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

NCT ID: NCT06791278

Last Updated: 2025-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-04

Study Completion Date

2032-12-31

Brief Summary

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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

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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

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Healthy Children Children Children in School Child Health Child Behavior Physical Activity Sleep Eating Behaviors Child Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention group

1-2 weekly sessions of 45-60 minutes of child-friendly exercise during after-school childcare programs. Duration: 1 year.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

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.

Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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physical activity

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- None
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aarhus Municipality, Denmark

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jens M Bruun, Professor

Role: PRINCIPAL_INVESTIGATOR

Aarhus University and Steno Diabetes Center Aarhus

Locations

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Aarhus Municipality

Aarhus, , Denmark

Site Status

Countries

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Denmark

Central Contacts

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Bjarke Westergaard, phd student

Role: CONTACT

+4527134351

Jens M Bruun, Professor

Role: CONTACT

Facility Contacts

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Marie Madsen

Role: primary

+4529209704

Other Identifiers

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ActChild

Identifier Type: -

Identifier Source: org_study_id

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