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| Name | Class |
|---|---|
| Universidad de Santiago de Chile | OTHER |
| Universidad de Granada | OTHER |
| Universidad Pública de Navarra | OTHER |
| Emory University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low physical activity program | Experimental | Three Physical Education sessions / week |
|
| High physical activity program | Experimental | Three Physical Education sessions / week (increased volume) |
|
| Low and High physical activity program | Experimental | Three Physical Education sessions / week (increased volume and intensity) |
|
| Conventional physical activity program | Active Comparator | One Physical Education sessions / week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low physical activity program | Behavioral | Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in liver enzymes | Changes in total alanine transaminase (ALT) after the 6 months intervention program | Baseline and 6 months |
| Changes in serum lipid profile | Changes in cholesterol total, LDL cholesterol, HDL cholesterol and triglycerides after the 6 months intervention program |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robinson Ramirez Velez, Ph.D | Universidad del Rosario | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35038337 | Derived | 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. | |
| 34734674 |
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| OTHER |
| University of Castilla-La Mancha | OTHER |
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| High physical activity program | Behavioral | 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 | Behavioral | 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 | Behavioral | One Physical Education sessions / week |
|
| Baseline and 6 months |
| 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 |
| 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 |
| 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 |
| Change from Baseline in Body composition | Fat mass as measured by Dual Energy X-ray Absorptiometry | Baseline and 6 months |
| Changes in physical activity using accelerometry | 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 | Baseline and 6 months |
| Changes in blood pressure | Changes in blood pressure after the 6 months intervention program | Baseline and 6 months |
| Changes in liver enzymes | Changes in total gamma-GT after the 6 months intervention program | Baseline and 6 months |
| Changes in liver enzymes | 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 | Changes in TNF-alpha after the 6 months intervention program | Baseline and 6 months |
| 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 |
| 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 |
| Change from Baseline in Body composition | Lean body mass as measured by Dual Energy X-ray Absorptiometry | Baseline and 6 months |
| Gonzalez-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. |
| 29941024 | Derived | Gonzalez-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. |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| D052439 | Lipid Metabolism Disorders |
| C564221 | Glucocorticoid Receptor Deficiency |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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