Body Composition, Beneficial, Lipid Metabolism Disorders, Mental Health Wellness 1, Metabolic Syndrome X, Obesity
Conditions
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.
Interventions
BEHAVIORALLow physical activity program
Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
BEHAVIORALHigh physical activity program
Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
BEHAVIORALLow and High physical activity program
Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
BEHAVIORALConventional physical activity program
One Physical Education sessions / week
Sponsors
Universidad de Santiago de Chile
Universidad de Granada
Universidad Pública de Navarra
Emory University
University of Castilla-La Mancha
Universidad Santo Tomas
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in hepatic fat measured by controlled attenuation parameter values (FibroScan®) | Baseline and 6 months | Changes in hepatic fat fraction measured by controlled attenuation parameter after the 6 months intervention program |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in serum lipid profile | Baseline and 6 months | Changes in cholesterol total, LDL cholesterol, HDL cholesterol and triglycerides after the 6 months intervention program |
| Changes in Insulin sensitivity measured by homeostasis model assessment (HOMA) | Baseline and 6 months | Changes in insulin sensitivity measured by homeostasis model assessment (HOMA) after the 6 months intervention program |
| Change from Baseline in Aerobic fitness measured on a maximum effort test | Baseline and 6 months | Change from Baseline in Cardiorespiratory fitness measured on a maximum effort test |
| Change from Baseline in Muscular Fitness assessed using handgrip test (maximum handgrip strength assessment) | Baseline and 6 months | 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® |
| Changes in liver enzymes | Baseline and 6 months | Changes in total alanine transaminase (ALT) after the 6 months intervention program |
| Changes in physical activity using accelerometry | Baseline and 6 months | Changes in physical activity estimated by accelerometry after the 6 months intervention program |
| 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 | Baseline and 6 months | Changes in blood pressure after the 6 months intervention program |
| Changes in inflammatory markers after the 6 months intervention program | Baseline and 6 months | Changes in TNF-alpha after the 6 months intervention program |
| Change from Baseline in Body composition | Baseline and 6 months | Fat mass as measured by Dual Energy X-ray Absorptiometry |
Outcome results
None listed