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Instituto Nacional de Salud Pública

2013, Número 6

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salud publica mex 2013; 55 (6)


Diseño y retos de un ensayo clínico aleatorizado para reducir el riesgo de síndrome metabólico en mujeres mexicanas mediante consumo de agua

Hernández-Cordero S, González-Castell D, Rodríguez-Ramírez S, Villanueva-Borbolla MÁ, Unar M, Barquera S, González de Cossío T, Rivera-Dommarco J, Popkin BM

Idioma: Ingles.
Referencias bibliográficas: 42
Paginas: 595-606
Archivo PDF: 217.45 Kb.


RESUMEN

Objetivo. Describir el diseño, métodos y dificultades logísticas enfrentadas durante un ensayo clínico aleatorizado con el objetivo de promover el aumento en el consumo de agua para reducir el riesgo metabólico en mujeres obesas. Material y métodos. Ensayo clínico aleatorizado, desarrollado en Cuernavaca, México. Mujeres con IMC ≥ 25 y ‹ 39, entre 18 y ‹ 45 años, con consumo de bebidas azucaradas ≥ 250 kcal/día, se asignaron aleatoriamente a a) grupo de agua y educación nutricional (n = 120), o b) educación nutricional únicamente (n = 120). Resultados. Se realizaron pruebas de tamizaje a 1 756 mujeres. Las principales dificultades para el desarrollo del estudio fueron identificar participantes que cumplieran criterios del estudio, entrega de agua y tiempo invertido por las participantes en actividades del proyecto. Conclusiones. Los retos del proyecto estuvieron relacionados con el reclutamiento, entrega de la intervención y demanda de tiempo a las participantes. Se implementaron modificaciones sin afectar la validez del estudio.


REFERENCIAS (EN ESTE ARTÍCULO)

  1. Barquera S, Campos-Nonato I, Hernández-Barrera L, Flores M, Durazo- Arvizu R, Kanter R, et al. Obesity and central adiposity in Mexican adults: results from the Mexican National Health and Nutrition Survey 2006. Salud Publica Mex 2009 51: S595-S603.

  2. Barquera S, Flores M, Olaiz-Fernandez G, Monterrubio E, Villalpando S, Gonzalez C, et al. Dyslipidemia and obesity in Mexico. Salud Publica Mex 2007;49:S338-S47.

  3. DiMeglio D, Mattes R. Liquid versus solid carbohydrate: effects on food intake and body weight. Int J Obes Relat Metab Disord 2000;24:794-800.

  4. Malik VS, Popkin BM, Bray GA, Despres JP, Willett WC, Hu FB. Sugar-sweetened beverages and risk of metabolic syndrome and type 2 diabetes: a meta-analysis. Diabetes Care 2010;33:2477-83.

  5. Ebbeling CB, Feldman HA, Osganian SK, Chomitz VR, Ellenbogen SJ, Ludwig DS. Effects of decreasing sugar-sweetened beverage consumption on body weight in adolescents: a randomized, controlled pilot study. Pediatrics 2006;117:673-80.

  6. Barquera S, Hernandez-Barrera L, Tolentino M, Espinosa J, Ng S, Rivera J, et al. Energy intake from beverages is increasing among Mexican adolescents and adults. J Nutr 2008;138:2454-2461.

  7. Rivera JA, Muñoz-Hernández O, Rosas-Peralta M, Aguilar-Salinas CA, Popkin BM, Willett WC. Consumo de bebidas para una vida saludable: recomendaciones para la población [Beverage consumption for a healthy life: recommendations for the Mexican population]. Salud Publica Mex 2008;50:173-195.

  8. Vartanian LR, Schwartz MB, Brownell KD. Effects of soft drink consumption on nutrition and health: a systematic review and meta-analysis. Am J Public Health 2007;97:667-675.

  9. Brownell KD, Farley T, Willett WC, Popkin BM, Chaloupka FJ, Thompson JW, et al. The public health and economic benefits of taxing sugar-sweetened beverages. N Engl J Med 2009;361:1599-1605.

  10. Malik VS, Schulze MB, Hu FB. Intake of sugar-sweetened beverages and weight gain: a systematic review. Am J Clin Nutr 2006;84:274-288.

  11. Mattes RD, Shikany JM, Kaiser KA, Allison DB. Nutritively sweetened beverage consumption and body weight: a systematic review and metaanalysis of randomized experiments. Obes Rev 2010:346-365.

  12. Guyatt G, Sackett D, Cook D. User´s Guide to Medical Literature. II. How to use and article about therapy of prevention. A. Are the results of the study Valid? JAMA 1993;270:2598-2601.

  13. Chow S-C, Chang M. Adaptive design methods in clinical trials- a review. Orphanet J Rare Dis 2008 3: doi:10.1186/750-72-3-11.

  14. Marmot M, Ghodse A, Jaruis S, Kemm J, Ritson E, Wallace P. Alcohol and the heart in perspective. Sensitive limits reaffirmed. A working Group of the Royal Colleges of Physicians, Psychiatrists and General Practitioners. JR Coll Physicians Lond 1995;29:266-271.

  15. Jensen MK, Andersen AT, Sorensen TI, Becker U, Thorsen T, Gronbaek M. Alcoholic beverage preference and risk of becoming a heavy drinker. Epidemiology 2002;13:127-132.

  16. Fishbein M. A reasoned action approach to health promotion. Med Decis Making 2008;28:834-844.

  17. Freire P. Pedagogía del Oprimido. Ciudad de México: Siglo XXI, 2002.

  18. Peace Corps. Nonformal education manual. Washington D.C.: Peace Corps Center for Field Assistance and Applied Research. ICE No. M0042, 2004.

  19. Holli B, Calabrese R, O’ Sullivan Maillet J. Communication and Education Skills for Dietetics Professionals. Nueva York: Lippincott Williams & Wilkins, 2003.

  20. Norma Oficial Mexicana NOM-043-SSA2-2005, Servicios básicos de salud. Promoción y educación para la salud en materia alimentaria. Criterios para brindar orientación. México: Secretaría de Salud, 2006.

  21. Shamah L, Villalpando S, Rivera Dommarco J, eds. Manual de Procedimientos para Proyectos de Nutrición. Cuernavaca: Instituto Nacional de Salud Pública, 2006.

  22. Higgins P, Fields D, Hunter G, Gower B. Effect of scalp and facial hair on air displacement plethysmography estimates of percentage of body fat. Obes Res 2001;9:326-330.

  23. Fields D, Higgins P, Hunter G. Assessment of body composition by air-displacement plethysmography: influence of body temperature and moisture. Dyn Med 2004;3:3.

  24. Siri W. Body composition from fluid spaces and density: analysis of methods. Nutrition 1993;1961(9):480-491.

  25. Lohman TG, Roche AF, Martorell R. Anthropometric standardization reference manual. Champaign, IL: Human Kinetics Publishers, 1988.

  26. Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, et al. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc 2003;35:1381-1395.

  27. USDA. Food and Nutrient Database for Dietary Studies, 4.1. Beltsville, MD: Agricultural Research Service, Food Surveys Research Group, 2010.

  28. USDA. USDA National Nutrient Database for Standard Reference, Release 24. U.S. Department of Agriculture, Agricultural Research Service, USDA Nutrient Data Laboratory, 2011.

  29. Stookey JD, Constant F, Gardner CD, Popkin BM. Replacing sweetened caloric beverages with drinking water is associated with lower energy intake. Obesity (Silver Spring) 2007;15:3013-3022.

  30. Aguilar-Salinas CA, Gomez-Perez FJ, Rull J, Villalpando S, Barquera S, Rojas R. Prevalence of dyslipidemias in the Mexican National Health and Nutrition Survey 2006. Salud Publica Mex 2010;52 Suppl 1:S44-53.

  31. Scafoglieri A, Tresignie J, Provyn S, Clarys J, Bautmans I. Reproducibility, accuracy and corcondance of Accutrend Plus for measuring circulating lipids concentration in adults. Biochem Med 2012;22:100-108.

  32. Chen L, Appel L, Loria C, Lin P-H, Champagne CM, Elmer P, et al. Reduction in consumption of sugar-sweetened beverage is associated with weight loss: the PREMIER trial. Am J Clin Nutr 2009;89:1299-1306.

  33. World Health Organization. Pandemic (H1N1) 2009 - update 70. ed. [ Accessed: October 2013]. Available at: http://www.who.int/csr/ don/2009_10_16/en/.

  34. Tate D, Erickson K, Turner-McGrievy G, Polzein K. Diamond M, Stevens J, et al. Replacing caloric beverages with water or diet beverages for weight loss in adults: Main results of the Choose Healthy Options Consciously Everyday (CHOICE) randomized clinical trial. Am J Clin Nutr 201;95:555-563.

  35. Muckelbauer R, Libuda L, Clausen K, Toschke A, Reinehr T, Kersting M. Promotion and provision of drinking water in schools for overweight prevention: randomized, controlled cluster trial. Pediatrics 2009;123:e661-7.

  36. Stookey JD, Constant F, Popkin BM, Gardner CD. Drinking water is associated with weight loss in overweight dieting women independent of diet and activity. Obesity (Silver Spring) 2008;16:2481-2488.

  37. Chow SC, Chang M. Adapttive Design Methods in Clinical Trials. Second ed. Florida: CRC Press Taylor and Francis Group, 2012.

  38. Chow SC, Chang M. Adaptive design methods in clinical trials - a review. Orphanet J Rare Dis 2008;3.

  39. Fundamentals of clinical trials. In: Yin G, ed. Clinical Trial Design: Bayesian and Frequentist Adaptive Methods. New Jersey: John Wiley and Sons, Inc ed, 2012:13-28:11.

  40. Blindness. In: Friedman L, Furberg C, DeMets D, eds., 4th ed. New York: Fundamentals on Clinical Trials: Springer, 2010:119-32.

  41. Higgins J, Green S. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011.

  42. Juni P, Altman D, Egger M. Assessing the quality of controlled clinical trials. BMJ 2001;323:42-46.




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