An interventional study of Social-HEROES Health-Promotion Program in Overweight and Obesity, sponsored by University of Minho. Enrolling by invitation at 1 site in Portugal. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2025-05-28.
Sponsored by University of Minho · Not applicable, Interventional, and Prevention
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
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 478 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →University of Minho is the lead sponsor of 39 studies on the registry; 9 are open to participants now.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Preschools (n = 5; \~ 239 children) continue their usual curriculum and health-education practices; no additional components are delivered. No intervention will occur.
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
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Dietary intake - fruit and vegetables
Mean daily servings of fruits and vegetables will be estimated through a parent-completed 24-hour dietary recall. Unit: servings/day.
Time frame: 6 months
Dietary intake - sugar-sweetened beverages
Daily consumption of sugar-sweetened beverages will be estimated through a parent-completed 24-hour dietary recall. Unit: millilitres/day.
Time frame: 6 months
Physical activity
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.
Time frame: 6 months
Sedentary time
Accelerometer data from the same 7-day period will be analysed to estimate sedentary behaviour, defined as \<100 counts per minute. Unit: minutes/day.
Time frame: 6 months
Sleep duration
Nightly sleep duration will be estimated using the Sadeh algorithm applied to 7-day ActiGraph GT3X+ wrist accelerometer data. Unit: hours/night.
Time frame: 6 months
Sleep quality
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.
Time frame: 6 months
Plan to share: No
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University of Minho