Metabolic Syndrome, Non-alcoholic Fatty Liver Disease, Obesity
Conditions
Keywords
overweight children, hepatic fat, exercise, nutritional education program, cardiometabolic risk
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.
Interventions
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.
Sponsors
University of the Basque Country (UPV/EHU)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* Overweight or obesity status * 9-11 years old
Exclusion criteria
* Medical conditions that hamper their participation in the exercise program * Secondary obesity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in hepatic fat | baseline and 6 months | Changes in hepatic fat fraction measured by magnetic resonance imaging after the 6 months intervention program |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in serum lipid profile | baseline and 6 months | Changes in total, LDL- and HDL-cholesterol after the 6 months intervention program |
| Changes in liver enzymes | baseline and 6 months | Changes in total, alanine transaminase (ALT), aspartate transaminase (AST) and gamma-GT after the 6 months intervention program |
| Changes in dietary habits | baseline and 6 months | Changes in dietary habits estimated by 24h recall and food frequency questionnaire after the 6 months intervention program |
| Changes in Insulin sensitivity | baseline and 6 months | Changes in insulin sensitivu¡ity measured by homeostasis model assessment (HOMA) after the 6 months intervention program |
| Changes in body composition | 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 |
| Changes in other cardiometabolic risk factors | baseline and 6 months | Changes in blood pressure, leptin, adiponectin, C-reactive protein (CRP) after the 6 months intervention program |
| Changes in physical activity | baseline and 6 months | Changes in physical activity estimated by accelerometry after the 6 months intervention program |
Countries
Spain
Outcome results
None listed