A Comprehensive Intervention Study on Klotho Gene Methylation and Cardiovascular Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Body weight of study children
研究概览
简要总结
The aim of this study is to evaluate the effects of comprehensive behavior on cardiovascular health among obese schoolchildren. The intervention methods include dietary instruction and exercise intervention. The main outcomes are weight, body mass index, blood pressure, lipids and glucose.
详细描述
Two public primary schools of a similar size were selected. They were allocated either to the intervention or control group. Children in Grade 4th and 5th in each school were invited to participate in the physical examination (height and weight measures).Obese children based on Chinese BMI cut-off points were included in this study.Children in the intervention group were encouraged to take healthy diet habits and increased their physical activity.After eight months healthy behavior intervention, Children's height, weight, waist, hip, blood pressure, cardiorespiratory fitness will be measured. Fasting blood will be taken to measure lipids and glucose levels.
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
- None
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obese children; Aged 8-12 years old.
排除标准
- •History of cardiovascular diseases and diabetes; Disability.
研究组 & 干预措施
Control
No intervention in the group with "control".
Intervention
Lifestyle intervention includes diet instruction and exercise intervention:
- Diet instruction: The children were asked to increase fruit/vegetables consumption, reduce high fat food, etc.
- Exercise intervention: The children participated sports 60 min/day,5d/week for 8 months.
干预措施: Intervention group (Behavioral)
结局指标
主要结局
Body weight of study children
时间窗: 8 months
Body weight will be measured with light clothes using a scale to the nearest 0.1 kg.
Body mass index of study children
时间窗: 8 months
Body mass index is defined as the individual's body weight divided by the square of his or her height (height is measured using a non- stretchable tape suspended from the wall is recorded to the nearest 0.1 cm).
Waist circumference of study children
时间窗: 8 months
Waist circumference will be measured using a tape around his or her bare abdomen to the nearest 0.1 cm.
Blood pressure
时间窗: 8 months
Blood pressure will be measured three times by auscultation method with appropriate cuff size after 20 minutes of rest.The average of the blood pressure measurements is defined as hypertension if it was \>95th percentile according to their age, gender and height percentile.
Blood lipids
时间窗: 8 months
Blood samples will be obtained in the morning by venipuncture after an overnight fast. Serum lipid profiles (total cholesterol ,triglycerides, low-density lipoprotein, high-density lipoprotein) will be measured using routine enzymatic methods.
cardiorespiratory fitness of study children
时间窗: 8 months
Cardiorespiratory refers to the ability of the circulatory and respiratory systems to supply oxygen to skeletal muscles during sustained physical activity. It is measured by 20 meter shuttle-run test.
Blood glucose
时间窗: 8 months
Blood samples is obtained in the morning by venipuncture after an overnight fast. The glucose oxidase method was used in the determination of blood glucose levels.
次要结局
- Depression of study children(8 months)
- Well-being of study children(8 months)
研究者
Qiqiang He
Professor
Wuhan University