Effect of Exercise on Hepatic Fat in Overweight Children

Study Overview
=================
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.

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.

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

Conditions
-----------------
Non-alcoholic Fatty Liver Disease, Obesity, Metabolic Syndrome

Intervention / Treatment
-----------------
* Other: Multidisciplinary intervention program


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>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<br>* 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.<br>|
| Experimental: Exercise group<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatic fat, overweight children, exercise, nutritional education program, cardiometabolic risk