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Effect of Exercise on Hepatic Fat in Overweight Children (EFIGRO)

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ClinicalTrials.gov Identifier: NCT02258126
Recruitment Status : Completed
First Posted : October 7, 2014
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
IDOIA LABAYEN, Basque Country University

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.


Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Obesity Metabolic Syndrome Other: Multidisciplinary intervention program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Exercise on Hepatic Fat in Overweight Children; the EFIGRO Study
Actual Study Start Date : November 2014
Actual Primary Completion Date : November 2017
Actual Study Completion Date : January 2018


Arm Intervention/treatment
Active Comparator: Control group
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:

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.


Experimental: Exercise group
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

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.





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Changes in Insulin sensitivity [ Time Frame: baseline and 6 months ]
    Changes in insulin sensitivu¡ity measured by homeostasis model assessment (HOMA) after the 6 months intervention program

  2. Changes in serum lipid profile [ Time Frame: baseline and 6 months ]
    Changes in total, LDL- and HDL-cholesterol after the 6 months intervention program

  3. Changes in liver enzymes [ Time Frame: baseline and 6 months ]
    Changes in total, alanine transaminase (ALT), aspartate transaminase (AST) and gamma-GT after the 6 months intervention program

  4. Changes in dietary habits [ Time Frame: baseline and 6 months ]
    Changes in dietary habits estimated by 24h recall and food frequency questionnaire after the 6 months intervention program

  5. Changes in physical activity [ Time Frame: baseline and 6 months ]
    Changes in physical activity estimated by accelerometry after the 6 months intervention program

  6. Changes in body composition [ Time Frame: baseline and 6 months ]
    Changes in visceral adipose tissue (MRI), abdominal and total adiposity (DEXA), lean tissue mass and bone mass (DEXA) the 6 months intervention program

  7. Changes in other cardiometabolic risk factors [ Time Frame: baseline and 6 months ]
    Changes in blood pressure, leptin, adiponectin, C-reactive protein (CRP) after the 6 months intervention program



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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Overweight or obesity status
  • 9-11 years old

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02258126


Locations
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Spain
Pediatric Endocrinology Unit of the University Hospital of Araba (HUA)
Vitoria-Gasteiz, Araba, Spain, 01009
Sponsors and Collaborators
Basque Country University
Investigators
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Principal Investigator: IDOIA LABAYEN, PhD Department of Nutrition and Food Sciences, Faculty of Pharmacy, University of the Basque Country
Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: IDOIA LABAYEN, Lecturer of Nutrition and Food Sciences, Basque Country University
ClinicalTrials.gov Identifier: NCT02258126    
Other Study ID Numbers: PI13/01335
First Posted: October 7, 2014    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Keywords provided by IDOIA LABAYEN, Basque Country University:
overweight children
hepatic fat
exercise
nutritional education program
cardiometabolic risk
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Metabolic Syndrome
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Digestive System Diseases