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The UnProcessed Pantry Project (UP3)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04241133
Acronym
UP3
Enrollment
78
Registered
2020-01-27
Start date
2020-01-24
Completion date
2020-08-15
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALThe 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.

Sponsors

Center for American Indian and Rural Health Equity
CollaboratorOTHER
Gallatin Valley Food Bank
CollaboratorOTHER
Livingston Food Resource Center
CollaboratorOTHER
Bozeman Deaconess Health Group
CollaboratorOTHER
Gallatin City-County Health Department
CollaboratorOTHER
Helena Food Share
CollaboratorOTHER
Montana State University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Dietary Quality ChangeChange from baseline dietary quality at 12 weeksThe 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.

Countries

United States

Participant flow

Recruitment details

UP3 participants who accessed one of the two food pantry sites were asked to participate in UP3 through flyers and on-site recruitment from December 2019 to January 2020. First participant enrolled on January 24, 2020. Control group participants were recruited through flyers and on-site recruitment in March 2020 from another food pantry site.

Participants by arm

ArmCount
Experimental Group
A 12 week pilot trial was conducted at two rural food pantries in Montana with low-income adults to measure within-participant changes over time. The UnProcessed Pantry Project (UP3): UP3 used 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 was hypothesized that UP3 will improve access to minimally processed foods and decrease access to ultra-processed foods at the food pantry, which would improve overall dietary quality of individuals as measured by the Healthy Eating Index-2015 compared to baseline and to the control group.
44
Control Group
Participants from a different food pantry were be enrolled into a control group with no intervention.
34
Total78

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyCOVID19 Precautions1434

Baseline characteristics

CharacteristicTotalExperimental GroupControl Group
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
14 Participants8 Participants6 Participants
Age, Categorical
Between 18 and 65 years
64 Participants36 Participants28 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants1 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
75 Participants43 Participants32 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Healthy Eating Index 2015 Scale49.58 units on a scale
STANDARD_DEVIATION 11.93
47.14 units on a scale
STANDARD_DEVIATION 13.41
52.01 units on a scale
STANDARD_DEVIATION 10.45
Race (NIH/OMB)
American Indian or Alaska Native
4 Participants2 Participants2 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants0 Participants1 Participants
Race (NIH/OMB)
More than one race
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants0 Participants2 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
69 Participants40 Participants29 Participants
Region of Enrollment
United States
78 participants44 participants34 participants
Sex: Female, Male
Female
53 Participants26 Participants27 Participants
Sex: Female, Male
Male
25 Participants18 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 440 / 34
other
Total, other adverse events
0 / 440 / 34
serious
Total, serious adverse events
0 / 440 / 34

Outcome results

Primary

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.

Time frame: Change from baseline dietary quality at 12 weeks

Population: 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.

ArmMeasureValue (MEAN)Dispersion
Experimental GroupDietary Quality Change57.01 Change in HEI-2015 baseline to 12 weeksStandard Deviation 13.94
Comparison: The experimental group was tested for significant difference in Healthy Eating Index 2015 (HEI-2015) scores at baseline and 12 weeks. SAS macros provided by the National Cancer Institute were used to compute HEI-2015 scores for each dietary recall at pre- (baseline) and post-intervention (12 weeks) using the Simple HEI Scoring Algorithm.p-value: <0.05t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026