Effects of Exercise Training and Diet Restriction on Cardiovascular Function and Their Related Factors in Obese Chinese Children and Adolescents: an Intervention Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change from flow-mediated dilation (FMD) at 6 weeks
研究概览
简要总结
Prevalence rates of childhood obesity have reached alarming levels. As childhood obesity may already be associated with serious comorbidities, obese adolescents are at significantly higher risk for obesity and increased morbidity and mortality during adulthood. Combined lifestyle interventions, which include regular physical activity and dietary restriction, have been shown to result in most significant improvements in cardiovascular function and their associated factors in the pediatric and adolescent population with obesity. The aim of this study is to investigate the effects of a combined exercise and diet intervention on cardiovascular function and their associated factors in obese children.
详细描述
Sixty obese children and adolescents will complete a 6-week program of exercise and diet intervention. Thirty normal-weight children and adolescents will be recruited as control group. Clinical characteristics, body composition, blood biochemistry, and circulating irisin levels of the subjects will be measured before and after 6-week intervention. Endothelial function will be assessed by a flow-mediated dilation test. Circulating exosome-derived miRNAs, exercise-induced epigenetic modifications, circulating irisin levels irisin concentration in plasma and arterial stiffness as well as cardiac autonomic function will be investigated before and after the 6-week intervention. Fecal samples were collected before and after the 6-week intervention for analysis of the compositional and functional changes in the human gut microbiota.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants aged 7-17 years
- •Participants satisfied the obesity diagnosis criteria is based on "Body mass index reference standards for the screening of overweight and obesity in Chinese children and adolescents" released in 2004, with cut-off points of p(95) for obesity
排除标准
- •Metabolic disease
- •Gastrointestinal disease
- •Cardiac disease
- •Taking medications which affected energy expenditure
- •Losing weight in the past three months whether by diet, taking weight-loss medication or more physical exercise than normal
研究组 & 干预措施
Obese intervention group
Obese children were received exercise and diet intervention for 6 weeks.
干预措施: Exercise (Behavioral)
Normal weight control group
Normal weight children were recruited as a control group without any intervention.
结局指标
主要结局
Change from flow-mediated dilation (FMD) at 6 weeks
时间窗: before and after the 6-week intervention
for brachial endothelial function assessment
次要结局
- Change from pulse wave velocity at 6 weeks(before and after the 6-week intervention)
- Change from heart rate variability at 6 weeks(before and after the 6-week intervention)
- Change from circulating exosome-derived miRNAs at 6 weeks(before and after the 6-week intervention)
- Change from circulating irisin levels at 6 weeks(before and after the 6-week intervention)
研究者
Min Hu
Director of Guangdong Provincial Key Laboratory of Sports and Health Promotion
Guangzhou Sport University