Effects of an Exercise Program on Hepatic Metabolism and Cardiovascular Health in Overweight/Obese Adolescent From Bogota, Colombia (HEPAFIT Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Change from Baseline in hepatic fat measured by controlled attenuation parameter values (FibroScan®)
研究概览
简要总结
The HEPAFIT Study aims to examine whether a 6-months physical education program has benefits on hepatic metabolism and cardiovascular health as well as on selected physical fitness and mental health outcomes among adolescent overweight/obese from Bogota, Colombia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight or obesity status
- •11-17 years old
- •Written informed consent
- •Interested in improving health and fitness
排除标准
- •Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial.
- •Clinical diagnosis of diabetes
- •Pregnancy
- •Drugs/alcohol abuse
研究组 & 干预措施
Low physical activity program
Three Physical Education sessions / week
干预措施: Low physical activity program (Behavioral)
High physical activity program
Three Physical Education sessions / week (increased volume)
干预措施: High physical activity program (Behavioral)
Low and High physical activity program
Three Physical Education sessions / week (increased volume and intensity)
干预措施: Low and High physical activity program (Behavioral)
Conventional physical activity program
One Physical Education sessions / week
干预措施: Conventional physical activity program (Behavioral)
结局指标
主要结局
Change from Baseline in hepatic fat measured by controlled attenuation parameter values (FibroScan®)
时间窗: Baseline and 6 months
Changes in hepatic fat fraction measured by controlled attenuation parameter after the 6 months intervention program
次要结局
- Changes in Insulin sensitivity measured by homeostasis model assessment (HOMA)(Baseline and 6 months)
- Changes in liver enzymes(Baseline and 6 months)
- Change from Baseline in Body composition(Baseline and 6 months)
- Changes in inflammatory markers after the 6 months intervention program(Baseline and 6 months)
- Changes in serum lipid profile(Baseline and 6 months)
- Change from Baseline in Muscular Fitness assessed using handgrip test (maximum handgrip strength assessment)(Baseline and 6 months)
- Change from Baseline in Aerobic fitness measured on a maximum effort test(Baseline and 6 months)
- Change from Baseline in Quality & satisfaction with life by SF Community - short-form survey (SF-12™) Colombian version(Baseline and 6 months)
- Changes in blood pressure(Baseline and 6 months)
- Changes in physical activity using accelerometry(Baseline and 6 months)
研究者
Robinson Ramírez-Vélez
Principal Investigator, Centro de Estudios en Medición de la Actividad Física (CEMA)
Universidad Santo Tomas