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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02753231
Other study ID # UR-21042016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2017
Est. completion date December 2017

Study information

Verified date November 2018
Source Universidad Santo Tomas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 17 Years
Eligibility 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


Intervention

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.
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.
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.
Conventional physical activity program
One Physical Education sessions / week

Locations

Country Name City State
n/a

Sponsors (6)

Lead Sponsor Collaborator
Universidad Santo Tomas Emory University, Universidad de Granada, Universidad de Santiago de Chile, Universidad Pública de Navarra, University of Castilla-La Mancha

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Changes in liver enzymes Changes in total alanine transaminase (ALT) after the 6 months intervention program Baseline and 6 months
Secondary Changes in serum lipid profile Changes in cholesterol total, LDL cholesterol, HDL cholesterol and triglycerides after the 6 months intervention program Baseline and 6 months
Secondary Changes in Insulin sensitivity measured by homeostasis model assessment (HOMA) Changes in insulin sensitivity measured by homeostasis model assessment (HOMA) after the 6 months intervention program Baseline and 6 months
Secondary Change from Baseline in Aerobic fitness measured on a maximum effort test Change from Baseline in Cardiorespiratory fitness measured on a maximum effort test Baseline and 6 months
Secondary Change from Baseline in Muscular Fitness assessed using handgrip test (maximum handgrip strength assessment) 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
Secondary Change from Baseline in Body composition Fat mass as measured by Dual Energy X-ray Absorptiometry Baseline and 6 months
Secondary Changes in physical activity using accelerometry Changes in physical activity estimated by accelerometry after the 6 months intervention program Baseline and 6 months
Secondary Change from Baseline in Quality & satisfaction with life by SF Community - short-form survey (SF-12™) Colombian version Baseline and 6 months
Secondary Changes in blood pressure Changes in blood pressure after the 6 months intervention program Baseline and 6 months
Secondary Changes in liver enzymes Changes in total gamma-GT after the 6 months intervention program Baseline and 6 months
Secondary Changes in liver enzymes Changes in total aspartate transaminase (AST) after the 6 months intervention program Baseline and 6 months
Secondary Changes in inflammatory markers after the 6 months intervention program Changes in TNF-alpha after the 6 months intervention program Baseline and 6 months
Secondary Changes in inflammatory markers after the 6 months intervention program Changes in IL-6 and IL-10 after the 6 months intervention program Baseline and 6 months
Secondary Changes in inflammatory markers after the 6 months intervention program Changes in C-reactive protein (CRP) after the 6 months intervention program Baseline and 6 months
Secondary Change from Baseline in Body composition Lean body mass as measured by Dual Energy X-ray Absorptiometry Baseline and 6 months
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