Multidisciplinary Health Literacy Intervention in Preschool Children

NCT07624695 | Completed

• 1 other identifier: Pre-HELP-2025
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Child Development; Health Literacy

Keywords

Preschool children; Health literacy; Physical literacy; Food literacy; Environmental education; Motor competence; School-based intervention; Cluster randomized trial

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Change in locomotor skills raw score

  Baseline and post-intervention, approximately 8 weeks.

• Change in ball skills raw score

  Baseline and post-intervention, approximately 8 weeks.

• Change in parent-reported family health-related habits

  Baseline and post-intervention, approximately 8 weeks.

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Pre-HELP Multidisciplinary Educational Program BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

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

Palermo, Palermo, Italy

Location

Study Officials

• Garden Tabacchi

  University of Palermo

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Preschool classes were cluster-randomized to either an intervention group receiving the multidisciplinary educational program or a control group continuing usual preschool activities.

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start: March 10, 2025
• Primary Completion: June 17, 2025
• Study Completion: June 17, 2025
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)