Exercise and Overweight Children's Cognition (Supplement)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 2
- 主要终点
- Change in Liver Fat
研究概览
简要总结
Nonalcoholic fatty liver disease is a serious health condition in overweight children which can lead to heart disease. This project will examine the links between liver health and cardiovascular risk factors in overweight and obese children, and will test the effect of a long-term after-school exercise program.
Provision of comprehensive evidence for the benefits of exercise on children's health may reduce barriers to vigorous physical activity programs during a childhood obesity epidemic.
详细描述
This is an ancillary study adding cardiometabolic outcome measures to an ongoing NIH-funded randomized trial of exercise in overweight children ("SMART study," R01 HL087923, P.I. Davis, NCT02227095). This presents the opportunity to obtain detailed measures of liver and vascular health to provide information about the effects of exercise on these conditions.
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 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •8-11 years of age
- •Overweight or obese (BMI-for-age >= 85th percentile)
- •Able to participate in exercise testing and intervention
- •Participating in the SMART Study
排除标准
- •Medical condition or medications that would interfere with measurements
- •Participation in weight control or formal exercise program outside physical education that meets more than 1 day/week
- •T-score > 75 on the BRIEF Behavior Regulation scale to avoid program disruption
- •Unable to complete magnetic resonance imaging.
结局指标
主要结局
Change in Liver Fat
时间窗: Baseline, 8 Months
Change in the proportion of liver fat via MRI
Change in Arterial Stiffness
时间窗: Baseline, 8 Months
Change in carotid-femoral pulse wave velocity
次要结局
- Change in Liver Fibrosis(Baseline, 8 Months)
- Change in Liver Inflammation(Baseline, 8 Months)
- Change in Quality of Life(Baseline, 8 Months)
- Associations among Liver Fat, Fibrosis and Inflammation, Arterial Stiffness, and Other Cardiovascular Risk Indices(Baseline)
研究者
Catherine Davis
Professor of Pediatrics, Graduate Studies and Physiology
Augusta University