Vytautas Magnus university, faculty of Natural Sciences, Environmental sciences
Kaunas, Lithuania
Location status: Recruiting
NCT Number: NCT07120516
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).
Interested in participating?
Request Info12 year–16 year
All sexes
Observational
Kaunas, Lithuania
Location status: Recruiting
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:
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.
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Day 0) and 3 months after intervention
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.
Time frame: Baseline (Day 0) and 3 months after intervention
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.
Contact information is provided by the study sponsor or research team.
Regina Grazuleviciene, prof.
CONTACT
Sandra Andrusaityte, PHD
CONTACT
Sandra Andrusaityte
Other
Acronym: Connection
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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