Improvements in Daily Activity and Exercise in School Children: the ActChild Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Between group change in time spent in moderate to vigorous physical activity (MVPA)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Schoolchildren, 0.-
- •Grade, 5-8 years of age,
- •Resident in Aarhus Municipality
排除标准
- 未提供
研究组 & 干预措施
Intervention group
1-2 weekly sessions of 45-60 minutes of child-friendly exercise during after-school childcare programs. Duration: 1 year.
干预措施: Exercise (Behavioral)
Control
No intervention
结局指标
主要结局
Between group change in time spent in moderate to vigorous physical activity (MVPA)
时间窗: 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 time
时间窗: 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.
Between group change in time spent in light physical activity (LPA)
时间窗: 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 sedentary
时间窗: 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.
Between group change in total sleep time (TST)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- 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.)