NCT02258126

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2014

Completed
25 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

April 1, 2019

Status Verified

March 1, 2019

Enrollment Period

3 years

First QC Date

October 3, 2014

Last Update Submit

March 29, 2019

Conditions

Non-alcoholic Fatty Liver DiseaseObesityMetabolic Syndrome

Keywords

overweight childrenhepatic fatexercisenutritional education programcardiometabolic risk

Outcome Measures

Primary Outcomes (1)

  • changes in hepatic fat

    Changes in hepatic fat fraction measured by magnetic resonance imaging after the 6 months intervention program

    baseline and 6 months

Secondary Outcomes (7)

  • Changes in Insulin sensitivity

    baseline and 6 months

  • Changes in serum lipid profile

    baseline and 6 months

  • Changes in liver enzymes

    baseline and 6 months

  • Changes in dietary habits

    baseline and 6 months

  • Changes in physical activity

    baseline and 6 months

  • +2 more secondary outcomes

Study Arms (2)

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

Other: Multidisciplinary intervention program

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.

Other: Multidisciplinary intervention program

Interventions

Multidisciplinary intervention programOTHER

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.

Control groupExercise group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Overweight or obesity status
  • years old

You may not qualify if:

  • Medical conditions that hamper their participation in the exercise program
  • Secondary obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Endocrinology Unit of the University Hospital of Araba (HUA)

Vitoria-Gasteiz, Araba, 01009, Spain

Location

Related Publications (21)

  • 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.

    PMID: 17552019BACKGROUND

  • 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.

    PMID: 21905818RESULT

  • 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.

    PMID: 23084707RESULT

  • 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.

    PMID: 17690317RESULT

  • 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.

    PMID: 18591439RESULT

  • 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.

    PMID: 22357180RESULT

  • 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.

    PMID: 23190373RESULT

  • 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.

    PMID: 22990269RESULT

  • 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.

    PMID: 22387009RESULT

  • 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.

    PMID: 21518734RESULT

  • 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.

    PMID: 21708823RESULT

  • 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.

    PMID: 22751691RESULT

  • 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.

    PMID: 23698242RESULT

  • 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.

    PMID: 37490040DERIVED

  • 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.

    PMID: 36441551DERIVED

  • 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.

    PMID: 36044664DERIVED

  • 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.

    PMID: 32237015DERIVED

  • 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.

    PMID: 31778277DERIVED

  • 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.

    PMID: 31227585DERIVED

  • 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.

    PMID: 29452135DERIVED

  • 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.

    PMID: 28939688DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseObesityMetabolic SyndromeMotor Activity

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesBehavior

Study Officials

  • IDOIA LABAYEN, PhD

    Department of Nutrition and Food Sciences, Faculty of Pharmacy, University of the Basque Country

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Nutrition and Food Sciences

Study Record Dates

First Submitted

October 3, 2014

First Posted

October 7, 2014

Study Start

November 1, 2014

Primary Completion

November 1, 2017

Study Completion

January 1, 2018

Last Updated

April 1, 2019

Record last verified: 2019-03

Locations

ES(1)