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NCT Number: NCT06791278

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

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.

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Key information

Conditions

Healthy Children Behavior Behavior, Animal Body Weight Child Behavior Child Health Child Obesity Children Children in School Eating Behaviors Feeding Behavior Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Physical Activity Signs and Symptoms Sleep

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Exercise

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.

Other names: physical activity

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Bjarke Westergaard, phd student

CONTACT

[email protected]

+4527134351

Jens M Bruun, Professor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus Municipality, Denmark

Registry information

Acronym: ActChild

Important dates

Study start
2025
Primary completion
2032
Study completion
2032
First posted
Jan 24, 2025
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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