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NCT Number: NCT06993051

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

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

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Key information

Conditions

Overweight Behavior Body Weight Disease Attributes Motor Activity Noncommunicable Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathologic Processes Pathological Conditions, Signs and Symptoms Sedentary Behavior Signs and Symptoms

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minho

Braga, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Overweight and obesity

    Time frame: 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.

  2. Risk of high blood pressure

    Time frame: 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.

  3. Health literacy

    Time frame: 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 outcomes

  1. Dietary intake - fruit and vegetables

    Time frame: 6 months

    Mean daily servings of fruits and vegetables will be estimated through a parent-completed 24-hour dietary recall. Unit: servings/day.

  2. Dietary intake - sugar-sweetened beverages

    Time frame: 6 months

    Daily consumption of sugar-sweetened beverages will be estimated through a parent-completed 24-hour dietary recall. Unit: millilitres/day.

  3. Physical activity

    Time frame: 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.

  4. Sedentary time

    Time frame: 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.

  5. Sleep duration

    Time frame: 6 months

    Nightly sleep duration will be estimated using the Sadeh algorithm applied to 7-day ActiGraph GT3X+ wrist accelerometer data. Unit: hours/night.

  6. Sleep quality

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Minho

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 28, 2025
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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