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临床试验/NCT07120516
NCT07120516招募中不适用

Co-creating School Community Intervention Program on Physical Activity to Increase Health Equity in Children and Adolescents

Sandra Andrusaityte1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年6月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Change in systolic and diastolic blood pressure in children aged 12-16 years

研究概览

简要总结

The goal of this observational and interventional study is to understand whether environmental and behavioral interventions can improve physical activity and health outcomes in children aged 12-16 years attending VDU Atžalynas Progymnasium, Lithuania.

The main questions it aims to answer are:

  1. Does higher physical activity and improved lifestyle reduce health disparities among children living in disadvantaged social and economic conditions?
  2. What is the relationship between environmental pollution, physical activity, and children's health indicators? Researchers will compare data from the cross-sectional group (baseline measurements only) and the intervention group (7-day activity tracking and follow-up after 3 months) to see if targeted environmental interventions improve children's physical activity, sleep quality, and health outcomes.

Participants will:

  • Fill in questionnaires about health behaviors, well-being, and living environment (children and parents).
  • Undergo physical measurements (blood pressure, height, weight, body composition).
  • Wear a smart wristband for 7 days to monitor activity, sleep, and heart rate (only for selected participants).
  • Attend a follow-up visit after 3 months (intervention group only).

详细描述

Non-communicable diseases (NCDs), such as cardiovascular diseases, obesity, and metabolic disorders, are a leading cause of morbidity and mortality worldwide. Evidence shows that insufficient physical activity, poor dietary habits, and exposure to environmental pollutants (such as PM2.5, PM10, and NO₂) significantly increase the risk of these conditions in children and adolescents. The negative impact of these risk factors is disproportionately higher in children living in socially and economically disadvantaged environments, perpetuating health inequalities from early life stages.

Physical activity and diet are modifiable risk factors. Interventions implemented at the community level, especially in school settings where children spend a large part of their day, have the potential to create long-term behavioral changes and reduce health disparities. However, the interaction between environmental exposures, social determinants, and physical activity on health outcomes is still poorly understood. There is a lack of comprehensive, evidence-based interventions targeting environmental and behavioral factors simultaneously in children from disadvantaged backgrounds.

The Connection Project is an international, multi-center observational and interventional study designed to:

  • Assess the relationship between environmental exposures, physical activity, and health indicators in children aged 12-16 years.
  • Implement and evaluate community-based environmental and behavioral interventions to promote healthier lifestyles.
  • Contribute to evidence-based recommendations for reducing health inequities in school-age populations.

This study is supported by the European Commission under the ERA4Health program and funded nationally by the Research Council of Lithuania, in collaboration with multiple European research institutions in Portugal, Belgium, Spain, Lithuania, Latvia, Denmark, the Netherlands, and Italy.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

年龄范围
12 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 12-16 years
  • Attending VDU Atžalynas Progymnasium (Kaunas, Lithuania)
  • Written informed consent from parents/legal guardians and assent from the child
  • Willingness to participate in questionnaires, physical measurements, and (if selected) wearable device monitoring

排除标准

  • Younger than 12 or older than 16 years
  • No signed informed consent from parents/legal guardians or refusal by the child
  • Medical or psychological conditions that may interfere with participation (e.g., severe cardiovascular disease, mobility impairments, skin allergies preventing wearable use)

结局指标

主要结局

Change in systolic and diastolic blood pressure in children aged 12-16 years

时间窗: Baseline (Day 0) and 3 months after intervention

This outcome assesses changes in systolic and diastolic blood pressure (measured in mmHg) in participating children. Blood pressure will be measured using calibrated, CE-certified devices to evaluate the effect of increased physical activity and improved environmental conditions on cardiovascular health.

Change in body composition indicators in children aged 12-16 years

时间窗: Baseline (Day 0) and 3 months after intervention

This outcome includes changes in body mass index (BMI), fat mass percentage, weight (kg), and height (m). Measurements will be collected using validated, CE-certified body composition analyzers to assess improvements in physical health related to the intervention.

次要结局

  • Change in physical activity levels in children aged 12-16 years(Baseline (Day 0) and 3 months after intervention)
  • Change in self-reported well-being in children aged 12-16 years(Baseline (Day 0) and 3 months after intervention)

研究者

发起方
Sandra Andrusaityte
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sandra Andrusaityte

associate professor

Vytautas Magnus University

研究点 (1)

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