Exercise Training and Hepatic Metabolism in Overweight/Obese Adolescent (HEPAFIT)

November 27, 2018 updated by: Robinson Ramírez-Vélez, Universidad Santo Tomas

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

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

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®)
Time Frame: Baseline and 6 months
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
Time Frame: Baseline and 6 months
Changes in total alanine transaminase (ALT) after the 6 months intervention program
Baseline and 6 months
Changes in serum lipid profile
Time Frame: Baseline and 6 months
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)
Time Frame: Baseline and 6 months
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
Time Frame: Baseline and 6 months
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)
Time Frame: 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®
Baseline and 6 months
Change from Baseline in Body composition
Time Frame: Baseline and 6 months
Fat mass as measured by Dual Energy X-ray Absorptiometry
Baseline and 6 months
Changes in physical activity using accelerometry
Time Frame: Baseline and 6 months
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
Time Frame: Baseline and 6 months
Baseline and 6 months
Changes in blood pressure
Time Frame: Baseline and 6 months
Changes in blood pressure after the 6 months intervention program
Baseline and 6 months
Changes in liver enzymes
Time Frame: Baseline and 6 months
Changes in total gamma-GT after the 6 months intervention program
Baseline and 6 months
Changes in liver enzymes
Time Frame: Baseline and 6 months
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
Time Frame: Baseline and 6 months
Changes in TNF-alpha after the 6 months intervention program
Baseline and 6 months
Changes in inflammatory markers after the 6 months intervention program
Time Frame: Baseline and 6 months
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
Time Frame: Baseline and 6 months
Changes in C-reactive protein (CRP) after the 6 months intervention program
Baseline and 6 months
Change from Baseline in Body composition
Time Frame: Baseline and 6 months
Lean body mass as measured by Dual Energy X-ray Absorptiometry
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Santo Tomas

Collaborators

Emory University
Universidad Pública de Navarra
Universidad de Granada
University of Castilla-La Mancha
Universidad de Santiago de Chile

Investigators

  • Study Chair: Robinson Ramirez Velez, Ph.D, Universidad del Rosario

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

April 21, 2016

First Submitted That Met QC Criteria

April 26, 2016

First Posted (Estimate)

April 27, 2016

Study Record Updates

Last Update Posted (Actual)

November 29, 2018

Last Update Submitted That Met QC Criteria

November 27, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UR-21042016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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