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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No prep ready-to-eat meals | Experimental |
| |
| Ingredient bundles (e.g. meal kits) | Active Comparator |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No prep ready-to-eat meals | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14-days |
| Measure | Description | Time Frame |
|---|---|---|
| Fruit and Vegetable Frequency | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Crossroads Community Services | Dallas | Texas | 75236 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38041070 | Result | 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. | |
| 37886450 |
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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.
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.
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Out of the total 85 participants enrolled, 70 were pantry clients that are part of the RCT, 15 pantry staff were not part of this RCT. Pantry staff group (No intervention Group) participated in qualitative interviews (anonymous) only. No demographic or other identifiable information were collected from them. They were not randomized. They did not receive an intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | No Prep Ready-to-eat Meals | 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. |
| FG001 | Ingredient Bundles (e.g. Meal Kits) | 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. |
| FG002 | Pantry Staff Group | Pantry staff only completed anonymous interviews during the study pilot. They participated in qualitative interviews only. They were not randomized. They did not receive an intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Pantry staff Group (15 count) is not included in Baseline Characteristics since any demographic or other identifiable information were not collected from them. They completed anonymous interviews only. They were not randomized. They did not receive an intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | No Prep Ready-to-eat Meals | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 (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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 14-days |
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.
Pantry staff Group (15 count) is not included in the Adverse Event (AE) Table since they were not monitored for AEs and no AE data were not collected from them. They were not assessed for adverse events. They completed anonymous interviews only. They were not randomized. They did not receive an intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Prep Ready-to-eat Meals | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelseanna Hollis-Hansen | UT Southwestern Medical Center | 214-645-7676 | kelseanna.hollis-hansen@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2022 | Oct 14, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 2, 2023 | Jan 24, 2025 | ICF_001.pdf |
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Randomized repeated measures between-subjects design
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|
| Ingredient bundles (e.g. meal kits) | Behavioral | 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. |
|
| 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. |
| BG001 | Ingredient Bundles (e.g. Meal Kits) | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | No Prep Ready-to-eat Meals | 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. |
| OG001 | Ingredient Bundles (e.g. Meal Kits) | 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. |
|
|
| Primary | 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." | 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. | Posted | Mean | Standard Deviation | score on a scale | 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" (5 = Excellent, 1 = Poor). Perceived diet quality is the scale title. | 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. | Posted | Mean | Standard Error | units on a scale | 14-days |
|
|
|
| Other Pre-specified | Fruit and Vegetable Frequency | 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. | 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. | Posted | Mean | Standard Error | cups of fruits and veg per day | 14-days |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Ingredient Bundles (e.g. Meal Kits) | 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. | 0 | 35 | 0 | 35 | 0 | 35 |
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