Non-alcoholic Fatty Liver DiseaseEFIGRONCT02258126
Effect of Exercise on Hepatic Fat in Overweight Children
A study testing Multidisciplinary intervention program in people with Non-alcoholic Fatty Liver Disease and Obesity, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease, Obesity, Metabolic Syndrome
- What is being tested?
- Multidisciplinary intervention program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2014to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Overweight or obesity status
- 9-11 years old
Who cannot join
- Medical conditions that hamper their participation in the exercise program
- Secondary obesity
Trial locations and contacts
1 site in 1 country.
Spain1 site
Pediatric Endocrinology Unit of the University Hospital of Araba (HUA)
Vitoria-Gasteiz, Araba, 01009
About this study
Official title: The Effect of Exercise on Hepatic Fat in Overweight Children; the EFIGRO Study
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.
Read the 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.
- Being tested
- Multidisciplinary intervention program
- Keywords
- overweight children, hepatic fat, exercise, nutritional education program, cardiometabolic risk
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Multidisciplinary intervention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in hepatic fat
Changes in hepatic fat fraction measured by magnetic resonance imaging after the 6 months intervention program
Measured: baseline and 6 months
Secondary outcomes (7)
Changes in Insulin sensitivity
Changes in insulin sensitivu¡ity measured by homeostasis model assessment (HOMA) after the 6 months intervention program
Measured: baseline and 6 months
Changes in serum lipid profile
Changes in total, LDL- and HDL-cholesterol after the 6 months intervention program
Measured: 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
Measured: 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
Measured: baseline and 6 months
Changes in physical activity
Changes in physical activity estimated by accelerometry after the 6 months intervention program
Measured: 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
Measured: 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
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Basque Country (UPV/EHU)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, IDOIA LABAYEN, University of the Basque Country (UPV/EHU)
- Investigators
- IDOIA LABAYEN, PhD, Principal investigator, Department of Nutrition and Food Sciences, Faculty of Pharmacy, University of the Basque Country
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258126
- Sponsor's protocol ID
- PI13/01335
- Acronym
- EFIGRO
- Status last verified
- Mar 2019
- First submitted
- 3 Oct 2014
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17552019Volovelsky 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.
PubMed 21905818Welsh 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.
PubMed 23084707Kotronen 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.
PubMed 17690317Schwimmer 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.
PubMed 18591439Wicklow 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.
PubMed 22357180Akin 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.
PubMed 23190373Davis 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.
PubMed 22990269Escalante 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.
PubMed 22387009Koot 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.
PubMed 21518734Hallsworth 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.
PubMed 21708823Lee 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.
PubMed 22751691Oh 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.
PubMed 23698242Labayen 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.
PubMed 37490040Cadenas-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.
PubMed 36441551
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise on Hepatic Fat in Overweight Children; the EFIGRO Study
- ClinicalTrials.gov ID
- NCT02258126
- Acronym / sponsor ID
- EFIGRO / PI13/01335
- Keywords
- overweight children, hepatic fat, exercise, nutritional education program, cardiometabolic risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of the Basque Country (UPV/EHU)University, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 7 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Multidisciplinary intervention programhealthy 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 | Other: Multidisciplinary intervention programmultidisciplinary 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Overweight or obesity status
- 9-11 years old
Key exclusion criteria (2 listed)
- Medical conditions that hamper their participation in the exercise program
- Secondary obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary intervention programExercise 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. | Other | Control group, Exercise group |
Primary outcome
changes in hepatic fat
Time frame: baseline and 6 months
Changes in hepatic fat fraction measured by magnetic resonance imaging after the 6 months intervention program
7 secondary outcomes
Changes in Insulin sensitivity
Time frame: baseline and 6 months
Changes in serum lipid profile
Time frame: baseline and 6 months
Changes in liver enzymes
Time frame: baseline and 6 months
Changes in dietary habits
Time frame: baseline and 6 months
Changes in physical activity
Time frame: baseline and 6 months
Changes in body composition
Time frame: baseline and 6 months
Changes in other cardiometabolic risk factors
Time frame: baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
- Background: PubMed 17552019Nobili 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.
- Results publication: PubMed 21905818Volovelsky 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.
- Results publication: PubMed 23084707Welsh 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.
- Results publication: PubMed 17690317Kotronen 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.
- Results publication: PubMed 18591439Schwimmer 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.
- Results publication: PubMed 22357180Wicklow 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.
- Results publication: PubMed 23190373Akin 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.
- Results publication: PubMed 22990269Davis 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.
- Results publication: PubMed 22387009Escalante 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.
- Results publication: PubMed 21518734Koot 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.
- Results publication: PubMed 21708823Hallsworth 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.
- Results publication: PubMed 22751691Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
IDOIA LABAYEN, PhD principal investigator
Department of Nutrition and Food Sciences, Faculty of Pharmacy, University of the Basque Country
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary intervention program in people with Non-alcoholic Fatty Liver Disease and Obesity, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in hepatic fat (time frame: baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02258126, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2019; AzTrials last refreshed its copy on 7 Nov 2026.