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

NCT07120516 | Recruiting DMC

• 1 other identifier: 2025 no. BE-2-27
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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).

Conditions

Obese Adolescents; Mental Health

Keywords

Child Health Inequalities; Physical Activity; Health Behavior in Adolescents

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• 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

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sandra Andrusaityte: lead

Study Sites (1)

Vytautas Magnus university, faculty of Natural Sciences, Environmental sciences

Kaunas, Lithuania

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being; Motor Activity

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Sandra Andrusaityte, PHD

CONTACT

+37068437989; sandra.andrusaityte@vdu.lt

Regina Grazuleviciene, prof.

CONTACT

+37065027090; regina.grazuleviciene@vdu.lt

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 13, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

LI (1)