Diet Habit, Diet, Healthy, Disease, Chronic, Health Behavior, Rural Health
Conditions
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
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
Study design
Intervention model description
Participants are assigned to an intervention group or control group (nonrandomized).
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Dietary Quality Change | Change from baseline dietary quality at 12 weeks | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | COVID19 Precautions | 14 | 34 |
Baseline characteristics
| Characteristic | Total | Experimental Group | Control Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 8 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 64 Participants | 36 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 75 Participants | 43 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Healthy Eating Index 2015 Scale | 49.58 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 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 69 Participants | 40 Participants | 29 Participants |
| Region of Enrollment United States | 78 participants | 44 participants | 34 participants |
| Sex: Female, Male Female | 53 Participants | 26 Participants | 27 Participants |
| Sex: Female, Male Male | 25 Participants | 18 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 34 |
| other Total, other adverse events | 0 / 44 | 0 / 34 |
| serious Total, serious adverse events | 0 / 44 | 0 / 34 |
Outcome results
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Dietary Quality Change | 57.01 Change in HEI-2015 baseline to 12 weeks | Standard Deviation 13.94 |