Co-creating School Community Intervention Program on Physical Activity to Increase Health Equity in Children and Adolescents
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-16
SponsorSandra Andrusaityte
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
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.
Trial design
Design model
Case-crossover
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (Day 0) and 3 months after intervention2
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.
Time frame
Baseline (Day 0) and 3 months after interventionSecondary outcomes
1
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.
Time frame
Baseline (Day 0) and 3 months after intervention2
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.
Time frame
Baseline (Day 0) and 3 months after interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sandra Andrusaityte
Lead sponsor
Vytautas Magnus University
Sponsor institution
Source ClinicalTrials.gov