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Enrolling by invitation NCT06993051

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

No phase Interventional Overweight Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Social-HEROES Health-Promotion Program.
Who it may be relevant to
Registry conditions: Overweight, Obesity. Basic parameters: 3 years — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Portugal
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Behavioral 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 engage

Primary outcome measures

  • Overweight and obesity [Time frame: 6 months]
  • Risk of high blood pressure [Time frame: 6 months]
  • Health literacy [Time frame: 6 months]
Secondary outcome measures (6)
  • Dietary intake - fruit and vegetables [Time frame: 6 months]
  • Dietary intake - sugar-sweetened beverages [Time frame: 6 months]
  • Physical activity [Time frame: 6 months]
  • Sedentary time [Time frame: 6 months]
  • Sleep duration [Time frame: 6 months]
  • Sleep quality [Time frame: 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Portugal · 1 center
  • University of Minho — Braga

Identifiers

NCT: NCT06993051 · U. Minho · LCF/PR/SR24/57010020

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗