Nurturing Healthy Teachers

Obesity Clinical Trial

— NHT  

Official title:

Nurturing Healthy Teachers: A Cluster-RCT to Improve the Health, Well-being, and Food Security of Early Care and Education (ECE) Professionals

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05542537
• Other study ID #: HSC-SPH-22-0276
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: December 2023

Study information

• Verified date: September 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: Shreela V Sharma, PhD, RD
• Phone: 713-500-9344
• Email: Shreela.V.Sharma[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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).

1. Brighter Bites (BB) is a 501c3 non-profit organization that implements an evidence-based coordinated school health program that combines access to fresh produce and nutrition education proven to improve dietary intake among preschool and elementary school teachers, low-income children, and their families. For 16 weeks in the school year, Brighter Bites teachers and families receive a weekly distribution of about 20 lbs (50 servings) of primarily donated fresh vegetables, plus weekly healthy recipe tastings, and nutrition education. The program has proven effectiveness at engaging teachers, parents, increasing healthy dietary behaviors and improving the school and home nutrition environment of low-income elementary school children in the short-term.

2. Developed and implemented by Penn State Extension Better Kid Care (BKC), Create Healthy Futures (CHF) is a web-based nutrition education program that targets nutrition knowledge, self-efficacy, mindfulness, and social support to create healthy habits among teachers. CHF also includes facilitated group meetings to reinforce information from the online modules.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for Teachers:

• Employed as a pre-K or kindergarten teaching staff at the participating study schools in the 2022-2023 school year.

• Ability to read English at the 4th grade reading level

• Ability to complete study measures

Exclusion Criteria for Teachers:

• Have recently (in the past 6 months) or are currently participating in an exercise or weight loss program

Inclusion Criteria for Schools:

• Have at least 25 eligible early childhood education (ECE) professionals

Related Conditions & MeSH terms

• Diabetes Mellitus Risk
• Mental Health Wellness 1
• Obesity

Intervention

Behavioral:
• Brighter Bites (BB) Produce Distribution
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 (BB) Nutrition Education
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.
• Create Healthy Futures (CHF) Weekly Wellness Groups
Peer-facilitators will lead virtual weekly group discussions. Penn State Better Kid Care will train the wellness facilitators.
• Create Healthy Futures (CHF) Web-Based Module
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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (5)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Brighter Bites, Penn State Better Kid Care, University of Texas at Austin, Vitamix Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline
Primary	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	4 months
Primary	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	9 months
Primary	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	14 months
Secondary	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.	baseline
Secondary	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.	9 months
Secondary	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.	baseline
Secondary	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.	9 months
Secondary	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.	14 months
Secondary	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.	baseline
Secondary	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.	9 months
Secondary	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.	14 months
Secondary	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.	baseline
Secondary	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.	9 months
Secondary	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.	14 months
Secondary	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.	baseline
Secondary	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.	9 months
Secondary	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.	14 months
Secondary	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.	baseline
Secondary	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.	9 months
Secondary	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.	14 months
Secondary	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.	baseline
Secondary	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.	9 months
Secondary	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.	14 months
Secondary	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.	baseline
Secondary	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.	9 months
Secondary	Blood pressure (systolic) as assessed by automated oscillometric device	Blood pressure measurements will be taken using an automated oscillometric device.	baseline
Secondary	Blood pressure (systolic) as assessed by automated oscillometric device	Blood pressure measurements will be taken using an automated oscillometric device.	9 months
Secondary	Blood pressure (diastolic) as assessed by automated oscillometric device	Blood pressure measurements will be taken using an automated oscillometric device.	baseline
Secondary	Blood pressure (diastolic) as assessed by automated oscillometric device	Blood pressure measurements will be taken using an automated oscillometric device.	9 months
Secondary	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.	baseline
Secondary	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.	9 months