The UnProcessed Pantry Project (UP3): A Novel Approach to Improving Dietary Quality for Low-Income Adults Served by Rural Food Pantries
Phase: NA
Conditions: Diet, Healthy, Diet Habit, Disease, Chronic, Health Behavior, Rural Health
Sponsor: Montana State University

Official Title: The UnProcessed Pantry Project (UP3): A Novel Approach to Improving 
Dietary Quality for Low-Income Adults Served by Rural Food Pantries   
NCT Number: NCT04241133 
Date of Document: 1/7/2020 

Study Protocol with Statistical Analysis Plan and Informed Consent Form  
 
STUDY PROTOCOL  
 
Title: The UnProcessed Pantry Project 
 
Principal Investigator (PI): Carmen Byker Shanks PhD RDN 
 
A. RATIONALE AND PURPOSE OF RESEARCH.   
 
The UnProcessed Pantry Project (UP3) a research study that aims to improve the health of food 
pantry participants by taking strategic steps within the food pantry environment and with clients 
to increase access to and consumption of unprocessed foods. The overall goal of UP3 is to 
develop a framework to apply in food pantries towards improving food pantry participant health 
through an improved diet with less ultra-processed foods. The specific research question being 
asked is: does minimizing ultra-processed food consumption improve dietary intake among rural 
food pantry clients?  
 
B. RESEARCH PROCEDURES 
 
The UP3 pilot study will be conducted by 2 rural food pantries in Montana for 12 weeks. There 
will be 1 control group that are eligible to be served by a different food pantry in Montana. 
Participants will undergo the following research methods upon consent.  
 
The pilot study will investigate potential short-term effects of UP3 on dietary quality (primary 
outcome) among participants. It is hypothesized that UP3 will improve access to less processed 
foods and decrease access to ultra-processed foods at the food pantry, which will improve 
overall dietary quality of individuals as measured by the Healthy Eating Index-2015 compared to 
baseline. Biomarkers of health data (i.e., weight, systolic blood pressure, HbA1c, fasting lipid 
panel) will be collected to determine the feasibility of measuring potential short-term health 
effects alongside UP3. Demographic and food security data will be collected by survey 
characterize the population. Psychosocial factors will be collected by survey to understand 
changes in knowledge, attitudes, and perceptions about processed foods. 
 
Beginning in December 2019 and January 2020, participants ages 18 and above who access 1 
of the 2 food pantry sites will be asked to participate in UP3 through flyers and on-site 
recruitment. 1 control group that are eligible to be served by a rural food pantry will be recruited. 
Stratified recruitment will occur to recruit for demographic diversity and risk for chronic disease 
as measured by baseline screening. Participants must be able to attend UP3 meetings. 
Exclusion criteria will include pregnancy, unstable vital signs, or food allergy as measured by 
baseline screening. All participants will give written informed consent.  
 
UP3 will begin at the same time for participants at each food pantry. UP3 will proceed by 
providing informed consent to the experimental and control groups. The control group will not 
receive an intervention. 
 
Experimental group participants will meet with a registered dietitian and research staff at the 
beginning of the intervention to learn the intervention protocol, including instruction to keep 
exercise constant. The experimental group of participants will pick up food every week, enough 
to make up at least 50% of their diet based off of calculations from USDA’s Dietary Guidelines 
for Americans 2015. Every other week, they will be provided with experiential nutrition education 

targeted toward knowledge, attitudes, and perceptions about increasing un-processed food 
intake and decreasing ultra-processed food intake. Every other week, the participants will check 
in with a research staff member about goals, successes, and challenges of the intervention.   
 
For the experimental group, dietary quality, survey data, and biomarkers of health measures 
(BMI, waist circumference, HbA1C, fasting lipid panel, systolic blood pressure) will be collected 
at pre (1 week) and post (12 weeks). Height, weight, survey data, and dietary quality will be 
collected at 6 weeks. These measures will be collected at the food pantry when participants pick 
up food. Measures taken at the food pantry will be collected in a closed off and private space 
and at a mobile draw station (compliant with Biosafety Committee Standards) by a certified 
phlebotomist and research staff. 
 
For the control group, dietary quality, survey data, and height and weight will be collected at pre 
(0 weeks) and post (12 weeks). These measures will be collected at a food pantry in a closed 
off and private space by a certified phlebotomist and research staff, compliant with Biosafety 
Committee Standards. 
 
C. RECRUITMENT PROCEDURES 
 
During December 2019 and January 2020, experimental group participants will be recruited 
among clients that are (1) currently served or (2) are eligible to be served by participating sites 
 
The sites will be provided with recruitment flyers. The 1-page recruitment flyers hung at sites. 
Staff that are not on the research team at each location will be trained to direct clients with 
questions to further inquire with a research team member. The staff at sites that are not on the 
research team will not participate in the informed consent process or data collection. When a 
client indicates interest in the study, the staff will refer the client to a research team member on 
location. If no research team member is available to talk to the client on location, staff will collect 
the client’s e-mail and phone number and provide to the research team member to make 
contact at a later time. Contact information will include name, phone number, and e-mail 
entered into a table. The client will also be provided with the study coordinator’s phone number 
and e-mail address through the recruitment flyer and can self-initiate contact to indicate interest. 
Upon contact, the research team member will provide a brief verbal overview of UP3 using a 
script. If the client still indicates interest, the client will be provided with a screening survey to 
collect information about exclusion factors and basic demographic information. The client will be 
provided with the opportunity for informed consent upon determining eligibility, explained below.  
 
Local health care providers will additionally identify patients at risk for chronic disease that 
qualify for a sliding fee scale. The provider will randomize a list of 100 individuals meeting the 
identification criteria. The first 20 individuals on the randomized list will be called and provided 
study details directly from a script (attached). If the patient indicates interest in participation in 
the study, the staff member will document contact information. Contact information will include 
name, phone number, and e-mail entered into a table and will notify a member of the research 
team who will follow up with the interested patient. If a patient is not interested in participating, 
the staff will tally the interaction but will not collect contact information. Staff that are not on the 
research team will be trained to direct patients with questions to further inquire with a member of 
the research team. The staff that are not on the research team will not participate in the 
informed consent process or data collection. When a patient indicates interest in the study, a 
research team member will call the participant and provide a brief verbal overview of UP3 using 
a script. If the client still indicates interest, the client will be provided with multiple days and 
times to complete a screening survey) to collect information about exclusion factors and basic 

demographic information. The client will be provided with the opportunity for informed consent 
upon determining eligibility, explained below. 
 
For control group participants, 1-page recruitment flyers will be hung in the food pantry at the 
control site. The staff at the control site that are not on the research team will not participate in 
the informed consent process or data collection. When a client indicates interest in the study, 
the staff will refer the client to a research team member on location. If no research team 
member is available to talk to the client on location, staff will collect the client’s e-mail and 
phone number and provide to the research team member to make contact at a later time. 
Contact information will include name, phone number, and e-mail entered into a table. The client 
will also be provided with the study coordinator’s phone number and e-mail address through the 
recruitment flyer and can self-initiate contact to indicate interest. Upon contact, the research 
team member will provide a brief verbal overview of the control group using a script. If the client 
still indicates interest, the client will be provided with a screening survey to collect information 
about exclusion factors and basic demographic information. The client will be provided with the 
opportunity for informed consent upon determining eligibility, explained below.  
 
Participants will take the screening survey in a private location at study sites. The screening 
survey will include a participant code to keep survey data anonymous. The participant code will 
be connected with the participant’s name and contact information on a separate Excel 
spreadsheet that is saved and stored securely on the research team’s computer. Contact 
information will include phone number and e-mail. The screening survey will be collected and 
stored in a locked cabinet. 
 
The top of the screening survey includes a statement about retention of the screening data: 
Data collected in the screening survey will be retained to track retention and characteristics of 
prospective participants that ultimately participate or decline participation in UP3. Prospective 
participants can stop taking the survey at any time. Participants can decline to answer screening 
survey questions. Your answers will be kept completely confidential and your name will not be 
associated with any of the screening results. 
 
After completing the screening survey, the client will be told that eligibility will be determined and 
will be contacted about their participation in UP3 as experimental or control group within a 
month of initial contact. The research staff will determine UP3 eligibility by reviewing the 
screening survey for inclusion and exclusion criteria.  
 
D. INFORMED CONSENT 
 
If eligible, the prospective participant will be contacted by a research team member using a 
script to discuss their eligibility in the study and schedule a time to provide informed consent 
and, if consenting, participate in baseline screening.  
 
During the informed consent, the prospective participant will be provided an informed consent 
document. The prospective participant will be provided an opportunity to discuss any questions 
about the study with the research team. The prospective participant will read the informed 
consent form and decide about participation. The prospective participant will provide a signature 
on the informed consent form upon agreeing to participate in UP3. Informed consent will be 
conducted at the study sites simultaneous with baseline screening. 
 
E. COMPENSATION 
Experimental group participants will receive incentives in the form of gift cards ($150 each, or 

$50 at 3 times during the study – baseline, 6 weeks, 12 weeks). Control group participants will 
receive incentives in the form of gift cards ($50 each, or $25 at 2 times during the study – 
baseline and 12 weeks). 
 
F. STUDY LOCATION 
 
Screening, consenting, study measures, and intervention activities will be carried out at the food 
pantry locations. Measures taken at the food pantry will be collected in a closed off and private 
space and at a mobile draw station (compliant with Biosafety Committee Standards) by a 
certified phlebotomist and research staff. 
 
G. RISKS AND BENEFITS (ADVERSE EFFECTS)  
 
The risk for the experimental group is considered minimal and no greater than obtaining blood 
for a medical procedure or food allergies. The participant will have drops of blood taken on two 
occasions. The blood will be taken from a finger by finger stick. The risks of taking blood include 
pain, a bruise at the point where the blood is taken, redness and swelling of the vein and 
infection, and a rare risk of fainting. The risk of consuming food includes an allergic reaction to 
foods provided. For the control group, there are no known risks to participation in this study 
beyond what is encountered in daily life. 
 
H. DATA CONFIDENTIALITY  
 
All data will be coded, kept in a locked file cabinet in the PI’s lab or on the PI’s computer.  
 
STATISTICAL ANALYSIS PLAN 
Descriptive statistics were performed for all study data. Participants provide 24 hour dietary 
recalls at 3 time point throughout the study period using the Automated Self-Administered 24 
hour (ASA24) assessment tool. The HEI-2015 uses a scoring system with a scale 0-100, where 
a score of 100 represents a diet in complete agreement with the Dietary Guidelines for 
Americans. The score is totaled from 13 component scores. High consumption of the following 
food groups corresponds to a higher component score: total fruits, whole fruits, total vegetables, 
greens and beans, whole grains, dairy, total protein foods, seafood and plant proteins, fatty 
acids. Alternatively, high consumption of refined grains, sodium, added sugars, and saturated 
fats corresponds to lower component scores, as these items should only be consumed in limited 
quantities. SAS macros provided by the National Cancer Institute were used to compute HEI-
2015 scores for each dietary recall at pre- and post-intervention using the Simple HEI Scoring 
Algorithm. HEI scores were presented as means and standard deviations (SD). A paired-sample 
t-test was conducted to test for differences between means at pre- and post- intervention.  
 
 
 
 
 
 
 
 
 
 
 
 

INFORMED CONSENT FORM  
 
Experimental Group  
 
 

 
 
 

Control Group