Improvements in Daily Activity and Exercise in School Children: the ActChild Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise.
- Who it may be relevant to
- Registry conditions: Healthy Children, Children, Children in School, Child Health. Basic parameters: 5 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Between group change in time spent in moderate to vigorous physical activity (MVPA) [Time frame: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups]
- Between group change in total movement time [Time frame: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups]
- Between group change in time spent in light physical activity (LPA) [Time frame: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups]
- Between group change in time spent being sedentary [Time frame: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups]
- Between group change in total sleep time (TST) [Time frame: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups]
- Between group change in sleep efficiency (SE) [Time frame: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups]
- Between group change in sleep onset latency (SOL) [Time frame: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups]
- Between group change in wake after sleep onset (WASO) [Time frame: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups]
Secondary outcome measures (4)
- Between group change in eating behavior [Time frame: The CEBQ will be answered at enrollment, and at 1-year, 3-year, and 5-year follow-ups]
- Between group changes in self-reported quality of life [Time frame: Questionnaires will be answered at enrollment, and at 1-year, 3-year, and 5-year follow-ups.]
- Between group change in BMI-SDS [Time frame: From enrollment to the end of 5-year follow-up.]
- Baseline characteristics and data from school questionnaires [Time frame: From enrollment to the end of the 5-year follow-up.]
Eligibility criteria
Inclusion criteria
- Schoolchildren, 0.-1. Grade, 5-8 years of age,
- Resident in Aarhus Municipality
Exclusion criteria
\- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Denmark · 1 center
- Aarhus Municipality — Aarhus
Identifiers
NCT: NCT06791278 · ActChild