The Effect of Exercise on Hepatic Fat in Overweight Children; the EFIGRO Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- changes in hepatic fat
研究概览
简要总结
The objective of the present study is to evaluate the effect of 6 months exercise intervention program on hepatic fat fraction in overweight children.
Methodology: A total of 160 children, 9-11 years old, will be randomly assigned to control (N=80) or intervention (N=80) groups. Training sessions will include 90 minutes of exercise, comprising warm-up and skill development. The control group will attend a healthy lifestyle education program (2 days/month) and the intervention group an exercise (3 days/week) and healthy lifestyle education (2 days/month) combined program. Before and after the intervention (6 months) hepatic fat fraction, body composition, , and cardiometabolic risk factors will be measured. Furthermore, dietary habits and physical activity, blood pressure and pubertal development will be evaluated before and after the intervention.
详细描述
The control group will attend a healthy lifestyle education program (2 days/month) and supportive therapy and behavioral advice for both children and parents to improve nutrition and physical activity (nutritionists and psychologists).
The intervention group will attend an exercise (3 days/week) and healthy lifestyle education (2 days/month) combined program. Training sessions will include 90 minutes of exercise, comprising warm-up and skill development, moderate to vigorous aerobic activities, flexibility and strength exercises.
Before (baseline) and after the intervention (6 months) total and abdominal adiposity, lean tissue mass and bone mass density (dual-X-ray-absorptiometry), abdominal visceral and hepatic adiposity (magnetic resonance imaging), and blood insulin, glucose, C-reactive protein, alanine aminotransferase, aspartate aminotransferase, gamma-glutamil transpeptidase and lipid profile will be measured. Furthermore, cardiorespiratory fitness (treadmill test) and blood pressure will be measured before and after the intervention. Changes (6 months - baseline) in dietary habits will be estimated by using two repeated 24h recalls and food frequency questionnaires and changes (6 months - baseline) in physical activity by accelerometry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight or obesity status
- •9-11 years old
排除标准
- •Medical conditions that hamper their participation in the exercise program
- •Secondary obesity
研究组 & 干预措施
Control group
healthy lifestyle education including healthy lifestyle education, supportive therapy and behavioral advice for both children and parents to improve nutrition and physical activity
干预措施: Multidisciplinary intervention program (Other)
Exercise group
multidisciplinary intervention program including healthy lifestyle education, supportive therapy and behavioral advice for for both children and parents to improve nutrition and physical activity and supervised exercise.
干预措施: Multidisciplinary intervention program (Other)
结局指标
主要结局
changes in hepatic fat
时间窗: baseline and 6 months
Changes in hepatic fat fraction measured by magnetic resonance imaging after the 6 months intervention program
次要结局
- Changes in serum lipid profile(baseline and 6 months)
- Changes in physical activity(baseline and 6 months)
- Changes in Insulin sensitivity(baseline and 6 months)
- Changes in liver enzymes(baseline and 6 months)
- Changes in dietary habits(baseline and 6 months)
- Changes in body composition(baseline and 6 months)
- Changes in other cardiometabolic risk factors(baseline and 6 months)
研究者
IDOIA LABAYEN
Lecturer of Nutrition and Food Sciences
University of the Basque Country (UPV/EHU)