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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Effects of an exercise program on hepatic metabolism, hepatic fat, and cardiovascular health in overweight/obese adolescents from Bogotá, Colombia (the HEPAFIT study): study protocol for a randomized controlled trial

Authors: Katherine González-Ruíz, Jorge Enrique Correa-Bautista, Mikel Izquierdo, Antonio García-Hermoso, María Andrea Dominguez-Sanchez, Rosa Helena Bustos-Cruz, Jorge Cañete García-Prieto, Vicente Martínez-Vizcaíno, Felipe Lobelo, Emilio González-Jiménez, Daniel Humberto Prieto-Benavides, Alejandra Tordecilla-Sanders, Jacqueline Schmidt-RioValle, Guillermo Perez, Robinson Ramírez-Vélez

Published in: Trials | Issue 1/2018

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Abstract

Background

A considerable proportion of contemporary youth have a high risk of obesity-related disorders such as cardiovascular disease, metabolic syndrome, or non-alcoholic fatty liver disease (NAFLD). Although there is consistent evidence for the positive effects of physical activity on several health aspects, most adolescents in Colombia are sedentary. It is, therefore, important to implement strategies that generate changes in lifestyle. The HEPAFIT study aims to examine whether a 6-month exercise program has benefits for hepatic fat content and cardiovascular health outcomes among overweight/obese adolescents from Bogotá, Colombia.

Methods/design

Altogether, 100 hundred overweight/obese, sedentary adolescents (aged 11–17 years) attending two public schools in Bogotá, Colombia, will be included in a parallel-group randomized controlled trial. Adolescents will be randomly assigned to an intervention group following one of four curricula: (1) the standard physical education curriculum (60 min per week of physical activity, n = 25) at low-to-moderate intensity; (2) a high-intensity physical education curriculum (HIPE, n = 25), consisting of endurance and resistance games and non-competitive activities, such as running, gymkhanas, lifting, pushing, wrestling, or hauling, for 60-min sessions, three times per week, with an energy expenditure goal of 300 to 500 kcal/session at 75–85% maximum heart rate (HRmax); (3) a low-to-moderate intensity physical education curriculum (LIPE, n = 25) consisting of endurance and resistance games and non-competitive activities (e.g., chasing, sprinting, dribbling, or hopping) for 60-min sessions, three times per week with an energy expenditure goal of 300 kcal/session at 55–75% HRmax; and (4) a combined HIPE and LIPE curriculum (n = 25). The HIPE, LIPE, and combined interventions were performed in addition to the standard physical education curriculum. The primary outcome for effectiveness is liver fat content, as measured by the controlled attenuation parameter 1 week after the end of the intervention program.

Discussion

The translational focus may be suitable for collecting new information in a school setting on the possible effects of physical activity interventions to reduce liver fat content and to improve metabolic profiles and the cardiometabolic health of overweight/obese adolescents. This may lead to the more efficient use of school physical education resources.

Trial registration

ClinicalTrials.gov, NCT02753231. Registered on 21 April 2016.
Appendix
Available only for authorised users
Literature
1.
Organization WHO. Obesity: preventing and managing the global epidemic: World Health Organization; 2000.
2.
NCD Risk Factor Collaboration (NCD-RisC). Trends in adult body-mass index in 200 countries from 1975 to 2014: a pooled analysis of 1698 population-based measurement studies with 19·2 million participants. Lancet. 2016;387(10026):1377–96.CrossRef
3.
Ogden CL, Carroll MD, Lawman HG, Fryar CD, Kruszon-Moran D, Kit BK, Flegal KM. Trends in obesity prevalence among children and adolescents in the United States, 1988-1994 through 2013-2014. JAMA. 2016;315:2292–9.CrossRefPubMed
4.
Rivera JÁ, de Cossío TG, Pedraza LS, Aburto TC, Sánchez TG, Martorell R. Childhood and adolescent overweight and obesity in Latin America: a systematic review. Lancet Diabetes Endocrinol. 2014;2(4):321–32.CrossRefPubMed
5.
González SA, Castiblanco MA, Arias-Gómez LF, Martinez-Ospina A, Cohen DD, Holguin GA, Almanza A, Lemos DM, Correa-Bautista JE, Escobar ID, García J, Gámez R, Garzon M, Beltrán YH, Hurtado H, Lozano O, Páez DC, Ramírez-Vélez R, Ruiz N, Tovar G, Sarmiento OL. Results from Colombia's 2016 report card on physical activity for children and youth. J Phys Act Health. 2016;13(11 Suppl 2):S129–6.CrossRefPubMed
6.
Finucane MM, Stevens GA, Cowan MJ, Danaei G, Lin JK, Paciorek CJ, Singh GM, Gutierrez HR, Lu Y, Bahalim AN, Farzadfar F, Riley LM, Ezzati M. Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group (Body Mass Index). National, regional, and global trends in body-mass index since 1980: systematic analysis of health examination surveys and epidemiological studies with 960 country-years and 9· 1 million participants. Lancet. 2011;377:557.CrossRefPubMedPubMedCentral
7.
Singh AS, Mulder C, Twisk JW, Van Mechelen W, Chinapaw MJ. Tracking of childhood overweight into adulthood: a systematic review of the literature. Obes Rev. 2008;9:474–88.CrossRefPubMed
8.
Danaei G, Ding EL, Mozaffarian D, Taylor B, Rehm J, Murray CJ, Ezzati M. The preventable causes of death in the United States: comparative risk assessment of dietary, lifestyle, and metabolic risk factors. PLoS Med. 2009;6:e1000058.CrossRefPubMedPubMedCentral
9.
Freedman DS, Khan LK, Dietz WH, Srinivasan SR, Berenson GS. Relationship of childhood obesity to coronary heart disease risk factors in adulthood: the Bogalusa heart study. Pediatr. 2001;108:712–8.CrossRef
10.
Tirosh A, Shai I, Afek A, Dubnov-Raz G, Ayalon N, Gordon B, Derazne E, Tzur D, Shamis A, Vinker S, Rudich A. Adolescent BMI trajectory and risk of diabetes versus coronary disease. N Engl J Med. 2011;364:1315–25.CrossRefPubMedPubMedCentral
11.
Stringhini S, Carmeli C, Jokela M, Avendaño M, Muennig P, Guida F, Ricceri F, d'Errico A, Barros H, Bochud M, Chadeau-Hyam M, Clavel-Chapelon F, Costa G, Delpierre C, Fraga S, Goldberg M, Giles GG, Krogh V, Kelly-Irving M, Layte R, Lasserre AM, Marmot MG, Preisig M, Shipley MJ, Vollenweider P, Zins M, Kawachi I, Steptoe A, Mackenbach JP, Vineis P, Kivimäki M, LIFEPATH consortium. Socioeconomic status and the 25 × 25 risk factors as determinants of premature mortality: a multicohort study and meta-analysis of 1·7 million men and women. Lancet. 2017;389(10075):1229–37.CrossRefPubMedPubMedCentral
12.
García-Hermoso A, Ramírez-Vélez R, Ramírez-Campillo R, Peterson MD, Martínez-Vizcaíno V. Concurrent aerobic plus resistance exercise versus aerobic exercise alone to improve health outcomes in paediatric obesity: a systematic review and meta-analysis. Br J Sports Med. 2018;52(3):161–6.CrossRefPubMed
13.
Chalasani N, Younossi Z, Lavine JE, Charlton M, Cusi K, Rinella M, Harrison SA, Brunt EM, Sanyal AJ. The diagnosis and management of nonalcoholic fatty liver disease: practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2018;67(1):328–57.CrossRefPubMed
14.
González-Ruiz K, Ramírez-Vélez R, Correa-Bautista JE, Peterson MD, García-Hermoso A. The effects of exercise on abdominal fat and liver enzymes in pediatric obesity: a systematic review and meta-analysis. Child Obes. 2017;13(4):272–82.CrossRefPubMed
15.
García-Hermoso A, Ceballos-Ceballos RJ, Poblete-Aro CE, Hackney AC, Mota J, Ramírez-Vélez R. Exercise, adipokines and pediatric obesity: a meta-analysis of randomized controlled trials. Int J Obes. 2017;41(4):475–82.CrossRef
16.
Milanovic Z, Sporis G, Weston M. Effectiveness of high-intensity interval training (HIT) and continuous endurance training for VO2max improvements: a systematic review and MetaAnalysis of controlled trials. Sports Med. 2015;45:1469–81.CrossRefPubMed
17.
García-Hermoso A, Cerrillo-Urbina A, Herrera-Valenzuela T, Cristi-Montero C, Saavedra J, Martínez-Vizcaíno V. Is high-intensity interval training more effective on improving cardiometabolic risk and aerobic capacity than other forms of exercise in overweight and obese youth? A meta-analysis. Obes Rev. 2016;17(6):531–40.CrossRefPubMed
18.
Medrano M, Maiz E, Maldonado-Martín S, Arenaza L, Rodríguez-Vigil B, Ortega FB, Ruiz JR, Larrarte E, Diez-López I, Sarasúa-Miranda A, Tobalina I, Barrenechea L, Pérez-Asenjo J, Kannengiesser S, Manhães-Savio A, Echaniz O, Labayen I. The effect of a multidisciplinary intervention program on hepatic adiposity in overweight-obese children: protocol of the EFIGRO study. Contemp Clin Trials. 2015;45(Pt B):346–55.CrossRefPubMed
19.
Lee S, Bacha F, Hannon T, Kuk JL, Boesch C, Arslanian S. Effects of aerobic versus resistance exercise without caloric restriction on abdominal fat, intrahepatic lipid, and insulin sensitivity in obese adolescent boys: a randomized, controlled trial. Diabetes. 2012;61:2787–95.CrossRefPubMedPubMedCentral
20.
Van der Heijden GJ, Wang ZJ, Chu ZD, Sauer PJ, Haymond MW, Rodriguez LM, Sunehag AL. A 12-week aerobic exercise program reduces hepatic fat accumulation and insulin resistance in obese, Hispanic adolescents. Obesity (Silver Spring). 2010;18:384–90.CrossRef
21.
Sénéchal M, Rempel M, Duhamel TA, MacIntosh AC, Hay J, Wicklow B, Wittmeier K, Shen GX, McGavock JM. Fitness is a determinant of the metabolic response to endurance training in adolescents at risk of type 2 diabetes mellitus. Obesity (Silver Spring). 2015;23:823–32.CrossRef
22.
Koot B, van der Baan-Slootweg O, Vinke S, Bohte AE, Tamminga-Smeulders CL, Jansen PL, Stoker J, Benninga MA. Intensive lifestyle treatment for non-alcoholic fatty liver disease in children with severe obesity: inpatient versus ambulatory treatment. Int J Obes. 2016;40:51–7.CrossRef
23.
Khoo J, Hsiang J, Taneja R, Law NM, Ang TL. Comparative effects of liraglutide 3 mg vs structured lifestyle modification on body weight, liver fat and liver function in obese patients with non-alcoholic fatty liver disease: a pilot randomized trial. Diabetes Obes Metab. 2017;19(12):1814–7.CrossRefPubMed
24.
Sargeant JA, Bawden S, Aithal GP, Simpson EJ, Macdonald IA, Turner MC, Cegielski J, Smith K, Dorling JL, Gowland PA, Nimmo MA, King JA. Effects of sprint interval training on ectopic lipids and tissue-specific insulin sensitivity in men with non-alcoholic fatty liver disease. Eur J Appl Physiol. 2018;118(4):817–28.CrossRefPubMed
25.
Ustyol A, Aycan Ustyol E, Gurdol F, Kokali F, Bekpınar S. P-selectin, endocan, and some adhesion molecules in obese children and adolescents with non-alcoholic fatty liver disease. Scand J Clin Lab Invest. 2017;77(3):205–9.CrossRefPubMed
26.
Liang S, Cheng X, Hu Y, Song R, Li G. Insulin-like growth factor 1 and metabolic parameters are associated with nonalcoholic fatty liver disease in obese children and adolescents. Acta Paediatr. 2017;106(2):298–303.CrossRefPubMed
27.
Perito ER, Ajmera V, Bass NM, Rosenthal P, Lavine JE, Schwimmer JB, Yates KP, Diehl AM, Molleston JP, Murray KF, Scheimann A, Gill R, Glidden D, Aouizerat B. Association between cytokines and liver histology in children with nonalcoholic fatty liver disease. Hepatol Commun. 2017;1(7):609–22.CrossRefPubMedPubMedCentral
28.
Cole TJ, Lobstein T. Extended international (IOTF) body mass index cut-offs for thinness, overweight and obesity. Pediatr Obes. 2012;7:284–94.CrossRefPubMed
29.
30.
Steckler A, Allegrante JP, Altman D. Health education intervention strategies. Health Educ Q. 1995;22:307–28.CrossRefPubMed
31.
Bronfenbrenner U. Ecological systems theory. Annals Child Dev. 1989;6:187–249.
32.
Martínez-Vizcaíno V, Sánchez-López M, Notario-Pacheco B, Salcedo-Aguilar F, Solera-Martínez M, Franquelo-Morales P, López-Martínez S, García-Prieto JC, Arias-Palencia N, Torrijos-Niño C, Mora-Rodríguez R, Rodríguez-Artalejo F. Gender differences on effectiveness of a school-based physical activity intervention for reducing cardiometabolic risk: a cluster randomized trial. Int J Behav Nutr Phys Act. 2014;11:154.CrossRefPubMedPubMedCentral
33.
Martínez Vizcaíno V, Salcedo Aguilar F, Franquelo Gutiérrez R, Solera Martínez M, Sánchez López M, Serrano Martínez S, López García E, Rodríguez Artalejo F. Assessment of an after-school physical activity program to prevent obesity among 9- to 10-year-old children: a cluster randomized trial. Int J Obes. 2008;32(1):12–22.CrossRef
34.
García-Prieto JC, Martinez-Vizcaino V, García-Hermoso A, Sánchez-López M, Arias-Palencia N, Fonseca JF, Mora-Rodriguez R. Energy expenditure in playground games in primary school children measured by accelerometer and heart rate monitors. Int J Sport Nutr Exerc Metab. 2017;27(5):467–74.CrossRefPubMed
35.
Graf S, Karsegard VL, Viatte V, Maisonneuve N, Pichard C, Genton L. Comparison of three indirect calorimetry devices and three methods of gas collection: a prospective observational study. Clin Nutr. 2013;32(6):1067–72.CrossRefPubMed
36.
37.
38.
Andersson K, Areskoug D, Hardenborg E. Exploring buffer space for molecular interactions. J Mol Recognit. 1999;12:310–5.CrossRefPubMed
39.
Kuroki K, Maenaka K. Analysis of receptor-ligand interactions by surface plasmon resonance. Methods Mol Biol. 2011;748:83–106.CrossRefPubMed
40.
Celermajer DS, Sorensen KE, Gooch VM, Spiegelhalter DJ, Miller OI, Sullivan ID, Lloyd JK, Deanfield JE. Non-invasive detection of endothelial dysfunction in children and adults at risk of atherosclerosis. Lancet. 1992;340:1111–5.CrossRefPubMed
41.
Ramírez-Vélez R. Postprandial lipemia induces endothelial dysfunction and higher insulin resistance in healthy subjects. Endocrinol Nutr. 2011;58:529–35.CrossRefPubMed
42.
Corretti MC, Anderson TJ, Benjamin EJ. International brachial artery reactivity task force: international brachial artery reactivity task force. Guidelines for the ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery: a report of the international brachial artery reactivity task force. J Am Coll Cardiol. 2002;39:257–65.CrossRefPubMed
43.
Hopkins ND, Dengel DR, Stratton G, Kelly AS, Steinberger J, Zavala H, Marlatt K, Perry D, Naylor LH, Green DJ. Age and sex relationship with flow-mediated dilation in healthy children and adolescents. J Appl Physiol (1985). 2015;119(8):926–33.CrossRef
44.
Harrington J, Pena AS, Gent R, Hirte C, Couper J. Aortic intima media thickness is an early marker of atherosclerosis in children with type 1 diabetes mellitus. J Pediatr. 2010;156(2):237–41.CrossRefPubMed
45.
WHO. Physical status: the use and interpretation of anthropometry. Report of a WHO Expert Consultation. WHO Technical Report Series Number 854. Geneva: World Health Organization; 1995.
46.
Marfell-Jones M, Olds T, Stewart A. International standards for anthropometric assessment; ISAK: Potchefstroom, South Africa, 2006.
47.
Ruiz JR, Cavero-Redondo I, Ortega FB, Welk GJ, Andersen LB, Martinez-Vizcaino V. Cardiorespiratory fitness cut points to avoid cardiovascular disease risk in children and adolescents; what level of fitness should raise a red flag? A systematic review and meta-analysis. Br J Sports Med. 2016; https://​doi.​org/​10.​1136/​bjsports-2015-095903. [Epub ahead of print]
48.
Leger LA, Mercier D, Gadoury C, Lambert J. The multistage 20 metre shuttle run test for aerobic fitness. J Sport Sci. 1988;6:93–101.CrossRef
49.
Ramírez-Vélez R, Morales O, Peña-Ibagon JC, Palacios-López A, Prieto-Benavides DH, Vivas A, Correa-Bautista JE, Lobelo F, Alonso-Martínez AM, Izquierdo M. Normative reference values for handgrip strength in Colombian schoolchildren: the FUPRECOL study. J Strength Cond Res. 2017;31(1):217–26.CrossRefPubMed
50.
Ramírez-Vélez R, Tordecilla-Sanders A, Correa-Bautista JE, Peterson MD, Garcia-Hermoso A. Handgrip strength and ideal cardiovascular health among Colombian children and adolescents. J Pediatr. 2016;179:82–89.e1.CrossRefPubMed
51.
Ramírez-Vélez R, Martínez M, Correa-Bautista JE, Lobelo F, Izquierdo M, Rodríguez-Rodríguez F, Cristi-Montero C. Normative reference of standing long jump for Colombian schoolchildren aged 9-17.9 years: the FUPRECOL study. J Strength Cond Res. 2016; [Epub ahead of print]
52.
Ramírez-Vélez R, Rodrigues-Bezerra D, Correa-Bautista JE, Izquierdo M, Lobelo F. Reliability of health-related physical fitness tests among Colombian children and adolescents: the FUPRECOL study. PLoS One. 2015;10(10):e0140875.CrossRefPubMedPubMedCentral
53.
Cadenas-Sanchez C, Vanhelst J, Ruiz JR, Castillo-Gualda R, Libuda L, Labayen I, De Miguel-Etayo P, Marcos A, Molnár E, Catena A, Moreno LA, Sjöström M, Gottrand F, Widhalm K, Ortega FB, HELENA project group. Fitness and fatness in relation with attention capacity in European adolescents: the HELENA study. Sci Med Sport. 2017;20(4):373–9.CrossRef
54.
Spreen O, Strauss E. A compendium of neuropsychological tests. New York: Oxford University Press; 1998.
55.
Kendzierski D, DeCarlo KJ. Physical-activity enjoyment scale—2 validation studies. J Sport Exercise Psy. 1991;13(1):50–64.CrossRef
56.
Haapala EA, Väistö J, Lintu N, Westgate K, Ekelund U, Poikkeus AM, Brage S, Lakka TA. Physical activity and sedentary time in relation to academic achievement in children. J Sci Med Sport. 2017;20(6):583–9.
57.
Davis JN, Gyllenhammer LE, Vanni AA, Meija M, Tung A, Schroeder ET, Spruijt-Metz D, Goran MI. Startup circuit training program reduces metabolic risk in Latino adolescents. Med Sci Sports Exerc. 2011;43(11):2195–203.CrossRefPubMedPubMedCentral
58.
Togashi K, Masuda H, Iguchi K. Effect of diet and exercise treatment for obese Japanese children on abdominal fat distribution. Res Sports Med. 2010;18(1):62–70.CrossRefPubMed
59.
Gutin B, Barbeau P, Owens S, Lemmon CR, Bauman M, Allison J, Kang HS, Litaker MS. Effects of exercise intensity on cardiovascular fitness, total body composition, and visceral adiposity of obese adolescents. Am J Clin Nutr. 2002;75(5):818–26.CrossRefPubMed
60.
Desmet L, Venet D, Doffagne E, Timmermans C, Burzykowski T, Legrand C, Buyse M. Linear mixed-effects models for central statistical monitoring of multicenter clinical trials. Stat Med. 2014;33(30):5265–79.CrossRefPubMed
61.
Xu S, Xue Y. Pediatric obesity: causes, symptoms, prevention and treatment. Exp Ther Med. 2016;11(1):1520.
62.
Katzmarzyk PT, Barlow S, Bouchard C, et al. An evolving scientific basis for the prevention and treatment of pediatric obesity. Int J Obes. 2014;38(7):887905.CrossRef
63.
Faigenbaum AD, Kraemer WJ, Blimkie CJ, et al. Youth resistance training: updated position statement paper from the national strength and conditioning association. J Strength Cond Res. 2009;23(5 Suppl):S6079.
64.
Janssen I, Leblanc AG. Systematic review of the health benefits of physical activity and fitness in schoolaged children and youth. Int J Behav Nutr Phys Act. 2010;7:40.CrossRefPubMedPubMedCentral
65.
Larouche R, Saunders TJ, Faulkner G, et al. Associations between active school transport and physical activity, body composition, and cardiovascular fitness: a systematic review of 68 studies. J Phys Act Health. 2014;11(1):20627.CrossRef
66.
Lambrick D, Westrupp N, Kaufmann S, Stoner L, Faulkner J. The effectiveness of a high-intensity games intervention on improving indices of health in young children. J Sports Sci. 2016;34(3):190–8.CrossRefPubMed
67.
Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.CrossRefPubMedPubMedCentral
Metadata
Title
Effects of an exercise program on hepatic metabolism, hepatic fat, and cardiovascular health in overweight/obese adolescents from Bogotá, Colombia (the HEPAFIT study): study protocol for a randomized controlled trial
Authors
Katherine González-Ruíz
Jorge Enrique Correa-Bautista
Mikel Izquierdo
Antonio García-Hermoso
María Andrea Dominguez-Sanchez
Rosa Helena Bustos-Cruz
Jorge Cañete García-Prieto
Vicente Martínez-Vizcaíno
Felipe Lobelo
Emilio González-Jiménez
Daniel Humberto Prieto-Benavides
Alejandra Tordecilla-Sanders
Jacqueline Schmidt-RioValle
Guillermo Perez
Robinson Ramírez-Vélez
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2721-5

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