A New Technological Intervention to Address Childhood Obesity: Approach to Multidimensional Intervention

Universidad de Córdoba2 个研究点分布在 1 个国家目标入组 215 人开始时间: 2024年5月30日最近更新: 2024年6月11日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 215
试验地点: 2
主要终点: Percentage Lean Mass (LM) (%)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Childhood obesity is a global public health issue, with rising prevalence rates. In Spain, the problem is significant, particularly in the southern regions. Factors contributing to childhood obesity include dietary habits, lack of physical activity, and socioeconomic influences.

Efforts to address childhood obesity in Spain include various programs focusing on dietary modification, increased physical activity, and family involvement. Despite these initiatives, there is a need for continued intervention, as changing dietary and lifestyle patterns have led to reduced fruit and vegetable consumption and increased sedentary behavior among children.

Childhood obesity has concerning health implications, including heart-related issues. Echocardiography plays a vital role in early detection.

Given the limited research on the impact of childhood obesity on musculoskeletal development and mobility, a comprehensive study is needed to analyze its prevalence and associated factors. The study aims to assess the effectiveness of nutritional interventions administered by school nurses.

In summary, childhood obesity in Spain is a growing concern, with multifaceted causes and health implications. Ongoing efforts are required to combat this issue and promote healthier lifestyles among children.

详细描述

An elevated Body Mass Index (BMI) in the child population represents a significant global public health concern. According to the World Health Organization (WHO), overweight occurs in children aged 6-19 when the BMI exceeds one or more standard deviations from the median established in WHO child growth patterns.

Epidemiological data reflects that since the late 20th century, childhood obesity has increased from 4.9% (31.5 million) to 6% (40.6 million) worldwide. According to data from the Childhood Obesity Surveillance Initiative (COSI) within the European Union (EU), children in Spain aged 6-9 have a 42% overweight rate and a 19% obesity rate. In comparison, girls have a 41% overweight rate and a 17% obesity rate, positioning Spain as the fourth EU country with the highest prevalence of overweight and obesity in children.

Within the national territory, 4 out of 10 schoolchildren have excess weight, with the highest prevalence in the southern regions. The autonomous community with the lowest incidence of childhood overweight is Navarra, with 15%, and the highest is the Region of Murcia, with 40%. Andalusians present a high prevalence rate of 33.4%. In general, the country's northern regions have lower figures, while the southern region has the highest rates of childhood overweight. It has also been observed that there is a higher likelihood of being overweight in rural areas than in urban areas.

This could be due to regional differences in habits during the three critical periods for the development of childhood obesity: the preconception period involving maternal factors, the first 1000 days of life (9 months of pregnancy + 2 years of life), and the adiposity rebound between 5-7 years. Childhood overweight is also highly influenced by factors such as maternal overweight, early introduction of complementary feeding before 6 months of age, smoking during pregnancy, low parental educational levels, and the excessive use of screens such as mobile phones or tablets at an early age.

The most relevant factors in overweight are diet, physical inactivity, physical activity, and lifestyle habits. However, when it comes to minors, all these factors are strongly influenced by the cultural, social, and institutional environment, as well as the family's socioeconomic level.

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: Single (Investigator)

盲法说明

The randomisation will be conducted based on an artificial model, utilising a coding system that assigns numerical identifiers to names, postal codes, and grade levels. This approach ensures a systematic and unbiased selection process, allowing for a fair representation of participants across various demographic factors.

The sampling has been estimaited by Epidat program. The experimental group, receiving nutritional intervention, will consist of approximately 50% of the total sample, equivalent to 215 participants. Meanwhile, the control group, not receiving the intervention, will comprise the remaining 50% of the sample, also around 215 participants. This distribution will enable an effective comparison of results between the two groups and assess the effectiveness of the nutritional intervention.

入排标准

年龄范围: 6 Years 至 16 Years（Child）
性别: All
接受健康志愿者: 是

入选标准

•Students from the school
•Pediatric from age 6 to 16
•Students from the school that confirmed approval
•Signed informed consent by the minor
•Signed informed consent by the minor's parents or guardians.

排除标准

•Presence of HbA1c levels below 5.7%
•Presence of HbA1c levels above 6.4%
•Presence of pathological metabolic diseases, such as diabetes or metabolic syndrome
•Presence of other diseases related to intestinal integrity or skin issues.
•Lack of the signed informed consent by the minor and legal guardian