Increasing Food Literacy in Preschoolers to Reduce Obesity Risk

NCT05977348 | Recruiting

• 2 other identifiers: OSP#2330452023-68015-39416
• Study Type: interventional
• Target: 770
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Food Preferences; Food Selection; Eating, Healthy; Obesity, Childhood

Keywords

Food literacy; Healthy growth; Child Development; Food Acceptance

Outcome Measures

Primary Outcomes (5)

• Children's Food Acceptance

  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

  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

  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

  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

  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 Outcomes (1)

• Child Weight Status/Adiposity

  Change from baseline to post-intervention (~6 months)

Other Outcomes (13)

• Child food requests (parent report)

  Change from baseline to post-intervention (~6 months)

• Children's Appetitive Traits and Behaviors (parent and teacher report)

  Baseline

• Children's Food Exposure (parent and teacher report)

  Baseline

Study Arms (2)

Healthy Bodies Project Comparison (HBP)

NO INTERVENTION

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).

Healthy Bodies Project Plus (HBP+)

EXPERIMENTAL

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; Behavioral: Improving the Classroom Food and Mealtime Environment; Behavioral: Parent Education; Behavioral: ECE Food Acceptance Training

Interventions

Healthy Eating Curriculum BEHAVIORAL

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.

Healthy Bodies Project Plus (HBP+)

Improving the Classroom Food and Mealtime Environment BEHAVIORAL

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.

Healthy Bodies Project Plus (HBP+)

Parent Education BEHAVIORAL

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.

Healthy Bodies Project Plus (HBP+)

ECE Food Acceptance Training BEHAVIORAL

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.

Healthy Bodies Project Plus (HBP+)

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Preschool children enrolled in participating centers

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

RECRUITING

MeSH Terms

Conditions

Food Preferences; Pediatric Obesity

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lori A Francis, Ph.D.

  Penn State University; Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lori A Francis, Ph.D.

CONTACT

814-863-0213; lfrancis@psu.edu

Regina H Lozinski, M.S.

CONTACT

814-865-0045; rmh215@psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study team members who will conduct individual research assessments with each child will be blinded to study condition.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Biobehavioral Health

Model Details: The project is a cluster-randomized trial, with a 1:1 ratio of classroom random assignment to intervention or control.

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 4, 2023
• Study Start: October 3, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be made available in perpetuity after all primary and secondary analyses are completed to address study aims.
• Access Criteria: The data can be accessed by contacting the principal investigator after the specified time period.

Locations

US (1)