are taken in the food shelf, the photos are only of the food clients select, never 
the clients themselves.  
 
If identifiable, sensitive information (illegal drug use, criminal activity, etc.) will be collected, state 
whether a Certificate of Confidentiality will be obtained.   
 
N/A 
 
Be sure to state whether any limits to confidentiality exist (e.g. mandated reporting) and identify any 
external agencies (study sponsor, FDA, etc.) that will have access to the data.   
 
NA 
 
If participants will be screened, describe the plans for storage or destruction of identifiable data for those 
that failed the screening.] 
 
NA 
 
Privacy/Confidentiality Part 2:  Complete the Data Security Assessment Form:  [This form 
IS REQUIRED for ALL studies.  The form is available here - 
https://ovpr.uconn.edu/services/rics/irb/irb-forms-infoed/.  This form will be used to assess 
procedures for protecting confidentiality of data collected during the study and stored after 
closure.  It will also be used to assess plans for storage and security of electronic data in 
accordance with University Best Practices.  Review the document proving tips to complete the 
form located at 
http://content.research.uconn.edu/pdf/storrs/rcs/irb/TipsDataSecurityAssessmentForm.docx.   
 
 
Informed Consent 
 
As PI, you are responsible for taking reasonable steps to assure that the participants in this study 
are fully informed about and understand the study.   Even if you are not targeting participants 
from “Special Populations” as listed on page 4, such populations may be included in recruitment 
efforts.  Please keep this in mind as you design the Consent Process and provide the information 
requested in this section. 
 

Page 20 of 25 
 
Consent/permission Setting:  [Describe the consent/permission process including who will obtain it, 
where and when will it be obtained, and how much time participants will have to make a decision.  
Describe how the privacy of the participants will be maintained throughout the consent process.   
 
 
State whether an assessment of consent/permission materials will be conducted to assure that 
participants understand the information (may be warranted in studies with complicated study 
procedures, those that require extensive time commitments or those that expose participants to 
greater than minimal risk).] 
 
Consent Process:   
No additional participants will be consented. The consent version to be used (attached) is 
formatted according to the University of Minnesota standards for obtaining consent. 
Trained research staff conducted the consent and recruitment process. Data collectors were 
hired and all had a minimum of one year of experience in obtaining informed consent in 
research studies. Data collectors obtaining informed consent were added to the IRB 
application. They have completed all relevant trainings.  
Recruitment took place at the food pantry during clients’ visits. After they selected their food 
(to avoid influencing choice), all clients were approached by data collectors to gauge interest 
in the study. Participants were eligible if they are ≥18 years old and were mentally capable of 
consent and participation, have access to a phone (Sample A only), and speak English, 
Spanish or Somali. 
Subjects were told that they are being invited to participate in a research study to evaluate the 
impact of food pantry changes on the food that is selected and consumed by clients. They 
were told all of what will be asked of them to do, including allowing us to record their 
selections from the food pantry for that day and taking a survey. They were told that for their 
participation they will receive an incentive of $15. Potential participants will be notified that 
participation is completely voluntary and confidential.  
If they were interested after hearing about the study activates, research staff will have a 
consent conversation with the participant in a private section of the food pantry. This area 
might be a spare room, office, or an area separate from where clients are selecting their food. 
Study staff will walk through the consent document, including discussing the background 
information of the study, study tasks that participants will be asked to complete, risks and 
benefits of the study, compensation for completing study tasks, confidentiality, the voluntary 
nature of the study, and study staff as well as IRB contact information. Subjects will consent 
for themselves. 
Questions such as the following were be asked to assess the subject’s understanding of 
participation in the study. 
• What questions do you have regarding what we are asking you to do? 
• What concerns about this process do you have? 
We obtained documented written consent. Participants could take as much time at the food 
pantry to decide whether to consent to participate, but because the measures are based on 
food selected that day, they could not decide to participate at another time. 
 
 
Capacity to Consent:  [Describe how the capacity to consent will be assessed for participants with 
limited decision-making capacity, language barriers or hearing difficulty. If a participant is incapable of 

Page 21 of 25 
 
providing consent, you will need to obtain consent from the participant’s legal guardian (please see the 
IRB website for additional information).] 
 
Non-English Speaking Participants:  
A protocol specific to non-English speakers will be followed. A bilingual Spanish-speaking or 
Somali-speaking data collector  will be present at food pantries where they are most likely to be 
needed. They are responsible for recruiting, obtaining informed consent, administering assessments 
with clients, and follow up over the phone.  
Participants Who Are Not Yet Adults (infants, children, teenagers under 18 years of age): N/A 
Cognitively Impaired Adults, or adults with fluctuating or diminished capacity to consent: N/A 
Adults Unable to Consent: N/A 
 
Parent/Guardian Permission and Assent:  [If enrolling children, state how many parents/guardians will 
provide permission, when the child’s assent will be obtained and if assent will be written or oral.  Provide 
a copy of the script to be used if oral assent will be obtained.  For longitudinal studies, assent may happen 
at several points during the study.  ] 
 
N/A 
 
Documentation of Consent:  [Specify the forms that will be used for each participant population, i.e., 
adult consent form, surrogate consent form, parental permission sheet. child assent form (written form or 
oral script) or an information sheet. Copies of all forms should be attached to this application in the same 
format that they will be given to participants (templates and instructions are available on the IRB 
website).] 
 
We obtained documented written consent. A copy of the consent for Sample B is included in 
this protocol. 
 
Waiver or Alteration of Consent:  [The IRB may waive or alter the elements of consent in some 
minimal risks studies. If you plan to request either a waiver of consent (i.e., participants will not be asked 
to give consent), an alteration of consent ( e.g., deception) or a waiver of signed consent (i.e., 
participants will give consent after reading an information sheet),  please answer the following questions 
using specific information from the study:] 
 
N/A 
 
Waiver (i.e. participants will not be asked to give consent) or alteration of consent (e.g. use of 
deception/incomplete disclosure in research): 
 
• 
Why is the study considered to be minimal risk?  N/A 
 
 
 
• 
How will the waiver affect the participants’ rights and welfare?  The IRB must find that 
participants’ rights are not adversely affected.  For example, participants may choose not to 
answer any questions they do not want to answer and they may stop their participation in the 
research at any time. 
 

Page 22 of 25 
 
N/A 
 
• 
Explain why the research could not be practicably carried out without the waiver.  For studies 
that involve deception, explain how the research could not be done if participants know the 
full purpose of the study. 
 
N/A 
 
• 
Explain why the research could not be practicably carried out without using identifiable 
private information and/or identifiable biospecimens.  
 
N/A 
 
• 
How will important information be returned to the participants, if appropriate?  For studies 
that involve deception, indicate that participants will be debriefed and that the researchers 
will be available in case participants have questions. 
 
N/A 
 
• 
Indicate if the waiver/alteration as noted above is applicable to the entire study or to a portion 
of the study.  
 
N/A 
 
Waiver of signed consent (i.e. , no signature, participants give consent only after reading an 
information sheet).  Tip:  if the investigator will obtain information through oral or written 
communication with the prospective participant or if the investigator will obtain private identifiable 
information or identifiable biospecimens by accessing records, then a waiver of signed consent is 
NOT required.,: 
 
N/A 
 
• 
Why is the study considered to be minimal risk?  
 
N/A 
 
 
• 
Does a breach of confidentiality constitute the principal risk to participants?  Relate this to the 
.risks associated with a breach of confidentiality and indicate how risks will be minimized 
because of the waiver of signed consent. 
 
N/A 
 
• 
Would the signed consent form be the only record linking the participant to the research?  
Relate this to the procedures to protect privacy/confidentiality. 
 
N/A 
 

Page 23 of 25 
 
• 
Does the research include any activities that would require signed consent in a non-research 
setting?  For example, in non-research settings, normally there is no requirement for written 
consent for completion of questionnaires.   
 
N/A 
 
• 
Describe if the participants or their legally authorized representatives are members of a 
distinct cultural group or community in which signing forms is not the norm, the research 
presents no more than minimal risk of harm to subjects and there is an appropriate alternative 
mechanism for documenting that informed consent was obtained.  Not applicable to FDA 
Regulated Studies. 
 
N/A 
 
References / Literature Review:    
 
 
 
 
References 
1.  Coleman-Jensen A, Rabbitt M, Singh A. Household Food Security in the United States in 2014. 
Unites States Department of Agriculture; 2015 Sep. Report No.: 194.  
2.  Chilton M, Black MM, Berkowitz C, Casey PH, Cook J, Cutts D, et al. Food insecurity and risk of 
poor health among US-born children of immigrants. Am J Public Health. 2009 Mar;99(3):556–62.  
3.  Drewnowski A, Eichelsdoerfer P. Can Low-Income Americans Afford a Healthy Diet? Nutr Today. 
2010 Nov;44(6):246–9.  
4.  Shin J-I, Bautista LE, Walsh MC, Malecki KC, Nieto FJ. Food insecurity and dyslipidemia in a 
representative population-based sample in the US. Prev Med. 2015 Aug;77:186–90.  
5.  Tayie FA, Zizza CA. Food insecurity and dyslipidemia among adults in the United States. Prev Med. 
2009 May;48(5):480–5.  
6.  Irving SM, Njai RS, Siegel PZ. Food insecurity and self-reported hypertension among Hispanic, 
black, and white adults in 12 states, Behavioral Risk Factor Surveillance System, 2009. Prev Chronic 
Dis. 2014;11:E161.  
7.  Ford ES. Food security and cardiovascular disease risk among adults in the United States: findings 
from the National Health and Nutrition Examination Survey, 2003-2008. Prev Chronic Dis. 
2013;10:E202.  
8.  Rush TJ, Ng V, Irwin JD, Stitt LW, He M. Food insecurity and dietary intake of immigrant food bank 
users. Can J Diet Pract Res. 2007;68(2):73–8.  
9.  Duffy P, Zizza C, Jacoby J, Tayie FA. Diet quality is low among female food pantry clients in 
Eastern Alabama. J Nutr Educ Behav. 2009 Dec;41(6):414–9.  
10.  Starkey LJ, Kuhnlein HV, Gray-Donald K. Food bank users: sociodemographic and nutritional 
characteristics. CMAJ. 1998 May 5;158(9):1143–9.  

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11.  Robaina KA, Martin KS. Food insecurity, poor diet quality, and obesity among food pantry 
participants in Hartford, CT. J Nutr Educ Behav. 2013 Mar;45(2):159–64.  
12.  Weinfeld N, Mills G, Borger C, Gearing M, Macaluso T, Montaquila J, et al. Hunger in America 
2014 [Internet]. Chicago, IL: Feeding America; 2014 [cited 2015 Nov 6]. Available from: 
http://help.feedingamerica.org/HungerInAmerica/hunger-in-america-2014-full-report.pdf 
13.  Verpy H, Smith C, Reicks M. Attitudes and behaviors of food donors and perceived needs and wants 
of food shelf clients. J Nutr Educ Behav. 2003 Feb;35(1):6–15.  
14.  Shimada T, Ross M, Campbell EC, Webb KL. A model to drive research-based policy change: 
Improving the nutritional quality of emergency food. Journal of Hunger & Environmental Nutrition. 
2013;8(3):281–93.  
15.  Ross CE, Hill TD. Reconceptualizing the Association between Food Insufficiency and Body Weight: 
Distinguishing Hunger from Economic Hardship. Sociological Perspectives. 2013 Dec;56(4):547–67.  
16.  Campbell EC, Ross M, Webb KL. Improving the nutritional quality of emergency food: A study of 
food bank organizational culture, capacity, and practices. Journal of Hunger & Environmental 
Nutrition. 2013;8(3):261–80.  
17.  Rochester JS, Nanney MS, Story M. Assessing foodshelves’ ability to distribute healthy foods to 
foodshelf clients. Journal of Hunger &amp; Environmental Nutrition. 2011;6(1):10–26.  
18.  Wilson NLW. When the Cupboards Are Bare: Nudging Food Pantry Clients to Healthier Foods. 
Jounral of the Association for Consumer Research. 2016 Jan;1(1).  
19.  Wilson NLW, Just DR, Swigert J, Wansink B. Food pantry selection solutions: a randomized 
controlled trial in client-choice food pantries to nudge clients to targeted foods. J Public Health (Oxf). 
2016 May 12;  
20.  Caspi CE, Canterbury M, Carlson S, Bain J, Bohen L, Grannon K, et al. A behavioural economics 
approach to improving healthy food selection among food pantry clients. Public Health Nutr. 2019 
Aug;22(12):2303–13.  
21.  Caspi C, Friebur R, Davey C, Nanney MS. Results of a pilot intervention to improve dietary 
outcomes among adults experiencing food insecurity. Journal of Hunger & Environmental Nutrition. 
2016 Apr;  
22.  Feskanich D, Sielaff BH, Chong K, Buzzard IM. Computerized collection and analysis of dietary 
intake information. Comput Methods Programs Biomed. 1989 Sep;30(1):47–57.  
23.  Johnson RK, Driscoll P, Goran MI. Comparison of multiple-pass 24-hour recall estimates of energy 
intake with total energy expenditure determined by the doubly labeled water method in young 
children. J Am Diet Assoc. 1996 Nov;96(11):1140–4.  
24.  Guenther PM, Reedy J, Krebs-Smith SM, Reeve BB. Evaluation of the Healthy Eating Index-2005. 
Journal of the American Dietetic Association. 2008;108(11):1854–64.  
25.  Guenther PM, Reedy J, Krebs-Smith SM. Development of the Healthy Eating Index-2005. Journal of 
the American Dietetic Association. 2008;108(11):1896–901.  

Page 25 of 25 
 
26.  Jahns L, Scheett AJ, Johnson LAK, Krebs-Smith SM, Payne CR, Whigham LD, et al. Diet Quality of 
Items Advertised in Supermarket Sales Circulars Compared to Diets of the US Population, as 
Assessed by the Healthy Eating Index-2010. Journal of the Academy of Nutrition and Dietetics. 
2016;116(1):115-122.e1.  
27.  Hager ER, Quigg AM, Black MM, Coleman SM, Heeren T, Rose-Jacobs R, et al. Development and 
validity of a 2-item screen to identify families at risk for food insecurity. Pediatrics. 2010 
Jul;126(1):e26-32.  
28.  Schnittker J, Bacak V. The Increasing Predictive Validity of Self-Rated Health. PLoS One [Internet]. 
2014 Jan 22 [cited 2020 May 21];9(1). Available from: 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3899056/ 
29.  Idler EL, Benyamini Y. Self-rated health and mortality: a review of twenty-seven community studies. 
J Health Soc Behav. 1997 Mar;38(1):21–37.  
30.  Bombak AE. Self-Rated Health and Public Health: A Critical Perspective. Front Public Health 
[Internet]. 2013 May 20 [cited 2020 May 21];1. Available from: 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3855002/ 
31.  Lloyd-Jones DM, Hong Y, Labarthe D, Mozaffarian D, Appel LJ, Horn LV, et al. Defining and 
setting national goals for cardiovascular health promotion and disease reduction: The American Heart 
Association’s strategic impact goal through 2020 and beyond. Circulation. 2010 Feb 2;121(4):586–
613.  
32.  Fretts AM, Howard BV, McKnight B, Duncan GE, Beresford SAA, Mete M, et al. Life’s Simple 7 
and incidence of diabetes among American Indians: the Strong Heart Family Study. Diabetes Care. 
2014 Aug;37(8):2240–5.  
33.  Kulshreshtha A, Vaccarino V, Goyal A, McClellan W, Nahab F, Howard VJ, et al. Family history of 
stroke and cardiovascular health in a national cohort. J Stroke Cerebrovasc Dis. 2015 Feb;24(2):447–
54.