Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-03 @ 9:16 PM
Study NCT ID:
NCT06993051
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-28
First Post:
2025-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Social-HEROES: Health and Education on Research Opportunities Empower Students and Tackle Inequalities
Sponsor:
University of Minho
Organization:
Study Overview
Official Title:
Social-HEROES: Health and Education on Research Opportunities Empower Students and Tackle Inequalities
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Social-HEROES (Social Health and Education Research Opportunities: Empower Students and tackle inequities) is a cluster-randomised study that aims to improve the health of vulnerable preschool children (3 to 6 years old) attending Portuguese TEIP\* schools.
Ten preschools (about 478 children) will be randomly assigned to one of two groups. Five preschools (≈ 239 children) will continue with their usual educational activities (control group). The other five preschools (≈ 239 children) will take part in a six-month "Social-HEROES" programme (intervention group).
The intervention is created in participatory innovation labs where children, educators, families, community members and policy-makers design activities together, guided by a systems-thinking approach. These activities encourage healthier eating, more balanced 24-hour movement (active play, less sitting, better sleep) and stronger socio-emotional skills.
The study pursues two main goals. First, it will develop this innovative, stakeholder-driven health-promotion programme. Second, it will test how well the programme works by measuring: (a) children's health-literacy levels, (b) their lifestyle habits (diet, physical activity, sedentary time and sleep), (c) rates of overweight and obesity, and (d) blood-pressure levels.
Researchers expect that, compared with the control group, children in the intervention group will show higher health-literacy scores, healthier lifestyle patterns and lower rates of excess weight and raised blood pressure. Data will be collected before the programme starts and again six months later, using short questionnaires, simple body measurements, blood-pressure readings and a wrist-worn activity tracker (accelerometer) worn for seven days. Participation is voluntary, can be stopped at any time without penalty, and all information is handled in accordance with GDPR.
Social-HEROES is funded by Fundación "la Caixa" (LCF/PR/SR24/57010020) and has ethical approval from the Life and Health Sciences Research Ethics Committee (CEICVS 189/2024). It addresses two pressing challenges at once: reducing early non-communicable-disease risks and narrowing social and educational health gaps among young children.
\*TEIP: Priority Intervention Educational Territories in Portugal
Ten preschools (about 478 children) will be randomly assigned to one of two groups. Five preschools (≈ 239 children) will continue with their usual educational activities (control group). The other five preschools (≈ 239 children) will take part in a six-month "Social-HEROES" programme (intervention group).
The intervention is created in participatory innovation labs where children, educators, families, community members and policy-makers design activities together, guided by a systems-thinking approach. These activities encourage healthier eating, more balanced 24-hour movement (active play, less sitting, better sleep) and stronger socio-emotional skills.
The study pursues two main goals. First, it will develop this innovative, stakeholder-driven health-promotion programme. Second, it will test how well the programme works by measuring: (a) children's health-literacy levels, (b) their lifestyle habits (diet, physical activity, sedentary time and sleep), (c) rates of overweight and obesity, and (d) blood-pressure levels.
Researchers expect that, compared with the control group, children in the intervention group will show higher health-literacy scores, healthier lifestyle patterns and lower rates of excess weight and raised blood pressure. Data will be collected before the programme starts and again six months later, using short questionnaires, simple body measurements, blood-pressure readings and a wrist-worn activity tracker (accelerometer) worn for seven days. Participation is voluntary, can be stopped at any time without penalty, and all information is handled in accordance with GDPR.
Social-HEROES is funded by Fundación "la Caixa" (LCF/PR/SR24/57010020) and has ethical approval from the Life and Health Sciences Research Ethics Committee (CEICVS 189/2024). It addresses two pressing challenges at once: reducing early non-communicable-disease risks and narrowing social and educational health gaps among young children.
\*TEIP: Priority Intervention Educational Territories in Portugal
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| LCF/PR/SR24/57010020 | OTHER_GRANT | "la Caixa" Foudation | View |