Clinical trial NCT02258126: Effect of Exercise on Hepatic Fat in Overweight Children
Official title: The Effect of Exercise on Hepatic Fat in Overweight Children; the EFIGRO Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-alcoholic Fatty Liver Disease
Obesity
Metabolic Syndrome
Keywords: overweight children
hepatic fat
exercise
nutritional education program
cardiometabolic risk
Lead sponsor: University of the Basque Country (UPV/EHU)
Sponsor class: OTHER
First posted: 2014-10-07
Enrollment: 115
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: changes in hepatic fat
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Changes in Insulin sensitivity
timeFrame: baseline and 6 months
measure: Changes in serum lipid profile
timeFrame: baseline and 6 months
measure: Changes in liver enzymes
timeFrame: baseline and 6 months
measure: Changes in dietary habits
timeFrame: baseline and 6 months
measure: Changes in physical activity
timeFrame: baseline and 6 months
measure: Changes in body composition
timeFrame: baseline and 6 months
measure: Changes in other cardiometabolic risk factors
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Vitoria-Gasteiz
country: Spain
facility: Pediatric Endocrinology Unit of the University Hospital of Araba (HUA)
state: Araba
Study officials:
affiliation: Department of Nutrition and Food Sciences, Faculty of Pharmacy, University of the Basque Country
name: IDOIA LABAYEN, PhD
role: PRINCIPAL_INVESTIGATOR
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