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

January 22, 2025 updated by: University of Aarhus

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Bjarke Westergaard, phd student
  • Phone Number: +4527134351
  • Email: bjarkeb@clin.au.dk

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

- None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No intervention
Experimental: Intervention group
1-2 weekly sessions of 45-60 minutes of child-friendly exercise during after-school childcare programs. Duration: 1 year.
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.
Other Names:
  • physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time spent in moderate to vigorous physical activity (MVPA). Physical activity levels will be measured with accelerometers (Axivity AX3) for 8 consecutive days. This will be repeated at each follow-up visit to compare changes in physical activity behavior between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of MVPA per day.
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
Total daily time the children spent moving in different body positions and engaging in different physical activities (standing, walking, running and biking). Physical activity levels will be measured with accelerometers (Axivity AX3) for 8 consecutive days. This will be repeated at each follow-up visit to compare changes in physical activity behavior between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of moderate to vigorous physical activity (MVPA) per day.
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
Time spent in light physical activity. Physical activity levels will be measured with accelerometers (Axivity AX3) for 8 consecutive days. This will be repeated at each follow-up visit to compare changes in physical activity behavior between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of moderate to vigorous physical activity (MVPA) per day.
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
Sedentary time is defined as any waking activity characterized as being in a sitting, reclining or lying posture with minimal stationary movement. Sedentary time will be measured with accelerometers (Axivity AX3) for 8 consecutive days. This will be repeated at each follow-up visit to compare changes in sedentary time between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of moderate to vigorous physical activity (MVPA) per day.
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
Total sleep time will be measured with accelerometers (Axivity AX3) for 8 consecutive days. This will be repeated at each follow-up visit to compare changes in sleep parameters between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of moderate to vigorous physical activity (MVPA) per day.
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
Sleep efficiency will be measured with accelerometers (Axivity AX3) for 8 consecutive days. This will be repeated at each follow-up visit to compare changes in sleep parameters between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of moderate to vigorous physical activity (MVPA) per day.
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
Sleep onset latency will be measured with accelerometers (Axivity AX3) for 8 consecutive days. This will be repeated at each follow-up visit to compare changes in sleep parameters between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of moderate to vigorous physical activity (MVPA) per day.
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
Wake after sleep onset will be measured with accelerometers (Axivity AX3) for 8 consecutive days. This will be repeated at each follow-up visit to compare changes in sleep parameters between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of moderate to vigorous physical activity (MVPA) per day.
Participants will wear accelerometers for 8 consecutive days at enrollment, and at 1-year, 3-year, and 5-year follow-ups

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Eating behavior traits assessed by Children's Eating Behavior Questionnaire (the CEBQ). The CEBQ is a 35-item parent-report questionnaire assessing eating behavior in children. Eating behavior is assessed on eight scales: food responsiveness (4 items), enjoyment of food (4 items), emotional overeating (4 items), desire to drink (3 items), satiety responsiveness (5 items), slowness in eating (4 items), emotional undereating (4 items), and food fussiness (7 items). CEBQ responses will be scored from 1 to 5 and means for each subscale will be calculated. Changes in eating behavior will be compared between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of moderate to vigorous physical activity (MVPA) per day.
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.

Quality of life will be assessed by the Pediatric Quality of Life Inventory (PedsQL). The PedsQL is a 23-item questionnaire with four Generic Core Scales: Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items) and School Functioning (5 items). Items on the PedsQL Generic Core Scales are reverse scored and transformed to a 0-100 scale. Higher scores indicate better health related quality of life. Two Summary Scores will be computed (the Psychosocial Health Summary Score and the Physical Health Summary Score), as well as a Total Scale Score. The Psychosocial Health Summary Score is the mean score on the Emotional, Social and School Functioning Scales. The Physical Health Summary Score is the mean score on the Physical Functioning Scale. The Total Scale Score is the mean of all items.

A subsample analysis will be conducted on children who do not meet the WHO recommendations of 60 minutes of MVPA per day.
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.

Anthropometry data (i.e. heigth in cm, weight in kg and BMI in kg/m^2) measured from routine visits with the school health nurse will be transferred from Aarhus Municipality. Anthropometry data will be converted to standard deviation scores (BMI-SDS).

Changes in BMI-SDS will be compared between intervention group and control group. A subsample analysis will be conducted on children who do not meet the WHO recommendation of 60 minutes of moderate to vigorous physical activity (MVPA) per day.
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.
Baseline characteristics is collected at enrollment. Aarhus Municipality will provide additional descriptive data from municipality-driven questionnaires (www.boernungeliv.dk).
From enrollment to the end of the 5-year follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus Municipality, Denmark

Investigators

  • Principal Investigator: Jens M Bruun, Professor, Aarhus University and Steno Diabetes Center Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 4, 2025

Primary Completion (Estimated)

December 1, 2032

Study Completion (Estimated)

December 1, 2032

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ActChild

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators have decided not to share individual participant data (IPD) due to ethical and privacy considerations, particularly given the sensitive nature of the data and the young age of the participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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