Randomized controlled trial protocol: A quanti-quali approach for analyzing the results of an intervention on the waiting list for bariatric surgery
Palavras-chave:
Bariatric surgery, Clinical trial, Obesity, Public Health SystemResumo
Objective
This article aims to describe the protocol of a randomized clinical trial and the baseline results of the study of a one-year interdisciplinary intervention in users of the public health system in the bariatric surgery waiting list.
Methods
A randomized, single-blind clinical trial will be conducted including 88 participants recruited on an outpatient clinic of the public health system. Participants were randomized into the control group (n=44), receiving the usual treatment; and into the intervention group (n=44), participating in the educational intervention. Participants had their food intake, negative affectivity and physical inactivity/sedentary behavior assessed, as well as anthropometric and body composition measurements; their blood samples were collected; and also had different physical capacity tests.
Results
Of the 157 participants invited, 27 had severe functional limitations, one was under-age, and four declined the study due to associated diseases. Eighty-eight participants were randomized: 44 for the Control Group and 44 for the Intervention Group. When comparing the demographic and biochemical characteristics, there were no differences between groups except for serum glucose (GC=110.4±46.8mg/dL and GI93.1±16.9mg/dL, p=0.039).
Conclusion
This study protocol describes the methodology used in the study of educational intervention for the promotion of health care of patients on the waiting list for bariatric surgery. It shows that there is similarity between the baseline comparison groups. Registro Brasileiro de Ensaios Clínicos (Brazilian Clinical Trials Registry), RBR-775y3d.
Referências
Agha M, Agha R. The rising prevalence of obesity: Part A: Impact on public health. Int J Surg Oncol. 2017;2(7):e17. http://dx.doi.org/10.1097/IJ9.0000000000000017
DiBonaventura M, Lay AL, Kumar M, Hammer M, Wolden ML. The association between body mass index and health and economic outcomes in the United States. J Occup Environ Med. 2015;57(10):1047-54. http://dx.doi.org/10.1097/JOM.0000000000000539
Vasileva LV, Marchev AS, Georgiev MI. Causes and solutions to “globesity”: The new fa(s)t alarming global epidemic. Food Chem Toxicol. 2018;121:173-93. http://dx.doi.org/10.1016/j.fct.2018.08.071
Courcoulas AP, Belle SH, Neiberg RH, Pierson SK, Eagleton JK, Kalarchian MA, et al. Three year outcomes of bariatric surgery vs. lifestyle intervention for type 2 diabetes mellitus treatment: A randomized trial. JAMA Surg. 2015;150(10):931-40. http://dx.doi.org/10.1001/jamasurg.2015.1534
Rasera I, Luque A, Junqueira SM, Brasil NC, Andrade PC. Effectiveness and safety of bariatric surgery in the public healthcare system in Brazil: Real-world evidence from a high-volume obesity surgery center. Obes Surg. 2017;27(2):536-40. http://dx.doi.org/10.1007/s11695-016-2439-y
Cohen RV, Luque A, Junqueira S, Ribeiro RA, Le Roux CW. What is the impact on the healthcare system if access to bariatric surgery is delayed? Surg Obes Relat Dis. 2017;13(9):1627-8. http://dx.doi.org/10.1016/j.soard.2017.03.025
Camolas J, Santos O, Moreira P, Carmo I. INDIVIDUO: Results from a patient-centered lifestyle intervention for obesity surgery candidates. Obes Res Clin Pract. 2017;11(4):475-88. http://dx.doi.org/10.1016/j.orcp.2016.08.003
Eaton CB, Hartman SJ, Perzanowski E, Pan G, Roberts MB, Risica PM, et al. A randomized clinical trial of a tailored lifestyle inter: Vention for obese, sedentary, primary care patients. Ann Fam Med. 2016;14(4):311-9. http://dx.doi.org/10.1370/afm.1952
Oliveira AEF, Araújo FLSM, Pinho JRO, Pacheco MAB. Redes de atenção à saúde: rede de atenção à saúde das pessoas com doenças crônicas no âmbito do Sistema Único de Saúde. EDUFMA. 2017;1(1):1-89.
Assis MMA, Nascimento MAA, Pereira MJB, Cerqueira EM. Cuidado integral em saúde: dilemas e desafios da Enfermagem. Rev Bras Enferm. 2015;68(2):333-8. http://dx.doi.org/10.1590/0034-7167.2015680221i
Nunes Pereira T, Alves Monteiro R, Pacheco Santos LM. Alimentación y nutrición en atención primaria en Brasil. Gac Sanit. 2017;32(3):297-303. http://dx.doi.org/10.1016/j.gaceta.2017.08.004
Blüher M. Obesity: Global epidemiology and pathogenesis. Nat Rev Endocrimol. 2019 [cited 2019 may 1];15(5):288-98. Available from: https://www.nature.com/articles/s41574-019-0176-8
Jantaratnotai N, Mosikanon K, Lee Y, McIntyre RS. The interface of depression and obesity. Obes Res Clin Pract. 2017;11(1):1-10. http://dx.doi.org/10.1016/j.orcp.2016.07.003
Nightingale BA, Cassin SE. Disordered eating among individuals with excess weight: A review of recent research. Curr Obes Rep. 2019;8(2):1-16. http://dx.doi.org/10.1007/s13679-019-00333-5
Chu DT, Minh Nguyet NT, Nga VT, Thai Lien NV, Vo DD, Lien N, et al. An update on obesity: Mental consequences and psychological interventions. Diabetes Metab Syndr. 2019;13(1):155-60. http://dx.doi.org/10.1016/j.dsx.2018.07.015
Parikh M, Dasari M, McMacken M, Ren C, Fielding G, Ogedegbe G. Does a preoperative medically supervised weight loss program improve bariatric surgery outcomes? A pilot randomized study. Surg Endosc. 2012;26(3):853-61. http://dx.doi.org/10.1007/s00464-011-1966-9
Kalarchian MA, Marcus MD, Courcoulas AP, Cheng Y, Levine MD. Preoperative lifestyle intervention in bariatric surgery: A randomized clinical trial. Surg Obes Relat Dis. 2016:12(1):180-7. http://dx.doi.org/10.1016/j.soard.2015.05.004.
Chan AW, Tetzlaff J, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: Defining standard protocol items for clinical trials. Annn Intern Med. 2013;158(3):200-7. http://dx.doi.org/10.7326/0003-4819-158-3-201302050-00583
Ministério da Saúde (Brasil). Política Nacional de Educação Permanente em Saúde: o que se tem produzido para o seu fortalecimento? Brasília: Ministério da Saúde; 2018.
Bacich L, Moran J. Metodologias ativas para uma educação inovadora: uma abordagem teórico-prática. Porto Alegre: Penso; 2018.
González K, Fuentes J, Márquez JL. Physical inactivity, sedentary behavior and chronic diseases. Korean J Fam Med. 2017;38(3):111-5. http://dx.doi.org/10.4082/kjfm.2017.38.3.111
Oliveira LR, Maruyama SAT, Silva EG, Costa ALRC. O cuidado nas práticas dos profissionais em cirurgia bariátrica. Rev Aten Saúde. 2017;54(15):83-9. http://dx.doi.org/10.13037/ras.vol15n54.4843
Cevato-Mancuso AM, Vincha KRR, Santiago DA. Educação alimentar e nutricional como prática de intervenção: reflexão e possibilidades de fortalecimento. Rev Saúde Coletiva. 2016;26(1):225-49. http://dx.doi.org/10.1590/S0103-73312016000100013
Lima RS, Neto JAF, Farias RCP. Food and culture: The exercise of commensality. Demetra. 2015;10(3):507-22. http://dx.doi.org/10.12957/demetra.2015.16072
Beato GC, Ravelli MN, Crisp AH, Oliveira MRM. Agreement between body composition assessed by bioelectrical impedance analysis and doubly labeled water in obese women submitted to bariatric surgery. Obes Surg. 2018;29(1):1-7. http://dx.doi.org/10.1007/s11695-018-3505-4
Thompson FE, Byers T. Dietary assessment resource manual. J Nutr. 1994;124(11Suppl):2245S-317S. http://dx.doi.org/10.1093/jn/124.suppl_11.2245s
Rossato SL, Fung TT, Rodrigues MP. A data entry system for dietary surveys based on visual basic for applications programming. J Acad Nutr Diet. 2017;11(8):1165-9. http://dx.doi.org/10.1016/j.jand.2016.08.004
Santana MS. Contribuicão da insatisfacão corporal e de variáveis demográficas e acadêmicas no comportamento alimentar de estudantes universitários brasileiros e portugueses [Tese]. Araraquara: Universidade Estadual Paulista; 2016.
Karlsson J, Persson LO, Sjöström L, Sullivan M. Psychometric properties and factor structure of the ThreeFactor Eating Questionnaire (TFEQ) in obese men and women: Results from the Swedish Obese Subjects (SOS) study. Int J Obes Relat Metab Disord. 2000 [cited 2018 Oct 15];24(12):1715-25. Available from: https://www.ncbi.nlm.nih.gov/pubmed/11126230
Lovibond SH, Lovibond PF. Manual for the depression anxiety stress scales (DASS). Psychol Found Monog. 1995;2(1):334-1423.
Vignola RCB, Tucci AM. Adaptation and validation of the depression, anxiety and stress scale (DASS) to Brazilian Portuguese. J Affect Disord. 2014;155:104-9. http://dx.doi.org/10.1016/j.jad.2013.10.031
Matsudo S, Araujo T, Matsudo V, Andrade D, Andrade E, Oliveira LC, et al. Questionário internacional de atividade fisica (IPAQ): estudo de validade e reprodutibilidade no Brasil. Rev Bras Ativ Fís Saúde. 2001 [citado 2018 out 15];6(2):5-18. Disponível em: http://rbafs.org.br/RBAFS/article/view/931
Global Physical Activity Questionnaire. Geneva: World Health Organization; 2014 [cited 2018 out 15]. Available from: http://www.who.int/ncds/ surveillance/steps/resources/GPAQ_Analysis_Guide.pdf
Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972 [cited 2018 Oct 15];18(6):499-502. Available from: https://www.ncbi.nlm.nih.gov/pubmed/4337382
Nobre F, Mion Jr. D, Gomes MAM, Barbosa ECD, Rodrigues CIS, Neves MFT, et al. 6a Diretrizes de Monitorização Ambulatorial da Pressão Arterial e 4a Diretrizes de Monitorização Residencial da Pressão Arterial. Arq Bras Cardiol. 2018;110(5Supl1):1-29.
Bohannon RW, Bubela DJ, Magasi SR, Wang YC, Gershon RC. Sit-to-stand test: Performance and determinants acr oss the age- span. Isokinet Exerc Sci. 2010;18(4):235-40. http://dx.doi.org/10.3233/IES-2010-0389
Bruch JP, Álvares-da-Silva MR, Alves BC, Dall’Alba V. Reduced hand grip strength in overweight and obese chronic hepatitis c patients. Arq Gastroentetol. 2016;53(1):31-5. http://dx.doi.org/10.1590/S0004-28032016000100007
Hansen N, Hardin E, Bates C, Bellatorre N, Eisenberg D. Preoperative change in 6-minute walk distance correlates with early weight loss after sleeve gastrectomy. JSLS. 2014;18(3):e2014. http://dx.doi.org/10.4293/JSLS.2014.00383
Carregaro RL, Silva LCCB, Gil Coury HJC. Comparação entre dois testes clínicos para avaliar a flexibilidade dos músculos posteriores da coxa. Rev Bras Fisioter. 2007;11(2):139-45. http://dx.doi.org/10.1590/S1413-35552007000200009
Wadden T, Sarwer T. Behavioral assessment of candidates for bariatric surgery: A patient-oriented approach. Surg Obes Relat Dis. 2006;2(2):171-9. http://dx.doi.org/10.1016/j.soard.2006.03.011
Batterham MJ, Tapsell LC, Charlton KE. Analyzing weight loss intervention studies with missing data: Which methods should be used? Nutrition. 2013;29(7-8):1024-9. http://dx.doi.org/10.1016/j.nut.2013.01.017
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Copyright (c) 2023 Mayara Martins EVANGELISTA, Alex Harley CRISP, Sinara Laurini ROSSATO, Carla Maria VIEIRA, Rayli BOSSA, Maria Rita Marques de OLIVEIRA
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