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Completed

NCT Number: NCT02258126

Effect of Exercise on Hepatic Fat in Overweight Children

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.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Behavior Body Weight Digestive System Diseases Fatty Liver Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Liver Diseases Metabolic Diseases Metabolic Syndrome Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Vitoria-Gasteiz, Araba, 01009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Overweight or obesity status
  • 9-11 years old

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of the Basque Country (UPV/EHU)

Other

Registry information

Official study title

The Effect of Exercise on Hepatic Fat in Overweight Children; the EFIGRO Study

Acronym: EFIGRO

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Oct 7, 2014
Registry last updated
Apr 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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