A Cluster Randomized Controlled Trial Evaluating the Effectiveness of a Healthy Lifestyle Program on Childhood Executive Functions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Change in dietary intake
研究概览
简要总结
In Portugal, 17.3% of children under 10 years old are overweight and 7.7% are obese. Research has shown the implementation of healthy lifestyle promotion programs and obesity prevention, however "best practices" are far from being defined. Also, the first five years of life are important for the executive functions development, namely memory, inhibition (including self-regulation) and flexibility, which includes creative thinking, thinking "outside of the box", important in problem solving. The importance of social and emotional dimensions, as well as physical health for the development of cognitive health is consensual, as sleep deprivation, low physical activity, unhealthy food may inhibit the proper development of executive functions.
This project aims to evaluate the effectiveness of a healthy lifestyle promotion program on emotional, social and cognitive development and eating habits, sleep and physical activity in children between 12 and 42 months of age.
A cluster randomised trial will be developed and 300 children, from 16 childcare centres will be invited to participate. Half of the childcare centres will be allocated to the control group and the other half to the intervention group. Data collection will occur before randomisation (at baseline) and after intervention. A feasibility study will be undertaken prior to the experimental study, in accordance with internationally accepted procedures.
The investigators intend to implement the concept that the development of executive functions requires the combination of healthy eating, physical activity and sleep.
The project will contribute with evidence-based to the cognitive, social and emotional development in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 12 Months 至 42 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy (with no pre-existing conditions) children aged 12-42 months at baseline.
排除标准
- •Children with disability
结局指标
主要结局
Change in dietary intake
时间窗: 12 months - 42 months
The child's eating habits will be collected using the one-day food record, completed by parents or early childhood educators.
Change in 24-h movement
时间窗: 12 months - 42 months
Physical activity, sleep and sedentary behavior will be assessed using the Actigraph accelerometer, which will be used for 5 consecutive days (3 days a week and 2 days a weekend).
Change in cognitive, social and emotional development
时间窗: 12 months - 42 months
The Bayley Scales of Infant and Toddler Development - III edition identifies the child's developmental competencies across five major developmental domains; identifies deficits in very young children; and determines the need for further in-depth assessment. Raw scores from the cognitive and social-emotional scale, which does not contain separate subtests, can be converted to a scaled score (M=10, SD=3), which can then additionally be converted to a composite score equivalent (M=100, SD=15). Raw scores for cognitive and motor subtests translate to scaled scores based on 10-day increments up to age 5 months 16 days, at which point norms are based on 1-month intervals (e.g., 5 months 16 days to 6 months 15 days, 35 months 16 days to 36 months 15 days). The normative sample for the social-emotional domain is divided into nine age categories (by months: 0-3, 4-5, 6-9, 10-14, 15-18, 19-24, 25-30, and 31-40). Higher values represent a better performance.
次要结局
- Change in weight(12 months - 42 months)
- Change in blood pressure (systolic and diastolic)(12 months - 42 months)
- Sociodemographic profile(12 months - 42 months)
- Family lifestyles(12 months - 42 months)
- Change in length and waist circumference(12 months - 42 months)
研究者
Helena Rafaela Vieira do Rosario
Principal Investigator
University of Minho