Obiasity Study: Evaluation of Body Composition in Pediatric Patients With Overweight or Obesity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Body composition
研究概览
简要总结
In recent decades, the prevalence of obesity and overweight has dramatically increased globally, representing a serious problem for society and for the health system of many countries, estimating an impact of 2-8% on global health spending. Obesity and overweight represent a problem not only for adults but also for children and adolescents: the latest data from the WHO estimate that about 340 million children and adolescents between 5 and 19 years are overweight or obese, data that increase drastically since 1975 from 4% of boys to 18% in 2016. (World Health Organization (WHO). The reduction and prevention of overweight and obesity in childhood is one of the main missions of public health at the global level, both for short-term and long-term implications. Recently, the importance of bioprothesiometric analysis (BIA) in the clinical routine has been evaluated, as it allows an estimation of body composition that would not otherwise be provided by the growth curves and the calculation of the Body Mass Index (BMI). In this study the investigators want to evaluate, in addition to the classic clinical parameters, the body composition of patients evaluated by means of an impedance balance (named TANITA MC780 MA P). With this study the investigators aim to investigate possible clinical and body composition changes in children and adolescents suffering from overweight and obesity with the ultimate aim of reducing cardio-metabolic risk factors related to it.
The objective of the study is the assessment of body composition, as an indicator of accuracy of lean mass, but especially of fat mass, of pediatric patients who are overweight and obesity in order to carry out a more complete evaluation of the clinical-metabolic condition for the prevention of cardiovascular risk.
The secondary objective is to assess the dietary compliance of the patients being studied and the possible correlation with the body composition.
详细描述
MATERIALS AND METHODS
The study will include all children and adolescents who visit the SCDU (Struttura Complessa a Direzione Universitaria) of Pediatrics, Surgery of Endocrinology and Auxology of the Major Charity Hospital of Novara for first visit or checkup for excess weight between 1 January 2024 and 30 May 2024 of both sexes that meet the following criteria of inclusion:
Criteria for inclusion:
Age between 6 and 17 years; BMI compatible with obesity or overweight according to International Obesity Task Force (IOTF) criteria Signature of informed consent by parents/legal guardians.
Criteria for exclusion:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 6 and 17 years;
- •BMI compatible with obesity or overweight according to IOTF criteria
- •Signature of informed consent by parents/legal tutors.
排除标准
- •Age below 6 years or over 18
- •Previous diagnosis of diabetes mellitus type 2 already placed in dietary or pharmacological therapy
- •Subjects already included in dieto-therapeutic regimen
- •Obesity secondary to diseases: genetic (Prader Willi syndrome, Down syndrome); metabolic and endocrine (Cushing syndrome, hypothyroidism)
结局指标
主要结局
Change in Body composition
时间窗: Change of body composition at baseline (V0) and after 3 months (V3) and 6 months (V6)
evaluation of body composition with Bioimpendence analysis (BIA)
次要结局
- Correlation between change in body composition (primary outcome) and dietary compliance (secondary outcome)(Change of dietary compliance at baseline (V0) and after 3 months (V3) and 6 months (V6). Change of BMI at baseline (V0) and after 3 months (V3) and 6 months (V6))
- Dietary compliance with questionnaires(Change of dietary compliance at baseline (V0) and after 3 months (V3) and 6 months (V6))
研究者
Simonetta Bellone
Professor
Azienda Ospedaliero Universitaria Maggiore della Carita