Clinical trial NCT05542537: Nurturing Healthy Teachers
Official title: Nurturing Healthy Teachers: A Cluster-RCT to Improve the Health, Well-being, and Food Security of Early Care and Education (ECE) Professionals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nutrition, Healthy
Mental Health Wellness 1
Diabetes Mellitus Risk
Obesity
Keywords: food insecurity
nutrition
healthy eating
wellness
teachers
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Brighter Bites
name: Penn State Better Kid Care
name: University of Texas at Austin
name: Vitamix Foundation
First posted: 2022-09-15
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Household Food Insecurity as assessed by the U.S. Department of Agriculture self-report food insecurity survey
timeFrame: baseline
measure: Household Food Insecurity as assessed by the U.S. Department of Agriculture self-report food insecurity measure
timeFrame: 4 months
measure: Household Food Insecurity as assessed by the U.S. Department of Agriculture self-report food insecurity measure
timeFrame: 9 months
measure: Household Food Insecurity as assessed by the U.S. Department of Agriculture self-report food insecurity measure
timeFrame: 14 months
Secondary outcomes:
measure: Dietary intake as assessed by self-report survey
timeFrame: baseline
measure: Dietary intake as assessed by self-report survey
timeFrame: 9 months
measure: Anxiety as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) survey
timeFrame: baseline
measure: Anxiety as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) survey
timeFrame: 9 months
measure: Anxiety as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) survey
timeFrame: 14 months
measure: Anxiety impact as assessed by the impact item of the GAD-7 survey
timeFrame: baseline
measure: Anxiety impact as assessed by the impact item of the GAD-7 survey
timeFrame: 9 months
measure: Anxiety impact as assessed by the impact item of the GAD-7 survey
timeFrame: 14 months
measure: Depression as assessed by the Patient Health 9-item Questionnaire (PHQ-9)
timeFrame: baseline
measure: Depression as assessed by the Patient Health 9-item Questionnaire (PHQ-9)
timeFrame: 9 months
measure: Depression as assessed by the Patient Health 9-item Questionnaire (PHQ-9)
timeFrame: 14 months
measure: Depression impact as assessed by the impact item of the PHQ-9
timeFrame: baseline
measure: Depression impact as assessed by the impact item of the PHQ-9
timeFrame: 9 months
measure: Depression impact as assessed by the impact item of the PHQ-9
timeFrame: 14 months
measure: Well-being as assessed by the 5-item World Health Organization Well-Being Index (WHO-5)
timeFrame: baseline
measure: Well-being as assessed by the 5-item World Health Organization Well-Being Index (WHO-5)
timeFrame: 9 months
measure: Well-being as assessed by the 5-item World Health Organization Well-Being Index (WHO-5)
timeFrame: 14 months
measure: 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)
timeFrame: baseline
measure: 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)
timeFrame: 9 months
measure: 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)
timeFrame: 14 months
measure: Glycosylated hemoglobin (HbA1c) level as assessed by blood test
timeFrame: baseline
measure: Glycosylated hemoglobin (HbA1c) level as assessed by blood test
timeFrame: 9 months
measure: Blood pressure (systolic) as assessed by automated oscillometric device
timeFrame: baseline
measure: Blood pressure (systolic) as assessed by automated oscillometric device
timeFrame: 9 months
measure: Blood pressure (diastolic) as assessed by automated oscillometric device
timeFrame: baseline
measure: Blood pressure (diastolic) as assessed by automated oscillometric device
timeFrame: 9 months
measure: Skin carotenoid level as assessed by The Veggie Meter
timeFrame: baseline
measure: Skin carotenoid level as assessed by The Veggie Meter
timeFrame: 9 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Shreela V Sharma, PhD
role: PRINCIPAL_INVESTIGATOR
References: