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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05593510
Other study ID # STU-2022-0809
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 13, 2023
Est. completion date April 26, 2023

Study information

Verified date May 2023
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date April 26, 2023
Est. primary completion date April 26, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Crossroads Community Services Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Fruit and vegetable frequency Fruit & Vegetable Screener from the Eating at America's Table Study (EATS) 14-days
Primary 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 with four measures of liking and four measures of dislike and a neutral "neither like nor dislike" 14-days
Primary Acceptability of study foods 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
Primary Satisfaction of study foods 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 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" 14-days
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