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

NCT06791278 | Not Yet Recruiting

• 1 other identifier: ActChild
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (8)

• Between group change in time spent in moderate to vigorous physical activity (MVPA)

  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

  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 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

  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)

  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)

  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)

  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)

  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 Outcomes (4)

• Between group change in eating behavior

  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

  Questionnaires will be answered at enrollment, and at 1-year, 3-year, and 5-year follow-ups.

• Between group change in BMI-SDS

  From enrollment to the end of 5-year follow-up.

• Baseline characteristics and data from school questionnaires

  From enrollment to the end of the 5-year follow-up.

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Behavioral: Exercise

Control

NO INTERVENTION

No intervention

Interventions

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.

Also known as: physical activity

Intervention group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• \- None

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus Municipality, Denmark: collaborator

Study Sites (1)

Aarhus Municipality

Aarhus, Denmark

Location

MeSH Terms

Conditions

Child Behavior; Motor Activity; Feeding Behavior; Pediatric Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Behavior, Animal; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jens M Bruun, Professor

  Aarhus University and Steno Diabetes Center Aarhus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bjarke Westergaard, phd student

CONTACT

+4527134351; bjarkeb@clin.au.dk

Jens M Bruun, Professor

CONTACT

jens.bruun@clin.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: January 24, 2025
• Study Start: February 4, 2025
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2032
• Last Updated: January 24, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)