The UnProcessed Pantry Project (UP3)

NCT ID: NCT04241133

Last Updated: 2022-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-24
• Study Completion Date: 2020-08-15

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

The UnProcessed Pantry Project (UP3)

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Center for American Indian and Rural Health Equity

OTHER

Sponsor Role: collaborator

Gallatin Valley Food Bank

OTHER

Sponsor Role: collaborator

Livingston Food Resource Center

OTHER

Sponsor Role: collaborator

Bozeman Deaconess Health Group

OTHER

Sponsor Role: collaborator

Gallatin City-County Health Department

OTHER

Sponsor Role: collaborator

Helena Food Share

OTHER

Sponsor Role: collaborator

Montana State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carmen Byker Shanks, PhD RDN

Role: PRINCIPAL_INVESTIGATOR

Montana State University

Locations

Montana State University Health Sciences Building

Bozeman, Montana, United States

Countries

United States

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. No abstract available.

Reference Type: BACKGROUND

PMID: 31483716 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33421084 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

CBS122118

Identifier Type: -

Identifier Source: org_study_id