A School-based Physical Activity Promotion Intervention in Children: Rationale and Study Protocol for the PREVIENE Project
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 主要终点
- Moderate physical activity
研究概览
简要总结
Background:The lack of physical activity and increasing time spent in sedentary behaviours during childhood place importance on developing low cost,easy-to-implement school-based interventions to increase physical activity among children. The PREVIENE Project will evaluate the effectiveness of five innovative, simple, and feasible interventions(active commuting to school, Physical Education lessons, active school recess physical activity, sleep health promotion, and an integrated program incorporating all 4 interventions) to improve physical activity, fitness, anthropometry, sleep health, academic achievement,and health-related quality of life in primary school children.
Methods:A total of 350 children (grade 3; 8-9 years of age) from six schools in Granada (Spain) will be enrolled in one of the 8-week interventions (one intervention per school; 50 children per school) or a control group (no intervention school; 50 children). Outcomes will include physical activity (measured by accelerometry), physical fitness (assessed using the ALPHA fitness battery), anthropometry (height, weight and waist circumference), sleep health (measured by accelerometers, a sleep diary, and sleep health questionnaires), academic achievement (grades from the official school's records), and health-related quality of life (child and parental questionnaires).To assess the effectiveness of the different interventions on objectively measured PA and the other outcomes, the generalized linear model will be used.
Discussion: The PREVIENE Project will provide the information about the effectiveness and implementation of different school-based interventions for physical activity promotion in primary schoolchildren.
Keywords:children, physical activity, school,active commuting, Physical Education, school recess, sleep health, fitness, academic achievement, health-related quality of life.
详细描述
Background
The lack of physical activity and increasing time spent in sedentary behaviours during childhood place importance on developing low cost,easy-to-implement school-based interventions to increase physical activity among children. The PREVIENE Project will evaluate the effectiveness of five innovative, simple, and feasible interventions (active commuting to school, Physical Education lessons, active school recess physical activity, sleep health promotion, and an integrated program incorporating all 4 interventions) to improve physical activity, fitness, anthropometry, sleep health, academic achievement,and health-related quality of life in primary school children.
Methods
The PREVIENE Project uses a quasi-experimental approach with a convenience sample size of 300 children (grade 3, 8-9 years old) from six primary schools in Granada (Spain) (2 classes per school x 6 schools = 12classesin total). With the average class size of 25 children and the expected recruitment rate is 90%, two classes will be selected in each participating school. All 79 primary schools in Granada will be invited to participate in this study. The schools will initially be contacted by email followed by a phone call. Research team will arrange a meeting with the interested schools and their staff (principal, physical education teacher and other relevant teachers). At this meeting, the researchers will explain the main objective of this study and the inclusion criteria for schools' participation: 1) At least 2 classes of grade 3 children at school, 2) the average class size has to be 25 or more children. Once determined the schools that satisfy the inclusion criteria and express their willingness to participate, a total of six schools will be randomly selected.
The Regional Ministry of Education will endorse the participation of each selected school in the study. At the beginning of the study, families of all children in the selected classes will receive an invitation to an initial meeting at school to receive information about the study. Both children and parents will be encouraged to participate in the study. Parents will sign an informed consent which include the participation of them and their child. The study protocol has been approved by the University of Granada Human Research EthicsCommittee (Reference: 57/CEIH/2015).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Schools with at least two groups of students
- •Each group with at least 25 students
排除标准
- 未提供
结局指标
主要结局
Moderate physical activity
时间窗: Change from baseline to week 8 and 5 months later
Moderate physical activity will be measured using a tri-axial accelerometer (Actigraph wGT3X-BT, Pensacola, FL, USA) on 7 consecutive days, 24 hours/day. Children will be instructed to wear an accelerometer attached to the non-dominant wrist. Children will take it off only while water-based activities.Children will also complete a log to record the time when they take off the accelerometer. The results will be registered in minutes.
Moderate-to-vigorous physical activity
时间窗: Change from baseline to week 8 and 5 months later
Moderate and vigorous physical activity will be combined to report moderate-to-vigorous physical activity
Light physical activity
时间窗: Change from baseline to week 8 and 5 months later
Light physical activity will be measured using a tri-axial accelerometer (Actigraph wGT3X-BT, Pensacola, FL, USA) on 7 consecutive days, 24 hours/day. Children will be instructed to wear an accelerometer attached to the non-dominant wrist. Children will take it off only while water-based activities.Children will also complete a log to record the time when they take off the accelerometer. The results will be registered in minutes.
Sedentary time
时间窗: Change from baseline to week 8 and 5 months later
Sedentary time will be measured using a tri-axial accelerometer (Actigraph wGT3X-BT, Pensacola, FL, USA) on 7 consecutive days, 24 hours/day. Children will be instructed to wear an accelerometer attached to the non-dominant wrist. Children will take it off only while water-based activities.Children will also complete a log to record the time when they take off the accelerometer. The results will be registered in minutes.
Vigorous physical activity
时间窗: Change from baseline to week 8 and 5 months later
Vigorous physical activity will be measured using a tri-axial accelerometer (Actigraph wGT3X-BT, Pensacola, FL, USA) on 7 consecutive days, 24 hours/day. Children will be instructed to wear an accelerometer attached to the non-dominant wrist. Children will take it off only while water-based activities.Children will also complete a log to record the time when they take off the accelerometer. The results will be registered in minutes.
次要结局
- Weight(Change from baseline to week 8 and 5 months later)
- Cardiorespiratory fitness(Change from baseline to week 8 and 5 months later)
- Total sleep time(Change from baseline to week 8 and 5 months later)
- Sleep efficiency(Change from baseline to week 8 and 5 months later)
- Pediatric Sleep Questionnaire(Change from baseline to week 8 and 5 months later)
- Height(Change from baseline to week 8 and 5 months)
- Pediatric Daytime Sleepiness Scale(Change from baseline to week 8 and 5 months later)
- Sociodemographic characteristics and health status(Change from baseline to week 8 and 5 months later)
- Body Mass Index(Change from baseline to week 8 and 5 months later)
- Explosive power of the legs(Change from baseline to week 8 and 5 months later)
- Speed-agility(Change from baseline to week 8 and 5 months later)
- Wake after sleep onset(Change from baseline to week 8 and 5 months later)
- Sleep knowledge and hygiene(Change from baseline to week 8 and 5 months later)
- Academic achievement(Change from baseline to week 8 and 5 months later)
- Waist circumference(Change from baseline to week 8 and 5 months)
- Handgrip strength(Change from baseline to week 8 and 5 months later)
- Commuting to school behaviour(Change from baseline to week 8 and 5 months later)
- Sleep onset latency(Change from baseline to week 8 and 5 months later)
- Health-Related Quality of Life(Change from baseline to week 8 and 5 months later)
研究者
Pablo Tercedor
Professor
Universidad de Granada