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Clinical Trial NCT05977348 for Food Preferences, Food Selection, Eating, Healthy, Obesity, Childhood is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Penn State UniversityIncreasing Food Literacy in Preschoolers to Reduce Obesity Risk 770
Clinical Trial NCT05977348 is an interventional study for Food Preferences, Food Selection, Eating, Healthy, Obesity, Childhood that is recruiting. It started on October 3, 2023 with plans to enroll 770 participants. Led by Penn State University, it is expected to complete by August 1, 2026. The latest data from ClinicalTrials.gov was last updated on March 17, 2025.
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 Sup...Show More
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...Show More
Official Title
Increasing Food Literacy as a Means of Increasing Preschool Children's Food Acceptance and Reducing Obesity Risk
Conditions
Food PreferencesFood SelectionEating, HealthyObesity, ChildhoodOther Study IDs
- OSP#233045
- 2023-68015-39416 (Other Grant/Funding Number) (United States Department of Agriculture)
NCT ID Number
Start Date (Actual)
2023-10-03
Last Update Posted
2025-03-17
Completion Date (Estimated)
2026-08
Enrollment (Estimated)
770
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Food literacy
Healthy growth
Child Development
Food Acceptance
Healthy growth
Child Development
Food Acceptance
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
No InterventionHealthy 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). | N/A |
ExperimentalHealthy 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. | 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. 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 chi...Show More 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. 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Child Weight Status/Adiposity | 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) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child
Minimum Age
3 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- Preschool children enrolled in participating centers
- 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
Penn State UniversityStudy Responsible Party
Lori Francis, Principal Investigator, Professor of Biobehavioral Health, Penn State University
Study Central Contact
Contact: Lori A Francis, Ph.D., 814-863-0213, [email protected]
Contact: Regina H Lozinski, M.S., 814-865-0045, [email protected]
1 Study Locations in 1 Countries
Pennsylvania
The Pennsylvania State University, University Park, Pennsylvania, 16802, United States
Lori A Francis, PhD, Contact, 814-863-0213, [email protected]
Recruiting