title: The effect of a multidisciplinary intervention program on hepatic adiposity in overweight-obese children: protocol of the EFIGRO study.
abstract: 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.
  
  
  OBJECTIVE
  (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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Nutrition, Exercise and Health Research Group, Elikadura, Ariketa Fisikoa eta Osasuna, ELIKOS group, University of the Basque Country, UPV/EHU, Vitoria-Gasteiz, Spain; Department of Physical Education and Sport, University of the Basque Country, UPV/EHU, Vitoria-Gasteiz, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Medrano
authors.affiliation: Nutrition, Exercise and Health Research Group, Elikadura, Ariketa Fisikoa eta Osasuna, ELIKOS group, University of the Basque Country, UPV/EHU, Vitoria-Gasteiz, Spain; Department of Personality, Assessment and Psychological Treatment, University of the Basque Country, UPV/EHU, San Sebastián-Donostia, Spain.
authors.forename: E
authors.initials: E
authors.lastname: Maiz
authors.affiliation: Nutrition, Exercise and Health Research Group, Elikadura, Ariketa Fisikoa eta Osasuna, ELIKOS group, University of the Basque Country, UPV/EHU, Vitoria-Gasteiz, Spain; Department of Physical Education and Sport, University of the Basque Country, UPV/EHU, Vitoria-Gasteiz, Spain.
authors.forename: S
authors.initials: S
authors.lastname: Maldonado-Martín
authors.affiliation: Nutrition, Exercise and Health Research Group, Elikadura, Ariketa Fisikoa eta Osasuna, ELIKOS group, University of the Basque Country, UPV/EHU, Vitoria-Gasteiz, Spain; Department of Nutrition and Food Science, University of the Basque Country, UPV/EHU, Vitoria-Gasteiz, Spain.
authors.forename: L
authors.initials: L
authors.lastname: Arenaza
authors.affiliation: Department of Magnetic Resonance Imaging, Osatek, University Hospital of Alava (HUA), Vitoria-Gasteiz, Spain.
authors.forename: B
authors.initials: B
authors.lastname: Rodríguez-Vigil
authors.affiliation: Promoting Fitness and Health through physical activity research group (PROFITH), Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Spain; Department of Biosciences and Nutrition at NOVUM, Karolinska Institutet, Huddinge, Sweden.
authors.forename: F B
authors.initials: FB
authors.lastname: Ortega
authors.affiliation: Promoting Fitness and Health through physical activity research group (PROFITH), Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Spain; Department of Biosciences and Nutrition at NOVUM, Karolinska Institutet, Huddinge, Sweden.
authors.forename: J R
authors.initials: JR
authors.lastname: Ruiz
authors.affiliation: Nutrition, Exercise and Health Research Group, Elikadura, Ariketa Fisikoa eta Osasuna, ELIKOS group, University of the Basque Country, UPV/EHU, Vitoria-Gasteiz, Spain; Health and Quality of Life, TECNALIA, Miñano, Spain.
authors.forename: E
authors.initials: E
authors.lastname: Larrarte
authors.affiliation: Paediatric Endocrinology Unit, University Hospital of Araba (HUA), Vitoria-Gasteiz, Spain.
authors.forename: I
authors.initials: I
authors.lastname: Diez-López
authors.affiliation: Paediatric Endocrinology Unit, University Hospital of Araba (HUA), Vitoria-Gasteiz, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Sarasúa-Miranda
authors.affiliation: Department of Nuclear Medicine, University Hospital of Araba (HUA), Vitoria-Gasteiz, Spain.
authors.forename: I
authors.initials: I
authors.lastname: Tobalina
authors.affiliation: Nutrition, Exercise and Health Research Group, Elikadura, Ariketa Fisikoa eta Osasuna, ELIKOS group, University of the Basque Country, UPV/EHU, Vitoria-Gasteiz, Spain; Department of Medicine, University of the Basque Country, UPV/EHU, Vitoria-Gasteiz, Spain.
authors.forename: L
authors.initials: L
authors.lastname: Barrenechea
authors.affiliation: Nutrition, Exercise and Health Research Group, Elikadura, Ariketa Fisikoa eta Osasuna, ELIKOS group, University of the Basque Country, UPV/EHU, Vitoria-Gasteiz, Spain; Department of Cardiology, Igualatorio Médico Quirúrgico (IMQ), Vitoria-Gasteiz, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Pérez-Asenjo
authors.affiliation: Siemens Healthcare GmbH, Erlangen, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Kannengiesser
authors.affiliation: Group of Computational Intelligence (GIC), University of the Basque Country, UPV/EHU, Donostia-San Sebastián, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Manhães-Savio
authors.affiliation: Group of Computational Intelligence (GIC), University of the Basque Country, UPV/EHU, Donostia-San Sebastián, Spain.
authors.forename: O
authors.initials: O
authors.lastname: Echaniz
authors.affiliation: Nutrition, Exercise and Health Research Group, Elikadura, Ariketa Fisikoa eta Osasuna, ELIKOS group, University of the Basque Country, UPV/EHU, Vitoria-Gasteiz, Spain; Department of Nutrition and Food Science, University of the Basque Country, UPV/EHU, Vitoria-Gasteiz, Spain; Promoting Fitness and Health through physical activity research group (PROFITH), Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Spain. Electronic address: idoia.labayen@ehu.es.
authors.forename: I
authors.initials: I
authors.lastname: Labayen
mesh_terms: D050154:Adiposity; D001521:Behavior Therapy / Q000379:methods; D001786:Blood Glucose; D001794:Blood Pressure; D001823:Body Composition; D015992:Body Mass Index; D002097:C-Reactive Protein; D002648:Child; D015444:Exercise; D005190:Family; D005260:Female; D015438:Health Behavior; D006801:Humans; D008019:Life Style; D008111:Liver Function Tests; D008297:Male; D065626:Non-alcoholic Fatty Liver Disease / Q000209:etiology* / Q000503:physiopathology; D050177:Overweight / Q000150:complications* / Q000628:therapy*; D063766:Pediatric Obesity / Q000150:complications* / Q000628:therapy*; D010809:Physical Fitness; D012107:Research Design; D061217:Weight Reduction Programs / Q000458:organization & administration*
chemical_list: D001786:Blood Glucose; D002097:C-Reactive Protein
keywords: Children; Exercise; Fatty liver; Metabolic syndrome; Obesity