Increasing Food Literacy in Preschoolers to Reduce Obesity Risk

March 12, 2025 updated by: Lori Francis, Penn State University

Increasing Food Literacy as a Means of Increasing Preschool Children's Food Acceptance and Reducing Obesity Risk

The goal of this clinical trial is to examine the effects of a nutrition education program on preschool children's food literacy and food acceptance, and to examine the added influence of a healthy eating curriculum and parent education on children's food knowledge and healthful food choices. The project will be evaluated with 450 children ages 3 to 5 years in center-based childcare programs serving predominantly Supplemental Nutrition Assistance Program (SNAP)-eligible families in Pennsylvania. Outcomes for children who receive the added healthy eating curriculum will be compared to children in classrooms that only receive the nutrition education program.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Repeatedly exposing young children to new foods can increase their willingness to try those foods, and they may - with time - learn to like those foods. Being able to learn about, touch and taste new foods can be a powerful tool to foster young children's liking of new foods. This project's goals are to test whether a preschool nutrition education program can improve (1) children's ability to name and identify fruits and vegetables, (2) children's knowledge about food and nutrition, (3) children's healthful food choices during a meal, and (4) parenting around children's eating. Participants will include 450 children ages 3 to 5 years in center-based childcare programs serving a large majority of families experiencing poverty in Pennsylvania. In all classrooms, children will receive food literacy lessons designed to help them learn about different fruits and vegetables, where they grow, and why they are good for our bodies. Children in intervention classrooms will receive food literacy lessons, in addition to lessons on healthy eating designed to improve children's nutrition knowledge. Teachers in intervention classrooms will be provided with materials designed to increase children's knowledge about nutrition and healthy eating. Intervention parents will receive web-based lessons designed to improve parenting practices related to children's eating behaviors. The study will be conducted over a 14-month period, and a variety of child, teacher, classroom and parent outcomes will be measured before, during and after the intervention. The results of this study are anticipated to add new information on ways to improve children's nutrition knowledge and acceptance of fruits and vegetables.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
770

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Lori A Francis, Ph.D.
  • Phone Number: 814-863-0213
  • Email: lfrancis@psu.edu

Study Contact Backup

  • Name: Regina H Lozinski, M.S.
  • Phone Number: 814-865-0045
  • Email: rmh215@psu.edu

Study Locations

  • United States
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • Recruiting
        • The Pennsylvania State University
        • Contact:
          • Lori A Francis, PhD
          • Phone Number: 814-863-0213
          • Email: laf169@psu.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Preschool children enrolled in participating centers

Exclusion Criteria:

  • Severe food allergies that prevent children from consuming project foods
  • Presence of a developmental or sensory disability that affects food intake and/or learning
  • Lack of English fluency (children and caregivers)
  • Children not regularly present during days/times that intervention lessons are delivered
  • Parents who are not involved in feeding/preparing meals for children at least 50% of the time

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Healthy Bodies Project Comparison (HBP)
All classrooms will receive the Eating the Alphabet curriculum, which includes 27 lessons that introduce children to a new fruit or vegetable from A-Z each week. Parents in comparison and intervention classrooms will receive access to web-based parent resources related to the Eating the Alphabet curriculum (e.g., food of the week fact sheets with recipes and suggestions for use, and coloring pages).
Experimental: Healthy Bodies Project Plus (HBP+)
Intervention classrooms will receive the Eating the Alphabet curriculum described above for comparison classrooms, in addition to (1) the Healthy Eating curriculum, (2) classroom materials and teacher training designed to improve the classroom food and mealtime environment in ways that increase food acceptance, and (3) parent/caregiver education on responsive food parenting.
Behavioral: Healthy Eating Curriculum
The Healthy Eating (HE) curriculum is designed to provide children with skills needed to develop healthy eating habits. Each lesson builds upon the overall goal of creating a healthy restaurant. Children are taught to identify differences between GO and WHOA foods, recognize the five food groups, and learn to make healthy food choices.
Behavioral: Improving the Classroom Food and Mealtime Environment
HBP+ Classrooms will receive additional sensory activities for each lesson (e.g., posters, food models, games) designed to improve the classroom food environment and provide repeated exposure to activities and messages about fruits and vegetables. Teachers in HBP+ classrooms will be provided with additional training on strategies shown to increase food acceptance in preschool children (e.g., modeling, encouraging children to try foods without coercion). In addition, HBP+ classrooms will include "tasting charts" that children will stamp to indicate their liking for each food each week.
Behavioral: Parent Education
Parents in intervention classrooms will be given access to 8 web-based lessons on food parenting and responsive parenting. Topics include: establishing mealtime routines, shopping healthy on a budget; modeling of healthy eating behaviors; addressing picky eating in children; structuring low-stress mealtime environments; the division of responsibility in feeding, and portion control.
Behavioral: ECE Food Acceptance Training
HBP+ early childhood educators (ECEs) will be asked to complete an online, self-paced course on increasing food acceptance in preschool children. Topics will include: repeated exposure to foods; modeling of healthy eating behaviors; addressing picky eating in children; structuring low-stress mealtime environments; and the division of responsibility in feeding.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Children's Food Acceptance
Time Frame: Change from baseline to post-intervention (~6 months)
Teachers reports of each child's willingness to try and liking of weekly target foods; lab-created measure. Scores for trying (yes/no) and liking (yes/no) are summed to create total scores for each. Scores range from 0 to 26 for trying and liking. Higher scores indicate a higher frequency of trying weekly foods and higher frequency of liking seeking foods.
Change from baseline to post-intervention (~6 months)
Children's willingness to try novel foods
Time Frame: Change from baseline to post-intervention (~6 months)
Observed measure of children's willingness to try 4 novel foods (The Tasting Game; lab-created measure). The child scores 1 point for each bite of food that is tasted or eaten. Scores for each range from 0 (none tasted/eaten) to 3 (all pieces tasted/eaten). Total scores range from 0 to 12, and are created by summing the points obtained for each food item. Higher scores indicate a greater willingness to try foods.
Change from baseline to post-intervention (~6 months)
Children's Food Literacy
Time Frame: Change from baseline to post-intervention (~6 months)
Observed measure of children's ability to name/identify 6 foods using pictures (Food Literacy Scale; lab-created measure). Children receive a score of 0 (incorrect/don't know), 1 (correctly identified on the second pass), or 2 (correctly named on the first pass) points. Total scores range from 0 to 12, and are created by summing the points obtained for each food item. Higher scores indicate higher food literacy or ability to identify foods.
Change from baseline to post-intervention (~6 months)
Children's Food Knowledge
Time Frame: Change from baseline to post-intervention (~6 months)
Observed measure of children's ability to differentiate between nutrient- and energy-dense foods using the Snack Selection Protocol (Sigma-Grant et al., 2014). Children receive 1 point for each nutrient-dense food item chosen. Scores range from 0-18, with higher scores indicating nutrient-dense foods being chosen more often energy-dense foods.
Change from baseline to post-intervention (~6 months)
Children's Food Choices
Time Frame: Change from baseline to post-intervention (~6 months)
Observed measure of children's food choices when given the option to choose a nutrient- vs. energy-dense snack (live-coded; lab-created measure). Children receive a score of either 0 (energy-dense food chosen) or 1 (nutrient-dense food chosen).
Change from baseline to post-intervention (~6 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Child Weight Status/Adiposity
Time Frame: Change from baseline to post-intervention (~6 months)
Child age- and sex-specific Body Mass Indices (BMI) from measured height and weight. Conditional weight gain (rate of change in children's BMIz), will be calculated as the standardized residual of the linear regression of post-intervention BMIz predicted by baseline BMIz, adjusted for child age and sex.
Change from baseline to post-intervention (~6 months)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Child food requests (parent report)
Time Frame: Change from baseline to post-intervention (~6 months)
Children's requests for foods used in the study, as well as general requests for fruits and vegetables (Fruit and Vegetable Survey; lab-created measure).
Change from baseline to post-intervention (~6 months)
Children's Appetitive Traits and Behaviors (parent and teacher report)
Time Frame: Baseline
Measure of food approach and avoidance behaviors (e.g., satiety responsiveness and food enjoyment) measured using the Children's Eating Behaviour Questionnaire (Wardle et al., 2001). Response options range from 1 to 5 and subscale scores are calculated by averaging the items within each subscale. Higher scores for any subscale indicate the respondent's perception of a greater degree of the particular eating style in the child.
Baseline
Children's Food Exposure (parent and teacher report)
Time Frame: Baseline
Measure of children's previous experience and familiarity with target foods using the Children's Food Exposure Questionnaire (lab-created). Scores are calculated by averaging the items within each subscale. Subscale 1 scores range from 0-8 points, subscales 2-6 scores range from 0-3. Higher scores for subscales indicate (1) higher availability of fruits and vegetables; (2) more encouragement to eat fruits and vegetables; (3) more modeling of fruit and vegetable consumption by mothers; (4) more asking for fruits and vegetables by children; (4) children have more barriers to eat fruits and vegetables; (6) and caregivers have more barriers to eat fruits and vegetables respectively.
Baseline
Children's Mealtime Behaviors
Time Frame: Change from baseline to post-intervention (~6 months)
A lab-created, parent-report measure of children's media use while eating. Response options on this 3-item measure range from 1 to 4. Scores are calculated by averaging the items, with higher scores indicate a higher frequency of the child eating while watching television.
Change from baseline to post-intervention (~6 months)
Food parenting practices (parent-report)
Time Frame: Change from baseline to post-intervention (~6 months)
Measure of parents' food-related practices (e.g., coercive vs. responsive feeding practices) using the Comprehensive Feeding Practices Questionnaire (Musher-Eizenman & Holub, 2007). This instrument includes 12 sub scales with response options ranging from 1-5; items are averaged to create each sub scale. Higher scores indicate a greater degree or frequency of use of the food parenting strategy.
Change from baseline to post-intervention (~6 months)
Parent Nutrition Knowledge
Time Frame: Change from baseline to post-intervention (~6 months)
Parent/caregiver knowledge about topics such as appropriate portion sizes, number of snacks preschoolers need each day, etc. using an adapted version of a Nutrition Knowledge Questionnaire developed by Rapson et al. (2020). This adapted 53-item questionnaire includes forced-choice and open-ended questions. Respondents score 1 point for correct answers on all nutrition knowledge items and 0 points for an incorrect or "choose not to answer" response. Incorrect responses, or responses that are contradictory to nutrition guidelines are also scored as 0 points. A composite score is obtained by summing answers to all nutrition knowledge items. Higher scores indicate a higher levels of nutrition knowledge to support healthy eating/feeding practices for preschool aged children.
Change from baseline to post-intervention (~6 months)
Household Food Security (parent-report)
Time Frame: Baseline
Household, adult and child food insecurity and hunger measured using the 18-item U.S. Household Food Security Survey. If there is no missing data, respondents can be categorized based on their sum score across all 18 questions. Categories and their respective scores are as follows: (1) High Food Security: 0-2 points, (2) Marginal Food Security: 3-7 points, (3) Low Food Security: 8-12 points, and (4) Very Low Food Security: 13-18 points. Affirmative items (with responses) are summed to create a raw score, with scores ranging from 0-18 points. Higher scores indicate greater household food insecurity.
Baseline
Household Demographics and Parents' General Health (parent-report)
Time Frame: Baseline
Sociodemographic information, parent height and weight (lab-created questionnaire).
Baseline
Childcare Provider Nutrition Knowledge
Time Frame: Change from baseline to post-intervention (~6 months)
Childcare provider knowledge about topics such as appropriate portion sizes, number of snacks preschoolers need each day, etc. measured using an Early Childhood Educator Nutrition Knowledge Questionnaire developed by Rapson et al. (2020). This 57-item questionnaire includes forced-choice and open-ended questions. Respondents score 1 point for correct answers on all nutrition knowledge items and 0 points for an incorrect or "choose not to answer" response. Incorrect responses, or responses that are contradictory to nutrition guidelines are also scored as 0 points. A composite score is obtained by summing answers to all nutrition knowledge items. Higher scores indicate a higher levels of nutrition knowledge to support healthy eating/feeding practices for preschool aged children.
Change from baseline to post-intervention (~6 months)
Childcare Provider Feeding Beliefs
Time Frame: Change from baseline to post-intervention (~6 months)
Childcare provider mealtime behaviors and feeding practices measured using the About Feeding Children questionnaire (Swindle et al., 2018). This questionnaire contains 31 items and 9 subscales. Higher scores on each of the subscales indicate the degree to which the respondent utilizes the mealtime strategy or agrees with particular mealtime beliefs.
Change from baseline to post-intervention (~6 months)
Childcare Provider Demographics
Time Frame: Baseline
Sociodemographic information, teaching experience, height, weight, physical activity frequency (lab-created questionnaire).
Baseline
Classroom Food and Mealtime Environment
Time Frame: Change from baseline to post-intervention (~6 months)
An observational measure of the classroom food and mealtime environment. Response options range from 1 to 4, and scores are calculated by averaging the items within each subscale. Higher scores indicate (1) a higher degree of visuals that support healthy eating; and (2) teacher and child dynamics during mealtime that are consistent with healthy eating practices.
Change from baseline to post-intervention (~6 months)
Classroom Chaos
Time Frame: Baseline
An adapted measure of classroom chaos using the Confusion, Hubbub and Order Scale for classrooms (Wachs et al., 2004). Response options range from 1 to 4, and a total score is calculated by averaging scores for 12 items. Higher scores indicate more chaos, disorganization, and noise level in the classroom.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Penn State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lori A Francis, Ph.D., Penn State University; Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 3, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OSP#233045
  • 2023-68015-39416 (Other Grant/Funding Number: United States Department of Agriculture)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared after all primary and secondary analyses are completed to address study aims.

IPD Sharing Time Frame

Data will be made available in perpetuity after all primary and secondary analyses are completed to address study aims.

IPD Sharing Access Criteria

The data can be accessed by contacting the principal investigator after the specified time period.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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