Trials / Not Yet Recruiting

Not Yet RecruitingNCT06791278

Improvements in Daily Activity and Exercise in School Children: the ActChild Study

Status: Not Yet Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 600 (estimated)

Sponsor: University of Aarhus · Academic / Other
Sex: All
Age: 5 Years – 12 Years
Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to assess the health-related effects of an exercise intervention in children aged 5-8 years. Main research questions: * Does a municipality-driven exercise intervention improve physical activity levels in children? * Does a municipality-driven exercise intervention improve sleep parameters in children? * Does a municipality-driven exercise intervention improve eating behaviors in children? * Does a municipality-driven exercise intervention improve quality of life in children? Study Design: Participants will be assigned to either: * Intervention group: Attend 1-2 weekly sessions of 45-60 minutes of child-friendly exercise for 1 year. * Control group: Receive no intervention. Data Collection: Participants will: * Complete questionnaires at baseline, and at 1-year, 3-year, and 5-year follow-ups. * Wear accelerometers for 7 consecutive days at baseline, and at 1-year, 3-year, and 5-year follow-ups.

Detailed description

Introduction: Being physically inactive is associated with increased risk of developing non-communicable, lifestyle diseases such as Type 2 Diabetes (T2D), overweight/obesity, coronary heart disease (CHD) and premature death. In Denmark it is estimated that physical inactivity is responsible for more than 6000 deaths and related costs of 5.3 billion Danish Kroner each year. Although not fully elucidated, an increase in physical inactivity among children has over the last 20-30 years been observed in parallel with an increase in childhood overweight and obesity. Aim: The overall aim of this study is to promote (increase and sustain) healthy physical activity behaviors in children aged 5-8 years. The investigators wish to investigate the effects of an exercise intervention on physical activity, sleep (e.g. quality and duration), eating behavior, quality of life and anthropometrics. Design The project is a collaborative clinical trial investigating the implementation of supervised physical activity in school children in Aarhus Municipality. Intervention Children aged 5-8 years from Aarhus municipality will be included in the study. Initially first-year students from selected schools will be recruited as a control group. After one year an intervention group will be formed out of first-year students from the same schools. The intervention group will be invited to participate in a supervised training intervention during after-school daycare time. The supervised physical activity will be conducted by after-school childcare educators in the municipalities, who have years of experience in handling children. The childcare educators will participate in a professional development course on delivering pedagogical and child-friendly exercise sessions. Parents/legal guardians and participants will be able to withdraw from the study at any time. Feasibility Feasibility and sustainability form the foundation of this exercise intervention. The project is developed, evaluated, and implemented in close collaboration with Aarhus Municipality. The intervention is designed to be easily maintained and scalable for implementation beyond the research setting.

Conditions

Interventions

Type	Name	Description
BEHAVIORAL	Exercise	After-school childcare educators will participate in a professional development course on delivering pedagogical and child-friendly exercise sessions. The children will receive 1-2 weekly sessions of 45-60 minutes of child-friendly exercise during after-school childcare programs. Duration: 1 year.

Timeline

Start date: 2025-02-04
Primary completion: 2032-12-01
Completion: 2032-12-01
First posted: 2025-01-24
Last updated: 2025-01-24

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT06791278. Inclusion in this directory is not an endorsement.