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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06993051
Enrollment
478
Registered
2025-05-28
Start date
2025-01-01
Completion date
2026-12-31
Last updated
2025-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Keywords

Health Promotion, Health Literacy, Life Style, Diet, Motor Activity, Sedentary Behavior, Sleep, Child Development, Health Equity, Noncommunicable Disease

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

Interventions

BEHAVIORALSocial-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.

Sponsors

University of Minho
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

Cluster-randomized (preschool-level) parallel assignment with two arms (intervention vs. control).

Eligibility

Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Overweight and obesity6 monthsWeight (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 pressure6 monthsBlood 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 literacy6 monthsAssessed 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

MeasureTime frameDescription
Sedentary time6 monthsAccelerometer data from the same 7-day period will be analysed to estimate sedentary behaviour, defined as \<100 counts per minute. Unit: minutes/day.
Dietary intake - fruit and vegetables6 monthsMean daily servings of fruits and vegetables will be estimated through a parent-completed 24-hour dietary recall. Unit: servings/day.
Sleep quality6 monthsAssessed 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.
Sleep duration6 monthsNightly sleep duration will be estimated using the Sadeh algorithm applied to 7-day ActiGraph GT3X+ wrist accelerometer data. Unit: hours/night.
Dietary intake - sugar-sweetened beverages6 monthsDaily consumption of sugar-sweetened beverages will be estimated through a parent-completed 24-hour dietary recall. Unit: millilitres/day.
Physical activity6 monthsModerate-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.

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026