Evaluating Diet, Food Insecurity, and Food Purchasing Outcomes of a Full-Service Mobile Food Market With a Cluster Randomized Trial
Phase: NA
Conditions: Healthy Diet, Nutrition, Healthy
Sponsor: University of Minnesota

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 1 of 64 
Template Revised On: 11/01/2021      
 
ANCILLARY REVIEWS 
DO NOT DELETE.  Submit the completed checklist below with your protocol. 
Which ancillary reviews do I need and when do I need them? 
Refer to HRP-309 for more information about these ancillary reviews. 
Select yes or 
no 
Does your study… 
If yes… 
Impact on 
IRB Review 
☐ Yes 
x No 
 
Include Gillette resources, staff 
or locations 
Gillette Scientific review and Gillette 
Research Administration approval is 
required.  Contact: 
research@gillettechildrens.com   
Required 
prior to IRB 
submission 
☐ Yes 
x No 
Involve Epic, or Fairview 
patients, staff, locations, or 
resources? 
The Fairview ancillary review will be 
assigned to your study by IRB staff 
Contact: ancillaryreview@Fairview.org 
Approval 
must be 
received 
prior to IRB 
committee/ 
designated 
review.   
 
Consider 
seeking 
approval 
prior to IRB 
submission. 
☐ Yes 
x No 
Include evaluation of drugs, 
devices, biologics, tobacco, or 
dietary supplements or data 
subject to FDA inspection? 
STOP – Complete the Medical Template 
Protocol (HRP-590) 
 
The regulatory ancillary review will be 
assigned to your study by IRB staff 
Contact: medreg@umn.edu  
See 
https://policy.umn.edu/research/indide  
☐ Yes 
x     No 
Require Scientific Review? Not 
sure? See guidance in the 
Investigator Manual (HRP-
103).      
 
ONLY REQUIRED      BIOMEDICAL 
RESEARCH REVIEWED BY FULL 
COMMITTEE 
  
☐ Yes 
x No 
Relate to cancer patients, 
cancer treatments, cancer 
screening/prevention, or 
tobacco? 
Complete the CPRC application process.  
Contact: ccprc@umn.edu  
☐ Yes 
x No 
Include the use of radiation? 
(x-ray imaging, 
radiopharmaceuticals, external 
beam or brachytherapy) 
 
Complete the AURPC Human Use 
Application and follow instructions on 
Approval 
from these 
committees 
must be 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 2 of 64 
Template Revised On: 11/01/2021      
the form for submission to the AURPC 
committee. 
Contact: barmstro@umn.edu  
received 
prior to IRB 
approval;  
 
These 
groups 
each have 
their own 
application 
process.  
☐ Yes 
x No 
Use the Center for Magnetic 
Resonance Research (CMRR) 
as a study location? 
Complete the CMRR pre-IRB ancillary 
review  
Contact: ande2445@umn.edu  
☐ Yes 
x No 
Include the use of 
recombinant or synthetic 
nucleic acids, toxins, or 
infectious agents? 
STOP – Complete the Medical Template 
Protocol (HRP-590) 
☐ Yes 
x No 
Include the use of human fetal 
tissue, human embryos, or 
embryonic stem cells? 
STOP – Complete the Medical Template 
Protocol (HRP-590) 
☐ Yes 
x No 
 
Include PHI or are you 
requesting a HIPAA waiver? 
If yes, HIPCO will conduct a review of this 
protocol. 
Contact: privacy@umn.edu  
☐ Yes 
x No 
Use data from the Information 
Exchange (IE)? 
The Information Exchange ancillary 
review will be assigned to your study by 
IRB staff 
Contact: ics@umn.edu  
Approval 
must be 
received 
prior to IRB 
approval. 
 
These 
groups do 
not have a 
separate 
application 
process but 
additional 
information 
from the 
study team 
may be 
required. 
 
☐ Yes 
x No 
Use the Biorepository and 
Laboratory Services to collect 
tissue for research? 
STOP – Complete the Medical Template 
Protocol (HRP-590)  
 
The BLS ancillary review will be 
assigned to your study by IRB staff. 
Contact: Jenny Pham 
Pham0435@umn.edu 
☐ Yes 
x No 
Have a PI or study team 
member with a conflict of 
interest? 
The CoI ancillary review will be 
assigned to your study by IRB staff 
Contact: becca002@umn.edu  
☐ Yes 
x No 
Need to be registered on 
clinicaltrials.gov? 
If you select “No” in ETHOS, the 
clinicaltrials.gov ancillary review will be 
assigned to your study by IRB staff 
Contact: kmmccorm@umn.edu  

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 3 of 64 
Template Revised On: 11/01/2021      
☐ Yes 
x No 
Require registration in 
OnCore? 
If you select “No” or “I Don’t Know” in 
ETHOS, the OnCore ancillary review will 
be assigned to your study by IRB staff 
Contact: oncore@umn.edu  
Does not 
affect IRB 
approval. 
 
 
 
 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 4 of 64 
Template Revised On: 11/01/2021      
 
PROTOCOL COVER PAGE 
Protocol Title 
Evaluating Diet, Food Insecurity, and Food Purchasing Outcomes of a 
Full-Service Mobile Food Market with a Cluster Randomized Trial 
Principal 
Investigator/Faculty 
Advisor 
Name: Melissa Horning 
Department: School of Nursing 
Telephone Number: 612-624-1947 (office) 
320-290-9043 (cell) 
Email Address: horn0199@umn.edu 
Student Investigator 
Name: 
Current Academic Status (Student, Fellow, Resident): 
  
Department: 
Telephone Number: 
Institutional Email Address: 
Scientific Assessment 
I believe Scientific Assessment is not required. 
Version 
Number/Date: 
Version: 7 
Date of this protocol: 1/10/2023 
 
 
 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 5 of 64 
Template Revised On: 11/01/2021      
REVISION HISTORY 
 
Revision # 
Version Date 
Summary of Changes 
Consent Change? 
1 
2/2/2022 
In response to request for 
modifications, we have: 
1) Revised to add the number of 
total contacts before 
someone is deemed lost to 
follow-up. 
2) Added language to the 
consent form to specify for 
the additional interview (for 
the selected subsample) that 
their interviews will be audio 
recorded with a digital voice 
recorder and occur in person 
or by phone. 
3) Selected the boxes indicating 
which type of storage will be 
used in section 18.7. 
4) Formally added the IIA for 
Stephanie Wagner to the 
appropriate location on 
ETHOS (vs. just in the 
comment we submitted last 
week). 
Yes. 
2 
6/29/2022 
We have revised the following 
elements of the study: 
1) We are shifting from two 
waves of six sites (12 total) for 
data collection/intervention 
to 3 waves of four sites each 
(12 total) for data 
collection/intervention as it 
works with the study timeline 
and is more feasible. 
2) We revised the figure in 
section 5 to reflect the 3 
waves. 
3) We have revised one instance 
of inconsistency among 
proposed sample size (from 
20 to 22) which aligns with 
our total proposed sample 
 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 6 of 64 
Template Revised On: 11/01/2021      
(n=264) and power 
discussions. 
4) We have revised site inclusion 
criteria. Specifically, some 
research criteria were 
removed specifically, as these 
are criteria for receiving the 
mobile market in general (not 
specific to the research). We 
have also delineated this 
differentiation between 
mobile market criteria vs. 
research criteria on the 
attached site screening script. 
5) We have added a site 
screening script and site 
recruitment flyer.   
3 
7/25/2022 
1) We have added language 
about community meetings 
that will be conducted by the 
Mobile Market in partnership 
with the research 
staff/investigators present 
that will inform us better 
about our proposed 
processes. These meetings 
are aligned with community 
engaged research principles 
and will occur with current 
Mobile Market customers 
who are like our proposed 
participants but will not be 
research participants.  
 
4 
9/23/2022 
1. The Food Purchasing 
outcomes and data collection 
forms have been updated to 
reflect a change in study 
scope after funding. 
2. Indicated that surveys will be 
completed via web-based 
REDCap survey on study iPad 
rather than paper-pen. 
3. Added nutrition security 
scales to food security 
outcomes measures. 
 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 7 of 64 
Template Revised On: 11/01/2021      
4. Streamlined and updated 
survey measures to reflect 
the best state of the science 
while also working to 
minimize participant burden. 
5. Added information and 
protocol about the Mobile 
Market purchasing outcomes 
that will rely on data from the 
Market Members program. 
6. Revised information about 
the Market Members’ 
incentives to indicate that 
they are standard part of 
Mobile Market operations. 
7. Updated process measure 
descriptions and added data 
collection 
protocols/instruments 
8. Updated information about 
study cell phones and security 
procedures. 
 
12/5/2022 
1. “Additional” outcomes from 
the dietary recalls and the 
timeline for recall completion 
is updated and a new dietary 
recall protocol is attached 
that contains a concise 
description of the recalls 
without unnecessary 
operating procedures. 
2. During the consent process, 
during the first data collection 
visit, we will provide a 
Participant Guide that 
succinctly summarizes the 
study activities (this guide is 
attached) 
3. Additional recruitment 
materials have been 
developed and are now 
described and attached. 
 
 
1/10/2023 
1. Updated the process for site 
randomization, which will 
allow the study statistician to 
communicate with the mobile 
Yes. Corrected 
typos, moved one 
text block and 
added link for 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 8 of 64 
Template Revised On: 11/01/2021      
market co-investigator so 
routes can be planned prior 
to the completion of baseline 
data collection. Sites, 
participants, research staff, 
PI, and UMN co-investigators 
will remain blinded to study 
site selection until after 
baseline data collection for 
each wave. 
2. Updated inclusion criteria to 
include ASL speakers, who are 
specifically supported as 
residents at one of our 
community sites. Revised 
recall procedures to 
accommodate using an 
interpreter with these 
participants. 
3. Updated website text to 
include URL. A screenshot is 
also now attached. 
4. Clarified that we may use the 
Twilio feature in REDCap to 
automate text message 
reminders. 
(future) ASL 
interpreted video of 
the document 
 
 
 
 
 
 
 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 9 of 64 
Template Revised On: 11/01/2021      
 
Table of Contents 
1.0 
Objectives ............................................................................................................................................ 8 
2.0 
Background ......................................................................................................................................... 8 
3.0 
Study Endpoints/Events/Outcomes ............................................................................................... 8 
4.0 
Study Intervention(s)/Interaction(s) .............................................................................................. 8 
5.0 
Procedures Involved .......................................................................................................................... 8 
6.0 
Data Banking ...................................................................................................................................... 9 
7.0 
Sharing of Results with Participants .............................................................................................. 9 
8.0 
Study Duration .................................................................................................................................... 9 
9.0 
Study Population ................................................................................................................................ 9 
10.0 
Vulnerable Populations .................................................................................................................. 10 
11.0 
Number of Participants ................................................................................................................... 12 
12.0 
Recruitment Methods ..................................................................................................................... 13 
13.0 
Withdrawal of Participants ........................................................................................................... 14 
14.0 
Risks to Participants ........................................................................................................................ 14 
15.0 
Incomplete Disclosure or Deception ............................................................................................ 14 
16.0 
Potential Benefits to Participants ................................................................................................. 15 
17.0 
Statistical Considerations ............................................................................................................... 15 
18.0 
Health Information and Privacy Compliance ............................................................................. 15 
19.0 
Confidentiality .................................................................................................................................. 19 
20.0 
Provisions to Monitor the Data to Ensure the Safety of Participants ................................... 19 
21.0 
Compensation for Research-Related Injury ................................................................................ 20 
22.0 
Consent Process ................................................................................................................................ 20 
23.0 
Setting ................................................................................................................................................ 24 
24.0 
Multi-Site Research ......................................................................................................................... 25 
25.0 
Coordinating Center Research ....................................................................................................... 26 
26.0 
Resources Available ......................................................................................................................... 26 
27.0 
References ......................................................................................................................................... 27 
 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 10 of 64 
Template Revised On: 11/01/2021      
ABBREVIATIONS/DEFINITIONS 
● NIH: National Institutes of Health 
● SNAP: Supplemental Nutrition Assistance Program 
● SSB: Sugar-Sweetened Beverages  
● CBPR: Community Based Participatory Research 
● USDA: United States Department of Agriculture  
● RE-AIM: reach, effectiveness, adoption, implementation, maintenance 
● HEI-2015: Healthy Eating Index-2015  
● 2015-2020 DGA: 2015-2020 Dietary Guidelines for Americans 
● NDSR: Nutrition Data System for Research 
● WIC: Women, Infants and Children Special Supplemental Nutrition Assistance Program 
● GED: General Educational Development  
● REDCap: Research Electronic Data Capture  
● ASL: American Sign Language 
 
 
 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 11 of 64 
Template Revised On: 11/01/2021      
1.0 
Objectives 
1.1 Purpose:  
The overall objective of the proposed study is to test the impact of an innovative 
full-service mobile market on diet quality, food insecurity, and food purchases and 
explore factors influencing adoption of mobile market shopping using a mixed 
methods approach. 
Aim 1: Evaluate the impact of the full-service mobile market on dietary quality and 
food insecurity. Aim 1a: Diet quality, assessed via dietary recalls, will be measured at 
baseline and follow-up (6-months after market implementation) with the Healthy 
Eating Index-2015, an important predictor of chronic disease outcomes. Hypothesis 
1a: We hypothesize relative to control site participants, intervention site 
participants will have improved diet quality at follow-up. Aim 1b: Food insecurity 
prevalence will be measured at baseline and follow-up with the 18-item U.S. Adult 
Food Security Survey Module. We will also use newly developed and validated 
measures to assess nutrition insecurity in the past 6 months, which helps us 
understand fuller contexts around choices people may make (e.g., compromise 
nutrition for a full stomach).137 Hypothesis 1b: We hypothesize relative to control 
site participants, intervention site participants will have increased food and nutrition 
security at follow-up. 
Aim 2: Evaluate the impact of the full-service mobile market on fruit and vegetable 
purchases. Forms documenting fruit and vegetable purchases will be collected from 
participants for 1 month at baseline and follow-up. Hypothesis 2: We hypothesize 
relative to control site participants, intervention site participants will purchase more 
servings of fruits and vegetables.  
Aim 3: Explore factors that influence intervention participant adoption of mobile 
market shopping using a mixed methods approach. Aim 3a. Validated measures of 
personal, social, behavioral, and environmental factors (e.g., demographic 
characteristics, self-efficacy, social support, mobile market features) will be 
surveyed. Shopping adoption will be objectively measured during market 
implementation and at follow-up. Aim 3b. After follow-up, qualitative interviews will 
be conducted with a subset of high and low adopters. Research question guiding 3a 
& 3b: What factors influenced mobile market shopping adoption? 
2.0 
Background 
2.1 Significance of Research Question/Purpose:  
SIGNIFICANCE  
Diet is a modifiable contributing factor for chronic health conditions that contribute 
to 4 of the 10 leading causes of death in the US,1–3 underscoring the importance of 
the NIH’s new strategic plan for nutrition research in 2020-2030.4 This plan calls for 
research to leverage behavioral science and interventions to target multiple levels of 
the food environment to initiate and sustain healthy eating behaviors.4 We will 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 12 of 64 
Template Revised On: 11/01/2021      
advance the field by testing a sustainable food environment intervention to address 
nutrition-related disparities. 
Individuals with low incomes and those who identify as being from racial/ethnic 
minority groups have disparately higher rates of poor diet quality, obesity, and 
related health conditions.5–10 They also experience poorer food access and higher 
food insecurity,11,12 which contribute to these disparities. Food insecurity (i.e., 
uncertain or insufficient access to enough food for an active, healthy life13,14) alone 
is linked to poorer diet quality,15–17 obesity,18,19 and diet/weight-related health 
conditions (e.g., hypertension, diabetes).18,20–23 Food insecurity specifically adds an 
estimated 77 billion dollars to annual health care costs.24 Further, food insecurity is 
associated with having multiple chronic conditions,25,26 care for which comprises 
66% of total U.S. health care expenditures.27 In recent years, 18% of Americans have 
poor food access28 and 11% experience food insecurity.29,30 Moreover, food 
insecurity and poor food access are exacerbated by lack of or inadequate 
transportation to full-service grocery stores31–33 and the unaffordability of healthy 
diets,34,35 which may lead to more frequent purchase and intake of low-cost, energy-
dense, low-nutrient foods.36–38 Thus, it is critical to address affordable, healthy food 
access in high-need, under-resourced areas to reduce disparities and achieve equity 
in diet quality, food security, and in turn, obesity and diet/weight-related health 
conditions.  
There are significant limitations to current food purchasing interventions, and 
mobile markets provide a promising means of enhancing this work. To date, 
evaluations of the effectiveness of local food retail access interventions, such as 
introducing supermarkets in food deserts, have produced equivocal results.39–47 
Online food shopping is a newly available potential strategy for increasing food 
access for Supplemental Nutrition Assistance Program (SNAP) participants; however, 
initial research indicates low use of the online shopping option provided to SNAP 
participants as part of a randomized trial evaluating acceptance of SNAP/EBT online 
food shopping.48 Online food shopping can also have cost-prohibitive fees not 
covered by SNAP benefits.49 Mobile markets can address food insecurity and poor 
healthy food access in a way other food retail interventions cannot – mobile markets 
bring low-cost, high quality, healthy foods directly to the doorsteps of areas in 
greatest need, like high-rise low-income housing units, without competing 
inexpensive, energy-dense, low-nutrient foods, additional fees, or need for internet. 
The scientific premise is that mobile markets alter underserved communities by 
making healthy foods more accessible at affordable prices. By changing the food 
environment, mobile markets may reduce food insecurity, improve dietary intake, 
and increase the healthiness of food purchases, while also targeting personal, social, 
and behavioral factors that influence food selection and mobile market shopping 
adoption. Several small, produce-only mobile market research studies have 
demonstrated increases in fruit and vegetable access, purchase, and/or intake 
among customers.50–54 Two cluster randomized trials have found produce-only 
mobile markets increased fruit and vegetable intake by as much as a half55 to one 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 13 of 64 
Template Revised On: 11/01/2021      
serving per day.56 Such findings are promising, however, sustainability concerns56,57 
limit confidence in produce-only mobile markets. These data warrant testing the 
effectiveness of a full-service mobile market that sells foods from all food groups 
and staple food items as we have proposed. Full-service markets have potential to 
be a convenient “one-stop shop” for under-resourced Americans. 
Full-service mobile markets are viable and sustainable. While some states like 
Minnesota are on the forefront of supporting mobile markets through funding 
legislation,58 most mobile markets nationwide are grant funded and/or supported by 
philanthropic donations. As such, many produce-only mobile markets close due to 
financial non-viability or when external funding ends.56,57 Full-service mobile 
markets also rely on a robust non-profit infrastructure and organizational 
partnerships to source foods at wholesale cost. However, aligned with 
recommendations from research, full-service mobile markets address viability and 
sustainability in two important ways.52,55 First, full-service mobile markets’ 
operational costs are supported by the sales of all food groups, thus, offsetting 
operational expenses more efficiently than through fruit and vegetable sales alone. 
Our formative work showed 50% of full-service mobile market sales were for fruits 
and vegetables and the other 50% were for protein, dairy, grain, and dry good 
purchases.59 Second, selling only produce reduces reach and deters shopping 
because customers must go elsewhere to purchase other essential foods.52,55 
Therefore, the full-service mobile market can increase sales and reach by providing 
one-stop shopping, and thus has greater potential for sustainability.52,55 Our study 
will evaluate the impact of an established and thriving non-profit full-service mobile 
market model on diet quality, food insecurity, and food purchases while also 
studying factors impacting market shopping adoption.  
The full-service mobile market to be evaluated has high potential to improve diet, 
food security, and food purchase patterns. The full-service Twin Cities Mobile 
Market was launched in 2014 in response to community need for affordable healthy 
food access. It operates two city buses retrofitted into grocery stores, with food 
display shelving, refrigeration, freezers, and shopping carts. The market serves 24 
community sites weekly60 and is operated by a 501c3 non-profit organization. 
Operation costs are covered in part by revenue generated from food sales, with a 
subsidy provided by the market’s non-profit infrastructure.  
 
This mobile market reaches a critically high-need population. In 2019, we 
completed customer intercept surveys (N=302) and found 85% experienced food 
insecurity in the past year, as compared to 10-12% of the population locally or 
nationally.61 Data also indicate customers had higher than average rates of 
diet/weight-related conditions: 30% of customers self-reported having a diabetes 
diagnosis compared to 12% of adults nationally,10 and 45% self-reported 
hypertension compared with 34% nationally.9 In a feasibility study with market 
customers and individuals recruited from the ever-growing waitlist of sites 
requesting market service, we measured height, weight, and blood pressure. 
Findings showed 58% customers had elevated blood pressure readings and 41% had 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 14 of 64 
Template Revised On: 11/01/2021      
readings consistent with stages 1 and 2 of hypertension.62 We also found 82% of 
market customers had BMI values classified as overweight or obese as compared to 
72% nationally.63  
 
The Twin Cities Mobile Market was designed to provide a shopping environment 
that promotes affordability, healthy food access, and diet quality. Implementation 
and design features include: (1) Attention to cultural food preferences based on 
input from community forums and customer requests;59,64 90% of customers 
reported in 2019 intercept surveys that the market was meeting their cultural 
needs. (2) Food stocking practices that focus on all food groups (e.g. fruits, 
vegetables, dairy, protein, grains) and limited inclusion of foods for which limited 
consumption is recommended (e.g. salty snacks, chips, desserts, sugar-sweetened 
beverages [SSBs]) aligned with behavioral nudging and choice architecture 
techniques that promote healthy food choices.65,66 (3) Low food pricing, on average 
10% below prices at local supermarkets. (4) Multiple payment options include cash, 
credit, debit, and EBT/SNAP. (5) Incentives for produce purchases through the state-
funded Market Bucks program are provided and match SNAP produce purchases up 
to $10.58 (6) Healthy recipes and food sampling demonstrations. (7) A safe, 
welcoming environment with exceptional customer service and opportunities for 
interacting with other customers/neighbors.64 (8) Recurring weekly market stop 
times set in conjunction with community sites to maximize participation. (9) 
Ongoing engagement with community site partners to address needs and concerns 
in real time. In addition, this shopping environment also reduces need to go 
elsewhere to meet dietary needs, thereby minimizing exposure to unhealthy foods 
that comprise 32% of household food expenditures.67,68 Of note, one theme that 
emerged from four focus groups with customers (N=29) was that the mobile market 
shopping environment helped customers make healthy food purchases by 
eliminating temptation to buy unhealthy foods.64 Increasing healthiness of 
purchases across food groups may impact diet outcomes beyond fruit and vegetable 
intake (as studied by prior mobile market research50–56) but also other key diet 
outcomes including sodium, saturated-fat, SSB intake and overall diet quality.69,70 
Thus, to extend our preliminary focus group and survey findings, we will measure 
diet quality and these important diet outcomes with 24-hour recalls, considered to 
be one of the most rigorous self-report measures of food intake.71  
Theoretical underpinnings. Aligned with the social cognitive theory72 and social 
ecological framework,73 there is a complex interplay between environmental, 
personal, social, and behavioral factors72,73  that influence food choices, food 
purchases, food insecurity, and diet quality.74–79 As depicted in Figure 1 (next page), 
the full-service mobile market addresses these factors in various ways to support 
positive outcomes. Specifically, a full-service mobile market alters the community 
food environment to reduce factors linked to unhealthy food intake, including: low 
food access; 11,12,28,74,75,80–82 lack of transportation;31–33 wide accessibility of low-cost, 
energy-dense, low-nutrient foods;36–38,83 high cost of healthy foods;34,35,83 and poor 
quality of healthy foods.84,85 Full-service markets designed with behavioral nudging 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 15 of 64 
Template Revised On: 11/01/2021      
and choice architecture promote healthy choices (e.g., by placing fruits/vegetables 
at eye level at market entry and having minimal presence of foods for which minimal 
consumption is recommended).65,66 Moreover, the market also addresses personal, 
social, and behavioral factors that may influence market adoption and food 
purchasing by targeting perceived food access and affordability,64,74,80,84,85 self-
efficacy for and knowledge of purchasing, cooking, and eating healthy foods,64,74,75 
and food preferences.75,76,86 The market also provides a supportive community64,75,77 
and safe shopping environment.64,85 Thus, the market has strong potential to 
improve diet quality, food security, and food purchases, while addressing personal, 
social, behavioral, and environmental factors that may influence market shopping 
adoption. These potential impacts warrant rigorous research evaluation of the full-
service mobile market. 
 
2.2 Preliminary Data:  
Preliminary studies led by the Principal Investigator provide evidence of feasibility, 
premise, and justification for the proposed study and aims.  
Figure 1. Theoretical model guided by the social ecological framework and social cognitive theory 
 
Note: Social cognitive theory and social ecological framework posit complex interplay between environment, personal, social 
and behavioral factors to influence outcomes. Full-Service Mobile Markets address these factors in many ways as depicted 
above.  

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 16 of 64 
Template Revised On: 11/01/2021      
Mixed-Method Mobile Market Feasibility Research [IRB study number: STUDY00000812]. 
A mixed-method feasibility CBPR study involved 4 focus groups (n=29) of full-service 
mobile market customers and a cross-sectional study (n=45). Focus groups were used to 
inductively assess mobile market impact as perceived by customers and to inform future 
research. Themes from focus group findings indicated customers reporting improved 
affordability, purchase patterns, and dietary intake. For example, this theme is 
exemplified with the quote: “I find that it’s better to go shopping on the bus . . . I find it 
better than going to the grocery store ’cause I don’t buy no junk. I stick with the food that 
I’m going in there for. Or I am buying more vegetables or I am buying more fruit. So that is 
one thing that the bus does help me with. Stick to the right diet.” 64 Focus group findings 
on research acceptability were incorporated into the subsequent cross-sectional study. 
The cross-sectional study assessed feasibility of measuring key outcomes (Table 1) in 
market customers and in non-customers recruited from market waitlist sites. All 
participants completed psychosocial measures and were trained to collect, annotate, and 
mail their food purchase receipts using an established protocol of the time;87–89 87% 
returned their receipts in the 2-week collection period. Rates of participation in receipt 
collection improved during the study (80% for the first 30 participants and 100% for the 
last 15) due to adaptations in the protocol. Purchasing outcomes of this feasibility study 
included median proportion of total purchases that were fruits/vegetables and SSBs. 
While cross-sectional outcomes trended in the right direction (Table 1), we realized that 
comparison of the proportion of spending by food category does not address the different 
quantity that can be purchased at the market because of the 10% market price discount. 
Thus, for the proposed study, we will use objective, annotated receipt collection that we 
found feasible to implement, but we will enhance our purchasing outcome to robustly 
measure purchase quantity by assessing total (edible) servings purchased of fruits, 
vegetables, and SSBs to eliminate the market price discount as a potential confounder. 
We also demonstrated capacity to 
measure fruit and vegetable intake, food 
insecurity, and personal, social, 
behavioral, and environmental factors; 
we observed trends in expected 
directions for most outcomes (Table 1). 
This preliminary study provided us with 
ample feasibility and acceptability data 
to inform the proposed trial. 
 
 
Customer Intercept Surveys [IRB study 
number STUDY00004137]. In an ongoing, 
repeated cross-sectional study, we are 
using brief customer intercept surveys to 
assess whether increased mobile market 
frequency (from biweekly to weekly) 
alters food access, food security, and 
diet intake at existing market stops. In 
Table 1. Feasibility of measuring key outcomes 
Aim/Outcome  
Mixed-Method Feasibility CBPR (N=45) 
Customers 
Non-Customers 
p 
Aim 1a.  Diet 
quality  
Mean FV servings (SD)a 
4.3 (3.7) 
2.9 (2.6) 
0.20 
Aim 1b.  Food 
Insecurity 
Food insecurity prevalenceb 
78%  
67%  
0.41 
Aim 2. Food 
purchases from 
all food sourcesc 
Median % of food purchases on FVd  
11% 
3% 
0.04 
Median % of food purchases on SSBd 
2% 
3% 
0.44 
Aim 3. Example 
measurement of 
personal, social, 
behavioral, 
environmental 
factors 
Mean self-efficacy for healthy cookingf 
10.9 (3.7) 
12.2 (3.8) 
0.27 
Mean social connectedness (SD) f 
25.9 (8.4) 
25.0 (9.1) 
0.74 
Mean health related quality of life f 
2.5(0.9) 
2.9 (0.9) 
0.14 
Notes. FV=Fruit/vegetable. SSB=Sugar sweetened beverage. 
aMeasured with a validated FV screener (excluding juice & 
fries).133,134  aAssessed with a validated two-item measure.135  
cParticipants were trained to collect, annotate, and mail all 
food purchase receipts for 2 weeks with a standardized 
protocol.87–89  dVariable was skewed; median non-parametric 
test assessed for differences.  fHigher scores indicate higher 
traits measured with validated measures.102,104,109,136 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 17 of 64 
Template Revised On: 11/01/2021      
June-July 2019, we surpassed our recruitment goal of 200 by recruiting 302 participants. 
Adjusted general linear and logistic regression models were used to evaluate associations 
between how long customers had been shopping at the mobile market and fruit and 
vegetable intake and odds of food insecurity 
(Table 2). We found longer market use was 
associated with higher fruit and vegetable 
intake and lower odds of being food insecure, 
supporting the scientific premise of the 
proposed study. We also found 85% of 
customers identified as food insecure and 
90% felt their cultural food preferences were 
met at the market. Results further support 
proposed trial feasibility. 
 
Point-of-Sales [IRB study number STUDY00000051]. We analyzed mobile market point-of-
sales data by food group for 2016.59 This data showed half of full-service mobile market 
sales were for fruits and vegetables, with all food groups contributing to the other half.59 
This work demonstrates our capacity to collect and analyze key implementation and 
process data that measure reach, adoption, and maintenance of mobile market shopping.  
 
Summary of Preliminary Studies and Relevance to Aims.  Aim 1. We have demonstrated 
feasibility of measuring diet intake (Aim 1a) and trends indicate better fruit and vegetable 
intake in customers (compared to non-customers) and in long-term market shoppers. We 
will increase the rigor of diet assessment in this trial by using interviewer administered 
diet recalls successfully used by Co-Investigator Harnack in the same communities.90 Diet 
recalls allow for assessment of overall diet quality using the validated Health Eating Index-
2015 (HEI-2015)69,70 in addition to other diet outcomes. With our preliminary work, we 
also demonstrated feasibility of measuring food insecurity (Aim 1b) and found lower odds 
of being food insecure with longer market use. We will expand these data with our 
proposed trial by using the United States Department of Agriculture (USDA) gold standard 
food insecurity measure that will allow us to delineate 4 levels of food security (e.g., very 
low, low, etc).91 Aim 2. We have demonstrated our ability to collect purchase receipt data, 
which has also been successfully done in research led by Dr. Harnack.92,93 Aim 3. We have 
demonstrated our ability to measure personal, behavioral, social and environmental 
factors that may influence mobile market adoption and our ability to collect and analyze 
qualitative data. Process data. We have demonstrated our capacity to collect and analyze 
transaction and sales data that are important process evaluation measures of market 
reach, adoption, and maintenance.59 
 
2.3 Existing Literature: 
Please see sections 2.1 and 2.2 above.  
 
Table 2. Year 1 Customer Survey (N=302) Outcomes 
Aim/Outcome 
Length of mobile market shopping 
Aim 1a. FV intakea 
β=0.26, SE:0.10, p=0.01 
Aim 1b. Odds of food 
insecurity in last yearb 
OR=0.77; 95% CI=0.60-0.997 
Notes. Models were adjusted for sociodemographic 
characteristics. FV=Fruit / vegetable. aAssessed with two 
questions found to rank individuals based on overall FV 
intake in population-based surveys.137 bAssessed with a 
two-item validated measure.135 Manuscript in press at 
Appetite. 
 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 18 of 64 
Template Revised On: 11/01/2021      
3.0 
Study Endpoints/Events/Outcomes 
3.1 Primary Endpoint/Event/Outcome:  
Diet quality. Trained research staff certified in collecting dietary recalls using 
Nutrition Data System for Research software will collect three 24-hour dietary recall 
interviews (2 weekdays, 1 weekend day) from each participant at each 
measurement period (baseline and follow up). Dietary recall data will be used to 
calculate the Health Eating Index-2015 Score. HEI-2015 is a scoring system designed 
to measure adherence to the 2015-2020 Dietary Guidelines for Americans (2015-
2020 DGA). 69,70 
3.2 Secondary Endpoint(s)/Event(s)/Outcome(s):  
Food insecurity. Food insecurity in the past 6 months will be measured with the 
gold-standard, 18-item food security screening module of the USDA, which will allow 
for assessment of both binary food insecurity (yes, food insecure; no, food secure) 
and level of food security (very low, low, marginal, and high food security).91 We will 
also use newly developed and validated nutrition insecurity measures to assess 
nutrition insecurity in the past 6 months, which helps us understand fuller contexts 
around choices people may make when money is tight (e.g., compromise nutrition 
for a full stomach).137 
Fruit & Vegetable purchasing outcomes: Participants will record their fruit and 
vegetable purchases using forms in a provided booklet, and mail their booklets to 
the researchers in prepaid addressed envelopes, which will be used to measure:  
• Average weekly servings of fruits and vegetables purchased 
• Total number of trips 
• Store types visited 
Mobile Market shopping patterns: Participants randomized to the intervention sites 
will participate in a “Market Members” program, which tracks their purchases at the 
Mobile Market (i.e. number of transactions, items purchased, dollars spent).  
Personal, social, behavioral, and environmental factors that may influence mobile 
market adoption. These factors include:  
• Neighborhood Healthy Food Availability (4 item scale; α=0.89);99  
• Social Connectedness (8 item scale, α=0.92);102  
• Health-related quality of life (4-items);103–107  
• Self-efficacy of Healthy Cooking (4 item scale, α=0.85).109  
• Self-efficacy for eating and cooking fruits and vegetables (4 item scale, 
α=0.90).108  
• Everyday Discrimination Scale (6 item scale α=0.77 + 2 follow-up 
items)139-140 
Mobile market features that could influence market shopping adoption will be 
measured at follow-up for participants who were located at intervention site 
locations. These factors include: 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 19 of 64 
Template Revised On: 11/01/2021      
• Perceived convenience of market service  
• Whether the market meets participant cultural food needs  
• Perceived affordability of market food prices 
• Would you recommend the market to a friend (yes/no)? 
• Satisfaction of the market’s: (a) location and timing; (b) selection of 
food items available; (c) prices; (d) customer service; and (e) overall 
shopping experience (not at all satisfied to very satisfied) will also be 
measured.  
Qualitative interview questions. Qualitative interviews will be conducted with a 
subsample of intervention participants (high and low adopters). Interviews will be 
audio recorded and occur in person or by phone. Main interview questions will 
inductively explore factors that influenced market shopping and shopping 
adoption.  
4.0 
Study Intervention(s)/Interaction(s) 
4.1 Description:  
Intervention and waitlist control. Following baseline participant data collection, sites will 
be randomized to receive the full-service mobile market intervention or serve as the wait 
list control.  
 
The Full-Service Mobile Market start-up involves two key components. 
(1) Initial community engagement: Prior to randomization, community sites will begin 
engagement activities aligned with CBPR best-practices.115–117 These activities include 
regular meetings with site location staff to develop logistical plans for research activities 
and market intervention. Following randomization, site group assignment will be revealed 
for participants and the UMN research team after baseline data collection for the wave is 
complete, continued site engagement will occur to finalize logistics, including selection of 
time for the weekly market stop. Resident meetings will be held to introduce how the 
market works (e.g., when it will come, foods / prices to expect, payment forms accepted). 
The market schedule will be advertised in community sites (e.g., elevators, community 
rooms, resident newsletters). Based on our ongoing work, this initial community 
engagement takes two-weeks to two months, is critical to launching new sites, and is 
essential for building/maintaining rapport and trust. These activities will be repeated for 
waitlist sites after follow-up data collection in each Wave. 
 
As a note, this community engagement occurs at new Mobile Market sites that are 
starting up unrelated to the trial as well – thus, this step (aside from the randomization) is 
not different than would/does occur normally with mobile market start-up at a new 
location. 
 
(2) Full-service mobile market implementation (the beginning of the intervention): After 
initial community engagement, the intervention will begin. Specifically, the market will 
visit intervention sites weekly. The market will carry items from all food groups including 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 20 of 64 
Template Revised On: 11/01/2021      
fresh, frozen and canned fruits and vegetables, whole grains, dairy / dairy substitutes, 
proteins (e.g., frozen meat/fish, beans, eggs), and dry goods (e.g., cooking oil, spices). 
Foods will be priced below the cost of local supermarkets (~10% below) and purchases 
can be made with cash, SNAP/EBT, or credit/debit. The state funded Market Bucks 
program will provide a dollar-for-dollar match, up to $10, for produce purchases made 
with SNAP benefits. Customers will be able to enroll in a “Market Members” loyalty card 
program that provides incentives for shopping more frequently (e.g. $5 off every third 
trip) and all customers will be asked at the point of sale if they are a Member. Community 
engagement will continue during this time; market staff will check in with site partners 
regularly to ensure smooth service, addressing any challenges and capitalizing on 
opportunities (e.g., community events to promote the market) in real time. Intervention 
site participants will be contacted monthly (e.g., sent a newsletter on the market 
offerings/sales) in addition to retention contacts described above.  
 
As a note, this the start-up and implementation of the mobile market occurs at new 
Mobile Market sites that are starting up or that are receiving ongoing service unrelated to 
the trial as well – thus, this step (aside from the randomization) is not different than 
would/does occur normally with mobile market start-up at a new location. 
 
 
Waitlist control. Sites randomized to the waitlist will not receive market service prior to 
follow-up data collection. After follow-up Wave 1 data collection, Wave 1 waitlist sites will 
participate in community engagement and then receive the market. After follow-up Wave 
2 data collection, Wave 2 waitlist sites will do the same. After follow-up Wave 3 data 
collection, Wave 3 waitlist sites will do the same. The use of a waitlist control was 
purposeful and informed by our community partners. We will be in communication with 
waitlist site participants during the 6-month implementation period at the intervention 
sites, as described above to ensure up-to-date contact information and to facilitate 
engagement/retention.  
 
5.0 
Procedures Involved 
5.1 Study Design:  
We will use a cluster randomized trial design. We will recruit 12 community sites 
(“clusters”) in low-income neighborhoods and/or adjacent to low-income housing 
residences with 22 participants per site. To enhance feasibility, we will conduct the 
study in three waves, with 4 community sites in wave 1, 4 community sites in wave 
Step 2
Recruitment of 
individuals at 
community 
sites for    
Wave 1
Step 3
Baseline 
data 
collection 
for Wave 1
Step 4
Randomization 
of communities 
for Wave 1, 
strategic 
engagement of 
intervention sites
Mobile Market 
implementation at 
intervention sites 
for 12 months
Newsletter at 
waitlist control 
sites 
Continued 
mobile market 
service
Step 6
Follow-up 
data 
collection 
Wave 1
Repeat 
steps 1-7 
for Waves 
2 and 3
Step 1
Community 
engagement 
and finalization 
of community 
site selection 
for Wave 1 
Data analysis
Step 7
Mobile Market 
implementation 
at Wave 1 
waitlist control 
sites
Step 5

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 21 of 64 
Template Revised On: 11/01/2021      
2, and 4 community sites in wave 3. For each wave, following participant baseline 
data collection that will occur at the same time across the sites of the wave, we will 
randomize sites to receive the full-service market intervention or serve as a waitlist 
control. Sites randomized to receive the market will begin weekly service 
immediately following 2 months of strategic community engagement led by the 
community partner at The Food Group with the Mobile Market (see section 4 
above). After 6 months of market operation, follow-up data collection will occur for 
outcome measurement followed by qualitative interviews with a subset of 
intervention participants (high and low adopters). The RE-AIM (reach, effectiveness, 
adoption, implementation, maintenance) framework guides our evaluation.87–89 This 
process will be repeated for Wave 2 and 3 sites. Intervention sites will continue to 
receive the market during and after the follow-up data collection period. The waitlist 
sites for Waves 1, 2, and 3 will receive the intervention following final data 
collection for the wave. 
 
5.2 Study Procedures:  
Recruitment of sites: See details in IRB protocol section 9.0 and 12. 
Recruitment of individuals from sites recruited for the trial. See details in IRB 
protocol section 9.0 and 12. See also “eligibility screening script” document. 
Baseline Data collection: The consent forms will be mailed to interested and eligible 
participants in advance of the baseline data collection visit. The process of informed 
consent will take place at baseline data visits in a private and confidential space 
[using a privacy screen if needed]. Data collection will occur at baseline (after site 
recruitment but before site randomization is known to sites, participants, research 
staff, the PI, and non-statistician University co-investigators) and again at follow-up 
(after 6 months of mobile market service at sites randomized to the intervention) 
for all sites. Data collection will occur simultaneously at intervention and waitlist 
sites to minimize the threat of temporal trends (e.g., changes in community, policy, 
or economic climate). Data collection will occur onsite or in nearby community 
locations and over the telephone. Mobile market purchasing data collection will 
occur during and after the intervention through the end of data collection for 
participants at sites randomized to receive the mobile market first. Implementation 
process data collection will occur throughout the trial and participant process data 
collection will occur after the 6 month implementation of the mobile market 
intervention. If sites do not have adequate privacy, we will create a private space 
with privacy screens. The surveys will be completed by participants using a Health 
Sciences registered iPad using a secure web-based REDCap survey. In case of 
technical failure, paper-pen back-up surveys will be available. If this is needed, 
paper-pen surveys will be entered into a secure REDCap database118 by two study 
staff and verified for accuracy. Diet recall data will be entered in Nutrition Data 
System for Research (NDSR) software by trained staff. The data will be stored on 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 22 of 64 
Template Revised On: 11/01/2021      
secure University laptops and backed-up to secure BOX data servers. Paper files will 
be stored in secured, locked file cabinets.  See the table below for a broad overview 
of timeline of data collection and measurement. Details for each of the measures is 
provided below the table. 
 
 
Screening 
Baseline 
6 month 
intervention 
Follow-up data 
collection 
Qualitative 
interviews  
Eligibility and study interest 
x 
 
 
 
 
Informed Consent 
 
X 
 
 
 
Diet Quality (measured with 3 dietary recalls - one 
in person, and 2 in the next three weeks by phone) 
 
X 
 
X 
 
Food security 
 
X 
 
X 
 
Fruit & Vegetable form completion for 4 weeks 
 
X 
 
X 
 
Personal, social, behavioral, and environmental 
factors survey 
 
X 
 
X 
 
Demographics 
 
X 
 
 
 
Randomization** 
 
X 
 
 
 
Adverse Events 
 
X 
X  
X 
 
Mobile market shopping purchases       
(intervention participants only) 
 
 
X  
 
 
Quantitative measures of mobile market factors 
that may influence shopping adoption  
(intervention participants only) 
 
 
 
X 
 
Qualitative interviews with a subset of 
intervention participants (high & low adpoters) 
 
 
 
 
X 
Process measures 
 
 
X 
X 
 
** Randomization occurs after site recruitment for the Wave is complete (about 2 months prior to the end of 
data collection for the wave. Sites (and the participants attached to those sites) will be randomized to receive 
mobile market service or to the waitlist (to receive mobile market service after data collection for the wave is 
complete). After randomization, the study statistician will be unblinded to site names by being provided access 
to the key that matches sites with their assigned numbers. This will inform him which sites were randomized to 
the intervention and waitlist control. The study statistician will inform the mobile market co-investigator of the 
sites randomized to the intervention approximately 2 months prior to the end of data collection to allow time for 
the mobile market to plan for market routes and schedules. Participants, site locations, the PI, and other UMN 
trial investigators and staff will be blinded to (i.e., not be informed of) site randomization results until after 
baseline data is collected. The mobile market co-investigator will explicitly instruct the market drivers (who will 
help plan the routes with the new stops for the trial sites) that the knowledge of sites is strictly confidential until 
after baseline data collection is complete and contact between mobile market staff (aside from the Mobile 
Market co-investigator) and research team, PI, and University staff will not occur during this time to reduce any 
potential for unintentional disclosure. 
 
Diet quality will be measured through 24-hour dietary recall interviews. Trained 
staff certified in collecting diet recalls using Nutrition Data System for Research 
(NDSR) will collect three 24-hour recall interviews (2 weekdays, 1 weekend day) 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 23 of 64 
Template Revised On: 11/01/2021      
from each participant at both measurement periods (baseline, follow-up). At each 
measurement, the first recall will be conducted in-person during data collection 
visits; the second two recalls will be by phone. NDSR,94 a diet analysis software 
developed and maintained by the University of Minnesota Nutrition Coordinating 
Center (led by co-investigator Harnack) will be used to collect recalls. The multiple-
pass interview technique will be used to prompt for complete recalls and 
descriptions.95 A Food Amounts Booklet adapted from Van Horn et al.96 will be 
provided to participants for use in estimating food and beverage amounts 
(attached).  
To measure diet quality, Healthy Eating Index-2015 (HEI-2015) total and 
components scores will be calculated from the recall data. The HEI-2015 is a scoring 
system to measure adherence to the 2015-2020 Dietary Guidelines for Americans 
(2015-2020 DGA).69,70 The HEI-2015 total score is the sum of 13 subcomponents that 
measure adequacy (Total Fruits, Whole Fruits, Total Vegetables, Greens and Beans, 
Whole Grains, Dairy Products, Total Protein Foods, Seafood and Plant Proteins, and 
Unsaturated:Saturated fats) and moderation (Refined Grains, Sodium, Added Sugars, 
and Saturated Fats). All subcomponents are scored from 0-5 or 0-10 based on intake 
between minimum and maximum standards. Moderation components are reverse 
scored so higher scores reflect lower intake. A higher HEI-2015 score (out of 100) 
represents greater consistency with the 2015-2020 DGA. Additional diet outcomes 
from recall data include mean daily intake of: energy, fruits and vegetables 
(servings/day), added sugar (% calories from added sugar) and sodium 
(mgs/day)..69,70 See dietary recall protocol. 
Food insecurity. Food insecurity in the past 6 months will be measured with 
the gold-standard, 18-item food security screening module of the USDA, which will 
allow for assessment of both binary food insecurity (yes, food insecure; no, food 
secure) and level of food security (very low, low, marginal, and high food security).91 
We will assess for change in prevalence of food insecurity and level of food security 
from baseline to follow-up (e.g., change in % very low food security from baseline to 
follow-up), as assessed in other community-based food intervention studies aiming 
to improve food security.97,98 We will also use newly developed and validated 
measures to assess nutrition insecurity in the past 6 months, which helps us 
understand fuller contexts around choices people may make when money is tight 
(e.g., compromise nutrition for a full stomach).137 These measures will be collected 
via REDCap, which makes the skip patterns invisible and easy for participants. 
Fruit & Vegetable purchasing outcomes: Participants will record the fruits 
and vegetables that they buy along with the date and place of purchase using forms 
in provided booklets, and mail these booklets to the researchers in prepaid 
addressed envelopes, which will be used to measure:  
Average weekly servings of fruits & vegetables. The purchase quantity 
(volume, weight, quantity) of fruits and vegetables from the forms will be 
entered into NDSR. Using these data, NDSR will calculate the edible 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 24 of 64 
Template Revised On: 11/01/2021      
servings for each item. This process accounts for and eliminates the 
inedible portions of foods (e.g., peels, pits). The edible servings purchased 
will be summed and averaged to obtain the average servings of fruits and  
vegetables purchased weekly across all purchase locations. See Fruit & 
Vegetable Purchasing data collection protocol and Fruit & Vegetable 
purchasing booklets for participants attachments. 
 Descriptive purchasing variables measured with data from the fruit & 
vegetable forms. Total number of trips and store types visited will be 
measured using the data from the fruit & vegetable forms. See the Fruit & 
Vegetable Purchasing Data Collection Protocol and Fruit & Vegetable 
purchasing booklets for participants attachments. 
Shopping adoption. Intervention participant shopping adoption will be 
measured in 2 ways: (A) average monthly dollars spent and frequency of 
shopping at the mobile market during the implementation period and 3 
months post-implementation as measured by purchases with customer 
loyalty cards (see Mobile Market purchasing data protocol attachment); 
and (B) self-reported average frequency of mobile market shopping each 
month (see process survey attachment).  
Quantitative measures of personal, social, behavioral, and environmental 
factors. At baseline and follow-up, surveys with validated psychosocial measures will 
be used to measure factors that may influence mobile market adoption. These 
factors include: Neighborhood Healthy Food Availability (4 item scale; α=0.89);99 
Social Connectedness (8 item scale, α=0.92);102 Health-related quality of life (4-
items);103–107 Self-efficacy of Healthy Cooking (4 item scale, α=0.85);109 Self-efficacy 
for eating and cooking fruits and vegetables (4 item scale, α=0.90);108 and Everyday 
Discrimination Scale (6 item scale α=0.77 + 2 follow-up items).139-140 Item responses 
will be coded and summed so a higher scale score indicates a higher trait (e.g., 
higher access to affordable quality foods). See psychosocial survey attachment. 
Other data to be collected 
Participant information, demographic information, and potential 
confounding variables. Participants will self-report by survey age; sex; income level 
(<10,000, 10,000 to <15,000, etc); education level (some high school, graduate 
equivalent degree [GED], some college, etc.); receipt of SNAP, WIC, free or reduced 
price school lunches, other food programs and medical assistance; household size; 
ethnicity; race (American Indian or Alaskan Native, Asian, Black or African American, 
Native Hawaiian and Other Pacific Islander, White; selecting all that apply); and 
diet/weight related health conditions. See attached surveys (Note: Most of these 
questions are in the demographics survey; the health related questions are in the 
psychosocial survey and the household size questions are in the food security 
survey.) 
Process data. Aligned with the RE-AIM framework,112–114 we will collect 
process measures during and immediately following the intervention to assess 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 25 of 64 
Template Revised On: 11/01/2021      
reach, adoption, implementation, and maintenance. See table below. 
Process Measures 
(RE-AIM alignment) Collection Method 
Data collected 
Who / When 
Analysis 
Site mobile market 
operation 
implementation 
fidelity (I) 
Assessments for deviations in scheduled 
operation (e.g., related to weather, traffic, 
repairs), stocking practices, and pricing.  
• Documented deviations (see 
Fidelity Bus Operations Data 
Collection Protocol) 
Regularly monitored by study 
staff during the implementation 
period 
Descriptive 
Site sales: use and 
reach by site 
(R, A) 
The cloud-based, electronic, point-of-
sale, cash register records all sales 
transactions. 
 
• Date, time, site of sale, 
payment type, and foods 
items/categories sold for all 
transactions (data to be 
collected are not identifiable 
or linked to participants – 
rather this data will be used to 
describe sales at intervention 
sites and make comparisons 
to waitlist and other non-
research sites) 
Downloaded monthly by study 
staff during the implementation 
period 
Descriptive. Total 
sales and sales by 
food category for 
intervention sites 
Contamination and 
dose—self-reported 
(R, A)  
Survey will include questions  
to assess market dose and 
contamination exposure 
• Shopping frequency 
• Length of time shopping at 
the mobile market (in months) 
(see Process Follow-up 
Survey) 
Study participants at follow-up 
data collection  
Descriptive and as 
described in Aim 1 
analysis plan 
Contamination and 
dose—objective  
(R, A)  
Fruit and vegetable purchase data 
collection  
Number of trips to Mobile 
Market  
Study participants at baseline 
and follow-up data collection 
Descriptive and as 
described in Aim 1 
analysis plan 
Intervention 
participant market 
purchases (R, A, M) 
Point of sale system with customer 
loyalty program (Market Members) to 
track purchases a 
• Frequency of purchases 
• Dollars spent on market 
purchases 
• Number and types of items 
purchased (see Mobile 
Market purchasing protocol) 
Intervention site participants 
during the implementation 
period 
Descriptive and as 
described in Aim 2 
analysis plan 
Key features and 
suggestions for 
improvement from 
intervention 
participants 
(A, I) 
Open-ended qualitative process survey 
and interviews about key features that 
make the market helpful and suggestions 
for improvement 
• Open-ended responses (see 
process survey) 
• Qualitative interview 
transcripts (see qualitative 
question guide) 
Intervention site participants at 
follow-up data collection and 
intervention site participants 
selected for interviews 
See Aim 3 
Notes: aIntervention site participants will all be enrolled in the Market Member program as part of their participation in the study. 
All Mobile Market customers, regardless of whether they are at a research site or are participating in the research study, can enroll 
in thid program and receive nominal discounts ($5 off) every 3-4 shopping trips (see Mobile Market purchasing data collection 
protocol attachment). 
5.3 Randomization: The sites recruited for the trial will be randomized to mobile market 
service first or the waitlist control (to receive mobile market service after the data 
collection for each wave is complete). The randomization will be completed by the 
study statistician who will be blinded to the study site location names. After 
randomization, the study statistician will be unblinded to site names by being 
provided access to the key that matches sites with their assigned numbers. This will 
inform him which sites were randomized to the intervention and waitlist control. 
The study statistician will then inform the mobile market co-investigator of the sites 
randomized to the intervention approximately 2 months prior to the end of data 
collection to allow time for the mobile market to plan for market routes and 
schedules. Participants, site locations, the PI and other UMN trial investigators and 
staff will be blinded to (i.e., not be informed of) site randomization results until after 
baseline data is collected. Of note, only the project manager and the study 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 26 of 64 
Template Revised On: 11/01/2021      
statistician will be aware of the key (the link between the site names and the 
assigned site numbers that will be used in analysis) until analysis is complete. 
Intervention/waitlist control: The intervention, Twin Cities Mobile Market service 
will be provided in the communities recruited for the trial. This service will be the 
same service provided to other community sites with ongoing Mobile Market 
service. Service will be available to anyone in the community regardless of trial 
enrollment. Intervention sites will receive mobile market service following two 
months of strategic community engagement. Waitlist control sites will receive 
mobile market service after follow-up data collection for the wave is complete. 
More detail is provided in IRB protocol section 4.1. 
Data analysis: Data will be analyzed by research staff to answer study related 
research questions and to determine the individuals who are the high and low 
adopters of mobile market shopping for qualitative interviews related to the study’s 
third aim. See details in IRB protocol section 17. 
The following actions will be taken if a participant misses a study visit: 
• 
The study team must attempt to contact the participant and reschedule the 
missed visit as soon as possible, counsel the participant on the importance of 
maintaining the assigned visit schedule, and ascertain whether the participant 
wishes to and/or should continue in the study. 
• 
Before a participant is deemed lost to follow-up, the investigator or designee 
must make every effort to regain contact with the participant, where possible, 
by text, email, telephone calls, and if necessary, a certified letter to the 
participant’s last known mailing address. These contact attempts will be 
documented in the participant’s contact log. Should the participant be 
unreachable for 5 consecutive attempts by phone or text without response/reply 
followed by a certified letter without response, the participant will be 
considered to have withdrawn from the study.  
 
5.4 
Follow-Up: The data collection process will be identical to that of baseline data 
collection with a few exceptions, noted below. There is not long-term follow-up data 
collected. 
Quantitative measures of mobile market features. Features of the market 
that could influence market shopping adoption will also be measured at follow-up 
data collection for the participants at sites randomized to receive mobile market 
services first (vs. waitlist service to start after final data collection). These features 
include perceived convenience of market service (not at all convenient to very 
convenient); whether the market meets participant cultural food needs (yes/no); 
perceived affordability of market food prices (not at all affordable to very 
affordable); and whether they would recommend the market to a friend (yes/no). 
Customer satisfaction of the market’s: (a) location and timing; (b) selection of food 
items available; (c) prices; (d) customer service; and I overall shopping experience 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 27 of 64 
Template Revised On: 11/01/2021      
(not at all satisfied to very satisfied) will also be measured. See process survey 
attachment. 
Qualitative interview questions. Qualitative interviews will be conducted with 
a subsample of intervention participants who are high and low mobile market 
adopters after the intervention is complete (see section 11 for specifics of how 
participants would be selected for the interviews). Interviews will be audio recorded 
with a digital voice recorder and occur in person or by phone. Main interview 
questions will inductively explore factors that influenced market shopping and 
shopping adoption.  Interviews will unfold consistent with qualitative methodology 
and allow the participants to shape the flow and content.110 Probing and clarifying 
questions will be asked as needed.110,111. See qualitative interview guide attachment. 
 
5.5 Individually Identifiable Health Information: This research study will collect 
participants’ names, contact information, dietary intake data, fruit and vegetable 
purchasing data and minimal self-reported health information (i.e. has a doctor ever 
told you that you have the following conditions or health problems (with yes, no 
response options): high blood pressure or hypertension, high cholesterol or 
hyperlipidemia, diabetes, heart disease, depression or anxiety, overweight/obesity. 
 
6.0 
Data Banking 
6.1 Storage and access: Deidentified data will be stored in the PI’s secure Box 
storage for future use by other researchers not on the research team. Data will be 
available 2 years following study completion ending 15 years after study start. 
6.2 Data: Deidentified dataset. 
6.3:  Release or sharing: Outside researchers who request to use the deidentified 
data would have to have IRB approval documented with the PI prior to sharing of 
the dataset via a secure box file. Additionally, publishing of these data may be 
required. Federal funders (e.g. National Institutes of Health), granting agencies (e.g. 
Bill & Melinda Gates Foundation), and journal publishers (e.g. PLoS) increasingly 
require datasets be made publicly available—often immediately upon associated 
article publication. If this is the case, all data published will be fully de-identified. 
7.0 
Sharing of Results with Participants 
7.1 General, group level (aggregate) survey results (e.g., means of participant scores) 
will be shared with participants and others as appropriate (e.g., academic research 
audiences, community groups). These group level study results will be conveyed in 
both peer-reviewed and lay publications (e.g., infographic/newsletter). The 
Community-Centered Dissemination Toolkit will be used to guide development of 
materials. 
8.0 
Study Duration 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 28 of 64 
Template Revised On: 11/01/2021      
8.1 The duration for participant involvement in trial procedures is less than 1 year. 
Enrollment per wave is expected to take approximately 3 months. The duration 
anticipated to complete all study procedures and data analysis is approximately 5 
years. 
9.0 
Study Population 
 
9.1 Inclusion Criteria:  
To achieve the proposed study aims, communities and human subjects from those 
communities will be recruited and data about operational procedures and costs 
will be collected.  
 
Community site selection (see letters of support of interested site locations):  
In order to be eligible to participate in this study, a community site (e.g., public 
housing hi-rise, low-income senior living residence) must meet the following criteria: 
(a) locale for low-income populations that experience difficulty in accessing healthy, 
affordable foods (e.g., public housing residences; low-income senior housing) or a 
community center in a low-income, low-food access (0.5 mile) census tract;  
(b) willingness to be randomized to the intervention or waitlist control;  
(c) located over 0.5 miles apart from other trial sites;  
(d) willingness to allow for recruitment and data collection to occur in onsite 
community rooms;  
 
 
Process for initial contact with sites: 
Steph Wagner at The Food Group with the Twin Cities Mobile Market regularly 
receives calls from site locations across the Twin Cities that may be interested in 
having the mobile market come. As these calls comes in, she will provide 
information on the mobile market service in general and also that there is a research 
study opportunity. She’ll provide the sites a site flyer. She will connect any 
interested sites with the Mobile Market researchers for specific questions related to 
the research, if any, prior to the formal conversation, as outlined in the attached site 
screening script (below). 
Flyer for site recruitment: We have created a flyer for sites (attached) interested in 
mobile market service study to provide information on the mobile market research 
study. This site flyer would serve as a preview to a more formal conversation about 
being both a mobile market site and research site. It should be noted that the site 
recruitment flyer lists the contact information for Co-Investigator Wagner given her 
position of regularly receiving this type of call at the Mobile Market currently. She 
will refer sites to the researchers for research specific questions as they arise prior 
to a formal conversation as outlined with the screening script. 
 
Site screening script: 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 29 of 64 
Template Revised On: 11/01/2021      
For sites that may be interested, a research team member and Co-Investigator 
Wagner will go through a formal conversation using the site screening script to guide 
the conversation. Please see the site screening script attached. 
 
When sites would like to join: 
If an interested site were to be interested, eligible and decide to participate, a letter 
of support would be written documenting this decision. This letter of support will be 
provided to the UMN IRB following signature. 
 
Sites meeting site eligibility criteria will be recruited in three waves, with 4 sites in 
wave 1, 4 sites in wave 2, and 4 sites in wave 3. After baseline data collection for 
each Wave, stratified randomization of sites by type (e.g., randomization within 
public housing, low-income senior living sites) will be conducted to ensure balance 
between groups. See support letters from sites on the market waitlist meeting the 
aforementioned criteria.  
Human subject recruitment will occur in the participating communities. 
In order to be eligible to participate in this study, an individual must meet the 
following criteria:  
(a) being aged 18 years or older;  
(b) identifying as the primary food shopper in their household;  
(c) being able to speak English or American Sign Language (ASL);  
(d) living within a half mile of the community site location; and 
(e) reporting to be likely or somewhat likely to shop at the market in response to: 
“how likely would you be to shop regularly at the Twin Cities Mobile Market if it 
came to your neighborhood each week (response options: likely to unlikely). 
(f) willing and able to participate in all study data collection activities  
● 
Please note: we may be amending these inclusion criteria and this protocol 
and all documents to include individuals who speak other languages once the 
community sites are selected and the other languages are known.  
9.2 Exclusion Criteria: An individual who meets any of the following criteria will be 
excluded from participation in this study:  
(a) planning to move in the next 12 months 
(b) not currently shopping at the mobile market 
(c) not having a phone number or mailing address 
(d) presence of a condition or abnormality that would prohibit participation in the 
study or the quality of the data  
 
9.3 Screening: Screening will occur in person or via phone using the eligibility screening 
script (attached). Participants will self-report answers to these questions. 
Participants will be asked to provide verbal consent prior to conducting the initial 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 30 of 64 
Template Revised On: 11/01/2021      
screen. Participants who consent to proceed with the screening process will be 
documented by study staff. 
If participants are found to be potentially eligible after phone screening, they will be 
invited to the study for a full written consent process that covers the remainder of 
the study, as described in this protocol. 
 
10.0 Vulnerable Populations 
10.1 
Vulnerable Populations:  
 
Population / Group 
Identify whether any of the 
following populations will be 
targeted, included (not necessarily 
targeted) or excluded from 
participation in the study.  
Children 
Excluded from Participation 
Pregnant women/fetuses/neonates 
Included/Allowed to Participate 
Prisoners 
Excluded from Participation 
Adults lacking capacity to consent 
and/or adults with diminished 
capacity to consent, including, but 
not limited to, those with acute 
medical conditions, psychiatric 
disorders, neurologic disorders, 
developmental disorders, and 
behavioral disorders 
Included/Allowed to Participate 
Non-English speakers 
Included/Allowed to Participate 
Those unable to read (illiterate) 
Included/Allowed to Participate 
Employees of the researcher 
Included/Allowed to Participate 
Students of the researcher 
Included/Allowed to Participate 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 31 of 64 
Template Revised On: 11/01/2021      
Undervalued or disenfranchised 
social group 
Targeted Population 
Active members of the military 
(service members), DoD personnel 
(including civilian employees) 
Included/Allowed to Participate 
Individual or group that is 
approached for participation in 
research during a stressful situation 
such as emergency room setting, 
childbirth (labor), etc. 
Excluded from Participation 
Individual or group that is 
disadvantaged in the distribution of 
social goods and services such as 
income, housing, or healthcare. 
Targeted Population 
Individual or group with a serious 
health condition for which there are 
no satisfactory standard treatments. 
Included/Allowed to Participate 
Individual or group with a fear of 
negative consequences for not 
participating in the research (e.g. 
institutionalization, deportation, 
disclosure of stigmatizing behavior). 
Included/Allowed to Participate 
Any other circumstance/dynamic 
that could increase vulnerability to 
coercion or exploitation that might 
influence consent to research or 
decision to continue in research. 
Excluded from Participation 
 
10.2 
Additional Safeguards:  
● 
This study is not recruiting based on pregnancy status. Rather, it is possible 
that a pregnant women would meet all criteria for inclusion in the study, given 
the nature of this research, there is no anticipated harm to pregnant women or 
the fetus, should she elect to enroll in the research. 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 32 of 64 
Template Revised On: 11/01/2021      
● 
Because the study will be recruiting in the community, no prisoners will be 
included.  
● 
No individuals less than 18 years of age are included based on inclusion 
criteria.  
● 
We do not anticipate enrolling individuals with impaired capacity to consent. 
Assessment of capacity to consent will be informally made during routine 
interactions with participants. No specific assessment or documentation of 
capacity is required under those circumstances. 
● 
American Sign Language speakers will be allowed to participate in this study, 
though they will not be specifically targeted for recruitment. If an ASL speaker 
indicates interest in the study while we are conducting recruitment, we will 
contact a certified interpreter to facilitate communication. An interpreter will 
be used for all study visits and be available to the participant if they have 
questions regarding any written forms. We will have an interpreter translate 
our consent form into a video, a link to which will be provided on the English 
consent form. In addition, if preferred by the participant, we will allow ASL 
speakers to conduct their follow-up dietary recalls in person with an 
interpreter rather than requiring these to be conducted by phone and will 
allow the interpreter to interpret the iPad written survey questions as read by 
a study staff member and the participant’s responses so they can be entered.  
Additional non-English speakers may be targeted for recruitment at a later 
time, but the languages are not yet known. We will amend this 
protocol/procedures and all related documents once the languages are 
solidified to add this inclusion criterion and related supporting documentation 
(e.g., consent form in selected languages etc) and will wait to receive IRB 
approval related to this modification prior to enrolling participants who do not 
speak English. 
● 
This study will not be targeting recruitment of individuals who are not literate. 
However, if an individual who is not able to read wants to participate, study 
staff will assist with completion of surveys, forms, etc. to ensure that the 
sample is inclusive of and represents all individuals that wish to use the mobile 
market including any that may not be literate. Participants who are illiterate 
may not be known, research staff will not be asking a direct question about 
literacy to potential participants. However, if it is made known to us that the 
participant is illiterate we will take extra care to go through the consent form 
and read it to the potential participant. An unbiased witness (non-study team 
member) will be present to attest that the consent form was described 
accurately. He/she will also sign the consent form. 
● 
Employees of the researcher: If an employee of the researcher presents as a 
potential participant eligible for this study, they will be seen for consenting and 
treatment by a member of the study team who is not the researcher. They will 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 33 of 64 
Template Revised On: 11/01/2021      
be told during consenting that their decision whether to participate will not 
affect their professional relationship with the researcher. 
● 
Student of the researcher: If a student of the researcher presents as a potential 
participant eligible for this study, they will be seen for consenting by a member 
of the study team who is not the researcher. They will be told during 
consenting that their decision whether to participate will not affect their 
professional relationship with the researcher nor will it have an impact on their 
graduation status, GPA, future job or internship opportunities or any other 
academic or professional status. 
● 
This study will recruit individuals who are disadvantaged in the distribution of 
social goods and services such as income, housing or health care and/or who 
may identify as an undervalued or disenfranchised social group. In particular, 
the mobile market aims to serve those who live in low-income, low food access 
communities; thus, it is critically important that the population the mobile 
market is trying to reach is included in the study, as it will ensure the results 
represent the target population. Caution was taken to provide appropriate 
levels of compensation for participants given their income level, so as to not be 
coercive while also providing appropriate compensation for the time spent in 
research activities. Levels were set in conjunction with community partner. 
When possible, diverse and multilingual research staff will be hired to reflect 
the individuals in the community site locations. 
● 
Active members of the military (service members), DoD personnel (including 
civilian employees): Members of the military may not be known, research staff 
will not be asking a direct question about military status to potential 
participants. We do not anticipate vulnerability for this group to be increased 
by participating in this study. 
● 
Individual or group with a serious health condition for which there are no 
satisfactory standard treatments: Participants with a serious health condition 
for which there is not satisfactory standard treatment will be fully informed of 
the potential risks and benefits of the research study. We do not anticipate 
vulnerability for this group to be increased by participating in this study. 
● 
Individual or group with a fear of negative consequences for not participating 
in the research (e.g. institutionalization, deportation, disclosure of stigmatizing 
behavior): Individuals with a fear of negative consequences for not 
participating in the research (e.g. institutionalization, deportation, disclosure 
of stigmatizing behavior) are not targeted but may be enrolled. All participants 
will be fully informed that the study is completely voluntary and that they may 
withdraw participation at any time. 
10.3 
If research includes potential for direct benefit to participant, provide rationale for 
any exclusions indicated in the table above: 
Prisoners are excluded as they will not have access to the mobile market while in 
custody. Children are excluded as they are not the primary food purchasers in this 
household, which is whom this intervention is targeted for – they may still benefit 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 34 of 64 
Template Revised On: 11/01/2021      
if their parent/guardian enrolls in the study. We are not including people in a 
stressful time sensitive situations like being in the emergency room or while in 
labor, as they are not the target population of the mobile market; these individuals 
would be eligible to participate when the stressful situation has resolved if 
meeting eligibility criteria.  
 
As a reminder: Non-English speakers, with the exception of ASL speakers, will be 
excluded from participation at this time. However, they may be targeted for 
recruitment at a later time, but the languages are not yet known. We will amend 
this protocol and all related documents once the languages are solidified to add 
this inclusion criterion and related supporting documentation and will wait to 
receive IRB approval related to this modification prior to enrolling participants 
who do not speak English. 
 
11.0 Number of Participants 
11.1 Number of Participants to be Consented:  
Targeting enrollment at 264 participants in full-data collection.  
For qualitative interviews, these will happen with a smaller subsample of 
participants enrolled. Specifically, the qualitative sample will be derived from 
purposive sampling of extremes119,120 in market adoption. Thus, participants 
selected for interviews will be from the highest and lowest quintiles of market 
shopping as measured by the number of trips to the Mobile Market during the final 
two months of the intervention period. The estimated number of interviews is 24 for 
low adopters and 24 for high adopters (48 total) selected from across intervention 
sites;121 however, the qualitative sample size will only be set after saturation has 
occurred during analysis and coding of the qualitative data.121   
For our primary outcome, with our planned sample size of 264 divided between 12 
clusters, we anticipate 80% power to detect a difference of 5.0 HEI points between 
the intervention and control groups. This calculation assumes an attrition rate of 
15%, so that our final analytic sample size is 224 individuals, and a conservative ICC 
of 0.01. If attrition is higher or recruitment is slower, a final analytic sample of n=160 
individuals will provide 80% power to detect a difference of 6.0 HEI points, which is 
still within the range of plausibility for the effect size of this intervention. 
Furthermore, smaller effects will be detectable even with this smaller sample if the 
ICC is closer to the value 0.004 observed in previous studies. Additionally, for our 
secondary outcomes, an even smaller sample would be acceptable for analysis. For 
example, for the third aim, we are aiming for 24 high mobile market shopping 
adopters and 24 low mobile market shopping adopters (final sample size will be 
determined once saturation is reached).  
12.0 Recruitment Methods 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 35 of 64 
Template Revised On: 11/01/2021      
12.1 Community and Participant Recruitment process: 
Community recruitment process: 
When: After grant is awarded. Process will begin approximately 2-5 months into the 
grant. 
Where: At/around the Twin Cities in low-income/low food access communities 
meeting site inclusion criteria. 
Strategies: Mobile market staff will work with their ongoing community partners, 
sites on their waitlist (interested in service when capacity to expand is available), 
and new potential partners to recruit sites meeting inclusion criteria to receive 
mobile market service as part of the trial (depending on randomization, as either 
intervention or waitlist control sites). While the sites will be specifically recruited for 
the trial, the mobile market service at these sites will be normal mobile market 
service (i.e., the same service that is currently ongoing at other community site 
locations that are not part of the trial). At the trial site locations of this trial, anyone 
will be able to shop at the mobile market, not just those enrolled in the trial.  
 
Participant recruitment process: 
When: After recruitment of community sites 
Where: At/around the community sites recruited for the trial before randomization 
of communities to mobile market service or waitlist control is known to sites, 
participants, research staff, the PI, and non-statistician University co-investigators. 
Strategies:  
• working closely with community site staff to get the information to 
community members 
• posting flyers and tabling in central locations around recruited site 
locations 
• attending resident meetings (e.g., resident council in public housing 
buildings) 
• sending trial information along with community newsletters/ updates 
• bringing the mobile market to each site for an informational event 
Retention strategies:  
• providing contact throughout the study to retain up-to-date contact 
information (e.g., calls/text messages/emails, reminder letters, 
seasonal cards, monthly newsletters),  
• continuing to collect data in a convenient location 
• providing culturally and linguistically competent staff 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 36 of 64 
Template Revised On: 11/01/2021      
12.2 Source of Participants: Community – specifically, community members in/around 
the 12 sites recruited for mobile market service as part of the trial will be recruited. 
See recruitment for details. 
12.3 Identification of Potential Participants:  
● 
See recruitment strategies for how potential participants will be identified 
(section 12.1). As additional information: 
o No recruitment will occur based on information contained in 
private/protected records. 
o When in-person recruitment occurs, the research staff will make 
initial contact by saying hello and offering to speak with potential 
participants when they pass by. 
o When recruitment occurs by flyer posting or newsletter, the 
participant will make the initial contact to reach the research staff. 
[Note, if information is sent via community newsletter, the 
information in the newsletter would be created by the research 
team but would be included in the normal sending of the 
community newsletters, such that the research staff would not 
have access to the community members names or addresses and 
the potential participant receiving the information would need to 
make the first contact to the research staff.] 
o Following the intervention period, a subset of participants from 
intervention sites who are either the highest or lowest users of the 
Twin Cities Mobile Market will be invited to participate in an 
additional interview. This will be participants who are in the highest 
and lowest quintile based on the number of trips made to the 
Mobile Market in the final two months of the intervention period. 
Each of these individuals will be invited during their follow-up data 
collection visit. 
12.4 Recruitment Materials:  
See attached recruitment materials:  
• flyers (to be hung in common areas at community sites) 
• door hangers (which can be delivered to all units within a community 
housing site) 
• newsletter text (which could be included in a community site’s newsletter 
or other communications with residents) 
• handout (which could be distributed during tabling or other community 
event) 
• screenshot of the study website (http://z.umn.edu/mobilemarketstudy; link 
is included on other recruitment materials) 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 37 of 64 
Template Revised On: 11/01/2021      
12.5 Payment:  
● 
Compensation (up to $200 across measurement periods) will be offered. An 
additional $20 will be provided to participants selected to participate in the 
qualitative interviews. More specifically: 
o Each participant will receive an incentive for specific data collection 
activities at baseline and follow-up data collection [$200 total; $100 
at baseline and $100 at follow-up]. Specifically, participants will be 
given $20 for completing the psychosocial survey and first dietary 
recall at the in-person data collection visit, $10 for completing the 
second dietary recall, and $15 for completing the third dietary 
recall. Participants will be given $10 for each week of fruit & 
vegetables purchase booklet collection (for weeks 1-4) and $15 
additional dollars in the final week (week 4) of fruit & vegetable 
purchase booklet collection, if participants collected and returned 
purchase receipts for the entire month. One Greenphire ClinCard 
pre-paid debit card will be provided at in-person measurement and 
the other payments will be reloaded onto the debit card after 
completion of the study activities (see Clincard information form 
attachment for information we will collect in order to provide 
payments). For participants selected for qualitative interviews, 
qualitative interview participation will result in participants 
receiving an additional $20 payment loaded to their debit card. We 
plan to recruit 264 and complete qualitative interviews with 48 
individuals already enrolled in the study. Qualitative interviews will 
occur during the follow-up period of each Wave. 
● 
No Research Experience Points will be awarded. 
13.0 Withdrawal of Participants 
13.1 
Withdrawal Circumstances: The following are the circumstances under which 
participants would be withdrawn from the research without their consent: 
• If they are lost to follow up 
• If they behave inappropriately toward study staff 
• If they show signs of diminished capacity to consent 
13.2 
Withdrawal Procedures: Participants will be informed that if any point they no 
longer wish to be in the study, they may withdraw from the study. If a participant tells the 
research staff they would like to withdraw from the study, the research staff will ask for and 
document reason for withdrawal. Any data provided by the participant will continue to be 
used in the study, unless they formally request that data is not used. No further data will be 
collected from a participant who withdraws from the study.  

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 38 of 64 
Template Revised On: 11/01/2021      
13.3 
Termination Procedures: This study may be temporarily suspended or prematurely 
terminated if there is sufficient reasonable cause (see stopping rules on the DSMP). Written 
notification, documenting the reason for study suspension or termination, will be provided 
by the suspending or terminating party to the funding agency and regulatory authorities. If 
the study is prematurely terminated or suspended, the PI will promptly inform the IRB and 
will provide the reason(s) for the termination or suspension. The study may resume once 
concerns about safety, protocol compliance, and/or data quality procedures are addressed 
and satisfy the funding agency and IRB. If the study is terminated, the study team will notify 
the participants of the study termination.  
Data collected for the study prior to the study termination will be handled in the following 
manner: 
• If the study is terminated due to safety reasons, the data related to 
AEs will be evaluated.  
• If the study is terminated for any other reason, the regulatory and/or 
institutional document/data retention policies will apply. 
 
14.0 Risks to Participants 
14.1 Foreseeable Risks:  
Data Risks and Protections: To follow participants from baseline data collection to 
follow-up data collection, identifiable information (e.g., names, contact information 
including phone, address, and other forms if available) and sensitive information 
(e.g., self-report of health conditions) will be collected. This collection of identifiable 
and/or sensitive data does pose a potential risk of a data breach. The risk of a 
system-wide data breach of the secure HIPAA compliant University of Minnesota 
Health Sciences Academic Health Center (UMNHSACH) computer/network serve is 
low. To minimize this potential but rare risk, all data linked to participants will be 
coded with a non-identifiable study ID number. Identifiable information (names, 
addresses, etc) will be stored on a secure password protected file on a secure 
UMNHSACH server and will only be accessible to those the PI has given permission. 
Participant forms will only contain the study ID number. De-identified data will be 
stored separate from identifiable information and will be accessible only to those 
with explicit permission of the PI and a secure password. Even with a password to 
the server, permission is required to access file level data. All passwords will 
conform to the requirements of the University of Minnesota for maximum security, 
which includes two factor identification. 
Data collected in the field from participants will be collected primarily via 
REDCap surveys administered using an iPad at data collection visits. The surveys will 
be directly entered into the secure REDCap Database and all other windows will be 
closed while a participant has an iPad. If there is a technical failure with the wi-fi or 
iPads, paper-pen surveys will be completed. The paper-pen surveys will be entered 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 39 of 64 
Template Revised On: 11/01/2021      
into the secure REDcap Database by two different study staff and verified for 
accuracy. Data for this study will be entered into a REDCap database, which 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 Health 
Science Academic Health Center’s 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 1 month, 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 only specific members of the study 
team by username and password and permission of the PI.118 The REDCap database 
will be downloaded daily while data collection is ongoing and weekly when data 
collection is not actively occurring by the project manage.  The REDCap data 
downloads will be stored on secure, password protected Box file.  
Survey Risks and Protections: During the survey, residents will be asked to 
report on their household’s own food security. It is possible that these questions 
could elicit an emotional response. Because we expect our study population is at 
high risk for food insecurity, we plan to offer all participants a handout that lists 
contact information for Hunger Solutions (an organization that helps people identify 
local food shelves and food assistance programs they may quality for and assistance 
with signing up for assistance.) Assistance contacting this organization or using their 
website to find local food shelves will also be provided, as appropriate. 
  
Full-Service Mobile Market Intervention Risks and Protections: The full-
service mobile market intervention is a community level intervention that already 
exists in the Twin Cities metropolitan area (there are 24 current weekly stops). While 
the full-service mobile market intervention will be newly available to the community 
sites participating in the proposed trial, the risk of participation in the mobile 
grocery store is minimal and equal to participation in mobile market service not 
associated with the trial. For example, participants of the trial will have the same 
opportunity to use the mobile market as will their neighbors who may or may not be 
in the trial. In addition, the mobile market staff on the full-service mobile market will 
not know (or have access to data to know) whether customers are participants in 
the trial or not; thus, accidental disclosure of study participation by staff will not be 
possible.  
14.2 Reproduction Risks: Not applicable. 
14.3 Risks to Others: Not applicable. 
15.0 Incomplete Disclosure or Deception 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 40 of 64 
Template Revised On: 11/01/2021      
15.1 Incomplete Disclosure or Deception:  
● 
Not Applicable. 
16.0 Potential Benefits to Participants 
16.1 Potential Benefits:  
The research participants may not see a direct benefit as a result of participation in 
the proposed study. However, research participants may benefit if they utilize the 
full-service mobile market, which may increase affordable food access, dietary 
intake, food security, and food purchasing outcomes. The mobile market will 
operate at the site locations recruited for this study after randomization/start-up for 
intervention sites and after final data collection for waitlist sites until the trial is 
complete. Then the sites will remain mobile market stops if they are well utilized 
and the community partners continue to wish to have mobile market service. 
17.0 Statistical Considerations 
17.1 Data Analysis Plan: See section 17.3 
17.2 Power Analysis:  
Power calculation. For the primary outcome of change in HEI scores, power is 
computed based on a t-test at the individual client level, but the 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. In Co-Investigator 
Harnack’s study with participants similar to the proposed study (i.e., from the same 
communities with similar income and diversity levels), the HEI SD was 11.2.90 In our 
preliminary customer intercept survey study, we found an ICC of 0.0004. Therefore, 
to be conservative, we assume an SD of 12 and an ICC of 0.01. Under these 
assumptions with a two-sided type I error rate of 5%, this study will have 80% power 
to detect a mean difference of 5.5 HEI points between intervention and control 
participants with an average cluster size m of 20 and number of clusters k of 12 for a 
total of 264 participants (132 per group). This calculation assumes an attrition rate 
of 20%. Detection of a 5.0 point difference in HEI is clinically significant, as it 
corresponds to a lower risk of cardiovascular mortality and lower risk of all-cause 
mortality.122 Additionally, given our conservative approach, we may ultimately be 
adequately powered to detect even smaller differences in HEI scores between 
intervention and control sites.  
17.3 Statistical Analysis: 
Aim 1:  The primary analysis will compare the mean within-person, baseline to 
follow-up change in HEI-2015 between the mobile market and waitlist control 
groups. Changes in HEI-2015 will be modeled via a Generalized Estimating Equation 
(GEE) linear model to account for the possible correlation of outcomes within 
community sites. Food insecurity, as measured by the U.S. Adult Food Security 
Survey Module, will be analyzed similarly. Baseline characteristics of randomized 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 41 of 64 
Template Revised On: 11/01/2021      
groups will be summarized to assess whether any chance imbalances between 
groups are scientifically meaningful. If necessary, imbalanced variables will be 
adjusted for in outcome analyses. For variables with > 10% missing values, we will 
compare characteristics between individuals with missing and non-missing values 
and perform multiple imputation if needed.123 Since several hypotheses on different 
outcomes are of interest, we will focus mainly on reporting confidence intervals 
rather than null hypothesis significance testing, an approach in line with current 
recommendations.124 If the overall intervention effect is sufficiently large (i.e., of 
similar clinically meaningful size that we are powered to detect), we will use 
exploratory analyses to assess the presence and magnitude of possible treatment-
covariate interactions, where again the focus will remain on identifying interactions 
of a clinically meaningful magnitude rather than those that achieve a pre-
determined significance threshold. In particular, we will investigate the influence of 
sex as a biological variable by assessing whether intervention effects vary by sex. 
While the primary analyses will be conducted within an intent-to-treat (as 
randomized) framework, we will also perform dose-adjusted analyses to investigate 
the association between frequency and volume of use of the mobile market and the 
outcomes of interest, and whether these usage measures mediate the effects of the 
intervention.125 For process and implementation measures taken at the site level, 
the focus will be mainly on creating meaningful descriptive statistics and 
visualizations. 
Aim 2: The main purchasing outcomes will be the average number of servings of 
fruits and vegetables purchased each week. These outcomes will be treated as 
continuous variables and modeled using mixed effects regression models with 
random effects for participant, site, and time. Initially, we will fit separate models 
for each outcome (average fruit, and vegetable servings purchased each week); we 
will also consider joint outcome models that use the vector of servings (fruit, 
vegetables) as the outcome. These models will be used to assess whether temporal 
trends in food purchases are different between study groups, and whether any 
differences in trends identified are modified by other baseline covariates, including 
sex as a biological variable. If any outcomes are zero-inflated, we will consider 
regression models which accommodate this, e.g., negative binomial regression. 
Similar approaches will be used to analyze intervention effects on other purchasing 
outcomes. Further, we will perform exploratory analyses to identify trends and 
patterns in intervention site participant mobile market purchases (tracked with 
customer loyalty cards) over the 6 month intervention period.  
Aim 3: Quantitative statistical procedures and analysis. We will use mixed effects 
(i.e., repeated measures) models similar to those in Aim 2 to quantify associations 
between personal, social, environmental, and behavioral factors and the 
quantitative shopping adoption outcome measures for intervention group 
participants. We will construct both univariate and multivariate models to consider 
the independent and joint effects of each of these explanatory factors, along with 
exploring other potential predictors of shopping adoption (e.g., sociodemographic 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 42 of 64 
Template Revised On: 11/01/2021      
characteristics, dietary quality, food insecurity). We will also perform additional 
analyses to quantify joint associations between baseline factors, shopping adoption, 
and perceived mobile market features at follow-up.  
Aim 3. Qualitative analysis procedures and analysis. Interviews will be transcribed 
verbatim and verified for accuracy.126 Transcripts will be analyzed separately for high 
and low adopters using conventional content analysis127 to identify major 
themes/subthemes. A team approach with two coders will facilitate analysis quality 
and rigor allowing for clearer and deeper understanding to be reached.128 Prior to 
analysis, both coders will document personal preconceptions, topic knowledge, and 
feelings related to the study to facilitate objectivity.128,129 Then, a two-step process 
will be used. First, transcripts will be reviewed to identify themes. Second, coders 
will independently read each transcript several times and code responses into the 
themes identified in step one using qualitative data analysis software.127 Codes 
assigned by the coders will be compared, and discrepancies in coding will be 
discussed to reach consensus.130,131 Next, the investigator team will compare themes 
and subthemes between high and low market adopters and assess for convergences 
and divergences between quantitative and qualitative findings. Similarities and 
differences will be detailed and supported with exemplar quotes. Additionally, as 
noted as part of the process evaluation, all intervention participants will answer 
open-ended qualitative questions about features that make the market helpful and 
suggestions for improvement. This opened-ended qualitative process data will 
provide further insights on mobile market implementation. This data will be 
analyzed apart from the qualitative interviews; however, content analysis and 
methods described above will be used to generate themes of findings from the 
data.127 
 
17.4 Data Integrity:  
Data collection is the responsibility of the study staff under the supervision 
of the study investigator.  The investigator is responsible for ensuring the accuracy, 
completeness, legibility, and timeliness of the data reported. Data collected in the 
field from participants will be collected primarily via web-based REDCap surveys 
completed on iPads with paper-pen back-ups in case of technical failure. If needed 
the paper-pen surveys will be entered into the secure REDcap Database by two 
different study staff and verified for accuracy.  
Data will be extracted from the REDCap study database and prepared for analysis in 
the statistical software R.132 Data quality checks will be performed to identify 
potential data entry errors. A comprehensive data dictionary will be maintained as a 
standalone CSV, allowing variables to be read and properly labeled by any statistical 
software program. 
 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 43 of 64 
Template Revised On: 11/01/2021      
18.0 Health Information and Privacy Compliance 
18.1 Select which of the following is applicable to your research: 
x My research does not require access to individual health information and 
therefore assert HIPAA does not apply.  The HIPCO office was contacted prior 
to submission to determine whether HIPAA would apply. We received the 
following guidance (also documented in a PDF submitted to ETHOS): 
“ Lauren Popp from HIPCO confirmed that since your study is asking just a 
cursory question and not collecting PHI or doing anything clinical, HIPAA would 
not apply. 
In your Protocol, you can just indicate that in the section about HIPAA 
Authorization (there is a check box for it) and you needn't worry about the 
Email or Text forms, etc.” 
☐ I am requesting that all research participants sign a HIPCO approved HIPAA 
Disclosure Authorization to participate in the research (either the standalone 
form or the combined consent and HIPAA Authorization). 
☐ I am requesting the IRB to approve a Waiver or an alteration of research 
participant authorization to participate in the research. 
Appropriate Use for Research:  
☐ An external IRB (e.g. Advarra) is reviewing and we are requesting use of the 
authorization language embedded in the template consent form in lieu of the U 
of M stand-alone HIPAA Authorization.  Note: External IRB must be serving as 
the privacy board for this option. 
 
18.2 
Identify the source of Private Health Information you will be using for your 
research (Check all that apply)   
☐ I will use the Informatics Consulting Services (ICS) available through CTSI (also 
referred to as the University's Information Exchange (IE) or data shelter) to pull 
records for me 
☐ I will collect information directly from research participants. 
☐ I will use University services to access and retrieve records from the Bone 
Marrow Transplant (BMPT) database, also known as the HSCT (Hematopoietic 
Stem Cell Transplant) database. 
☐ I will pull records directly from EPIC. 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 44 of 64 
Template Revised On: 11/01/2021      
☐ I will retrieve record directly from axiUm / MiPACS 
☐ I will receive data from the Center for Medicare/Medicaid Services  
☐ I will receive a limited data set from another institution  
☐ Other.  Describe:  
18.3 
Explain how you will ensure that only records of patients who have agreed to have 
their information used for research will be reviewed. Not applicable. 
18.4 
Approximate number of records required for review: Not applicable. 
18.5 
Please describe how you will communicate with research participants during the 
course of this research.  Check all applicable boxes 
☐ This research involves record review only. There will be no communication with 
research participants. 
☐ Communication with research participants will take place in the course of 
treatment, through MyChart, or other similar forms of communication used 
with patients receiving treatment.  
☐ Communication with research participants will take place outside of treatment 
settings. If this box is selected, please describe the type of communication and 
how it will be received by participants.  
18.6 
Access to participants: not applicable. 
 
18.7 Location(s) of storage, sharing and analysis of research data, including any links to 
research data (check all that apply).   
☐ In the data shelter of the Information Exchange (IE)  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In the Bone Marrow Transplant (BMT) database, also known as the HSCT 
(Hematopoietic Stem Cell Transplant) Database  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In REDCap (recap.ahc.umn.edu)  
 x Store  
☐ Analyze 
☐ Share 
☐ In Qualtrics (qualtrics.umn.edu) 
 ☐ Store 
☐ Analyze 
☐ Share 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 45 of 64 
Template Revised On: 11/01/2021      
☐ In OnCore (oncore.umn.edu)  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In the University’s Box Secure Storage (box.umn.edu) 
 x Store  
x Analyze 
x Share 
☐ In an AHC-IS supported server. Provide folder path, location of server and IT 
Support Contact: 
 ☐ Store 
☐ Analyze 
☐ Share 
☐In an AHC-IS supported desktop or laptop.  
Provide UMN device numbers of all devices: 
HIPCO requires and will confirm that devices used in this manner are properly 
encrypted.  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ Other.  
Indicate if data will be collected, downloaded, accessed, shared or stored using a 
server, desktop, laptop, external drive or mobile device (including a tablet computer 
such as an iPad or a smartform (iPhone or Android devices) that you have not 
already identified in the preceding questions 
☐I will use a server not previously listed to collect/download research data 
☐I will use a desktop or laptop not previously listed 
☐I will use an external hard drive or USB drive (“flash” or “thumb” drives) not 
previously listed  
x I will use a mobile device such as an tablet or smartphone not previously listed: 
We will purchase two study cell phones to be able to contact research participants 
with by text or phone. These cell phones will be password protected and contain no 
information besides participants names and phone numbers for communication. All 
contact information will be deleted at the end of each Wave. We will also have a 
digital voice recorder to record qualitative interviews. Upon completion of each 
interview the audio file will be moved to BOX immediately and then deleted from 
the recorder.  
18.8 Consultants. Vendors. Third Parties. NA 
18.9 Links to identifiable data: NA 
 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 46 of 64 
Template Revised On: 11/01/2021      
18.10 Sharing of Data with Research Team Members. Any research related data will be 
stored and shared in a secure, password protected Box file and shared only with 
IRB-approved members of the study team.  
 
18.11 Storage of Documents: NA 
 
18.12 Disposal of Documents:  NA 
19.0 Confidentiality 
19.1 Data Security: 
Training. All study staff will be appropriately trained to this protocol and its 
requirements, including maintenance of participant confidentiality. 
Authorization of access. Only designated IRB-approved staff will have access to the 
data. 
Confidentiality. Individual participant information obtained as a result of this study  
is considered confidential. Information will be accessible to authorized parties or 
personnel only. All reports, and other records will be identified in a manner 
designed to maintain participant confidentiality. All paper study records will be kept 
in a secure storage area with limited access. Any paper-pen surveys will be entered 
into the electronic secure database (REDCap) and then stored in a locked space in a 
locked file cabinet within the School of Nursing. Any physical files that have 
identifiable data (e.g., consent form) will be secured and locked separately than files 
identified only with participant ID number. The consent form and other research 
study information will not be placed in the participants’ medical, employment, or 
educational records. 
Certificates of Confidentiality. Since this study will be funded by an NIH Grant, a 
Certificate of Confidentiality is automatically granted. All entities that are part of this 
study will be subject to the requirements of this Certificate.  
Separation of Identifiers and data. Participants will be assigned a unique identifier 
assigned sequentially as they enroll. The Contact Log database that links 
participants’ identifiable information to their identifier will be password protected 
accessible only to those who need the information to do their jobs.   
Research databases in REDCap will contain the participant’s unique ID number along 
with name and phone number to allow for text message reminders via REDCap’s 
Twilio feature. However, these fields will be marked as “identifiers” within REDCap 
and only staff who need this information to do their jobs will be able to export these 
fields. All data files exported for analysis will not include identifiers.  
All other research data will be identified only with the participant’s unique ID 
number and will be stored in a separate database that will be password protected 
accessible only to those who need the data to do their jobs. The links will be 
destroyed after the completion of the study.  

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 47 of 64 
Template Revised On: 11/01/2021      
Data storage. Data for this study will be collected using web-based REDCap survey 
or with paper-pen that will be entered into a REDCap database, which 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 
Center’s 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 1 month, 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. The electronic deidentified data will be downloaded from the Redcap and 
stored in Box in a password-protected file structure, password-protected server.  
NDSR is a software program that will be used to collect dietary recall 
interviews from participants and assess nutritional quality of participant food 
purchases. For recalls, the data stored in NDSR is deidentified in that it will contain 
participant first name (so the interviewer can greet the participant by name), 
participant study ID number, date of dietary recall interview/fruit & vegetable form, 
participant sex, recall number (first, second, or third), dietary data, any notes about 
the recall interview/fruit & vegetable form, and staff who completed the recall. 
Similarly, for fruit and vegetable form data entry, the data stored in NDSR will 
contain participant study ID number, sex, date & location of purchase, which 
purchase form it was (i.e., week 1, 2, 3, or 4), dietary data, any notes about the 
form, and staff who completed the data entry. These deidentified dietary data will 
be extracted from NDSR and stored on Box. 
We will also have a digital voice recorder to record qualitative interviews. 
Upon completion of each interview the audio file will be moved to BOX immediately 
and then deleted from the recorder.  
We will collect participant purchasing data through the Market Members 
loyalty program. This loyalty program and the data it collects is for all mobile market 
customers who sign up for business purposes and not just for those enrolled in the 
study. UMN study staff will extract participant-specific purchase data from the larger 
mobile market loyalty database (that does not link to whether a person is in the 
study or study ID number) through the matching of participants to those in the 
larger database using unique customer numbers that are generated by the Market 
Members software that can be matched with our participant IDs. After the purchase 
data is extracted, the names and customer numbers will be removed and replaced 
with the participant study ID number. The purchase data linked to the participant ID 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 48 of 64 
Template Revised On: 11/01/2021      
number will then be uploaded into REDCap or BOX. See the Mobile Market 
purchasing data protocol.  
Password protection/encryption/physical controls: All electronic data will 
be stored in REDCap and Box. Audio files will be downloaded from audio recorders 
to Box immediately after the interview. Voice recordings and de-identified 
transcriptions of the audio will also be saved on Box. Password protected files / data 
sets will be stored and accessible through REDCap or Box for those research team 
members. Research team members will only be given access to the 
databases/files/documents that they need to complete their work.  
 
20.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
20.1 Data Integrity Monitoring.  
Team meetings will occur regularly (at least monthly) with study investigators to 
discuss regular monitoring of study progress and study safety. At these meetings, 
the study team will discuss recruitment efforts, monitoring participant distribution 
and progress toward enrollment targets.  
Data collected since the previous meeting will be discussed, and the team will 
review whether approved protocols are working well.  
20.2 Data Safety Monitoring.  
Please see the attached DSMP reviewed by the project officer at NINR. Any 
modifications to this DSMP will be submitted to NINR for pre-review prior to 
submission to the UMN IRB for review and approval. 
21.0 Compensation for Research-Related Injury 
21.1 Compensation for Research-Related Injury: In the event that research-related 
activities result in an injury, treatment will be provided to the participant (e.g., first 
aid, emergency treatment, and follow-up care as needed). Care for such injuries will 
be billed in the ordinary manner to the participant or the participant’s insurance 
company. 
21.2 Contract Language: Not applicable.  
22.0 Consent Process 
22.1 Consent Process:  
• Where the consent process will take place: The consent forms will be 
mailed to interested and eligible participants in advance of the 
baseline data collection visit. The process of informed consent will 
take place at baseline data visits in a private and confidential space 
[using a privacy screen if needed]. Prior to beginning data collection, 
the trained research staff will read through the consent form with 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 49 of 64 
Template Revised On: 11/01/2021      
each participant, answering any questions the participant has, and 
using teach back to make sure the participant understands what 
he/she/they is consenting to (e.g., time commitment, research 
methods inclusive of baseline and follow-up surveys, dietary recalls, 
fruit & vegetable data collection, risks, benefits, compensation, 
voluntary, etc as outlined in full in the consent form). Following this, if 
the participant is willing to consent and participate in the study, the 
research staff and participant will complete and sign the consent form.  
The participants may withdraw consent at any time throughout the 
course of the study. A copy of the signed informed consent document 
will be given to the participants for their records. The rights and 
welfare of the participants will be protected by emphasizing to them 
that their ability to shop at the mobile market will not be adversely 
affected if they decline to participate in this study.   
Participants will also be provided with a Participant Guide that 
describes the study activities to help participants understand the study 
activities if/when they consent. 
• Any waiting period available between informing the prospective participants 
and obtaining the consent. There will be no waiting period required between 
informing the prospective participants and obtaining the consent, unless 
participants wish to think about their decision. Participants will have the 
opportunity to carefully review the informed consent form and ask questions 
prior to signing. The participants will also have the opportunity to discuss the 
study with others or think about it prior to agreeing to participate if they wish. 
• Any process to ensure ongoing consent. Participants will be informed that at 
any point in time, they are free to no longer be in the study and may choose 
to leave the trial. Formal written consent will take place only at the start of 
the study; however, at subsequent study encounters, interest in continued 
participation will be assessed at study visits. 
22.2 Waiver or Alteration of Consent Process (when consent will not be obtained, 
required information will not be disclosed, or the research involves deception):  
● 
Not applicable.  
22.3 Waiver of Written/Signed Documentation of Consent (when written/signed consent 
will not be obtained):  
● 
Not applicable.  
22.4 Non-English Speaking Participants: We are currently allowing ASL speakers to 
participate in the study. There may be recruitment and inclusion of additional non-
English speaking participants as part of this research study eventually, as we expand 
the study to community sites that have larger non-English speaking populations. The 
languages selected will be based on the communities we recruit for mobile market 
stops (anticipated languages are Spanish and Hmong). However, we will amend this 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 50 of 64 
Template Revised On: 11/01/2021      
protocol with additional protocols/processes, safeguards, and certified translations 
of study materials like the consent forms, surveys, etc after we know what 
languages the trial will be completed in. We will make these modifications, submit 
for IRB approval, and await IRB approval prior to recruiting or enrolling participants 
who speak languages other than English. 
22.5 Participants Who Are Not Yet Adults (infants, children, teenagers under 18 years of 
age): 
● 
Not applicable – not recruiting individuals under 18 years of age (Participants 
will be asked upon screening if they are 18 years of age or over. If not 18 years 
of age or older they will not be able to participate in the study).  
22.6 Cognitively Impaired Adults, or adults with fluctuating or diminished capacity to 
consent: 
● 
We do not anticipate enrolling individuals with impaired capacity to consent. 
Assessment of capacity to consent will be informally made during routine 
interactions with participants. No specific assessment or documentation of 
capacity is required under those circumstances. 
22.7 Adults Unable to Consent: 
● 
Not applicable.  
23.0 Setting 
23.1 Research Sites:  
● 
The trial investigator team is housed at the 
o University of Minnesota and  
o The Twin Cities Mobile Market of The Food Group. The Twin Cities 
Mobile Market that brings affordable, fresh and healthy food 
options to low income or low food access communities. The Mobile 
Market provides service in partnership with their community site 
partners.  
● 
Recruitment will occur in the community in/around the community site 
partner locations recruited for the trial. 
● 
Data collection will occur in the community meeting spaces in/around the 
community site partner locations (e.g., community meeting rooms, library 
meeting rooms). Data collection will also occur by phone and mail. 
● 
Mobile market service for community site locations recruited for the trial will 
occur at the location agreed upon between the community site partner and 
the Twin Cities Mobile Market. Again, important to note, that this service will 
occur just as it does at ongoing sites currently receiving the mobile market 
with no affiliation with the trial and anyone within the community (regardless 
of their participation in the trial) will be able to shop at the mobile market.  

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 51 of 64 
Template Revised On: 11/01/2021      
● 
The Food Group does not engage in research outside of this grant. It provides 
food resources and services throughout the community. Thus, it does not have 
site specific regulations/customs related to research and will follow those at 
the University of Minnesota and will work with PI Horning and the UMN IRB for 
ethical oversight. 
23.2 International Research:  
● 
Not applicable.  
23.3 Community Based Participatory Research:  
● 
Twin Cities Mobile Market is the community partner of the study that has been 
involved in preliminary studies and during grant development. This 
involvement will continue and one of their staff is a co-investigator on the 
study. They will continue to advise to ensure the research is acceptable and 
aligned with their community values and priorities. All research related 
actions/materials (e.g., survey, flyer, etc) will be reviewed and adapted per 
their recommendations, as needed, and will be sent to the IRB for re-review if 
changes are made. 
● 
As a result of participation at the level of co-investigator, Ms. Stephanie 
Wagner has completed the Human Research: Social / Behavioral or Humanist 
Research Investigators and Key Personnel training. She will complete the 
required HIPAA confidentiality training as well.  
● 
Other mobile market staff will provide regular mobile market service at the 
community sites recruited for this trial. This service will be the same service 
they provide at their other community site locations that currently receive 
service (those that are active an ongoing, not part of the study) and service at 
the community sites of this trial will be open to the general public (not just 
those enrolled in the study). Because the staff’s involvement is limited to 
providing a service that is currently being provided in the city, these mobile 
market staff will receive a training on research ethics and the process and 
protocols of the study by the researcher or designated research staff in case a 
participant self-identifies themselves to a staff member while on the mobile 
market and has a question about the research study. In this case, the mobile 
market staff will be trained to refer these individuals to the researcher if the 
question is about research. 
● 
To align our work with community engaged research principles, we seek to 
make sure the research process is as smooth and friendly to potential research 
participants as can be. Thus, the Mobile Market in partnership with university 
research staff/investigator(s) will be hosting informal community meetings 
with ongoing customers at existing non-research sites. These individuals are 
NOT potential research participants to discuss what works on the mobile 
market, what could be improved to make mobile market service even better, 
and to inform the proposed research processes (e.g., review of flyers, 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 52 of 64 
Template Revised On: 11/01/2021      
recruitment/retention plans, participant flow through data collection 
experience, data collection instruments for ease of use, etc.). Community 
members who take part in these meetings will receive a light meal (breakfast 
or lunch) and a $20 mobile market gift card for their time in the meeting and a 
t-shirt (if they have not already received one). 
24.0 See letters of support from the grant. Multi-Site Research  
24.1 Study-Wide Number of Participants: 264 
24.2 Study-Wide Recruitment Methods: See plan for human subjects recruitment above – 
only UMN research staff will be conducting human subjects recruitment.  
24.3 Study-Wide Recruitment Materials: See plan for human subjects recruitment above 
– only UMN research staff will be conducting human subjects recruitment. 
24.4 Communication Among Sites:  
● 
The Food Group and the UMN team will meet regularly. Depending on time in 
the study this meeting interval may vary from weekly (for instance when in 
active recruitment or mobile market launch) to biweekly or at most no longer 
than monthly (for instance when in data analysis phase) to discuss the trial 
activities and updates. 
● 
The most current approved versions of the protocol and documents will be 
stored in a Box secured file (as well as in ETHOS).  
● 
The initial, continuing review, and modification IRB approvals required will be 
documented and stored in the shared secure password protected Box file as 
well as within the ETHOS system.  
● 
All modification submissions and approvals will also be communicated at 
meetings and through email. Until formal communication (by email or meeting 
minutes) of approvals of modifications, no modifications will be able to be 
implemented.  
● 
Identifiable and research survey data is only being collected by the UMN 
research staff.  
● 
The mobile market will be collecting real-time purchasing data as part of their 
Market Members program from all customers (not just those within the trial) 
as part of their mobile market program. The mobile market will provide a UMN 
research staff member access to this data to be able to extract the data for 
research participants only per the research participants consent with their 
consent form. The mobile market co-I nor mobile market staff will not be given 
the identifiable information of research participants, as it will not be needed to 
do their job.  
● 
The mobile market will also collect process data related to overall sales of the 
mobile market at mobile market sites receiving service as part of the trial. This 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 53 of 64 
Template Revised On: 11/01/2021      
data is not linked to individual customers. This data will be shared with UMN 
research staff by giving UMN research staff access to download the data from 
the mobile market’s electronic cash register that collects point of sale data. 
● 
De-identified data will be stored and shared in password protected secure box 
files and those who need access will be granted access to the files. 
● 
All local site investigators will conduct the study in accordance with applicable 
federal regulations and local laws. 
● 
All non-compliance with the study protocol or applicable requirements will be 
reported in accordance with university or local policy. 
● 
All other reportable events in accordance with university or local policy. 
24.5 Communication to Sites:  
● 
Problems (inclusive of reportable events) will be communicated by the 
timelines as outlined in the DSMP document referred to in this protocol in 
section 20.2. 
● 
Study progression will be communicated in regular meetings and email 
communication between UMN and Mobile Market staff. 
● 
The closure of the study will be planned for and communicated in budget 
conversations, regular meetings and emails between UMN and Mobile Market 
staff. 
25.0 Coordinating Center Research 
Not applicable. 
26.0 Resources Available 
26.1 Resources Available:  
● 
We are recruiting from community site locations that the mobile market bring 
service to. Thus, we are sampling from the community and the inclusion 
criteria requires the participant to live within a half mile of the community site 
location closest to them, which provides us with an ample population to 
recruit from.  
● 
The grant will fund the time of the research team and mobile market staff for 
the intervention; the grant will also fund the intervention itself and all other 
research activities. 
● 
Please see the attached facilities and resources attachment for facilities and 
resources. 
● 
It is not anticipated that the study participants will need medical or 
psychological resources as a result of participating in the study. However, if 
such resources are requested by a participant, the research staff will make the 
appropriate referral.  

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 54 of 64 
Template Revised On: 11/01/2021      
● 
Because we expect our study population is at high risk for food insecurity, we 
plan to offer all participants a handout that lists food relief services (e.g., food 
shelves) and contact information for Hunger Solutions (an organization that 
helps people identify food assistance programs they may quality for and 
assistance with signing up for assistance.  
● 
All persons who will assist with the research will receive training to the study 
protocols and procedures by the PI or designated research team member (e.g., 
project manager) and will be trained in all human subjects research ethics 
training. These individuals will all be added to the study team within ETHOS for 
IRB approval and review. The persons who assist with the research will also be 
given training on how to perform their role within the study by the PI or 
designated research team member and demonstrate they are proficient in the 
activities assigned. 
27.0 References 
1.  
Centers for Disease Control and Prevention. Leading Causes of Death. Published 2020. 
http://www.cdc.gov/nchs/fastats/leading-causes-of-death.htm 
2.  
National Academies of Sciences  and Medicine E. Guiding Principles for Developing Dietary 
Reference Intakes Based on Chronic Disease. (Kumanyika S, Oria MP, eds.). The National 
Academies Press; 2017. doi:10.17226/24828 
3.  
Afshin A, Sur PJ, Fay KA, et al. Health effects of dietary risks in 195 countries, 1990-2017: 
Asystematic analysis for the Global Burden of Disease Study 2017. Lancet. 
2019;393(10184):1958-1972. doi:10.1016/S0140-6736(19)30041-8 
4.  
NIH. 2020 – 2030 Strategic Plan for NIH Nutrition Research. Published online 2020:1-21. 
https://www.niddk.nih.gov/about-niddk/strategic-plans-reports/strategic-plan-nih-
nutrition-research 
5.  
Rehm CD, Peñalvo JL, Afshin A, Mozaffarian D. Dietary intake among US Adults, 1999-2012. 
JAMA - J Am Med Assoc. 2016;315(23):2542-2553. doi:10.1001/jama.2016.7491 
6.  
Centers for Disease Control and Prevention. Adult Obesity Facts. Published 2018. 
https://www.cdc.gov/obesity/data/adult.html 
7.  
Hales CM, Carroll MD, Fryar CD, Ogden CL. Prevalence of Obesity among Adults and Youth: 
United States 2015-2016.; 2017. 
8.  
Ogden CL, Fakhouri TH, Carroll MD, et al. Prevalence of Obesity Among Adults, by 
Household Income and Education - United States, 2011-2014. MMWR Morb Mortal Wkly 
Rep. 2017;66(50):1369-1373. doi:10.15585/mmwr.mm6650a1 
9.  
Benjamin EJ, Virani SS, Callaway CW, et al. Heart Disease and Stroke Statistics - 2018 
Update: A Report from the American Heart Association. Vol 137.; 2018. 
doi:10.1161/CIR.0000000000000558 
10.  
Centers for Disease Control Prevention. Diabetes 2017 Report Card.; 2018. 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 55 of 64 
Template Revised On: 11/01/2021      
https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf 
11.  
United States Department of Agriculture. Key statistics & graphics: Food insecurity status. 
Published 2019. https://www.ers.usda.gov/topics/food-nutrition-assistance/food-security-
in-the-us/key-statistics-graphics.aspx#foodsecure 
12.  
Leonard T, Hughes AE, Donegan C, Santillan A, Pruitt SL. Overlapping geographic clusters of 
food security and health: Where do social determinants and health outcomes converge in 
the U.S? SSM - Popul Heal. 2018;5(February):160-170. doi:10.1016/j.ssmph.2018.06.006 
13.  
United States Department of Agriculture. Definitions of Food Security. Published 2019. 
https://www.ers.usda.gov/topics/food-nutrition-assistance/food-security-in-the-
us/definitions-of-food-security.aspx 
14.  
United States Department of Agriculture. Food security in the United States. Published 
2019. https://www.ers.usda.gov/topics/food-nutrition-assistance/food-security-in-the-us/ 
15.  
Leung CW, Tester JM. The Association between Food Insecurity and Diet Quality Varies by 
Race/Ethnicity: An Analysis of National Health and Nutrition Examination Survey 2011-
2014 Results. J Acad Nutr Diet. Published online 2018. doi:10.1016/j.jand.2018.10.011 
16.  
Bruening M, MacLehose R, Loth K, Story M, Neumark-Sztainer D. Feeding a family in a 
recession: Food insecurity among Minnesota parents. Am J Public Health. 2012;102(3):520-
526. doi:10.2105/AJPH.2011.300390 
17.  
Hanson KL, Connor LM. Food insecurity and dietary quality in US adults and children: A 
systematic review. Am J Clin Nutr. 2014;100(2):684-692. doi:10.3945/ajcn.114.084525 
18.  
Arenas DJ, Zhou S, Thomas A, et al. Negative health outcomes associated with food 
insecurity status in the United States of America : A systematic review of peer-reviewed 
studies. Published online 2018:1-41. doi:10.31232/OSF.IO/UK9XW 
19.  
Moradi S, Mirzababaei A, Dadfarma A, et al. Food insecurity and adult weight abnormality 
risk: a systematic review and meta-analysis. Eur J Nutr. 2019;58(1):45-61. 
doi:10.1007/s00394-018-1819-6 
20.  
Gundersen BC, Ziliak JP. Food Insecurity And Health Outcomes. Health Aff. 
2015;34(11):1830-1839. doi:10.1377/hlthaff.2015.0645 
21.  
Gregory CA, Coleman-Jensen A. Economic Research Service Food Insecurity, Chronic 
Disease, and Health Among Working-Age Adults.; 2017. www.ers.usda.gov 
22.  
Abdurahman AA, Chaka EE, Nedjat S, Dorosty AR, Majdzadeh R. The association of 
household food insecurity with the risk of type 2 diabetes mellitus in adults: a systematic 
review and meta-analysis. Eur J Nutr. 2019;58(4):1341-1350. doi:10.1007/s00394-018-
1705-2 
23.  
Vercammen KA, Moran AJ, McClain AC, Thorndike AN, Fulay AP, Rimm EB. Food Security 
and 10-Year Cardiovascular Disease Risk Among U.S. Adults. Am J Prev Med. 
2019;56(5):689-697. doi:10.1016/j.amepre.2018.11.016 
24.  
Berkowitz SA, Basu S, Meigs JB, Seligman HK. Food Insecurity and Health Care Expenditures 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 56 of 64 
Template Revised On: 11/01/2021      
in the United States, 2011–2013. Health Serv Res. 2018;53(3):1600-1620. 
doi:10.1111/1475-6773.12730 
25.  
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. doi:10.1017/S1368980017004062 
26.  
Tarasuk V, Mitchell A, Mclaren L, Mcintyre L. Chronic physical and mental health conditions 
among adults may increase vulnerability to household food insecurity. Int J Nutr. 
2013;143:1785-1793. doi:10.3945/jn.113.178483.food 
27.  
U.S. Department of Health & Human Services. Multiple Chronic Conditions—A Strategic 
Framework: Optimum Health and Quality of Life for Individuals with Multiple Chronic 
Conditions.; 2010. 
https://www.hhs.gov/sites/default/files/ash/initiatives/mcc/mcc_framework.pdf 
28.  
United States Department of Agriculture. Food access. Published 2019. 
https://www.ers.usda.gov/data-products/food-access-research-atlas/documentation/ 
29.  
United States Department of Agriculture. Food Security and Nutrition Assistance.; 2019. 
https://www.ers.usda.gov/data-products/ag-and-food-statistics-charting-the-
essentials/food-security-and-nutrition-assistance/ 
30.  
Hunger Solutions. 2017 USDA food insecurity data. Published 2019. 
http://www.hungersolutions.org/data-posts/2017-usda-food-insecurity-data/ 
31.  
MacNell L, Elliott S, Hardison-Moody A, Bowen S. Black and Latino urban food desert 
residents’ perceptions of their food environment and factors that influence food shopping 
decisions. J Hunger Environ Nutr. 2017;12(3):375-393. 
doi:10.1080/19320248.2017.1284025 
32.  
Kaiser ML, Carr JK, Fontanella S. A tale of two food environments: Differences in food 
availability and food shopping behaviors between food insecure and food secure 
households. J Hunger Environ Nutr. Published online December 18, 2017:1-21. 
doi:10.1080/19320248.2017.1407723 
33.  
Theuri SW, McCullough JL, Rennels J. Assessing access to fruit and vegetable in urban 
underserved communities. J Hunger Environ Nutr. 2016;11(1):59-71. 
doi:10.1080/19320248.2015.1045669 
34.  
Horning ML, Fulkerson JA. A systematic review on the affordability of a healthful diet for 
families in the United States. Public Health Nurs. 2015;32(1). doi:10.1111/phn.12145 
35.  
Rogus S. Do the poor pay more for food? A review of food price disparities in urban 
environments. J Hunger Environ Nutr. 2015;10(4):549-566. 
doi:10.1080/19320248.2014.962775 
36.  
Drewnowski A. Obesity and the food environment: Dietary energy density and diet costs. 
Am J Prev Med. 2004;27(3):154-162. doi:10.1016/j.amepre.2004.06.011 
37.  
Seligman HK, Schillinger D. Hunger and socioeconomic disparities in chronic disease. N Engl 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 57 of 64 
Template Revised On: 11/01/2021      
J Med. 2010;363(1):6-9. doi:10.1056/NEJMp1000072 
38.  
Dinour LM, Bergen D, Yeh M-C. The food insecurity-obesity paradox: a review of the 
literature and the role food stamps may play. J Am Diet Assoc. 2007;107(11):1952-1961. 
doi:10.1016/j.jada.2007.08.006 
39.  
Abeykoon AMH, Engler-stringer R, Muhajarine N. Health-related outcomes of new grocery 
store interventions : a systematic review. 2017;20(12):2236-2248. 
doi:10.1017/S1368980017000933 
40.  
Cummins S, Flint E, Matthews SA. New Neighborhood Grocery Store Increased Awareness 
Of Food Access But Did Not Alter Dietary Habits Or Obesity. Health Aff. 2014;33(2):283-
291. doi:10.1377/hlthaff.2013.0512 
41.  
Dubowitz T, Ghosh-Dastidar M, Cohen DA, et al. Diet and perceptions change with 
supermarket introduction in a food desert, but not because of supermarket use. Health 
Aff. 2015;34(11):1858-1868. doi:10.1377/hlthaff.2015.0667 
42.  
Rogus S, Athens J, Cantor J, Elbel B. Measuring micro-level effects of a new supermarket: 
Do Residents within 0.5 mile have improved dietary behaviors? J Acad Nutr Diet. 
2018;118(6):1037-1046. doi:https://doi.org/10.1016/j.jand.2017.06.360 
43.  
Engler-Stringer R, Fuller D, Abeykoon AMH, Olauson C, Muhajarine N. An examination of 
failed Grocery store interventions in former food deserts. Heal Educ Behav. 
2019;46(5):749-754. doi:10.1177/1090198119853009 
44.  
Elbel B, Mijanovich T, Kiszko K, Abrams C, Cantor J, Dixon LB. The introduction of a 
supermarket via tax-credits in a low-income area: The influence on purchasing and 
consumption. Am J Heal Promot. 2017;31(1):59-66. doi:10.4278/ajhp.150217-QUAN-733 
45.  
Elbel B, Moran A, Dixon LB, et al. Assessment of a government-subsidized supermarket in a 
high-need area on household food availability and children’s dietary intakes. Public Health 
Nutr. 2015;18(15):2881-2890. doi:10.1017/S1368980015000282 
46.  
Hollis-Hansen K, Vermont L, Zafron ML, Seidman J, Leone L. The introduction of new food 
retail opportunities in lower-income communities and the impact on fruit and vegetable 
intake: a systematic review. Transl Behav Med. 2019;9(5):837-846. 
doi:10.1093/tbm/ibz094 
47.  
Moran AJ, Gu Y, Clynes S, Goheer A, Roberto CA, Palmer A. Associations between 
governmental policies to improve the nutritional quality of supermarket purchases and 
individual, retailer, and community health outcomes: An integrative review. Int J Environ 
Res Public Health. 2020;17(20):1-23. doi:10.3390/ijerph17207493 
48.  
Martinez O, Tagliaferro B, Rodriguez N, Athens J, Abrams C, Elbel B. EBT payment for 
online grocery orders: A mixed-methods study to understand its uptake among SNAP 
recipients and the barriers to and motivators for its use. 2018;50(4):396-403. 
doi:10.1016/j.jneb.2017.10.003 
49.  
Brandt EJ, Silvestri DM, Mande JR, Holland ML, Ross JS. Availability of grocery delivery to 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 58 of 64 
Template Revised On: 11/01/2021      
food deserts in states participating in the online purchase pilot. JAMA Netw Open. 
2019;2(12):10-13. doi:10.1001/jamanetworkopen.2019.16444 
50.  
AbuSabha R, Namjoshi D, Klein A. Increasing Access and Affordability of Produce Improves 
Perceived Consumption of Vegetables in Low-Income Seniors. J Am Diet Assoc. 
2011;111(10):1549-1555. doi:10.1016/j.jada.2011.07.003 
51.  
Gorham G, Dulin-Keita A, Risica PM, et al. Effectiveness of Fresh to You, a discount fresh 
fruit and vegetable market in low-income neighborhoods, on children’s fruit and vegetable 
consumption, Rhode Island, 2010-2011. Prev Chronic Dis. 2015;12:E176. 
doi:10.5888/pcd12.140583 
52.  
Zepeda L, Reznickova A, Lohr L. Overcoming challenges to effectiveness of mobile markets 
in US food deserts. Appetite. 2014;79:58-67. doi:10.1016/j.appet.2014.03.026 
53.  
Tester J, Yen I, Laraia B. Using mobile fruit vendors to increase access to fresh fruit and 
vegetables for schoolchildren. Prev Chronic Dis. 2012;9(October 2008):1-5. 
doi:10.5888/pcd9.110222 
54.  
Hsiao B, Sibeko L, Wicks K, Troy LM. Mobile produce market influences access to fruits and 
vegetables in an urban environment. Public Health Nutr. 2018;21(7):1332-1344. doi:DOI: 
10.1017/S1368980017003755 
55.  
Gans KM, Risica PM, Keita AD, et al. Multilevel approaches to increase fruit and vegetable 
intake in low-income housing communities: final results of the ‘Live Well, Viva Bien’ 
cluster-randomized trial. Int J Behav Nutr Phys Act. 2018;15(1):80. doi:10.1186/s12966-
018-0704-2 
56.  
Leone LA, Tripicchio GL, Haynes-Maslow L, et al. Cluster randomized controlled trial of a 
mobile market intervention to increase fruit and vegetable intake among adults in lower-
income communities in North Carolina. Int J Behav Nutr Phys Act. 2018;15(1):2. 
doi:10.1186/s12966-017-0637-1 
57.  
Robinson JA., Weissman E, Adair S, Potteiger M, Villanueva J. An oasis in the desert ? The 
benefits and constraints of mobile markets operating in Syracuse , New York food deserts. 
Agric Human Values. 2016;33(4):877-893. doi:10.1007/s10460-016-9680-9 
58.  
Sparks D, Rudd C, Dahms GH, Tomassoni DJ, Ingebrigtsen B. 17.1017 Good Food Access 
Program: 2016 Minnesota Statutes.; 2016. 
https://www.revisor.mn.gov/statutes/?id=17.1017 
59.  
Horning ML, Porter LR. Twin Cities Mobile Market food delivery model : A preliminary 
study describing results of a customer intercept survey and point of sale data for 2016. J 
Hunger Environ Nutr. 2020;15(4):484-495. doi:10.1080/19320248.2019.1654426 
60.  
Amherst H Wilder Foundation. Twin Cities Mobile Market. 
61.  
Coleman-Jensen A, Rabbitt MP, Gregory CA, Singh A. Household Food Security in the United 
States in 2018, ERR-270.; 2019. 
62.  
Whelton P, Carey R, Aronow W, et al. 2017 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 59 of 64 
Template Revised On: 11/01/2021      
ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the 
prevention, detection, evaluation, and management of high blood pressure in adults: a 
report of the American College of Cardiology/American Heart Guidelines. J Am Coll Cardiol. 
2018;71:e127–248. doi:10.1016/j.jacc.2017.11.006 
63.  
National Center for Health Statistics Centers for Disease Control and Prevention. Obesity 
and Overweight. Published 2016. https://www.cdc.gov/nchs/fastats/obesity-
overweight.htm 
64.  
Horning ML, Porter LR, Hassan A, Edson E. Full-service Twin Cities Mobile Market Impact: 
Qualitative findings from focus groups with customers. J Acad Nutr Diet. 2020;120(9):1548-
1556.e1. doi:https://doi.org/10.1016/j.jand.2020.02.016 
65.  
Bucher T, Collins C, Rollo ME, et al. Nudging consumers towards healthier choices: a 
systematic review of positional influences on food choice. Br J Nutr. 2016;115(12):2252-
2263. doi:DOI: 10.1017/S0007114516001653 
66.  
Thaler RH, Sunstein CR, Balz JP. Choice Architecture. In: Shafir E, ed. The Behavioral 
Foundations of Public Policy. Princeton University Press; 2013:428-439. 
67.  
Garasky S, Mbwana K, Romualdo A, Tenaglio A, Roy M. Foods Typically Purchased by 
Supplemental Nutrition Assistance Program (SNAP) Households.; 2016. 
https://www.fns.usda.gov/snap/foods-typically-purchased-supplemental-nutrition-
assistance-program-snap-households 
68.  
Consumer Expenditure Survey Bureau of Labor Statistics. Selected Midwestern 
Metropolitan Statistical Areas: Average Annual Expenditures and Characteristics, Consumer 
Expenditure Survey, 2014-2015 (Table 3014). Vol Table 3014. Bureau of Labor Statistics; 
2016. http://www.bls.gov/cex/2015/msas/midwest.pdf 
69.  
Krebs-Smith SM, Pannucci TE, Subar AF, et al. Update of the Healthy Eating Index: HEI-
2015. J Acad Nutr Diet. 2018;118(9):1591-1602. 
doi:https://doi.org/10.1016/j.jand.2018.05.021 
70.  
Reedy J, Lerman JL, Krebs-Smith SM, et al. Evaluation of the Healthy Eating Index-2015. J 
Acad Nutr Diet. 2018;118(9):1622-1633. doi:https://doi.org/10.1016/j.jand.2018.05.019 
71.  
National Cancer Institute. Evaluating the Effect of an Intervention on Diet. Dietary 
Assessment Primer. Published 2019. 
https://dietassessmentprimer.cancer.gov/approach/intervention.html 
72.  
Bandura A. Health promotion from the perspective of social cognitive theory. 
2012;(March):37-41. 
73.  
Bronfenbrenner U.  Ecological models of human development. Int Encycl Educ. 
1994;3(2):37-43. http://www.psy.cmu.edu/~siegler/35bronfebrenner94.pdf 
74.  
Symmank C, Mai R, Hoffmann S, et al. Predictors of food decision making: A systematic 
interdisciplinary mapping (SIM) review. Appetite. 2017;110:25-35. 
doi:https://doi.org/10.1016/j.appet.2016.11.023 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 60 of 64 
Template Revised On: 11/01/2021      
75.  
Dover RVH, Lambert E V. “Choice Set” for health behavior in choice-constrained settings to 
frame research and inform policy: examples of food consumption, obesity and food 
security. Int J Equity Health. 2016;15(1):48. doi:10.1186/s12939-016-0336-6 
76.  
Sobal J, Bisogni CA. Constructing Food Choice Decisions. Ann Behav Med. 
2009;38(suppl_1):s37-s46. doi:10.1007/s12160-009-9124-5 
77.  
Stok FM, Hoffmann S, Volkert D, et al. The DONE framework: Creation, evaluation, and 
updating of an interdisciplinary, dynamic framework 2.0 of determinants of nutrition and 
eating. PLoS One. 2017;12(2):e0171077. https://doi.org/10.1371/journal.pone.0171077 
78.  
Rafacz SD. Healthy Eating: Approaching the Selection, Preparation, and Consumption of 
Healthy Food as Choice Behavior. Perspect Behav Sci. 2019;42(3):647-674. 
doi:10.1007/s40614-018-00190-y 
79.  
Winkler MR, Zenk SN, Baquero B, et al. A model depicting the retail food environment and 
customer interactions: Components, outcomes, and future directions. Int J Environ Res 
Public Health. 2020;17(20):1-21. doi:10.3390/ijerph17207591 
80.  
Caspi CE, Kawachi I, Subramanian S V, Adamkiewicz G, Sorensen G. The relationship 
between diet and perceived and objective access to supermarkets among low-income 
housing residents. Soc Sci Med. 2012;75(7):1254-1262. 
doi:http://dx.doi.org/10.1016/j.socscimed.2012.05.014 
81.  
Caspi CE, Sorensen G, Subramanian S V, Kawachi I. The local food environment and diet: A 
systematic review. Health Place. 2012;18(5):1172-1187. 
doi:http://dx.doi.org/10.1016/j.healthplace.2012.05.006 
82.  
Bivoltsis A, Cervigni E, Trapp G, Knuiman M, Hooper P, Ambrosini GL. Food environments 
and dietary intakes among adults: does the type of spatial exposure measurement matter? 
A systematic review. Int J Health Geogr. 2018;17(1):19. doi:10.1186/s12942-018-0139-7 
83.  
Darmon N, Drewnowski A. Contribution of food prices and diet cost to socioeconomic 
disparities in diet quality and health: A systematic review and analysis. Nutr Rev. 
2015;73(10):643-660. doi:10.1093/nutrit/nuv027 
84.  
Puddephatt J-A, Keenan GS, Fielden A, Reaves DL, Halford JCG, Hardman CA. ‘Eating to 
survive’: A qualitative analysis of factors influencing food choice and eating behaviour in a 
food-insecure population. Appetite. 2020;147:104547. 
doi:https://doi.org/10.1016/j.appet.2019.104547 
85.  
Evans A, Banks K, Jennings R, et al. Increasing access to healthful foods: a qualitative study 
with residents of low-income communities. Int J Behav Nutr Phys Act. 2015;12(1):S5. 
doi:10.1186/1479-5868-12-S1-S5 
86.  
Sleddens EFC, Kroeze W, Kohl LFM, et al. Correlates of dietary behavior in adults: an 
umbrella review. Nutr Rev. 2015;73(8):477-499. doi:10.1093/nutrit/nuv007 
87.  
French SA, Wall M, Mitchell NR. Household income differences in food sources and food 
items purchased. Int J Behav Nutr Phys Act. 2010;7:77. doi:10.1186/1479-5868-7-77 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 61 of 64 
Template Revised On: 11/01/2021      
88.  
French SA, Wall M, Mitchell NR, Shimotsu ST, Welsh E. Annotated receipts capture 
household food purchases from a broad range of sources. Int J Behav Nutr Phys Act. 
2009;6:37. doi:10.1186/1479-5868-6-37 
89.  
French SA, Shimotsu ST, Wall M, Gerlach AF. Capturing the spectrum of household food 
and beverage purchasing behavior: A review. J Acad Nutr Diet. 2008;108(12):2051-2058. 
doi:10.1016/j.jada.2008.09.001 
90.  
Harnack L, Oakes JM, Elbel B, Beatty T, Rydell S, French S. Effects of Subsidies and 
Prohibitions on Nutrition in a Food Benefit Program: A Randomized Clinical Trial. JAMA 
Intern Med. 2016;176(11):1610-1618. doi:10.1001/jamainternmed.2016.5633 
91.  
United States Department of Agriculture ERS. U.S. Adult Food Security Survey Module: 
Three-Stage Design with Screeners.; 2012. 
http://www.ers.usda.gov/datafiles/Food_Security_in_the_United_States/Food_Security_S
urvey_Modules/ad2012.pdf 
92.  
Valluri S, French SA, Elbel B, Oakes JM, Rydell SA, Harnack LJ. Within- and between-
household variation in food expenditures among low-income households using a novel 
simple annotated receipt method. Front Nutr. 2020;7:212. doi:10.3389/fnut.2020.582999 
93.  
French SA, Rydell SA, Mitchell NR, Michael Oakes J, Elbel B, Harnack L. Financial incentives 
and purchase restrictions in a food benefit program affect the types of foods and 
beverages purchased: results from a randomized trial. Int J Behav Nutr Phys Act. 
2017;14(1):127. doi:10.1186/s12966-017-0585-9 
94.  
Feskanich D, Sielaff BH, Chong K, Buzzard IM. Computerized collection and analysis of 
dietary intake information. Comput Methods Programs Biomed. 1989;30(1):47-57. 
doi:https://doi.org/10.1016/0169-2607(89)90122-3 
95.  
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;96(11):1140-1144. 
doi:https://doi.org/10.1016/S0002-8223(96)00293-3 
96.  
Van Horn L V, Stumbo P, Moag-Stahlberg A, et al. The Dietary Intervention Study in 
Children (DISC): Dietary assessment methods for 8- to 10-year-olds. J Am Diet Assoc. 
1993;93(12):1396-1403. doi:https://doi.org/10.1016/0002-8223(93)92241-O 
97.  
Berkowitz SA, O’Neill J, Sayer E, et al. Health center–based community-supported 
agriculture: An RCT. Am J Prev Med. Published online 2019. 
doi:https://doi.org/10.1016/j.amepre.2019.07.015 
98.  
Briefel RR, Chojnacki GJ, Gabor V, et al. A Cluster Randomized Controlled Trial of a Home-
Delivered Food Box on Food Security in Chickasaw Nation. J Acad Nutr Diet. 
2021;121(1):S46-S58. doi:10.1016/j.jand.2020.07.021 
99.  
Flocke SA, Ohri-Vachispati P, Shon E-J, et al. Developing multidimensional measures of 
healthy food access among low-income adults in Cleveland, Ohio, USA. Public Health Nutr. 
2017;20(16):2859-2868. doi:DOI: 10.1017/S1368980017002002 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 62 of 64 
Template Revised On: 11/01/2021      
100.  Campbell KJ, Crawford DA, Salmon J, Carver A, Garnett SP, Baur LA. Associations between 
the home food environment and obesity-promoting eating behaviors in adolescence. 
Obesity (Silver Spring). 2007;15(3):719-730. doi:10.1038/oby.2007.553 
101.  Baranowski T, Missaghian M, Broadfoot A, et al. Fruit and Vegetable Shopping Practices 
and Social Support Scales: A Validation. J Nutr Educ Behav. 2006;38(6):340-351. 
doi:http://dx.doi.org/10.1016/j.jneb.2006.06.005 
102.  Peterson NA, Speer PW, McMillan DW. Validation of A Brief Sense of Community Scale: 
Confirmation of the Principal Theory of Sense of Community. J Community Psychol. 
2008;36(1):61-73. doi:10.1002/jcop.20217 
103.  Andresen EM, Catlin TK, Wyrwich KW, Jackson-Thompson J. Retest reliability of 
surveillance questions on health related quality of life. J Epidemiol Community Heal. 
2003;57:339-343. doi:10.1136/jech.57.5.339 
104.  Andresen EM, Vahle VJ, Lollar D. Proxy reliability: Health-related quality of life (HRQoL) 
measures for people with disability. Qual Life Res. 2001;10(7):609-619. 
doi:10.1023/A:1013187903591 
105.  Andresen E, Catlin T, Wyrwich K, Jackson-Thompson J. Retest reliability and validity of a 
surveillance measure of health-related quality of life. Qual Life Res. 2001;10(3):199. 
doi:doi:10.1023/A:1016836728226 
106.  Mielenz T, Jackson E, Currey S, DeVellis R, Callahan LF. Psychometric properties of the 
Centers for Disease Control and Prevention Health-Related Quality of Life (CDC HRQOL) 
items in adults with arthritis. Health Qual Life Outcomes. 2006;4(1):66. doi:10.1186/1477-
7525-4-66 
107.  Dankel SJ, Loenneke JP, Loprinzi PD. The WATCH (Weight Activity and Time Contributes to 
Health) paradigm and quality of life: the impact of overweight/obesity duration on the 
association between physical activity and health-related quality of life. Int J Clin Pract. 
2016;70(5):409-415. doi:10.1111/ijcp.12797 
108.  Condrasky MD, Williams JE, Catalano PM, Griffin SF. Development of psychosocial scales 
for evaluating the impact of a culinary nutrition education program on cooking and 
healthful eating. J Nutr Educ Behav. 2011;43(6):511-516. 
doi:https://doi.org/10.1016/j.jneb.2010.09.013 
109.  Beshara M, Hutchinson A, Wilson C. Preparing meals under time stress. The experience of 
working mothers. Appetite. 2010;55(3):695-700. doi:10.1016/j.appet.2010.10.003 
110.  May K. Interview techniques in qualitative research: Concerns and challenges. In: Morse 
JM, ed. Qualitative Nursing Research: A Contemporary Dialogue. Apsen Publishers; 
1991:188-202. 
111.  Rubin HJ, Rubin IS. Assembling the parts: Structuring the qualitative interview. In: 
Qualitative Interviewing: The Art of Hearing Data. Sage Publications; 1995:145-167. 
112.  Glasgow RE, Harden SM, Gaglio B, et al. RE-AIM Planning and Evaluation Framework: 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 63 of 64 
Template Revised On: 11/01/2021      
Adapting to New Science and Practice With a 20-Year Review. Front Public Heal. 2019;7:64. 
doi:10.3389/fpubh.2019.00064 
113.  Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion 
interventions: the RE-AIM framework. Am J Public Health. 1999;89(9):1322-1327. 
doi:10.2105/AJPH.89.9.1322 
114.  RE-AIM.org. About RE-AIM. Published 2020. https://www.re-aim.org/about/ 
115.  Israel BA. Methods in Community-Based Participatory Research for Health. Jossey-Bass; 
2005. 
116.  University of Minnesota CTSI. Guiding Principles for Community-Engaged Research. 
Published 2016. http://www.ctsi.umn.edu/sites/default/files/guiding-principles-
community-engaged-research-4.18.2016.pdf 
117.  Minkler M, Wallerstein N. Community-Based Participatory Research for Health : From 
Process to Outcomes. Vol 2nd. Jossey-Bass; 2008. 
118.  Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data 
capture (REDCap)—A metadata-driven methodology and workflow process for providing 
translational research informatics support. J Biomed Inform. 2009;42(2):377-381. 
doi:https://doi.org/10.1016/j.jbi.2008.08.010 
119.  Teddlie C, Yu F. Mixed Methods Sampling: A Typology With Examples. J Mix Methods Res. 
2007;1(1):77-100. doi:10.1177/1558689806292430 
120.  Bazeley P. Mixed methods data analysis. In: Andrew S, Halcomb E, eds. Mixed Methods 
Research for Nursing and the Health Sciences. Wiley-Blackwell; 2009:84-118. 
121.  Morse JM. Quantitative and qualitative research: Issues in sampling. In: Chinn PL, ed. 
Nursing Research Methodology: Issues and Implementation. Aspen Publishers; 1986:181-
194. 
122.  Hu EA, Steffen LM, Coresh J, Appel LJ, Rebholz CM. Adherence to the Healthy Eating Index–
2015 and other dietary patterns may reduce risk of cardiovascular disease, cardiovascular 
mortality, and all-cause mortality. J Nutr. Published online September 2019. 
doi:10.1093/jn/nxz218 
123.  Schafer JL. Multiple imputation: a primer. Stat Methods Med Res. 1999;8(1):3-15. 
doi:10.1177/096228029900800102 
124.  Wasserstein RL, Lazar NA. The ASA Statement on p-Values: Context, process, and purpose. 
Am Stat. 2016;70(2):129-133. doi:10.1080/00031305.2016.1154108 
125.  Imai K, Keele L, Tingley D. A general approach to causal mediation analysis. Psychol 
Methods. 2010;15(4):309-334. doi:10.1037/a0020761 
126.  Sandelowski M. Focus on Qualitative Methods Notes on Transcription. Published online 
1994:311-314. 
127.  Hsieh H-F, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: Mobile Food Market Cluster Randomized Trial 
VERSION DATE: 1/5/2023 
 
Page 64 of 64 
Template Revised On: 11/01/2021      
2005;15(9):1277-1288. doi:10.1177/1049732305276687 
128.  Van Manen M. Researching the Lived Experience. 2nd ed. Althouse Press; 1997. 
129.  Koch T, Harrington A. Reconceptualizing rigour: the case for reflexivity. J Adv Nurs. 
1998;28(4):882-890. doi:10.1046/j.1365-2648.1998.00725.x 
130.  Bailey PH. Assuring quality in narrative analysis. West J Nurs Res. 1996;18(2):186-194. 
http://www.ncbi.nlm.nih.gov/pubmed/8638423 
131.  Whittemore R, Chase SK, Mandle CL. Validity in Qualitative Research. Qual Health Res. 
2001;11(4):522-537. doi:10.1177/104973201129119299 
132.  R Core Team. R: A language and environment for statistical computing. Published online 
2019. 
133.  Yaroch AL, Tooze J, Thompson FE, et al. Evaluation of Three Short Dietary Instruments to 
Assess Fruit and Vegetable Intake: The National Cancer Institute’s Food Attitudes and 
Behaviors Survey. J Acad Nutr Diet. 2012;112(10):1570-1577. 
doi:https://doi.org/10.1016/j.jand.2012.06.002 
134.  National Cancer Institute Division of Cancer Control and Population Sciences. Fruit & 
Vegetable Screeners in the Eating at America’s Table Study (EATS): Instruments. Published 
2000. http://epi.grants.cancer.gov/diet/screeners/fruitveg/allday.pdf 
135.  Hager ER, Quigg AM, Black MM, et al. Development and validity of a 2-item screen to 
identify families at risk for food insecurity. Pediatrics. 2010;126(1):e26-e32. 
doi:10.1542/peds.2009-3146 
136.  Centers for Disease Control and Prevention. Health-Related Quality of Life (HRQOL): 
Methods and Measures. Published 2016. https://www.cdc.gov/hrqol/methods.htm 
137.  Coyne T, Ibiebele TI, McNaughton S, et al. Evaluation of brief dietary questions to estimate 
vegetable and fruit consumption – using serum carotenoids and red-cell folate. Public 
Health Nutr. 2005;8(3):298-308. doi:10.1079/PHN2004688 
138.   Calloway EE, Carpenter LR, Gargano T, Sharp JL, Yaroch AL. Development of new measures 
to assess household nutrition security, and choice in dietary characteristics. Appetite. e 
2022;106288. doi:10.1016/j.appet.2022.106288 
139. Williams DR, Yu Y, Jackson JS, Anderson NB. Racial differences in physical and mental health: 
Socio-economic status, stress and discrimination. J Health Psychol. 1997;2(3):335-351. 
doi:10.1177/135910539700200305 
140.  Williams D. Everyday Discrimination Scale. Published 2022. Accessed September 21, 2022. 
https://scholar.harvard.edu/davidrwilliams/node/32397