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

Not Applicable

• Conditions: Overweight; Obesity

• Registration Number: NCT06993051
• Lead Sponsor: University of Minho

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-01
• Status Verified: 2025-04
• Study First Submitted: 2025-05-07
• Study First Submitted QC: 2025-05-19
• Last Update Submitted: 2025-05-19
• Study First Posted: 2025-05-28
• Last Update Posted: 2025-05-28
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 478

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overweight and obesity	6 months	Weight (kg) and height (m) will be measured by trained staff and used to calculate body mass index (BMI = kg/m²). Values will be converted into BMI-for-age z-scores using the WHO 2006 growth standards.
Risk of high blood pressure	6 months	Blood pressure percentile - Systolic and diastolic blood pressure will be measured using a validated paediatric oscillometric device. Percentiles adjusted for age, sex and height will be calculated according to AAP 2017 guidelines.
Health literacy	6 months	Assessed using the Health Literacy Survey for Children (HLS-Child), a 20-item scale scored from 1 (very difficult) to 4 (very easy). Total score range: 20 to 80. Higher scores indicate better health literacy.

Secondary Outcome Measures

Name	Time	Method
Dietary intake - fruit and vegetables	6 months	Mean daily servings of fruits and vegetables will be estimated through a parent-completed 24-hour dietary recall. Unit: servings/day.
Dietary intake - sugar-sweetened beverages	6 months	Daily consumption of sugar-sweetened beverages will be estimated through a parent-completed 24-hour dietary recall. Unit: millilitres/day.
Physical activity	6 months	Moderate-to-vigorous physical activity (MVPA) Assessed using wrist-worn ActiGraph GT3X+ accelerometers over 7 consecutive days. Activity counts per minute will be processed using validated cut-points to calculate average daily MVPA. Unit: minutes/day.
Sedentary time	6 months	Accelerometer data from the same 7-day period will be analysed to estimate sedentary behaviour, defined as \<100 counts per minute. Unit: minutes/day.
Sleep duration	6 months	Nightly sleep duration will be estimated using the Sadeh algorithm applied to 7-day ActiGraph GT3X+ wrist accelerometer data. Unit: hours/night.
Sleep quality	6 months	Assessed using the Portuguese version of the Children's Sleep Habits Questionnaire (CSHQ-PT), which includes 33 items scored from 1 (rarely) to 3 (usually). Total score range: 33 to 99. Higher scores indicate poorer sleep quality.

Trial Locations

Locations (1)

University of Minho; 🇵🇹 Braga, Portugal