About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Schoolchildren, 0.-1. Grade, 5-8 years of age,
Resident in Aarhus Municipality
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Exercise
BehavioralAfter-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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
Between group change in eating behavior
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.
Between group changes in self-reported quality of life
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.
Between group change in BMI-SDS
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.
Baseline characteristics and data from school questionnaires
Baseline characteristics is collected at enrollment. Aarhus Municipality will provide additional descriptive data from municipality-driven questionnaires (www.boernungeliv.dk).
Sponsors and contacts
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University of Aarhus
Lead sponsor
Aarhus Municipality, Denmark
Collaborator
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