Health LiteracyPre-HELPNCT07624695
Multidisciplinary Health Literacy Intervention in Preschool Children
A study testing Pre-HELP Multidisciplinary Educational Program in people with Health Literacy and Child Development, run by University of Palermo at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Literacy, Child Development
- What is being tested?
- Pre-HELP Multidisciplinary Educational Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- 10 Mar 2025to 17 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Medical or developmental conditions preventing participation in school-based motor and educational activities.
- Absence of written informed consent from a parent or legal guardian.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Sport and Exercise Sciences Research Unit, Department of Psychology, Educational Science and Human Movement, University of Palermo
Palermo, Palermo
About this study
Official title: 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.
Read the 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.
- Conditions
- Health Literacy, Child Development
- Being tested
- Pre-HELP Multidisciplinary Educational Program
- Keywords
- Preschool children, Health literacy, Physical literacy, Food literacy, Environmental education, Motor competence, School-based intervention, Cluster randomized trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-HELP Multidisciplinary Educational ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and post-intervention, approximately 8 weeks.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and post-intervention, approximately 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start10 Mar 2025
- Primary completion17 Jun 2025
- Study completion17 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health LiteracyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Garden Tabacchi, University of Palermo
- Investigators
- Garden Tabacchi, Principal investigator, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624695
- Sponsor's protocol ID
- Pre-HELP-2025
- Acronym
- Pre-HELP
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agnese M, Massaro S, Cottone R, Scardina A, Lo Dico F, Honorio S, Bellafiore M, Tabacchi G. Domain-specific motor skill outcomes following a structured play-based motor intervention in preschool children: a cluster-randomized controlled trial. Front Sports Act Living. 2026 Aug 24;8:1917249. doi: 10.3389/fspor.2026.1917249. eCollection 2026.
PubMed 42707388
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preschoolers' Health Literacy Project: A Cluster-Randomized Controlled Trial of Multidisciplinary Educational Interventions in Preschool Children
- ClinicalTrials.gov ID
- NCT07624695
- Acronym / sponsor ID
- Pre-HELP / Pre-HELP-2025
- Conditions
- Health Literacy, Child Development
- Keywords
- Preschool children, Health literacy, Physical literacy, Food literacy, Environmental education, Motor competence, School-based intervention, Cluster randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 17 Jun 2025 (actual)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Pre-HELP Multidisciplinary Educational ProgramPreschool 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. |
| 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. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Medical or developmental conditions preventing participation in school-based motor and educational activities.
- Absence of written informed consent from a parent or legal guardian.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-HELP Multidisciplinary Educational ProgramThe 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. | Behavioural | Intervention Group |
Primary outcome
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.
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.
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.
3 secondary outcomes
Change in locomotor skills raw score
Time frame: Baseline and post-intervention, approximately 8 weeks.
Change in ball skills raw score
Time frame: Baseline and post-intervention, approximately 8 weeks.
Change in parent-reported family health-related habits
Time frame: Baseline and post-intervention, approximately 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Derived from this study: PubMed 42707388Agnese M, Massaro S, Cottone R, Scardina A, Lo Dico F, Honorio S, Bellafiore M, Tabacchi G. Domain-specific motor skill outcomes following a structured play-based motor intervention in preschool children: a cluster-randomized controlled trial. Front Sports Act Living. 2026 Aug 24;8:1917249. doi: 10.3389/fspor.2026.1917249. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Garden Tabacchi principal investigator
University of Palermo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-HELP Multidisciplinary Educational Program in people with Health Literacy and Child Development, run by University of Palermo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gross Motor Index (time frame: Baseline to post-intervention, approximately 8 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07624695, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.