MedPath

Exercise Training and Hepatic Metabolism in Overweight/Obese Adolescent

Not Applicable
Completed
Conditions
Lipid Metabolism Disorders
Obesity
Metabolic Syndrome X
Mental Health Wellness 1
Body Composition, Beneficial
Interventions
Behavioral: Low physical activity program
Behavioral: Low and High physical activity program
Behavioral: High physical activity program
Behavioral: Conventional physical activity program
Registration Number
NCT02753231
Lead Sponsor
Universidad Santo Tomas
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
120
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
Low physical activity programLow physical activity programThree Physical Education sessions / week
Low and High physical activity programLow and High physical activity programThree Physical Education sessions / week (increased volume and intensity)
High physical activity programHigh physical activity programThree Physical Education sessions / week (increased volume)
Conventional physical activity programConventional physical activity programOne Physical Education sessions / week
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
Change from Baseline in Body compositionBaseline and 6 months

Lean body mass as measured by Dual Energy X-ray Absorptiometry

Changes in liver enzymesBaseline and 6 months

Changes in total aspartate transaminase (AST) after the 6 months intervention program

Changes in serum lipid profileBaseline and 6 months

Changes in cholesterol total, LDL cholesterol, HDL cholesterol and triglycerides after the 6 months intervention program

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 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 testBaseline and 6 months

Change from Baseline in Cardiorespiratory fitness measured on a maximum effort test

Change from Baseline in Quality & satisfaction with life by SF Community - short-form survey (SF-12™) Colombian versionBaseline and 6 months
Changes in blood pressureBaseline and 6 months

Changes in blood pressure after the 6 months intervention program

Changes in physical activity using accelerometryBaseline and 6 months

Changes in physical activity estimated by accelerometry after the 6 months intervention program

Changes in inflammatory markers after the 6 months intervention programBaseline and 6 months

Changes in C-reactive protein (CRP) after the 6 months intervention program

© Copyright 2025. All Rights Reserved by MedPath