MuLtidimensional School-based and Family Involved interVentions, to Promote a hEalthy and Sustainable LifestYle for the Childhood Obesity Primary Prevention: the LIVELY Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Investigate prevalence of childhood overweight and/or obesity
研究概览
简要总结
Childhood obesity condition has increased 10 times in the last 40 years, representing one of the most important public health challenges of our century.
The overweight and obesity in children are conditions associated with several determinants, mostly related to dietary habits, physical activity, and environmental behavior.
To counteract childhood obesity, several prevention programs have been promoted, however evidence concerning their efficacy was contrasting, especially among the younger population and in the long term.
Moreover, due to the wide variety of interventions administered it is not clear which specific strategy (or combinations of strategies) was the most effective.
The LIVELY study aims 1) to assess the prevalence and the factors associated to childhood overweight and obesity; 2) to develop multidimensional strategies for prevention of childhood obesity by involving families and recognizing the role of schools as an environment for raising awareness on healthy and sustainable dietary patterns and lifestyle.
详细描述
LIVELY is a study with a one group pre-test - post-test design (without control). The study will be conducted in the primary schools of the Istituto Luigi Cadorna in Milano (Lombardy Region, Northern Italy). The study population will involve children (6-11 years) belonging to different socioeconomic status and ethnic groups, attending classes of the school whose teachers will accept to participate.
The educational interventions will consist in:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children 6-11 years
- •children whose parents will provide written consent to participate.
排除标准
- •Children who do not have inclusion criteria.
结局指标
主要结局
Investigate prevalence of childhood overweight and/or obesity
时间窗: Baseline
Weight and height will be combined to report BMI in kg/m\^2
Assessment of the consumption of ultra-processed food by children
时间窗: Baseline
NOVA classification, which will classify ultra-processed foods in four groups according to their level of processing (Group 1: unprocessed foods - Group 4: ultra-processed foods)
Investigation of family lifestyles
时间窗: Baseline
Children Feeding Questionnaire (CFQ) will be used. It measures parental feeding practices and attitudes. The CFQ contains originally 31 items and measures the following seven factors: Perceived Responsibility (three items), Parent Perceived Weight (four items), Perceived Child Weight (six items), Parents Concern about Child Weight (three items), Parents' feeding practices: Restriction (eight items), Pressure to Eat (four items), and Monitoring (three items). The responses to all items are coded on a 5-point Likert scale ranging from one to five.
Investigation on adherence to Mediterranian diet
时间窗: Baseline
Mediterranean Diet Quality Index for children and adolescents (KIDMED) will be used. The index ranges from 0 to 12 and is based on 16 questions. The sums of the values from the test are classified into three levels: scores ≥8 are considered optimal, 4-7 as average Mediterranean Diet adherence, and ≤3 as very low diet quality.
次要结局
- Feasibility of multidimensional school-based educational interventions(6 months)
- Investigation of changes in adherence to Mediterranian diet(Baseline, 6 and 12 months)
- Assessment of changes of the consumption of ultra-processed food by children(Baseline, 6 and 12 months)
- Investigation of changes of family lifestyles(Baseline, 6 and 12 months)