Trial Outcomes & Findings for The UnProcessed Pantry Project (UP3) (NCT NCT04241133)

Last Updated: 2022-05-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

78 participants

Primary outcome timeframe

Change from baseline dietary quality at 12 weeks

Results posted on

2022-05-02

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	44	34
Overall Study COMPLETED	30	0
Overall Study NOT COMPLETED	14	34

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study COVID19 Precautions	14	34

Baseline Characteristics

The UnProcessed Pantry Project (UP3)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Group n=44 Participants 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.	Control Group n=34 Participants Participants from a different food pantry were be enrolled into a control group with no intervention.	Total n=78 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants	28 Participants n=7 Participants	64 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	27 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	7 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=5 Participants	32 Participants n=7 Participants	75 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	40 Participants n=5 Participants	29 Participants n=7 Participants	69 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	44 participants n=5 Participants	34 participants n=7 Participants	78 participants n=5 Participants
Healthy Eating Index 2015 Scale	47.14 units on a scale STANDARD_DEVIATION 13.41 • n=5 Participants	52.01 units on a scale STANDARD_DEVIATION 10.45 • n=7 Participants	49.58 units on a scale STANDARD_DEVIATION 11.93 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Experimental Group n=30 Participants 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.	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.
Dietary Quality Change	57.01 Change in HEI-2015 baseline to 12 weeks Standard Deviation 13.94	—

Adverse Events

Experimental Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Carmen Byker Shanks

Montana State University

Phone: 406-994-1952

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place