Exercise Training and Hepatic Metabolism in Overweight/Obese Adolescent

Study Overview
=================
Brief Summary
-----------------
The HEPAFIT Study aims to examine whether a 6-months physical education program has benefits on hepatic metabolism and cardiovascular health as well as on selected physical fitness and mental health outcomes among adolescent overweight/obese from Bogota, Colombia.

Official Title
-----------------
Effects of an Exercise Program on Hepatic Metabolism and Cardiovascular Health in Overweight/Obese Adolescent From Bogota, Colombia (HEPAFIT Study)

Conditions
-----------------
Obesity, Metabolic Syndrome X, Lipid Metabolism Disorders, Body Composition, Beneficial, Mental Health Wellness 1

Intervention / Treatment
-----------------
* Behavioral: Low physical activity program
* Behavioral: High physical activity program
* Behavioral: Low and High physical activity program
* Behavioral: Conventional physical activity program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overweight or obesity status 11-17 years old Written informed consent Interested in improving health and fitness Exclusion Criteria: Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial. Clinical diagnosis of diabetes Pregnancy Drugs/alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low physical activity program<br>Three Physical Education sessions / week | Behavioral: Low physical activity program<br>* Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.<br>|
| Experimental: High physical activity program<br>Three Physical Education sessions / week (increased volume) | Behavioral: High physical activity program<br>* Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.<br>|
| Experimental: Low and High physical activity program<br>Three Physical Education sessions / week (increased volume and intensity) | Behavioral: Low and High physical activity program<br>* Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.<br>|
| Active Comparator: Conventional physical activity program<br>One Physical Education sessions / week | Behavioral: Conventional physical activity program<br>* One Physical Education sessions / week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in hepatic fat measured by controlled attenuation parameter values (FibroScan®) | Changes in hepatic fat fraction measured by controlled attenuation parameter after the 6 months intervention program | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in liver enzymes | Changes in total alanine transaminase (ALT) after the 6 months intervention program | Baseline and 6 months | 
| Changes in serum lipid profile | Changes in cholesterol total, LDL cholesterol, HDL cholesterol and triglycerides after the 6 months intervention program | Baseline and 6 months | 
| Changes in Insulin sensitivity measured by homeostasis model assessment (HOMA) | Changes in insulin sensitivity measured by homeostasis model assessment (HOMA) after the 6 months intervention program | Baseline and 6 months | 
| Change from Baseline in Aerobic fitness measured on a maximum effort test | Change from Baseline in Cardiorespiratory fitness measured on a maximum effort test | Baseline and 6 months | 
| Change from Baseline in Muscular Fitness assessed using handgrip test (maximum handgrip strength assessment) | Muscular fitness will be assessed using handgrip test (maximum handgrip strength assessment) using a standard adjustable handle analogue handgrip dynamometer T-18 TKK SMEDLY III® | Baseline and 6 months | 
| Change from Baseline in Body composition | Fat mass as measured by Dual Energy X-ray Absorptiometry | Baseline and 6 months | 
| Changes in physical activity using accelerometry | Changes in physical activity estimated by accelerometry after the 6 months intervention program | Baseline and 6 months | 
| Change from Baseline in Quality & satisfaction with life by SF Community - short-form survey (SF-12™) Colombian version |  | Baseline and 6 months | 
| Changes in blood pressure | Changes in blood pressure after the 6 months intervention program | Baseline and 6 months | 
| Changes in liver enzymes | Changes in total gamma-GT after the 6 months intervention program | Baseline and 6 months | 
| Changes in liver enzymes | Changes in total aspartate transaminase (AST) after the 6 months intervention program | Baseline and 6 months | 
| Changes in inflammatory markers after the 6 months intervention program | Changes in TNF-alpha after the 6 months intervention program | Baseline and 6 months | 
| Changes in inflammatory markers after the 6 months intervention program | Changes in IL-6 and IL-10 after the 6 months intervention program | Baseline and 6 months | 
| Changes in inflammatory markers after the 6 months intervention program | Changes in C-reactive protein (CRP) after the 6 months intervention program | Baseline and 6 months | 
| Change from Baseline in Body composition | Lean body mass as measured by Dual Energy X-ray Absorptiometry | Baseline and 6 months |