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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:
Participants will:
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 NOâ‚‚) 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:
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.
Study Objectives
Primary Objectives:
Secondary Objectives:
Study Design and Methodology: This is a two-phase study combining a cross-sectional baseline assessment and an in-depth interventional follow-up.
Phase 1 - Cross-Sectional Study: Population: Approximately 200 children aged 12-16 years attending *VDU Atžalynas Progymnasium in Kaunas, Lithuania.
* **Sampling:** Random selection from eligible students whose parents/legal guardians provide informed consent and who agree to participate.
Data Collection:
Questionnaires:
Objective Measurements:
All collected data will be pseudonymized and entered into secure electronic data capture systems. Each participant will be assigned a unique study ID to protect confidentiality.
Phase 2 - Interventional Study:
Behavioral feedback will be provided to children and parents to encourage healthy routines. Community-level initiatives may include adjustments to the school environment (e.g., safe walking paths, organized activity breaks, improved playground access) to promote physical activity.
Timeline: Baseline monitoring (Visit 1): Placement of wristband, instructions provided (10 min). Day 7 (Visit 2): Retrieval of wristband, verbal feedback on experience (10 min). 3-Month Follow-Up (Visit 3): Repeated health measurements and 7-day monitoring period to assess changes in activity, sleep, and health indicators.
The goal is to evaluate feasibility, adherence, and preliminary health impact of combining environmental and behavioral interventions.
Data Management and Analysis: Personal identifiers will be kept separate from research data. Electronic files will be encrypted and stored on password-protected servers at Vytautas Magnus University. Access will be limited to authorized study staff. Data will be retained for 5 years after project completion before secure destruction.
Statistical Analysis:
Ethical Considerations: The study has been reviewed and approved by the Kaunas Regional Biomedical Research Ethics Committee.
Participation is voluntary; informed consent from parents/legal guardians and assent from children will be obtained prior to enrollment.
Participants may withdraw at any time without consequences. All procedures are non-invasive and involve minimal risk, limited to mild discomfort from measurements or wearing a wristband.
No compensation is provided; participation is voluntary and free of charge. Data confidentiality will be protected according to GDPR and national laws.
Expected Outcomes and Impact: The Connection Project is expected to:
International Collaboration: This project is part of a European consortium with research partners in: Portugal: University of Porto, Institute of Public Health; Belgium: Ghent University; Spain: ISGlobal, Barcelona; Latvia: Riga Stradins University; Denmark: University of Copenhagen; Netherlands: Amsterdam Public Health Research Institute and Italy: University of Turin
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| Measure | Description | Time Frame |
|---|---|---|
| Change in systolic and diastolic blood pressure in children aged 12-16 years | 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. | Baseline (Day 0) and 3 months after intervention |
| Change in body composition indicators in children aged 12-16 years | 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. | Baseline (Day 0) and 3 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in physical activity levels in children aged 12-16 years | Assesses change in average daily step count and active minutes using CE-certified smart wristbands worn for 7 consecutive days. The data will reflect children's habitual physical activity levels before and after the intervention. | Baseline (Day 0) and 3 months after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of children aged 12-16 years enrolled in VDU Atžalynas Progymnasium (Kaunas, Lithuania). Participants will be selected from a general school population, with priority given to inclusion of children living in socially and economically disadvantaged environments. Eligible participants will be healthy volunteers without medical conditions that could interfere with the study procedures. Both parental consent and child assent are required for participation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandra Andrusaityte, PHD | Contact | +37068437989 | sandra.andrusaityte@vdu.lt | |
| Regina Grazuleviciene, prof. | Contact | +37065027090 | regina.grazuleviciene@vdu.lt |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vytautas Magnus university, faculty of Natural Sciences, Environmental sciences | Recruiting | Kaunas | Lithuania |
De-identified individual participant data (IPD) collected during this study (questionnaire responses, anthropometric measurements, body composition, physical activity, and sleep monitoring data) may be shared with qualified researchers upon reasonable request for purposes of scientific validation, secondary analyses, and meta-analyses, in compliance with GDPR and national data protection laws. Data will be coded to protect participant identity and shared only after Ethics Committee approval and a signed data use agreement.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 20, 2024 | Jul 30, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed consent form (parents) | Jan 22, 2025 | Jul 30, 2025 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed consent form (children) | Jan 22, 2025 | Jul 30, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| Change in self-reported well-being in children aged 12-16 years | Assesses well-being using the KIDSCREEN-10 Index (range: 10-50; higher scores indicate better well-being). Children complete the validated questionnaire at each time point to capture psychological and social well-being changes post-intervention. | Baseline (Day 0) and 3 months after intervention |