Multidisciplinary Health Literacy Intervention in Preschool Children (Pre-HELP)

Preschoolers' Health Literacy Project: A Cluster-Randomized Controlled Trial of Multidisciplinary Educational Interventions in Preschool Children

The Preschoolers' Health Literacy Project (Pre-HELP) was a school-based study designed to promote health literacy in preschool children through age-appropriate educational activities. The project included activities focused on movement, food, and environmental health. The main purpose of the study was to examine whether a multidisciplinary educational program could improve health-related knowledge, skills, and behaviors in children aged 3 to 6 years. Preschool classes were assigned to either an intervention group or a control group. Children in the intervention group participated in structured educational laboratories, including a play-based motor program, while children in the control group continued their usual preschool activities. Outcomes were assessed before and after the intervention period.

Study Overview

• Status: Completed
• Conditions: Child Development; Health Literacy
• Intervention / Treatment: Behavioral: Pre-HELP Multidisciplinary Educational Program

Detailed Description

Pre-HELP was a multidisciplinary educational intervention conducted in preschool settings with children aged 3 to 6 years. The project included integrated laboratories focused on movement, food, and environmental health, with the aim of supporting early health literacy through play-based and experiential activities.

The study used a cluster-randomized controlled design, with preschool classes serving as the unit of randomization. Classes were assigned to either an intervention group or a control group. The intervention group received the multidisciplinary educational program, whereas the control group continued usual preschool activities. The motor component consisted of a structured, play-based program delivered twice per week over 8 weeks and designed to promote fundamental motor skills.

Assessments were conducted at baseline and after the intervention period. Motor competence was assessed using the Test of Gross Motor Development-Third Edition. Other project components addressed food literacy and environmental health education. The study was approved by the Bioethics Committee of the University of Palermo.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Palermo
    • Palermo, Palermo, Italy
      • Sport and Exercise Sciences Research Unit, Department of Psychology, Educational Science and Human Movement, University of Palermo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Enrollment in a participating preschool class.
• Age between 3 and 6 years.
• Regular participation in usual preschool activities.
• Written informed consent provided by a parent or legal guardian.

Exclusion Criteria:

• Medical or developmental conditions preventing participation in school-based motor and educational activities.
• Absence of written informed consent from a parent or legal guardian.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Preschool classes assigned to the intervention group received the multidisciplinary educational program, including structured laboratories focused on movement, food, and environmental health. The motor component consisted of a play-based program designed to promote fundamental motor skills.	Behavioral: Pre-HELP Multidisciplinary Educational Program; The intervention consisted of age-appropriate educational laboratories focused on movement, food, and environmental health. The motor component included a structured, play-based program informed by physical literacy principles and delivered twice per week over 8 weeks. Activities were designed to promote fundamental motor skills, engagement, task variability, and experiential learning in preschool children.
No Intervention: Control Group; Preschool classes assigned to the control group continued their usual preschool activities and did not receive the additional multidisciplinary educational program during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gross Motor Index	Gross motor competence was assessed using the Test of Gross Motor Development-Third Edition. The Gross Motor Index is derived from age- and sex-adjusted standard scores, with higher scores indicating better overall gross motor competence.	Baseline to post-intervention, approximately 8 weeks.
Change in food literacy assessment score	Food literacy was assessed using a study-specific Food Literacy Assessment Tool based on five educational modules addressing body weight and foods, food quality and quantity, organic and seasonal foods, traditional and Mediterranean foods, and the food pyramid. Each module included age-appropriate tasks scored according to correct responses or associations. Higher scores indicate better food-related knowledge and skills.	Baseline and post-intervention, approximately 8 weeks.
Change in environmental literacy assessment score	Environmental literacy was assessed using a study-specific Environmental Literacy Assessment Tool based on five educational modules addressing water conservation, food production cycles, composting and waste, seasons and natural elements, and recycling and reuse. Each module included age-appropriate tasks scored according to correct responses or associations. Higher scores indicate better environmental health-related knowledge and skills.	Baseline and post-intervention, approximately 8 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in locomotor skills raw score	Locomotor skills were assessed using the Test of Gross Motor Development-Third Edition. The locomotor skills raw score was calculated by summing performance criteria across locomotor skill items. Scores range from 0 to 46, with higher scores indicating better locomotor skill performance.	Baseline and post-intervention, approximately 8 weeks.
Change in ball skills raw score	Ball skills were assessed using the Test of Gross Motor Development-Third Edition. The ball skills raw score was calculated by summing performance criteria across ball skill items. Scores range from 0 to 54, with higher scores indicating better ball skill performance.	Baseline and post-intervention, approximately 8 weeks.
Change in parent-reported family health-related habits	Family health-related habits were assessed using a parent-reported questionnaire including items on the child's and parent's dietary habits, physical activity, sedentary behavior, and screen time. Items addressed fruit and vegetable intake, sugar-sweetened beverage intake, breakfast frequency, packaged snacks, ready-to-eat foods, physical activity, and sedentary behaviors.	Baseline and post-intervention, approximately 8 weeks.

Collaborators and Investigators

• Sponsor: University of Palermo
• Investigators: Principal Investigator: Garden Tabacchi, University of Palermo

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2025
• Primary Completion (Actual): June 17, 2025
• Study Completion (Actual): June 17, 2025

Study Registration Dates

• First Submitted: May 28, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cluster randomized trial; School-based intervention; Preschool children; Health literacy; Food literacy; Motor competence; Physical literacy; Environmental education
• Other Study ID Numbers: Pre-HELP-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No