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Completed

NCT Number: NCT07624695

Multidisciplinary Health Literacy Intervention 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.

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Key information

Conditions

Health Literacy Child Development

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Palermo, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Gross Motor Index

    Time frame: Baseline to post-intervention, approximately 8 weeks.

    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.

  2. Change in food literacy assessment score

    Time frame: Baseline and post-intervention, approximately 8 weeks.

    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.

  3. Change in environmental literacy assessment score

    Time frame: Baseline and post-intervention, approximately 8 weeks.

    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.

Secondary outcomes

  1. Change in locomotor skills raw score

    Time frame: Baseline and post-intervention, approximately 8 weeks.

    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.

  2. Change in ball skills raw score

    Time frame: Baseline and post-intervention, approximately 8 weeks.

    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.

  3. Change in parent-reported family health-related habits

    Time frame: Baseline and post-intervention, approximately 8 weeks.

    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.

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study title

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

Acronym: Pre-HELP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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