Food Pantry Client and Staff Preferences for Nutritious no Prep Ready-to-eat Meals

March 5, 2025 updated by: Kelseanna Hollis-Hansen, University of Texas Southwestern Medical Center

Identifying Food Pantry Client and Staff Preferences for Nutritious no Prep Ready-to-eat Meals Versus Ingredient Bundles as an Effort to Increase Food Security, Improve Nutrition, and Promote Well-being

The specific aims of this pilot study are: Aim 1) To identify whether no prep ready to eat meals (intervention) or ingredient bundles (control) have higher client acceptability, liking, satisfaction, and perceived diet quality ratings. Aim 2) To identify whether no prep ready to eat meals (intervention) or ingredient bundles (control) have higher feasibility ratings with food pantry staff. Exploratory Aim) To identify whether no prep ready to meals (intervention) or ingredient bundles (control) lead to greater improvements in food security, perceived diet quality, and fruit and vegetable consumption.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To test the first hypothesis, we will use a randomized repeated measures between-subjects design with half of the participants randomized to receive 14-days of no prep ready-to-eat meals (intervention, n=35) and half of the participants randomized to receive 14-days of ingredient bundles (control, n=35). To test the second hypothesis, we will use a mixed-methods approach with food pantry staff (N=15), including questionnaires with fixed and open-ended items on feasibility and satisfaction of each distribution strategy followed by 30-minute semi-structured 1-1 interviews conducted by UT Southwestern study staff.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
85

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75236
        • Crossroads Community Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years of age or older;
  • ability to read, write, and speak English or Spanish;
  • ability to provide informed consent;
  • current or new pantry user at our community partner;
  • willing to participate;
  • no dietary restrictions, allergies, or sensitivities that would put the participant at-risk of harm from consuming study foods.

Exclusion Criteria:

  • Under 18 years of age;
  • inability to read, write, and speak English or Spanish;
  • unable to provide informed consent;
  • not a pantry user at our community partner or uninterested in becoming a pantry user;
  • not wanting to participate;
  • dietary restrictions, allergies, or sensitivities that would put the participant at-risk of harm from consuming study foods.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: No prep ready-to-eat meals
Behavioral: No prep ready-to-eat meals
Pantry clients will select no prep ready-to-eat meals for up to 14-days' worth of meals for themselves and 2-members of their household using an online food selection platform. The food retailer supplying the meals produces over 70 meals. We have elected to study 14-days of meals to offer clients variety and determine which flavors are most desirable to clients. After ordering, meals will be retrieved from a refrigeration unit, boxed by pantry staff, and brought to the participant to take home. An example dinner is "Teriyaki Chicken with Roasted Potatoes and Broccoli", and an example breakfast is "Omelet with Peppers and Zucchini". Meals can be stored in a refrigerator or freezer and eaten immediately or after reheating depending on the meal and consumer preference.
Active Comparator: Ingredient bundles (e.g. meal kits)
Behavioral: Ingredient bundles (e.g. meal kits)
Ingredient bundles will group individual meal ingredients (e.g., chicken, teriyaki, broccoli, potatoes) in a bag or box and pair those healthy food items with a recipe that instructs the client on how to make a healthier meal. Similar to the no prep ready-to-eat meal initiative, clients will select ingredient bundles for themselves and 2-members of their household using the food pantry online food selection platform. The ingredient bundles will closely replicate the no prep ready-to-eat meals.
No Intervention: Pantry Staff Group
They participate in qualitative interviews only. No demographic or other identifiable information from them. They do not receive an intervention. No Intervention Group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hedonic Liking of Study Foods
Time Frame: 14-days
Liking of study foods will be measured by showing the name and picture of the meal or ingredient bundle and asking participants to respond to a hedonic 9-point bipolar scale (this scale does not have an official name or title, therefore, 9-point hedonic liking scale can be considered the unabbreviated scale name). The scale has four measures of liking (6-9) and four measures of dislike (1-4) and a neutral "neither like nor dislike" (5). A higher score = more liking of the food. The average of all hedonic liking ratings for each meal was taken to create a hedonic liking score across meals.
14-days
Satisfaction of Study Foods
Time Frame: 14-days
Satisfaction items were adapted from previously validated food pantry client satisfaction surveys (e.g., "How satisfied are you with the amount/variety/frequency of food that you and others in your household receive at this food pantry?") (Dunmire M. Level of satisfaction among food pantry clients, staff/volunteers, and directors and its association with client choice in food pantry layouts. South Dakota State University; 2019.). Response options were "Strongly agree" "Agree" "Disagree" and "Strongly disagree". The items were summed to create an Intervention Satisfaction variable with the lowest possible score of 4 if all responses were "Strongly disagree" and the highest possible score of 20 if all responses were "Strongly agree."
14-days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceived Diet Quality
Time Frame: 14-days
Perceived dietary quality will be measured using a single validated item that asks participants to rate their overall diet quality as "excellent," "very good," "good," "fair," or "poor" (5 = Excellent, 1 = Poor). Perceived diet quality is the scale title.
14-days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fruit and Vegetable Frequency
Time Frame: 14-days
Fruit & Vegetable Screener from the Eating at America's Table Study (EATS) - this is the measure title. Information on how to score the measure can be found at cancer.gov (https://epi.grants.cancer.gov/diet/screeners/fruitveg/instrument.html). The measure is cups of fruits and vegetables per day. A higher number is better.
14-days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 26, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 26, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU-2022-0809

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will publish the study protocol in a journal willing to publish pilot study protocols. Deidentified data will be uploaded as supplemental files along with manuscript submissions to PubMed.

IPD Sharing Time Frame

Deidentified data will be available in January 2024 and will be submitted as supplemental files along with manuscript submissions to PubMed, meaning the data will be available so long as PubMed hosts supplementary data files.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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