Diet, HealthyNCT05593510

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

A study testing No prep ready-to-eat meals and Ingredient bundles (e.g. meal kits) in people with Diet, Healthy and Food Security, run by University of Texas Southwestern Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Diet, Healthy, Food Security
What is being tested?: No prep ready-to-eat meals and Ingredient bundles (e.g. meal kits)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 85 participants
Where: 1 siteUnited States
Study dates: 12 Feb 2023to 26 Apr 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Crossroads Community Services
Dallas, Texas, 75236

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Diet, Healthy, Food Security
Being tested: No prep ready-to-eat meals, Ingredient bundles (e.g. meal kits)
Keywords: Food security, Food pantry, Diet quality, Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No prep ready-to-eat mealsBehavioural
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.
Ingredient bundles (e.g. meal kits)Behavioural
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.

Study groups in NCT05593510
Study group	Role	What they receive
No prep ready-to-eat meals	Experimental	Not described Receives: Behavioral: No prep ready-to-eat meals
Ingredient bundles (e.g. meal kits)	Active comparator	Not described Receives: Behavioral: Ingredient bundles (e.g. meal kits)
Pantry Staff Group	No intervention	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 being measured

The primary outcome is the main question the study is designed to answer.

Hedonic Liking of Study Foods
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.
Measured: 14-days
Satisfaction of Study Foods
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."
Measured: 14-days

Secondary outcomes (1)

Perceived Diet Quality
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.
Measured: 14-days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Feb 202326 Apr 2023

First posted25 Oct 2022
Study start12 Feb 2023
Primary completion26 Apr 2023
Study completion26 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Diet, HealthyStudies of the same condition, open and under way.
More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Model description: Randomized repeated measures between-subjects design
Masking: None (open label)
Enrolment: 85 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05593510
Sponsor's protocol ID: STU-2022-0809
Status last verified: Mar 2025
First submitted: 20 Oct 2022
Last updated: 11 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

Hollis-Hansen K, Haskins C, Turcios J, Bowen ME, Leonard T, Lee M, Albin J, Wadkins-Chambers B, Thompson C, Hall T, Pruitt SL. A pilot randomized controlled trial comparing nutritious meal kits and no-prep meals to improve food security and diet quality among food pantry clients. BMC Public Health. 2023 Dec 1;23(1):2389. doi: 10.1186/s12889-023-17355-3.
PubMed 38041070
Hollis-Hansen K, Haskins C, Turcios J, Bowen ME, Leonard T, Lee M, Albin J, Chambers BW, Thompson C, Hall T, Pruitt SL. A pilot randomized controlled trial comparing nutritious meal kits and no-prep meals to improve food security and diet quality among food pantry clients. Res Sq [Preprint]. 2023 Oct 6:rs.3.rs-3029813. doi: 10.21203/rs.3.rs-3029813/v1.
PubMed 37886450

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05593510
Acronym / sponsor ID: STU-2022-0809
Conditions: Diet, Healthy, Food Security
Keywords: Food security, Food pantry, Diet quality, Intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 85 participants (actual)
Lead sponsor: University of Texas Southwestern Medical CenterUniversity, hospital or other
Study start: 12 Feb 2023 (actual)
Primary completion: 26 Apr 2023 (actual)
Study completion: 26 Apr 2023 (actual)
First posted: 25 Oct 2022 (actual)
Results: Posted 11 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 3
Model description: Randomized repeated measures between-subjects design

Arm	Type	Receives
No prep ready-to-eat meals	Experimental	Behavioral: No prep ready-to-eat meals
Ingredient bundles (e.g. meal kits)	Active comparator	Behavioral: Ingredient bundles (e.g. meal kits)
Pantry Staff Group	No intervention	–They participate in qualitative interviews only. No demographic or other identifiable information from them. They do not receive an intervention. No Intervention Group.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (6 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No prep ready-to-eat mealsPantry 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.	Behavioural	No prep ready-to-eat meals
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.	Behavioural	Ingredient bundles (e.g. meal kits)

Primary outcome

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.
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."

1 secondary outcome

Perceived Diet Quality
Time frame: 14-days

Results and safety

Results posted to the registry on 11 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
No Prep Ready-to-eat Meals	35	31
Ingredient Bundles (e.g. Meal Kits)	35	35
Pantry Staff Group	15	15

Primary outcome: Hedonic Liking of Study Foods

Time frame: 14-days. Mean (Standard Deviation). Unit: score on a scale

Measure	No Prep Ready-to-eat Meals n = 31	Ingredient Bundles (e.g. Meal Kits) n = 35
Value	7.2 (0.9)	7.2 (1.1)

Population analysed: There were anonymous qualitative interviews conducted with food pantry staff as a separate aim of this study. Food Pantry staff enrolled are not part of the pilot randomized controlled trial (RCT) for which this outcome measure is analyzed since out of the total participants enrolled, only the pantry clients are part of the RCT and the pantry clients who completed this study were analyzed for this outcome. So Food Pantry staff is not included as a separate arm here for this outcome.

Primary outcome: Satisfaction of Study Foods

Time frame: 14-days. Mean (Standard Deviation). Unit: score on a scale

Measure	No Prep Ready-to-eat Meals n = 31	Ingredient Bundles (e.g. Meal Kits) n = 35
Value	15.74 (2.70)	17.29 (2.31)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected over 1 month - the duration of participation (two weeks) and two weeks following. However, no adverse events were anticipated or reported.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No Prep Ready-to-eat Meals	0 of 35 (0%)	0 of 35 (0%)	0 of 35
Ingredient Bundles (e.g. Meal Kits)	0 of 35 (0%)	0 of 35 (0%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 38041070Hollis-Hansen K, Haskins C, Turcios J, Bowen ME, Leonard T, Lee M, Albin J, Wadkins-Chambers B, Thompson C, Hall T, Pruitt SL. A pilot randomized controlled trial comparing nutritious meal kits and no-prep meals to improve food security and diet quality among food pantry clients. BMC Public Health. 2023 Dec 1;23(1):2389. doi: 10.1186/s12889-023-17355-3.
Derived from this study: PubMed 37886450Hollis-Hansen K, Haskins C, Turcios J, Bowen ME, Leonard T, Lee M, Albin J, Chambers BW, Thompson C, Hall T, Pruitt SL. A pilot randomized controlled trial comparing nutritious meal kits and no-prep meals to improve food security and diet quality among food pantry clients. Res Sq [Preprint]. 2023 Oct 6:rs.3.rs-3029813. doi: 10.21203/rs.3.rs-3029813/v1.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hedonic Liking of Study Foods (time frame: 14-days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05593510, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.