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Multidisciplinary Health Literacy Intervention in Preschool Children

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07624695
Acronym
Pre-HELP
Enrollment
160
Registered
2026-06-03
Start date
2025-03-10
Completion date
2025-06-17
Last updated
2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Development, Health Literacy

Keywords

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

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.

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.

Interventions

BEHAVIORALPre-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.

Sponsors

University of Palermo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Gross Motor IndexBaseline 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.
Change in food literacy assessment scoreBaseline 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.
Change in environmental literacy assessment scoreBaseline 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

MeasureTime frameDescription
Change in locomotor skills raw scoreBaseline 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.
Change in ball skills raw scoreBaseline 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.
Change in parent-reported family health-related habitsBaseline 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.

Countries

Italy

Contacts

PRINCIPAL_INVESTIGATORGarden Tabacchi

University of Palermo

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 26, 2026