An interventional study of Brighter Bites (BB) Produce Distribution and Brighter Bites (BB) Nutrition Education in Nutrition, Healthy, Mental Health Wellness 1 and Diabetes Mellitus Risk, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-09.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Prevention
The purpose of this trial is to compare the impact of a fruit and vegetable access plus nutrition education intervention to a nutrition education-only control on the health, well-being, and food security of early care and education (ECE) professionals. The intervention, called Nurturing Healthy Teachers, combines strategies from two evidence-based programs - Create Healthy Futures (CHF) and Brighter Bites (BB).
The purpose of this trial is to evaluate the impact of the Nurturing Healthy Teachers program on food insecurity, dietary behaviors, mental health, and cardiometabolic health among early care and education (ECE) professionals who teach Pre-Kindergarten or Kindergarten. Nurturing Healthy Teachers is a novel, comprehensive program that combines strategies from two evidence-based programs - Brighter Bites (implemented by Brighter Bites 501c3 non-profit) and Create Healthy Futures (implemented by Penn State Better Kid Care).
The trial will be conducted in 30 elementary schools that have pre-Kindergarten and Kindergarten classes that serve predominantly low-income families in Houston. Schools in the intervention arm (n=15) will receive Brighter Bites plus the complete Create Healthy Futures program including online modules and in-person meetings, and they will be drawn from schools that are already scheduled to receive Brighter Bites during the 2022-2023 school year. Schools in the control arm (n=15) will only receive passive access to the online modules of the Create Healthy Futures program, and they will be drawn from remaining schools across the district, as long as they have not participated in Brighter Bites in the previous two years. The intervention and control programs will be implemented over one school year (9months). Brighter Bites non-profit organization and Penn State Better Kid Care will implement the Nurturing Healthy Teachers program, while UTHealth School of Public Health investigators will conduct the evaluation of the program.
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Inclusion Criteria for Teachers:
Exclusion Criteria for Teachers:
Inclusion Criteria for Schools:
BB is Brighter Bites. CHF is Create Healthy Futures.
Behavioral: Brighter Bites (BB) Produce Distribution · Behavioral: Brighter Bites (BB) Nutrition Education · Behavioral: Create Healthy Futures (CHF) Weekly Wellness Groups · Behavioral: Create Healthy Futures (CHF) Web-Based Module
CHF is Create Healthy Futures.
Behavioral: Create Healthy Futures (CHF) Web-Based Module
For 16 weeks in the school year, teachers in participating program schools will receive distributions of 8-10 different types of produce items.
Brighter Bites Nutrition Education will consist of recipes, food preparation and storage ideas, and tips and tools to budget and plan meals. Teachers will be trained in a nutrition education curriculum, which will be implemented in the program schools as part of the BB program.
Peer-facilitators will lead virtual weekly group discussions. Penn State Better Kid Care will train the wellness facilitators.
Create Healthy Futures Web-Based Module is self-paced and focuses on the following topics: 1) Introduction, 2) Challenges of the food environment, 3) Nutrition and your health, 4) Food culture reform, and 5) Providers' role in creating healthy futures. The Create Healthy Futures module utilizes several educational methods to increase interactivity and engagement, including video footage of content experts, reflection activities, downloadable handouts, and action planning. Each chapter takes approximately 30-40 minutes to complete. The program is delivered on the Better Kid Care On Demand platform, an asynchronous learning management system that provides professional development training for teachers in all 50 states and 69 countries.
Household Food Insecurity as assessed by the U.S. Department of Agriculture self-report food insecurity survey
Household Food insecurity will be measured on an electronically administered using the 10-item self-report previously validated U.S. Department of Agriculture food insecurity survey. The survey will measure food insecurity over the past 30 days. The total score is the sum of affirmative responses to the 10 questions, with a total score range of 0-10. Scores indicate the following about extent of food insecurity: * score of zero-High food security * score of 1-2-Marginal food security * score of 3-5-Low food security * score of 6-10-Very low food security
Time frame: baseline
Household Food Insecurity as assessed by the U.S. Department of Agriculture self-report food insecurity measure
Household Food insecurity will be measured on an electronically administered using the 10-item self-report previously validated U.S. Department of Agriculture food insecurity survey. The survey will measure food insecurity over the past 30 days. The total score is the sum of affirmative responses to the 10 questions, with a total score range of 0-10. Scores indicate the following about extent of food insecurity: * score of zero-High food security * score of 1-2-Marginal food security * score of 3-5-Low food security * score of 6-10-Very low food security
Time frame: 4 months
Household Food Insecurity as assessed by the U.S. Department of Agriculture self-report food insecurity measure
Household Food insecurity will be measured on an electronically administered using the 10-item self-report previously validated U.S. Department of Agriculture food insecurity survey. The survey will measure food insecurity over the past 30 days. The total score is the sum of affirmative responses to the 10 questions, with a total score range of 0-10. Scores indicate the following about extent of food insecurity: * score of zero-High food security * score of 1-2-Marginal food security * score of 3-5-Low food security * score of 6-10-Very low food security
Time frame: 9 months
Household Food Insecurity as assessed by the U.S. Department of Agriculture self-report food insecurity measure
Household Food insecurity will be measured on an electronically administered using the 10-item self-report previously validated U.S. Department of Agriculture food insecurity survey. The survey will measure food insecurity over the past 30 days. The total score is the sum of affirmative responses to the 10 questions, with a total score range of 0-10. Scores indicate the following about extent of food insecurity: * score of zero-High food security * score of 1-2-Marginal food security * score of 3-5-Low food security * score of 6-10-Very low food security
Time frame: 14 months
Dietary intake as assessed by self-report survey
Dietary intake will be self-reported on an electronically administered survey using a food frequency screener. The survey items will measure the frequency of consumption of various foods including fruits, vegetables, whole grains, protein, water, beverages, desserts, processed food, and candy. Data will be reported categorically as the number of times the surveyed foods were consumed.
Time frame: baseline
Dietary intake as assessed by self-report survey
Dietary intake will be self-reported on an electronically administered survey using a food frequency screener. The survey items will measure the frequency of consumption of various foods including fruits, vegetables, whole grains, protein, water, beverages, desserts, processed food, and candy. Data will be reported categorically as the number of times the surveyed foods were consumed.
Time frame: 9 months
Anxiety as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) survey
The Generalized Anxiety Disorder 7-item (GAD) survey has a total score from 0 to 21, with a higher score indicating greater anxiety.
Time frame: baseline
Anxiety as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) survey
The Generalized Anxiety Disorder 7-item (GAD) survey has a total score from 0 to 21, with a higher score indicating greater anxiety.
Time frame: 9 months
Anxiety as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) survey
The Generalized Anxiety Disorder 7-item (GAD) survey has a total score from 0 to 21, with a higher score indicating greater anxiety.
Time frame: 14 months
Anxiety impact as assessed by the impact item of the GAD-7 survey
For participants who scored 1 or above on the GAD-7, they will be asked how difficult the anxiety-related issues have made it to do work, take care of things at home, or get along with other people. Data will be reported categorically as number of participants who answered: Not difficult at all; Somewhat difficult; Very difficult; Extremely difficult; Prefer not to say.
Time frame: baseline
Anxiety impact as assessed by the impact item of the GAD-7 survey
For participants who scored 1 or above on the GAD-7, they will be asked how difficult the anxiety-related issues have made it to do work, take care of things at home, or get along with other people. Data will be reported categorically as number of participants who answered: Not difficult at all; Somewhat difficult; Very difficult; Extremely difficult; Prefer not to say.
Time frame: 9 months
Anxiety impact as assessed by the impact item of the GAD-7 survey
For participants who scored 1 or above on the GAD-7, they will be asked how difficult the anxiety-related issues have made it to do work, take care of things at home, or get along with other people. Data will be reported categorically as number of participants who answered: Not difficult at all; Somewhat difficult; Very difficult; Extremely difficult; Prefer not to say.
Time frame: 14 months
Depression as assessed by the Patient Health 9-item Questionnaire (PHQ-9)
The Patient Health 9-item Questionnaire (PHQ-9) has a total score of 0 to 27, with a higher score indicating greater depression.
Time frame: baseline
Depression as assessed by the Patient Health 9-item Questionnaire (PHQ-9)
The Patient Health 9-item Questionnaire (PHQ-9) has a total score of 0 to 27, with a higher score indicating greater depression.
Time frame: 9 months
Depression as assessed by the Patient Health 9-item Questionnaire (PHQ-9)
The Patient Health 9-item Questionnaire (PHQ-9) has a total score of 0 to 27, with a higher score indicating greater depression.
Time frame: 14 months
Depression impact as assessed by the impact item of the PHQ-9
For participants who scored 1 or above on the PHQ-9, they will be asked how difficult the depression-related issues have made it to do work, take care of things at home, or get along with other people. Data will be reported categorically as number of participants who answered: Not difficult at all; Somewhat difficult; Very difficult; Extremely difficult; Prefer not to say.
Time frame: baseline
Depression impact as assessed by the impact item of the PHQ-9
For participants who scored 1 or above on the PHQ-9, they will be asked how difficult the depression-related issues have made it to do work, take care of things at home, or get along with other people. Data will be reported categorically as number of participants who answered: Not difficult at all; Somewhat difficult; Very difficult; Extremely difficult; Prefer not to say.
Time frame: 9 months
Depression impact as assessed by the impact item of the PHQ-9
For participants who scored 1 or above on the PHQ-9, they will be asked how difficult the depression-related issues have made it to do work, take care of things at home, or get along with other people. Data will be reported categorically as number of participants who answered: Not difficult at all; Somewhat difficult; Very difficult; Extremely difficult; Prefer not to say.
Time frame: 14 months
Well-being as assessed by the 5-item World Health Organization Well-Being Index (WHO-5)
The 5-item World Health Organization Well-Being Index (WHO-5) has a total score or 0 -25, with a higher score indicating greater well-being.
Time frame: baseline
Well-being as assessed by the 5-item World Health Organization Well-Being Index (WHO-5)
The 5-item World Health Organization Well-Being Index (WHO-5) has a total score or 0 -25, with a higher score indicating greater well-being.
Time frame: 9 months
Well-being as assessed by the 5-item World Health Organization Well-Being Index (WHO-5)
The 5-item World Health Organization Well-Being Index (WHO-5) has a total score or 0 -25, with a higher score indicating greater well-being.
Time frame: 14 months
General health as assessed by the general health item of the Centers for Disease Control and Prevention (CDC) Health-related quality of life (HRQoL) 4-item questionnaire (CDC HRQoL-4)
Only one item on the CDC HRQoL-4 will be asked, and this is the item related to general health. Participants will be asked if they would say that in general that their health is Excellent, Very good, Good, Fair, Poor, or Prefer not to say. Data will be reported categorically as number of participants who answered: Excellent; Very good; Good; Fair; Poor; Prefer not to say.
Time frame: baseline
General health as assessed by the general health item of the Centers for Disease Control and Prevention (CDC) Health-related quality of life (HRQoL) 4-item questionnaire (CDC HRQoL-4)
Only one item on the CDC HRQoL-4 will be asked, and this is the item related to general health. Participants will be asked if they would say that in general that their health is Excellent, Very good, Good, Fair, Poor, or Prefer not to say. Data will be reported categorically as number of participants who answered: Excellent; Very good; Good; Fair; Poor; Prefer not to say.
Time frame: 9 months
General health as assessed by the general health item of the Centers for Disease Control and Prevention (CDC) Health-related quality of life (HRQoL) 4-item questionnaire (CDC HRQoL-4)
Only one item on the CDC HRQoL-4 will be asked, and this is the item related to general health. Participants will be asked if they would say that in general that their health is Excellent, Very good, Good, Fair, Poor, or Prefer not to say. Data will be reported categorically as number of participants who answered: Excellent; Very good; Good; Fair; Poor; Prefer not to say.
Time frame: 14 months
Glycosylated hemoglobin (HbA1c) level as assessed by blood test
Finger stick blood samples will be obtained from teachers in the school, and HbA1c level in the blood sample will be analyzed.
Time frame: baseline
Glycosylated hemoglobin (HbA1c) level as assessed by blood test
Finger stick blood samples will be obtained from teachers in the school, and HbA1c level in the blood sample will be analyzed.
Time frame: 9 months
Blood pressure (systolic) as assessed by automated oscillometric device
Blood pressure measurements will be taken using an automated oscillometric device.
Time frame: baseline
Blood pressure (systolic) as assessed by automated oscillometric device
Blood pressure measurements will be taken using an automated oscillometric device.
Time frame: 9 months
Blood pressure (diastolic) as assessed by automated oscillometric device
Blood pressure measurements will be taken using an automated oscillometric device.
Time frame: baseline
Blood pressure (diastolic) as assessed by automated oscillometric device
Blood pressure measurements will be taken using an automated oscillometric device.
Time frame: 9 months
Skin carotenoid level as assessed by The Veggie Meter
Skin carotenoid level will be assessed by The Veggie Meter, which is a small, portable non-invasive device that can be clipped to the finger briefly to detect skin carotenoid concentrations in ∼15-20 seconds for a single reading.
Time frame: baseline
Skin carotenoid level as assessed by The Veggie Meter
Skin carotenoid level will be assessed by The Veggie Meter, which is a small, portable non-invasive device that can be clipped to the finger briefly to detect skin carotenoid concentrations in ∼15-20 seconds for a single reading.
Time frame: 9 months
Plan to share: Undecided
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The University of Texas Health Science Center, Houston