Exercise Training and Hepatic Metabolism in Overweight/Obese Adolescent
HEPAFIT
Effects of an Exercise Program on Hepatic Metabolism and Cardiovascular Health in Overweight/Obese Adolescent From Bogota, Colombia (HEPAFIT Study)
1 other identifier
interventional
120
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Jan 2017
Shorter than P25 for not_applicable obesity
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2016
CompletedFirst Posted
Study publicly available on registry
April 27, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedNovember 29, 2018
November 1, 2018
11 months
April 21, 2016
November 27, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (15)
Changes in liver enzymes
Baseline and 6 months
Changes in serum lipid profile
Baseline and 6 months
Changes in Insulin sensitivity measured by homeostasis model assessment (HOMA)
Baseline and 6 months
Change from Baseline in Aerobic 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)
Baseline and 6 months
- +10 more secondary outcomes
Study Arms (4)
Low physical activity program
EXPERIMENTALThree Physical Education sessions / week
High physical activity program
EXPERIMENTALThree Physical Education sessions / week (increased volume)
Low and High physical activity program
EXPERIMENTALThree Physical Education sessions / week (increased volume and intensity)
Conventional physical activity program
ACTIVE COMPARATOROne Physical Education sessions / week
Interventions
Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
One Physical Education sessions / week
Eligibility Criteria
You may qualify if:
- Overweight or obesity status
- years old
- Written informed consent
- Interested in improving health and fitness
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidad Santo Tomaslead
- Universidad de Santiago de Chilecollaborator
- Universidad de Granadacollaborator
- Universidad Pública de Navarracollaborator
- Emory Universitycollaborator
- University of Castilla-La Manchacollaborator
Related Publications (3)
Ramirez-Velez R, Garcia-Hermoso A, Correa-Rodriguez M, Fernandez-Irigoyen J, Palomino-Echeverria S, Santamaria E, Correa-Bautista JE, Gonzalez-Ruiz K, Izquierdo M. Effects of Different Doses of Exercise on Inflammation Markers Among Adolescents With Overweight/Obesity: HEPAFIT Study. J Clin Endocrinol Metab. 2022 May 17;107(6):e2619-e2627. doi: 10.1210/clinem/dgac021.
PMID: 35038337DERIVEDGonzalez-Ruiz K, Correa-Bautista JE, Izquierdo M, Garcia-Hermoso A, Martinez-Vizcaino V, Lobelo F, Gonzalez-Jimenez E, Schmidt-RioValle J, Correa-Rodriguez M, Fernandez-Irigoyen J, Palomino-Echeverria S, Santamaria E, Ramirez-Velez R. Exercise dose on hepatic fat and cardiovascular health in adolescents with excess of adiposity. Pediatr Obes. 2022 Apr;17(4):e12869. doi: 10.1111/ijpo.12869. Epub 2021 Nov 4.
PMID: 34734674DERIVEDGonzalez-Ruiz K, Correa-Bautista JE, Izquierdo M, Garcia-Hermoso A, Dominguez-Sanchez MA, Bustos-Cruz RH, Garcia-Prieto JC, Martinez-Vizcaino V, Lobelo F, Gonzalez-Jimenez E, Prieto-Benavides DH, Tordecilla-Sanders A, Schmidt-RioValle J, Perez G, Ramirez-Velez R. Effects of an exercise program on hepatic metabolism, hepatic fat, and cardiovascular health in overweight/obese adolescents from Bogota, Colombia (the HEPAFIT study): study protocol for a randomized controlled trial. Trials. 2018 Jun 25;19(1):330. doi: 10.1186/s13063-018-2721-5.
PMID: 29941024DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Robinson Ramirez Velez, Ph.D
Universidad del Rosario
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Centro de Estudios en Medición de la Actividad Física (CEMA)
Study Record Dates
First Submitted
April 21, 2016
First Posted
April 27, 2016
Study Start
January 1, 2017
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
November 29, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share