The effect of a multidisciplinary intervention program on hepatic adiposity in overweight-obese children: protocol of the EFIGRO study

Contemp Clin Trials. 2015 Nov;45(Pt B):346-355. doi: 10.1016/j.cct.2015.09.017. Epub 2015 Sep 25.


Background: Non-alcoholic fatty liver disease is the most frequent liver abnormality observed in overweight or obese children and is strongly associated with metabolic syndrome and insulin resistance.

Objectives: (i) To evaluate the effect of a 22-week multidisciplinary intervention program on hepatic fat fraction in overweight or obese children and (ii) to examine the effect of the intervention on cardiometabolic risk factors, self-esteem and well-being.

Methods: A total of 160 children, 9-11 years, will be recruited by pediatricians and randomly assigned to control (N = 80) or intervention (N = 80) groups. The control group will receive a family-based lifestyle and psycho-educational program (2 days/month), while the intervention group will attend the same lifestyle education and psycho-educational program plus the exercise program (3 days/week). The duration of training sessions will be 90 min of exercise, including warm-up, moderate to vigorous aerobic activities, and strength exercises. The primary outcome is the change in hepatic fat fraction (magnetic resonance imaging, MRI). Secondary outcomes include cardiometabolic risk factors such as total adiposity (dual Xray absorptiometry), visceral adiposity (MRI), functional peak aerobic capacity (cardiopulmonary exercise testing), blood pressure, muscular fitness, speed–agility, and fasting blood insulin, glucose, C-reactive protein, alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase, lipid profile and psychological measurements (questionnaires). All the measurements will be evaluated at baseline prior to randomization and after the intervention.

Discussion: This study will provide insight in the efficacy of a multidisciplinary intervention program including healthy lifestyle education, psycho-education and supervised exercise to reduce hepatic fat and cardiometabolic risk in overweight children.

Keywords: Children; Exercise; Fatty liver; Metabolic syndrome; Obesity.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adiposity
  • Behavior Therapy / methods
  • Blood Glucose
  • Blood Pressure
  • Body Composition
  • Body Mass Index
  • C-Reactive Protein
  • Child
  • Exercise
  • Family
  • Female
  • Health Behavior
  • Humans
  • Life Style
  • Liver Function Tests
  • Male
  • Non-alcoholic Fatty Liver Disease / etiology*
  • Non-alcoholic Fatty Liver Disease / physiopathology
  • Overweight / complications*
  • Overweight / therapy*
  • Pediatric Obesity / complications*
  • Pediatric Obesity / therapy*
  • Physical Fitness
  • Research Design
  • Weight Reduction Programs / organization & administration*


  • Blood Glucose
  • C-Reactive Protein