Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Center for American Indian and Rural Health Equity | OTHER |
| Gallatin Valley Food Bank | OTHER |
| Livingston Food Resource Center | OTHER |
| Bozeman Deaconess Health Group |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Carmen Byker Shanks, PhD RDN | Montana State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montana State University Health Sciences Building | Bozeman | Montana | 59718 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31483716 | Background | 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. | |
| 33421084 | Background |
Not provided
Not provided
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.
Only available on a secure server and file to study staff when needed for planning and analysis.
A researcher with IRB approval
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Group | For a 12 week pilot trial, 44 adults enrolled in the UP3 intervention and within-participant changes were measured over time. 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 was 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. |
| FG001 | Control Group | 34 participants enrolled from a different food pantry were enrolled into a control group. The post assessment was cancelled due to COVID-19 precautions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | Change in HEI-2015 baseline to 12 weeks | Change from baseline dietary quality at 12 weeks |
|
12 weeks during intervention
Serious Adverse Event Data was collected about health measures that may lead to inpatient hospitalization, including hemoglobin A1c, blood pressure, lipid panel, and weight change.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carmen Byker Shanks | Montana State University | 406-994-1952 | cbykershanks@montana.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 7, 2020 | Feb 15, 2022 | Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D002908 | Chronic Disease |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
Not provided
Not provided
| OTHER |
| Gallatin City-County Health Department | OTHER |
| Helena Food Share | OTHER |
Participants are assigned to an intervention group or control group (nonrandomized).
Not provided
Not provided
Not provided
Not provided
|
| 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. |
| BG001 | Control Group | Participants from a different food pantry were be enrolled into a control group with no intervention. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Healthy Eating Index 2015 Scale | Data 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. | Mean | Standard Deviation | units on a scale |
|
A 12 week pilot trial will be conducted at two rural food pantries in Montana with 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. 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.
| OG001 | Control Group | Participants from a different food pantry will be enrolled into a control group. The primary outcome measure will be dietary intake. No intervention will be applied. |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Control Group | Participants from a different food pantry were be enrolled into a control group with no intervention. The Healthy Eating Index-2015 was the primary outcome measure. | 0 | 34 | 0 | 34 | 0 | 34 |
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |