- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05593510
Food Pantry Client and Staff Preferences for Nutritious no Prep Ready-to-eat Meals
May 3, 2023 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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
70
Phase
- 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
- Name: Kelseanna Hollis-Hansen, PhD, MPH
- Phone Number: 214-648-3260
- Email: kelseanna.hollis-hansen@utsouthwestern.edu
Study Contact Backup
- Name: Carolyn Haskins, MS
- Phone Number: 2146483260
- Email: carolyn.haskins@utsouthwestern.edu
Study Locations
-
-
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
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 |
Intervention / Treatment |
---|---|
Experimental: 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)
|
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.
|
What is the study measuring?
Primary Outcome Measures
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 with four measures of liking and four measures of dislike and a neutral "neither like nor dislike"
|
14-days
|
Acceptability of study foods
Time Frame: 14-days
|
Acceptability will be measured by showing the name and picture of the meal and asking the client whether they and/or members of their household ate the meal within the past 2-weeks and whether they would select the meal again if given the opportunity in the future
|
14-days
|
Satisfaction of study foods
Time Frame: 14-days
|
Satisfaction items will be 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?")
|
14-days
|
Secondary Outcome Measures
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"
|
14-days
|
Other Outcome Measures
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)
|
14-days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
February 13, 2023
Primary Completion (Actual)
April 26, 2023
Study Completion (Actual)
April 26, 2023
Study Registration Dates
First Submitted
October 20, 2022
First Submitted That Met QC Criteria
October 20, 2022
First Posted (Actual)
October 25, 2022
Study Record Updates
Last Update Posted (Estimate)
May 5, 2023
Last Update Submitted That Met QC Criteria
May 3, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID 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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