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临床试验/NCT06993051
NCT06993051Enrolling By Invitation不适用

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

University of Minho1 个研究点 分布在 1 个国家目标入组 478 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
478
试验地点
1
主要终点
Overweight and obesity

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Overweight and obesity

时间窗: 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.

Risk of high blood pressure

时间窗: 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.

Health literacy

时间窗: 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.

次要结局

  • 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)
  • Sleep quality(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Helena Rafaela Vieira do Rosario

PhD

University of Minho

研究点 (1)

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