The UnProcessed Pantry Project (UP3)

Overview

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.

Full Title of Study: “The UnProcessed Pantry Project (UP3): A Novel Approach to Improving Dietary Quality for Low-Income Adults Served by Rural Food Pantries”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 30, 2020

Interventions

  • Behavioral: The UnProcessed Pantry Project (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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Dietary quality change
    • Time Frame: Change from baseline dietary quality at 6 and 12 weeks
    • Assessed using 24-hour dietary recall data collected using the ASA24 (Automated-Self Administered Recall System) a computerized dietary assessment tool

Secondary Measures

  • Psychosocial factors change assessed by FRESH Food Survey
    • Time Frame: Change from baseline psychosocial factors at 6 and 12 weeks
    • Measured using the FRESH Food Survey, developed by Drs. Seligman, Yaroch, and colleagues. The survey is based on NCI’s psychometrically tested FLASHE Survey.
  • Food security change assessed by a 2-item USDA ERS questions
    • Time Frame: Change from baseline food security at 6 and 12 weeks
    • Assessed through a survey administered based on the USDA Food Security Module, a 2-item scale to assess food security status level.
  • Hemoglobin A1c Percent (HbA1c %) change
    • Time Frame: Change from baseline hemoglobin A1c (HbA1c) at 12 weeks
    • Assessed through a finger stick and analyzed by Afinion under standard procedures.
  • Lipid panel change
    • Time Frame: Change from baseline lipid panel at 0 and 12 weeks
    • Assessed through a finger stick and analyzed by LDX under standard procedures.
  • Systolic and diastolic blood pressure change
    • Time Frame: Change from baseline systolic and diastolic blood pressure at 0 and 12 weeks
    • Measured using Phillips SureSigns VSi under standard procedure

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Montana State University
  • Collaborator
    • Center for American Indian and Rural Health Equity
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Carmen Byker Shanks, PhD RDN, Principal Investigator, Montana State University
  • Overall Contact(s)
    • Carmen Byker Shanks, PhD RDN, 406-994-1952, cbykershanks@montana.edu

References

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.