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

NCT06993051 | Enrolling By Invitation DMC

• 2 other identifiers: U. MinhoLCF/PR/SR24/57010020
• Study Type: interventional
• Target: 478
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Overweight and obesity

  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.

  6 months

• Risk of high blood pressure

  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.

  6 months

• Health literacy

  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.

  6 months

Secondary Outcomes (6)

• Dietary intake - fruit and vegetables

  6 months

• Dietary intake - sugar-sweetened beverages

  6 months

• Physical activity

  6 months

• Sedentary time

  6 months

• Sleep duration

  6 months

Study Arms (2)

Usual Education Control

NO INTERVENTION

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

Social-HEROES Intervention

EXPERIMENTAL

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).

Behavioral: Social-HEROES Health-Promotion Program

Interventions

Social-HEROES Health-Promotion Program 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.

Social-HEROES Intervention

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Minho: lead

Study Sites (1)

University of Minho

Braga, Portugal

Location

MeSH Terms

Conditions

Overweight; Obesity; Motor Activity; Sedentary Behavior; Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Disease Attributes; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

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

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 28, 2025
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)