Social-HEROES: Health and Education on Research Opportunities Empower Students and Tackle Inequalities

NCT ID: NCT06993051

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 478 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-12-31

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

Conditions

Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Usual Education Control

Preschools (n = 5; ~ 239 children) continue their usual curriculum and health-education practices; no additional components are delivered.

No intervention will occur.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Social-HEROES Intervention

Six-month, cluster-level programme co-created in participatory innovation labs. Includes classroom activities and family workshops to improve diet, 24-h movement (physical activity, sedentary time, sleep) and socio-emotional skills. Implemented in 5 preschools (\~ 239 children).

Group Type: EXPERIMENTAL

Social-HEROES Health-Promotion Program

Intervention Type: BEHAVIORAL

Six-month, cluster-level, stakeholder-co-created health-promotion programme delivered in preschool settings. The programme is developed through participatory innovation labs and includes:

• Educator training sessions (monthly)
• Classroom activities on healthy eating, active play and socio-emotional skills (weekly)
• Family workshops and take-home materials promoting 24-hour movement behaviour (diet, physical activity, reduced sedentary time, adequate sleep) (every 4-6 weeks)
• Community engagement events (beginning and end of intervention). Implementation period: 6 months; dosage approx. 20-24 contact hours per child.

Interventions

Social-HEROES Health-Promotion Program

Six-month, cluster-level, stakeholder-co-created health-promotion programme delivered in preschool settings. The programme is developed through participatory innovation labs and includes:

• Educator training sessions (monthly)
• Classroom activities on healthy eating, active play and socio-emotional skills (weekly)
• Family workshops and take-home materials promoting 24-hour movement behaviour (diet, physical activity, reduced sedentary time, adequate sleep) (every 4-6 weeks)
• Community engagement events (beginning and end of intervention). Implementation period: 6 months; dosage approx. 20-24 contact hours per child.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Children from TEIP schools
• Ages between 3 to 6 years old

Exclusion Criteria

• Children/families who don't speak/understand Portuguese

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minho

OTHER

Sponsor Role: lead

Responsible Party

Helena Rafaela Vieira do Rosario

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Minho

Braga, , Portugal

Countries

Portugal

Other Identifiers

LCF/PR/SR24/57010020

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

U. Minho

Identifier Type: -

Identifier Source: org_study_id