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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Santo Tomas

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Emory University
Universidad Pública de Navarra
Universidad de Granada
University of Castilla-La Mancha
Universidad de Santiago de Chile

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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