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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | healthy lifestyle education including healthy lifestyle education, supportive therapy and behavioral advice for both children and parents to improve nutrition and physical activity |
|
| Exercise group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multidisciplinary intervention program | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| changes in hepatic fat | Changes in hepatic fat fraction measured by magnetic resonance imaging after the 6 months intervention program | baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Insulin sensitivity | Changes in insulin sensitivu¡ity measured by homeostasis model assessment (HOMA) after the 6 months intervention program | baseline and 6 months |
| Changes in serum lipid profile |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| IDOIA LABAYEN, PhD | Department of Nutrition and Food Sciences, Faculty of Pharmacy, University of the Basque Country | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Endocrinology Unit of the University Hospital of Araba (HUA) | Vitoria-Gasteiz | Araba | 01009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17552019 | Background | Nobili V, Manco M. Therapeutic strategies for pediatric non-alcoholic fatty liver disease: a challenge for health care providers. World J Gastroenterol. 2007 May 14;13(18):2639-41. doi: 10.3748/wjg.v13.i18.2639. | |
| 21905818 | Result | Volovelsky O, Weiss R. Fatty liver disease in obese children--relation to other metabolic risk factors. Int J Pediatr Obes. 2011 Sep;6 Suppl 1:59-64. doi: 10.3109/17477166.2011.583661. |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D050177 | Overweight |
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|
Changes in total, LDL- and HDL-cholesterol after the 6 months intervention program
| baseline and 6 months |
| Changes in liver enzymes | Changes in total, alanine transaminase (ALT), aspartate transaminase (AST) and gamma-GT after the 6 months intervention program | baseline and 6 months |
| Changes in dietary habits | Changes in dietary habits estimated by 24h recall and food frequency questionnaire after the 6 months intervention program | baseline and 6 months |
| Changes in physical activity | Changes in physical activity estimated by accelerometry after the 6 months intervention program | baseline and 6 months |
| Changes in body composition | Changes in visceral adipose tissue (MRI), abdominal and total adiposity (DEXA), lean tissue mass and bone mass (DEXA) the 6 months intervention program | baseline and 6 months |
| Changes in other cardiometabolic risk factors | Changes in blood pressure, leptin, adiponectin, C-reactive protein (CRP) after the 6 months intervention program | baseline and 6 months |
| 23084707 | Result | Welsh JA, Karpen S, Vos MB. Increasing prevalence of nonalcoholic fatty liver disease among United States adolescents, 1988-1994 to 2007-2010. J Pediatr. 2013 Mar;162(3):496-500.e1. doi: 10.1016/j.jpeds.2012.08.043. Epub 2012 Oct 17. |
| 17690317 | Result | Kotronen A, Yki-Jarvinen H. Fatty liver: a novel component of the metabolic syndrome. Arterioscler Thromb Vasc Biol. 2008 Jan;28(1):27-38. doi: 10.1161/ATVBAHA.107.147538. Epub 2007 Aug 9. |
| 18591439 | Result | Schwimmer JB, Pardee PE, Lavine JE, Blumkin AK, Cook S. Cardiovascular risk factors and the metabolic syndrome in pediatric nonalcoholic fatty liver disease. Circulation. 2008 Jul 15;118(3):277-83. doi: 10.1161/CIRCULATIONAHA.107.739920. Epub 2008 Jun 30. |
| 22357180 | Result | Wicklow BA, Wittmeier KD, MacIntosh AC, Sellers EA, Ryner L, Serrai H, Dean HJ, McGavock JM. Metabolic consequences of hepatic steatosis in overweight and obese adolescents. Diabetes Care. 2012 Apr;35(4):905-10. doi: 10.2337/dc11-1754. Epub 2012 Feb 22. |
| 23190373 | Result | Akin L, Kurtoglu S, Yikilmaz A, Kendirci M, Elmali F, Mazicioglu M. Fatty liver is a good indicator of subclinical atherosclerosis risk in obese children and adolescents regardless of liver enzyme elevation. Acta Paediatr. 2013 Mar;102(3):e107-13. doi: 10.1111/apa.12099. Epub 2012 Dec 29. |
| 22990269 | Result | Davis CL, Pollock NK, Waller JL, Allison JD, Dennis BA, Bassali R, Melendez A, Boyle CA, Gower BA. Exercise dose and diabetes risk in overweight and obese children: a randomized controlled trial. JAMA. 2012 Sep 19;308(11):1103-12. doi: 10.1001/2012.jama.10762. |
| 22387009 | Result | Escalante Y, Saavedra JM, Garcia-Hermoso A, Dominguez AM. Improvement of the lipid profile with exercise in obese children: a systematic review. Prev Med. 2012 May;54(5):293-301. doi: 10.1016/j.ypmed.2012.02.006. Epub 2012 Feb 23. |
| 21518734 | Result | Koot BG, van der Baan-Slootweg OH, Tamminga-Smeulders CL, Rijcken TH, Korevaar JC, van Aalderen WM, Jansen PL, Benninga MA. Lifestyle intervention for non-alcoholic fatty liver disease: prospective cohort study of its efficacy and factors related to improvement. Arch Dis Child. 2011 Jul;96(7):669-74. doi: 10.1136/adc.2010.199760. Epub 2011 Apr 25. |
| 21708823 | Result | Hallsworth K, Fattakhova G, Hollingsworth KG, Thoma C, Moore S, Taylor R, Day CP, Trenell MI. Resistance exercise reduces liver fat and its mediators in non-alcoholic fatty liver disease independent of weight loss. Gut. 2011 Sep;60(9):1278-83. doi: 10.1136/gut.2011.242073. Epub 2011 Jun 27. |
| 22751691 | Result | Lee S, Bacha F, Hannon T, Kuk JL, Boesch C, Arslanian S. Effects of aerobic versus resistance exercise without caloric restriction on abdominal fat, intrahepatic lipid, and insulin sensitivity in obese adolescent boys: a randomized, controlled trial. Diabetes. 2012 Nov;61(11):2787-95. doi: 10.2337/db12-0214. Epub 2012 Jun 29. |
| 23698242 | Result | Oh S, Tanaka K, Warabi E, Shoda J. Exercise reduces inflammation and oxidative stress in obesity-related liver diseases. Med Sci Sports Exerc. 2013 Dec;45(12):2214-22. doi: 10.1249/MSS.0b013e31829afc33. |
| 37490040 | Derived | Labayen I, Cadenas-Sanchez C, Idoate F, Medrano M, Tobalina I, Villanueva A, Rodriguez-Vigil B, Alvarez de Eulate N, Oses M, Cabeza R. Liver Fat, Bone Marrow Adipose Tissue, and Bone Mineral Density in Children With Overweight. J Clin Endocrinol Metab. 2023 Dec 21;109(1):e253-e258. doi: 10.1210/clinem/dgad429. |
| 36441551 | Derived | Cadenas-Sanchez C, Cabeza R, Idoate F, Oses M, Medrano M, Villanueva A, Arenaza L, Sanz A, Ortega FB, Ruiz JR, Labayen I. Effects of a Family-Based Lifestyle Intervention Plus Supervised Exercise Training on Abdominal Fat Depots in Children With Overweight or Obesity: A Secondary Analysis of a Nonrandomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2243864. doi: 10.1001/jamanetworkopen.2022.43864. |
| 36044664 | Derived | Cadenas-Sanchez C, Idoate F, Cabeza R, Villanueva A, Rodriguez-Vigil B, Medrano M, Oses M, Ortega FB, Ruiz JR, Labayen I. Effect of a Multicomponent Intervention on Hepatic Steatosis Is Partially Mediated by the Reduction of Intermuscular Abdominal Adipose Tissue in Children With Overweight or Obesity: The EFIGRO Project. Diabetes Care. 2022 Sep 1;45(9):1953-1960. doi: 10.2337/dc21-2440. |
| 32237015 | Derived | Medrano M, Arenaza L, Migueles JH, Rodriguez-Vigil B, Ruiz JR, Labayen I. Associations of physical activity and fitness with hepatic steatosis, liver enzymes, and insulin resistance in children with overweight/obesity. Pediatr Diabetes. 2020 Jun;21(4):565-574. doi: 10.1111/pedi.13011. Epub 2020 Apr 12. |
| 31778277 | Derived | Medrano M, Arenaza L, Ramirez-Velez R, Ortega FB, Ruiz JR, Labayen I. Prevalence of responders for hepatic fat, adiposity and liver enzyme levels in response to a lifestyle intervention in children with overweight/obesity: EFIGRO randomized controlled trial. Pediatr Diabetes. 2020 Mar;21(2):215-223. doi: 10.1111/pedi.12949. Epub 2019 Dec 10. |
| 31227585 | Derived | Labayen I, Medrano M, Arenaza L, Maiz E, Oses M, Martinez-Vizcaino V, Ruiz JR, Ortega FB. Effects of Exercise in Addition to a Family-Based Lifestyle Intervention Program on Hepatic Fat in Children With Overweight. Diabetes Care. 2020 Feb;43(2):306-313. doi: 10.2337/dc19-0351. Epub 2019 Jun 21. |
| 29452135 | Derived | Medrano M, Cadenas-Sanchez C, Alvarez-Bueno C, Cavero-Redondo I, Ruiz JR, Ortega FB, Labayen I. Evidence-Based Exercise Recommendations to Reduce Hepatic Fat Content in Youth- a Systematic Review and Meta-Analysis. Prog Cardiovasc Dis. 2018 Jul-Aug;61(2):222-231. doi: 10.1016/j.pcad.2018.01.013. Epub 2018 Feb 13. |
| 28939688 | Derived | Nystrom CD, Henriksson P, Martinez-Vizcaino V, Medrano M, Cadenas-Sanchez C, Arias-Palencia NM, Lof M, Ruiz JR, Labayen I, Sanchez-Lopez M, Ortega FB. Does Cardiorespiratory Fitness Attenuate the Adverse Effects of Severe/Morbid Obesity on Cardiometabolic Risk and Insulin Resistance in Children? A Pooled Analysis. Diabetes Care. 2017 Nov;40(11):1580-1587. doi: 10.2337/dc17-1334. Epub 2017 Sep 22. |
| D044343 |
| Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D001519 | Behavior |