Translational study of obesity management using the Diabetes Prevention Program "Group Lifestyle Balance" in primary care clinics and public hospitals from Mexico: study protocol
DOI:
https://doi.org/10.14306/renhyd.21.4.391Keywords:
Diabetes Prevention Program, Translational Medical Research, Weight Loss, Obesity, Life Style, Health Knowledge, Attitudes, Practice.Abstract
Introduction: Obesity is the main modifiable risk factor for the development of chronic diseases in Mexico. Several randomized controlled trials have shown that intensive lifestyle programs are efficacious for the management of obesity. These programs include frequent sessions (14 or more contacts in the first 6 months) focused on diet and physical activity and use a behavior change protocol. However, most Mexican primary care clinics and public hospitals apply traditional treatments for obesity management with limited results on weight loss. The purpose of the study is to evaluate the effectiveness of the Diabetes Prevention Program (DPP) “Group Lifestyle Balance” for weight loss among adults with overweight and obesity from baseline to 6 months and from baseline to 12 months in primary care clinics and public hospitals from Sonora, Mexico.Material and Methods: This is a translational, multi-center, non-controlled, 6 and 12-month follow-up clinical study with a pre-test and post-test design. Healthcare providers from two primary care clinics, two hospitals and one university clinic will be trained with the DPP protocol to implement on their patients with overweight and obesity. Body weight, body mass index, waist circumference, systolic and diastolic blood pressure, depression, quality of life and stress scales will be measured in participants receiving the program at baseline, 6 and 12 months. Biochemical parameters will be measured at baseline and 12 months. The primary outcome is the change in body weight at 6 and 12 months.
Discussion: This study will provide scientific evidence of the effectiveness of the DPP protocol as a model for obesity management in real world clinical practice among the adult Mexican population.
References
(1) Gutiérrez JP, Rivera-Dommarco J, Shamah-Levy T, Villalpando-Hernández S, Franco A, Cuevas-Nasu L, et al. Encuesta Nacional de Salud y Nutrición 2012. Resultados Nacionales. Cuernavaca, México: Instituto Nacional de Salud Pública (MX); 2012. Disponible en: http://ensanut.insp.mx/informes/ENSANUT2012ResultadosNacionales.pdf
(2) Lozano R, Gómez-Dantés H, Garrido-Latorre F, Jiménez-Corona A, Campuzano-Rincón JC, Franco-Marina F, et al. La carga de enfermedad, lesiones, factores de riesgo y desafíos para el sistema de salud en México. Salud Publica Mex. diciembre de 2013;55(6):580-94.
(3) Jensen MD, Ryan DH, Donato KA, Apovian CM, Ard JD, Comuzzie AG, et al. Guidelines (2013) for managing overweight and obesity in adults. Obesity. 2014;22(S2):S1-410.
(4) Wadden TA, Webb VL, Moran CH, Bailer BA. Lifestyle modification for obesity: new developments in diet, physical activity, and behavior therapy. Circulation. 2012;125(9):1157-70.
(5) Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346(6):393-403.
(6) Look AHEAD Research Group. Eight-year weight losses with an intensive lifestyle intervention: the look AHEAD study. Obesity (Silver Spring). 2014;22(1):5-13.
(7) Gregg EW, Chen H, Wagenknecht LE, Clark JM, Delahanty LM, Bantle J, et al. Association of an intensive lifestyle intervention with remission of type 2 diabetes. JAMA. 2012;308(23):2489-96.
(8) Look AHEAD Research Group, Pi-Sunyer X, Blackburn G, Brancati FL, Bray GA, Bright R, et al. Reduction in weight and cardiovascular disease risk factors in individuals with type 2 diabetes: one-year results of the look AHEAD trial. Diabetes Care. 2007;30(6):1374-83.
(9) Pi-Sunyer X. The Look AHEAD Trial: A review and discussion of its outcomes. Curr Nutr Rep. 2014; 3(4): 387-91.
(10) Secretaría de Salud (MX). NORMA Oficial Mexicana NOM-008-SSA3-2010, Para el tratamiento integral del sobrepeso y la obesidad. Sec. Primera. Diario Oficial. 2010 p. 1-10.
(11) Instituto Mexicano del Seguro Social. Prevención, Diagnóstico y Tratamiento del Sobrepeso y la Obesidad Exógena. Mexico DF: IMSS; 2012.
(12) Tárraga ML, Rosich N, Panisello JM, Gálvez A, Serrano JP, Rodríguez-Montes JA, et al. Eficacia de las estrategias de motivacion en el tratamiento del sobrepeso y obesidad. Nutr Hosp. 2014;30(4):741-8.
(13) Christian JG, Bessesen DH, Byers TE, Christian KK, Goldstein MG, Bock BC. Clinic-based support to help overweight patients with type 2 diabetes increase physical activity and lose weight. Arch Intern Med. 2008;168(2):141-6.
(14) Cohen MD, D’Amico FJ, Merenstein JH. Weight reduction in obese hypertensive patients. Fam Med. 1991;23(1):25-8.
(15) Martin PD, Dutton GR, Rhode PC, Horswell RL, Ryan DH, Brantley PJ. Weight loss maintenance following a primary care intervention for low-income minority women. Obesity (Silver Spring). 2008;16(11):2462-7.
(16) Cabieses B, Espinoza M. La investigación traslacional y su aporte para la toma de decisiones en políticas de salud. Rev Peru Med Exp Salud Publica. 2011; 28(2): 288-97.
(17) Whittemore R. A systematic review of the translational research on the Diabetes Prevention Program. Transl Behav Med. 2011;1(3):480-91.
(18) Armenta BI, Díaz RG, Valencia MEF, Quizán T. Manejo de la obesidad en el primer nivel de atención con un programa intensivo de cambio de estilo de vida. Nutr Hosp. 2015;32(4):1526-34.
(19) Katula JA, Vitolins MZ, Rosenberger EL, Blackwell CS, Morgan TM, Lawlor MS, et al. One-year results of a community-based translation of the Diabetes Prevention Program: Healthy-Living Partnerships to Prevent Diabetes (HELP PD) Project. Diabetes Care. 2011;34(7):1451-7.
(20) Johns DJ, Hartmann-Boyce J, Jebb SA, Aveyard P, Behavioural Weight Management Review Group. Weight change among people randomized to minimal intervention control groups in weight loss trials. Obesity (Silver Spring). 2016;24(4):772-80.
(21) Bray GA, Bouchard C. Handbook of obesity: clinical applications. New York: Informa Healthcare; 2008.
(22) Wesche-Thobaben JA. The development and description of the comparison group in the Look AHEAD trial. Clin Trials. 2011;8(3):320-9.
(23) Khaodhiar L, Blackburn GL. Medical consequences of obesity and benefits of weight loss. En: The management of eating disorders and obesity. 2ª ed. Totowa, NJ: Humana Press; 2005. p. 119-42.
(24) Institute of Medicine of the National Academies. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, DC: The National Academies Press; 2002.
(25) Heymsfield SB, van Mierlo C a. J, van der Knaap HCM, Heo M, Frier HI. Weight management using a meal replacement strategy: meta and pooling analysis from six studies. Int J Obes Relat Metab Disord. 2003;27(5):537-49.
(26) Pérez AB, Palacios B, Castro AL. Sistema mexicano de alimentos equivalentes. 3ª ed. México: Fomento de Nutrición y Salud; 2008.
(27) Kramer MK, Kriska AM, Venditti EM, Miller RG, Brooks MM, Burke LE, et al. Translating the Diabetes Prevention Program: a comprehensive model for prevention training and program delivery. Am J Prev Med. 2009;37(6):505-11.
(28) Jekel JF, Katz DL, Elmore JG, Wild DM. Epidemiology, biostatistics, and preventive medicine. 3ª ed. Philadelphia: Saunders/Elsevier; 2007.
(29) Gibson RS. Principles of Nutritional Assessment. 2ª ed. New York: Oxford University Press; 2005.
(30) Secretaría de Salud (MX). Norma Oficial Mexicana NOM-030-SSA2-2009, Para la prevención, detección, diagnóstico, tratamiento y control de la hipertensión arterial sistémica. NOM-030-SSA2-2009 2009.
(31) Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985;28(7):412-9.
(32) Beck AT, Ward CH, Mendelson M, Mock J, Erbaugh J. An inventory for measuring depression. Arch Gen Psychiatry. 1961;4:561-71.
(33) Zúniga MA, Carrillo-Jiménez GT, Fos PJ, Gandek B, Medina-Moreno MR. Evaluación del estado de salud con la Encuesta SF-36: resultados preliminares en México. Salud pública Méx. 1999;41(2):110-8.
(34) González MT, Landero R. Cuestionario de afrontamiento del estrés (CAE): Validación en una muestra mexicana. Rev Psicopatol Psicol Clin. 2007;12(3):189-98.
(35) Boltri JM, Davis-Smith YM, Seale JP, Shellenberger S, Okosun IS, Cornelius ME. Diabetes prevention in a faith-based setting: results of translational research. J Public Health Manag Pract. 2008;14(1):29-32.
(36) Yeh M-C, Heo M, Suchday S, Wong A, Poon E, Liu G, et al. Translation of the Diabetes Prevention Program for diabetes risk reduction in Chinese immigrants in New York City. Diabet Med. 2016;33(4):547-51.