Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT06791278

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age5 Years to 12 Years

SexAll

Healthy volunteersAccepted

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

Full registry criteria

Inclusion Criteria: * Schoolchildren, 0.-1. Grade, 5-8 years of age, * Resident in Aarhus Municipality Exclusion Criteria: \- None

Treatments and study arms

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.

Primary outcomes

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

Between group change in total movement timeParticipants 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.

Between group change in time spent in light physical activity (LPA)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.

Between group change in time spent being sedentaryParticipants 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.

Between group change in total sleep time (TST)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.

Between group change in sleep efficiency (SE)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.

Between group change in sleep onset latency (SOL)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.

Between group change in wake after sleep onset (WASO)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.

Study locations

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Aarhus Municipality🇩🇰 Aarhus, Denmark

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Marie MadsenContact

Email · Call +4529209704