Healthy Weight Management Project for Overweight and Obesity Children in Ningbo City
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 331
- 试验地点
- 1
- 主要终点
- change in controlled attenuation parameters (CAP)
研究概览
简要总结
Childhood obesity is a significant public health concern worldwide. In China, childhood obesity has dramatically increased as the economy has grown quickly over the past decades. Nonalcoholic fatty liver disease (NAFLD) is tightly associated with obesity, in China, the prevalence of NAFLD in obesity children is 40.0%，the main interventions for NAFLD are lifestyle interventions. Effective strategies to helping students lose weight and alleviate NAFLD through lifestyle interventions may help promote the physical and mental health of obese students.
This study aimed (1)to assess the effectiveness of the intervention compared with the usual practice in treating childhood overweight and obesity; (2) to determine the sustainability of the treatment in preventing overweight and obesity; (3) to help alleviate or reverse NAFLD in obesity children.
Children with overweight and obesity in six primary schools in Ningbo City, Zhejiang Province will be seleted and randomly divided into two groups: the treatment group and the usual practice group. The participants of the study were students in the third grade of primary school, and the treatment will last for one academic year. This treatment activity on lifestyle interventions will target the dietary and exercise factors of childhood obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •parents agree and support their children's weight loss, and students and parents have informed consent;
- •students in third grade aged 8 and 10 years old;
- •students with childhood overweight/obesity defined according to the criteria for Chinese children and adolescents.
排除标准
- •medical history of heart disease, hypertension, diabetes, tuberculosis, asthma, hepatitis or nephritis;
- •obesity caused by endocrine diseases or side effects of drugs;
- •abnormal physical development like dwarfism or gigantism;
- •physical deformity such as severe scoliosis, pectus carinatum, limp, obvious O-leg or X-leg;
- •inability to participate in school sport activities;
- •a loss in weight by vomiting or taking drugs during the past 3 months.
结局指标
主要结局
change in controlled attenuation parameters (CAP)
时间窗: 3 months，9 months , 24 months and 36 months
* CAP will be detected by Fibroscan * caculated by terminal value minus baseline value
Change in liver stiffness measurement (LSM)
时间窗: 3 months，9 months , 24 months and 36 months
* LSM will be detected by Fibroscan * caculated by terminal value minus baseline value
change in body mass index (BMI)
时间窗: 3 months，9 months , 24 months and 36 months
* weight and height will be combined to report BMI in kg/m\^2 * caculated by terminal value minus baseline value
次要结局
- change in fasting insulin(9 months)
- change in body fat percentage(3 months and 9 months)
- change in blood glucose(9 months)
- Change in BMI z- score(3 months，9 months , 24 months and 36 months)
- change in blood lipids(9 months)
- change in waist circumference(3 months，9 months , 24 months and 36 months)
- change in weight(3 months，9 months , 24 months and 36 months)
- change in ALT(alanine transaminase)(9 months)
- change in cardiorespiratory endurance test(3 months，9 months , 24 months and 36 months)