Clinical trial NCT06993051: Social-HEROES: Health and Education on Research Opportunities Empower Students and Tackle Inequalities
Official title: Social-HEROES: Health and Education on Research Opportunities Empower Students and Tackle Inequalities
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Overweight
Obesity
Keywords: Health Promotion, Health Literacy, Life Style, Diet, Motor Activity, Sedentary Behavior, Sleep, Child Development, Health Equity, Noncommunicable Disease
Lead sponsor: University of Minho
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 478
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized (preschool-level) parallel assignment with two arms (intervention vs. control).
Primary purpose: PREVENTION

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


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

Primary outcomes:
measure: Overweight and obesity
timeFrame: 6 months
measure: Risk of high blood pressure
timeFrame: 6 months
measure: Health literacy
timeFrame: 6 months
Secondary outcomes:
measure: Dietary intake - fruit and vegetables
timeFrame: 6 months
measure: Dietary intake - sugar-sweetened beverages
timeFrame: 6 months
measure: Physical activity
timeFrame: 6 months
measure: Sedentary time
timeFrame: 6 months
measure: Sleep duration
timeFrame: 6 months
measure: Sleep quality
timeFrame: 6 months
Other outcomes:
Locations:
city: Braga
country: Portugal
facility: University of Minho
Study officials:
References: