A Healthy Lifestyle-based Randomized Controlled Trial on 24-h Movement Behaviors and Adherence to the Mediterranean Diet in Schoolchildren - The Archena Infancia Saludable Project: A Protocol Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Adherence to the Mediterranean diet
研究概览
简要总结
The purpose of this study is to determine the effects of the Archena Infancia Saludable project on adherence to MD and 24-h movement behaviors in schoolchildren
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Schoolchildren aged 6-13 years will be eligible
排除标准
- •Participants with any pathology that contraindicate exercise or that request special attention.
- •Participants under pharmacological treatment that prevent them from receiving the contents of the activities of the program.
- •Participants or parents/legal guardians presenting Spanish learning difficulties.
- •Participants do not authorized by the parents/guardians to be included in the research project.
- •Participants do not agree to take part in the research project.
结局指标
主要结局
Adherence to the Mediterranean diet
时间窗: From baseline to 36 weeks later
To assess the adherence to the Mediterranean Diet, the Mediterranean Diet Quality Index for Children and Teenagers (KIDMED) index will be used.
24-h movement behaviors (self-reported)
时间窗: From baseline to 36 weeks later
Self-report of physical activity levels and sedentary behaviors in youth will assessed by the Youth Activity Profile - Spain. In this questionnaire, a rating scale is used with a score from 1 to 5 in which, in the first two sections, "1" indicates low intensity and frequency of physical activity and "5" indicates high intensity and frequency of physical activity; while, in the third section, "1" indicates a low amount of sedentary behaviors and "5" an excess of them.
24-h movement behaviors (accelerometers) sedentary time
时间窗: From baseline to 36 weeks later
A tri-axial accelerometer (Actigraph GT3x, Pensacola, FL, USA) will be used to assess sedentary time over seven consecutive days.
24-h movement behaviors (accelerometers) physical activity
时间窗: From baseline to 36 weeks later
A tri-axial accelerometer (Actigraph GT3x, Pensacola, FL, USA) will be used to assess physical activity over seven consecutive days.
24-h movement behaviors (accelerometers) sleep duration
时间窗: From baseline to 36 weeks later.
A tri-axial accelerometer (Actigraph GT3x, Pensacola, FL, USA) will be used to assess sleep duration over seven consecutive days.
次要结局
- Anthropometrics measurements(From baseline to 36 weeks later)
- Resting blood pressure(From baseline to 36 weeks later)
- Active transportation(From baseline to 36 weeks later)
- Self-reported physical fitness(From baseline to 36 weeks later)
- Health-related quality of life(From baseline to 36 weeks later)
- Sleep disorders(From baseline to 36 weeks later)
- Parents'/guardians' perception of their children's body mass index status(From baseline to 36 weeks later)
- Academic performance(From baseline to 36 weeks later.)