Clinical trial NCT06791278: Improvements in Daily Activity and Exercise in School Children: the ActChild Study
Official title: Improvements in Daily Activity and Exercise in School Children: the ActChild Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy Children
Children
Children in School
Child Health
Child Behavior
Physical Activity
Sleep
Eating Behaviors
Child Obesity
Keywords: Exercise Intervention
Children
School Children
CEBQ
Eating Behavior
Sleep
Physical Activity
Quality of Life
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus Municipality, Denmark
First posted: 2025-01-24
Enrollment: 600
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a quasi-experimental study and participants will be assigned to intervention or control based on the time of inclusion. Each participating school will include controls at baseline. After one year, new participants will be included to the intervention group.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Schoolchildren, 0.-1. Grade, 5-8 years of age,
* Resident in Aarhus Municipality

Exclusion Criteria:

- None

Primary outcomes:
measure: Between group change in time spent in moderate to vigorous physical activity (MVPA)
timeFrame: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups
measure: Between group change in total movement time
timeFrame: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups
measure: Between group change in time spent in light physical activity (LPA)
timeFrame: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups
measure: Between group change in time spent being sedentary
timeFrame: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups
measure: Between group change in total sleep time (TST)
timeFrame: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups
measure: Between group change in sleep efficiency (SE)
timeFrame: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups
measure: Between group change in sleep onset latency (SOL)
timeFrame: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups
measure: Between group change in wake after sleep onset (WASO)
timeFrame: Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups
Secondary outcomes:
measure: Between group change in eating behavior
timeFrame: The CEBQ will be answered at enrollment, and at 1-year, 3-year, and 5-year follow-ups
measure: Between group changes in self-reported quality of life
timeFrame: Questionnaires will be answered at enrollment, and at 1-year, 3-year, and 5-year follow-ups.
measure: Between group change in BMI-SDS
timeFrame: From enrollment to the end of 5-year follow-up.
measure: Baseline characteristics and data from school questionnaires
timeFrame: From enrollment to the end of the 5-year follow-up.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus Municipality
Study officials:
affiliation: Aarhus University and Steno Diabetes Center Aarhus
name: Jens M Bruun, Professor
role: PRINCIPAL_INVESTIGATOR
References: