NCT05593510

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 25, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

February 12, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2023

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

March 11, 2025

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

October 20, 2022

Results QC Date

July 19, 2024

Last Update Submit

March 5, 2025

Conditions

Keywords

Food securityFood pantryDiet qualityIntervention

Outcome Measures

Primary Outcomes (2)

  • 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.

    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."

    14-days

Secondary Outcomes (1)

  • Perceived Diet Quality

    14-days

Other Outcomes (1)

  • Fruit and Vegetable Frequency

    14-days

Study Arms (3)

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.

Interventions

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.

No prep ready-to-eat meals

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.

Ingredient bundles (e.g. meal kits)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Crossroads Community Services

Dallas, Texas, 75236, United States

Location

Related Publications (2)

  • 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.

  • 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.

Results Point of Contact

Title
Kelseanna Hollis-Hansen
Organization
UT Southwestern Medical Center

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: Randomized repeated measures between-subjects design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 20, 2022

First Posted

October 25, 2022

Study Start

February 12, 2023

Primary Completion

April 26, 2023

Study Completion

April 26, 2023

Last Updated

March 11, 2025

Results First Posted

March 11, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
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.

Locations