Prevention of Child Obesity: an Interventional Study of a Personalized Multidisciplinary Care Efficacy in Children of Primary School
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- Changes in BMI Z-score
研究概览
简要总结
Obesity could be avoided but once declared it become a chronic disease with numerous health complications, including cardiovascular and metabolic diseases, cancers, and finally a loss of life expectancy. Considering that after the age of 6 years old, half of the obese children will become obese adults, the WHO has been declared childhood obesity prevention as a health priority area. Large-scale prevention of obesity is challenging and it would be more efficient to proceed to early identification of high risks children to implement personalized prevention.
The ELIPSE study main objective is to evaluate the efficacy of personalized multidisciplinary care to reduce the BMI of overweight or obese children. A 2 years educational program will be evaluated at short and longer terms (after a 12 months follow-up), and its benefits will also be assessed based on comparison with a historical control group.
Along with efficacy evaluation, scientific objectives were designed to investigate clinical, genetic, social, and behavioural risk factors and to analyse potential correlations between these factors and a predisposition to overweight or obesity. Moreover, advanced analyses will be performed to decipher the impact of diverse risk profiles on the efficacy of the educational program.
The motive of the ELIPSE study is to promote the health and well-being of children and their families to tackle the health burden represented by childhood overweight and obesity. Combined with innovative scientific objectives, this study ambitions to develop more efficient and more personalized preventive care methods.
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
- 5 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children from the first year of primary school in Lille City
- •Overweight or obese children as defined by the IOTF and/or with at least one of the following risk factors: 1) early adiposity rebound (before 6 years old), 2) an upward crossing of major percentiles on the BMI curve (after 6 years old).
- •Children whose legal tutor(s) is(are) able to understand the enlightened information.
- •Children whose legal tutor(s) has(ve) signed the free and informed consent.
排除标准
- •Refusal from children or their tutors to participate in the study.
- •Impossibility to participate in the study in its totality.
- •Pathology known to impact the BMI: follow-up care for eating behaviour problems, endocrine disorders (hypercorticism, hypothyroidism, growth factor deficiency, hypothalamic-hypophysis lesions), genetic disorders (Prader Willi syndrome, Bardet-Biedl syndrome), drugs that affect body weight (antidepressant, neuroleptics, corticoids).
- •Previous participation in a similar educational program.
结局指标
主要结局
Changes in BMI Z-score
时间窗: At the end of the educational program, an average of 2 years after inclusion
The objective is to estimate the mean variation of the BMI Z-score between the inclusion and the end of the educational program, after 2 years. Body mass index z score is based on previous results, estimate that the BMI Z-score will be decreased by 0.3 +/- 0.6 SD.
次要结局
- Impact of rare pathogenic mutations causing obesity on changes in BMI Z-score.(Through study completion, an average of 3 years after inclusion)
- BMI Z-score between children included in the study and a historical control group(At the end of the educational program, an average of 2 years after inclusion)
- Changes in BMI Z-score.(At the end of the educational program follow-up, an average of 3 years after inclusion)
- Impact of polygenic risk scores of obesity on changes in BMI Z-score(Through study completion, an average of 3 years after inclusion)
- Correlation between clinical and environmental variables and changes in BMI Z-score(At the end of the educational program, an average of 2 years after inclusion)