- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05542537
Nurturing Healthy Teachers (NHT)
Nurturing Healthy Teachers: A Cluster-RCT to Improve the Health, Well-being, and Food Security of Early Care and Education (ECE) Professionals
Study Overview
Status
Detailed 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).
- 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.
- 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shreela V Sharma, PhD, RD
- Phone Number: 713-500-9344
- Email: Shreela.V.Sharma@uth.tmc.edu
Study Locations
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Texas
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Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
-
Contact:
- Shreela V Sharma, PhD, RD
- Phone Number: 713-500-9344
- Email: Shreela.V.Sharma@uth.tmc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BB Produce Distribution + BB Nutrition Education + CHF Weekly Wellness Groups + CHF Web-Based Module
BB is Brighter Bites.
CHF is Create Healthy Futures.
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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.
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Active Comparator: CHF Web-Based Module
CHF is Create Healthy Futures.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Household Food Insecurity as assessed by the U.S. Department of Agriculture self-report food insecurity survey
Time Frame: baseline
|
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:
|
baseline
|
Household Food Insecurity as assessed by the U.S. Department of Agriculture self-report food insecurity measure
Time Frame: 4 months
|
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:
|
4 months
|
Household Food Insecurity as assessed by the U.S. Department of Agriculture self-report food insecurity measure
Time Frame: 9 months
|
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:
|
9 months
|
Household Food Insecurity as assessed by the U.S. Department of Agriculture self-report food insecurity measure
Time Frame: 14 months
|
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:
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14 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dietary intake as assessed by self-report survey
Time Frame: baseline
|
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.
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baseline
|
Dietary intake as assessed by self-report survey
Time Frame: 9 months
|
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
|
Anxiety as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) survey
Time Frame: baseline
|
The Generalized Anxiety Disorder 7-item (GAD) survey has a total score from 0 to 21, with a higher score indicating greater anxiety.
|
baseline
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Anxiety as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) survey
Time Frame: 9 months
|
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
|
Anxiety as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) survey
Time Frame: 14 months
|
The Generalized Anxiety Disorder 7-item (GAD) survey has a total score from 0 to 21, with a higher score indicating greater anxiety.
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14 months
|
Anxiety impact as assessed by the impact item of the GAD-7 survey
Time Frame: baseline
|
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
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Anxiety impact as assessed by the impact item of the GAD-7 survey
Time Frame: 9 months
|
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
|
Anxiety impact as assessed by the impact item of the GAD-7 survey
Time Frame: 14 months
|
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.
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14 months
|
Depression as assessed by the Patient Health 9-item Questionnaire (PHQ-9)
Time Frame: baseline
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The Patient Health 9-item Questionnaire (PHQ-9) has a total score of 0 to 27, with a higher score indicating greater depression.
|
baseline
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Depression as assessed by the Patient Health 9-item Questionnaire (PHQ-9)
Time Frame: 9 months
|
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
|
Depression as assessed by the Patient Health 9-item Questionnaire (PHQ-9)
Time Frame: 14 months
|
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
|
Depression impact as assessed by the impact item of the PHQ-9
Time Frame: baseline
|
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
|
Depression impact as assessed by the impact item of the PHQ-9
Time Frame: 9 months
|
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
|
Depression impact as assessed by the impact item of the PHQ-9
Time Frame: 14 months
|
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.
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14 months
|
Well-being as assessed by the 5-item World Health Organization Well-Being Index (WHO-5)
Time Frame: baseline
|
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
|
Well-being as assessed by the 5-item World Health Organization Well-Being Index (WHO-5)
Time Frame: 9 months
|
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
|
Well-being as assessed by the 5-item World Health Organization Well-Being Index (WHO-5)
Time Frame: 14 months
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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.
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14 months
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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)
Time Frame: baseline
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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.
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baseline
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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)
Time Frame: 9 months
|
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
|
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)
Time Frame: 14 months
|
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.
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14 months
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Glycosylated hemoglobin (HbA1c) level as assessed by blood test
Time Frame: baseline
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Finger stick blood samples will be obtained from teachers in the school, and HbA1c level in the blood sample will be analyzed.
|
baseline
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Glycosylated hemoglobin (HbA1c) level as assessed by blood test
Time Frame: 9 months
|
Finger stick blood samples will be obtained from teachers in the school, and HbA1c level in the blood sample will be analyzed.
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9 months
|
Blood pressure (systolic) as assessed by automated oscillometric device
Time Frame: baseline
|
Blood pressure measurements will be taken using an automated oscillometric device.
|
baseline
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Blood pressure (systolic) as assessed by automated oscillometric device
Time Frame: 9 months
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Blood pressure measurements will be taken using an automated oscillometric device.
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9 months
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Blood pressure (diastolic) as assessed by automated oscillometric device
Time Frame: baseline
|
Blood pressure measurements will be taken using an automated oscillometric device.
|
baseline
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Blood pressure (diastolic) as assessed by automated oscillometric device
Time Frame: 9 months
|
Blood pressure measurements will be taken using an automated oscillometric device.
|
9 months
|
Skin carotenoid level as assessed by The Veggie Meter
Time Frame: baseline
|
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
|
Skin carotenoid level as assessed by The Veggie Meter
Time Frame: 9 months
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Shreela V Sharma, PhD, The University of Texas Health Science Center, Houston
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HSC-SPH-22-0276
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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