NCT07120516|RecruitingDMC
Co-creating School Community Intervention Program on Physical Activity to Increase Health Equity in Children and Adolescents
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Sponsor study identifier
observational
200
1 country
1
Study Start
June 1, 2025
Actual (reported)Primary Completion
June 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2025
Actual (reported)July 30, 2025
Actual (reported)August 13, 2025
Actual (reported)June 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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.
Vytautas Magnus university, faculty of Natural Sciences, Environmental sciences
Kaunas, Lithuania
First Submitted
July 30, 2025
First Posted
August 13, 2025
Study Start
June 1, 2025
Actual (reported)Primary Completion
June 2026
Estimated (date passed)Family Foundations for Special Education Trial
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 13, 2025
Record last verified: 2025-08
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Source: ClinicalTrials.gov.
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