NCT05542537

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
379

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 4, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2024

Completed
Last Updated

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

1.5 years

First QC Date

September 12, 2022

Last Update Submit

July 3, 2025

Conditions

Keywords

food insecuritynutritionhealthy eatingwellnessteachers

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (28)

  • Dietary intake as assessed by self-report survey

    baseline

  • Dietary intake as assessed by self-report survey

    9 months

  • Anxiety as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) survey

    baseline

  • Anxiety as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) survey

    9 months

  • Anxiety as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) survey

    14 months

  • +23 more secondary outcomes

Study Arms (2)

BB Produce Distribution + BB Nutrition Education + CHF Weekly Wellness Groups + CHF Web-Based Module

EXPERIMENTAL

BB is Brighter Bites. CHF is Create Healthy Futures.

Behavioral: Brighter Bites (BB) Produce DistributionBehavioral: Brighter Bites (BB) Nutrition EducationBehavioral: Create Healthy Futures (CHF) Weekly Wellness GroupsBehavioral: Create Healthy Futures (CHF) Web-Based Module

CHF Web-Based Module

ACTIVE COMPARATOR

CHF is Create Healthy Futures.

Behavioral: Create Healthy Futures (CHF) Web-Based Module

Interventions

For 16 weeks in the school year, teachers in participating program schools will receive distributions of 8-10 different types of produce items.

BB Produce Distribution + BB Nutrition Education + CHF Weekly Wellness Groups + CHF Web-Based Module

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.

BB Produce Distribution + BB Nutrition Education + CHF Weekly Wellness Groups + CHF Web-Based Module

Peer-facilitators will lead virtual weekly group discussions. Penn State Better Kid Care will train the wellness facilitators.

BB Produce Distribution + BB Nutrition Education + CHF Weekly Wellness Groups + 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.

BB Produce Distribution + BB Nutrition Education + CHF Weekly Wellness Groups + CHF Web-Based ModuleCHF Web-Based Module

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Have recently (in the past 6 months) or are currently participating in an exercise or weight loss program
  • Have at least 25 eligible early childhood education (ECE) professionals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Shreela V Sharma, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 12, 2022

First Posted

September 15, 2022

Study Start

November 4, 2022

Primary Completion

May 20, 2024

Study Completion

May 20, 2024

Last Updated

July 9, 2025

Record last verified: 2025-07

Locations