- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04241133
The UnProcessed Pantry Project (UP3) (UP3)
April 28, 2022 updated by: Montana State University
The UnProcessed Pantry Project (UP3): A Novel Approach to Improving Dietary Quality for Low-Income Adults Served by Rural Food Pantries
There is a need to develop evidence-based interventions that rural food pantries can use to limit the distribution and intake of ultra-processed foods and promote the distribution and intake of minimally processed foods in the food environment and among low-income populations to promote better dietary quality and health outcomes.
This research project, The UnProcessed Pantry Project (UP3): A Novel Approach to Improving Dietary Quality for Low-Income Adults Served by Rural Food Pantries, uses the Social-Ecological Model to target multiple levels, including the food supply in the rural study location (community level), the food environment at the food pantry (environmental level), and participant dietary intake (individual level).
Aim 1 will adapt evidence-based strategies to inform UP3.
UP3 will improve dietary quality by influencing the food supply through organization-wide nutrition policies, modifying the food environment with minimally processed foods and nudges, and changing participant dietary intake through experiential nutrition education.
The UP3 pilot study will be conducted during Aim 2 with 40 participants served by two rural food pantries in Montana.
The purpose of the pilot study is to investigate potential short-term effects on nutrient intake and dietary quality (primary outcome), assess acceptability of UP3 among participants, and evaluate feasibility in rural food pantry environments.
It is hypothesized that UP3 will improve access to minimally 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 and to the control group.
Demographic and food security data will characterize the population.
Psychosocial factors will be collected to understand changes in knowledge, attitudes, and perceptions about processed foods.
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.
A control group of 20 participants at a rural food pantry will be used to assess dietary intake, psychosocial factors, height, and weight.
Aim 3 will tailor UP3 for a scalable intervention suited for an R01 grant application to conduct a randomized controlled trial (RCT).
UP3 is positioned to demonstrate the positive effects of limiting processed foods and increasing unprocessed and minimally processed foods on diets and, potentially, health among low-income populations.
The short-term goals of this research are to develop an adaptable and scalable intervention suitable for rural food pantries serving low-income populations, as well as potentially contribute to a knowledge base around potential short-term effects of the minimally processed foods diet on dietary quality and health risks in those populations.
The longer-term goals are to test the efficacy of the intervention in an RCT and then disseminate the approach to be integrated into rural food pantries serving low-income populations with the goal of decreasing health risks.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
78
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Montana
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Bozeman, Montana, United States, 59718
- Montana State University Health Sciences Building
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ages 18 and above
- Attend 1 of the food pantry sites
- Ability to attend intervention and measurement activities
- Chronic disease risk
Exclusion Criteria:
- Pregnancy
- Unstable vital signs
- Food allergy as measured by baseline screening
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Group
A 12 week pilot trial will be conducted at two rural food pantries in Montana with 40 low-income adults to measure within-participant changes over time.
The study will provide the initial investigation of the extent to which UP3 will improve overall dietary quality as measured by the Healthy Eating Index-2015 (HEI) compared to baseline.
Psychosocial factors will be measured to understand changes in knowledge, attitudes, and perceptions about processed foods.
Data on biomarkers of health (i.e., weight, systolic blood pressure, HbA1c, fasting lipid panel) will be collected to assess the feasibility of measuring potential short-term health effects of UP3.
|
UP3 uses the Social-Ecological Model to target multiple levels, including the food supply in the rural study location (community level), the food environment at the food pantry (environmental level), and participant dietary intake (individual level).
It is hypothesized that UP3 will improve access to minimally 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 and to the control group.
Demographic and food security data will characterize the population.
Psychosocial factors will be collected to understand changes in knowledge, attitudes, and perceptions about processed foods.
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.
|
No Intervention: Control Group
20 separate participants from a different food pantry will be enrolled into a control group.
The control group will be assessed at baseline and 12 weeks for dietary intake, height, weight, waist circumference, food security, demographics, and psychosocial factors.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dietary Quality Change
Time Frame: Change from baseline dietary quality at 12 weeks
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The Healthy Eating Index-2015 scale was calculated from collected 24-hour dietary recall data collected using the ASA24 (Automated-Self Administered Recall System) a computerized dietary assessment tool.
ata collected through Automated Self-Administered 24-hour dietary recall to calculate HEI-2015 scores.
The scores range from 0 to 100, with higher scores reflecting greater adherence with dietary recommendations from the Dietary Guidelines for Americans.
A score of 100 reflects high adherence and a score of 0 reflects no adherence.
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Change from baseline dietary quality at 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Carmen Byker Shanks, PhD RDN, Montana State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Byker Shanks C, Weinmann E, Holder J, McCormick M, Parks CA, Vanderwood K, Coburn C, Johnson N, Yaroch AL. The UnProcessed Pantry Project Framework to Address Nutrition in the Emergency Food System. Am J Public Health. 2019 Oct;109(10):1368-1370. doi: 10.2105/AJPH.2019.305292. No abstract available.
- Byker Shanks C, Webber E, Larison L, Wytcherley B. The translational implications of applying multiple measures to evaluate the nutrient quality of the food supply: a case study of two food pantries in Montana. Transl Behav Med. 2020 Dec 31;10(6):1367-1381. doi: 10.1093/tbm/ibaa108.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 24, 2020
Primary Completion (Actual)
August 15, 2020
Study Completion (Actual)
August 15, 2020
Study Registration Dates
First Submitted
September 26, 2019
First Submitted That Met QC Criteria
January 23, 2020
First Posted (Actual)
January 27, 2020
Study Record Updates
Last Update Posted (Actual)
May 2, 2022
Last Update Submitted That Met QC Criteria
April 28, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CBS122118
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Each participant will be assigned a code.
The 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 PI's computer.
Only coded IPD will be shared with other researchers.
IPD Sharing Time Frame
Only available on a secure server and file to study staff when needed for planning and analysis.
IPD Sharing Access Criteria
A researcher with IRB approval
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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