Effect of Exercise on Hepatic Fat in Overweight Children
Condition: Non-alcoholic Fatty Liver Disease; Obesity; Metabolic Syndrome
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Overweight; Metabolic Syndrome
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Multidisciplinary intervention program
Intervention type(s): Other
Intervention description(s): Exercise group:
The intervention program includes an education program promoting healthy dietary habits and physical activity (nutritionist), supportive therapy and behavioral advice for the family to improve nutrition and physical activity (psychologist) (2 times/month, for children and parents) and supervised exercise (3 times/week, 90 mins) program for 6 months.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: overweight children; hepatic fat; exercise; nutritional education program; cardiometabolic risk