The UnProcessed Pantry Project (UP3)

NCT04241133 | Completed Results

• 1 other identifier: CBS122118
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diet, Healthy; Diet Habit; Disease, Chronic; Health Behavior; Rural Health

Outcome Measures

Primary Outcomes (1)

• Dietary Quality Change

  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.

  Change from baseline dietary quality at 12 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Behavioral: The UnProcessed Pantry Project (UP3)

Control Group

NO INTERVENTION

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.

Interventions

The UnProcessed Pantry Project (UP3) BEHAVIORAL

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18 and above
• Attend 1 of the food pantry sites
• Ability to attend intervention and measurement activities
• Chronic disease risk

You may not qualify if:

• Pregnancy
• Unstable vital signs
• Food allergy as measured by baseline screening

Sponsors & Collaborators

• Montana State University: lead
• Center for American Indian and Rural Health Equity: collaborator
• Gallatin Valley Food Bank: collaborator
• Livingston Food Resource Center: collaborator
• Bozeman Deaconess Health Group: collaborator
• Gallatin City-County Health Department: collaborator
• Helena Food Share: collaborator

Study Sites (1)

Montana State University Health Sciences Building

Bozeman, Montana, 59718, United States

Location

Related Publications (2)

• 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.

  PMID: 31483716 BACKGROUND

• 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.

  PMID: 33421084 BACKGROUND

MeSH Terms

Conditions

Feeding Behavior; Chronic Disease; Health Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Due to the onset of COVID19 at the same time of the post measure (simultaneous with stay at home orders), 14 participants did not complete the experimental group and the control group data was not collected.

Results Point of Contact

• Title: Dr. Carmen Byker Shanks
• Organization: Montana State University

cbykershanks@montana.edu

406-994-1952

Study Officials

• Carmen Byker Shanks, PhD RDN

  Montana State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to an intervention group or control group (nonrandomized).

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: January 27, 2020
• Study Start: January 24, 2020
• Primary Completion: August 15, 2020
• Study Completion: August 15, 2020
• Last Updated: May 2, 2022
• Results First Posted: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Only available on a secure server and file to study staff when needed for planning and analysis.
• Access Criteria: A researcher with IRB approval

Locations

US (1)