Randomized controlled trial protocol: A quanti-quali approach for analyzing the results of an intervention on the waiting list for bariatric surgery
Autor(a) principal: | |
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Data de Publicação: | 2023 |
Outros Autores: | , , , , |
Tipo de documento: | Artigo |
Idioma: | por |
Título da fonte: | Revista de Nutrição |
Texto Completo: | https://periodicos.puc-campinas.edu.br/nutricao/article/view/7584 |
Resumo: | ObjectiveThis 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. MethodsA 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. ResultsOf 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). ConclusionThis 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. |
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Randomized controlled trial protocol: A quanti-quali approach for analyzing the results of an intervention on the waiting list for bariatric surgeryBariatric surgeryClinical trialObesityPublic Health SystemObjectiveThis 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. MethodsA 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. ResultsOf 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). ConclusionThis 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.Núcleo de Editoração – PUC-Campinas2023-03-06info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://periodicos.puc-campinas.edu.br/nutricao/article/view/7584Brazilian Journal of Nutrition; Vol. 32 (2019): Revista de NutriçãoRevista de Nutrição; Vol. 32 (2019): Revista de NutriçãoRevista de Nutrição; v. 32 (2019): Revista de Nutrição1678-9865reponame:Revista de Nutriçãoinstname:Pontifícia Universidade Católica de Campinas (PUC-CAMPINAS)instacron:PUC_CAMPporhttps://periodicos.puc-campinas.edu.br/nutricao/article/view/7584/5125Copyright (c) 2023 Mayara Martins EVANGELISTA, Alex Harley CRISP, Sinara Laurini ROSSATO, Carla Maria VIEIRA, Rayli BOSSA, Maria Rita Marques de OLIVEIRAhttps://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessMartins EVANGELISTA, Mayara Harley CRISP, Alex Laurini ROSSATO, SinaraVIEIRA, Carla Maria BOSSA, Rayli Marques de OLIVEIRA, Maria Rita 2023-03-08T12:03:23Zoai:ojs.periodicos.puc-campinas.edu.br:article/7584Revistahttp://www.scielo.br/rnPRIhttps://periodicos.puc-campinas.edu.br/nutricao/oai||sbi.submissionrn@puc-campinas.edu.br1678-98651415-5273opendoar:2023-03-08T12:03:23Revista de Nutrição - Pontifícia Universidade Católica de Campinas (PUC-CAMPINAS)false |
dc.title.none.fl_str_mv |
Randomized controlled trial protocol: A quanti-quali approach for analyzing the results of an intervention on the waiting list for bariatric surgery |
title |
Randomized controlled trial protocol: A quanti-quali approach for analyzing the results of an intervention on the waiting list for bariatric surgery |
spellingShingle |
Randomized controlled trial protocol: A quanti-quali approach for analyzing the results of an intervention on the waiting list for bariatric surgery Martins EVANGELISTA, Mayara Bariatric surgery Clinical trial Obesity Public Health System |
title_short |
Randomized controlled trial protocol: A quanti-quali approach for analyzing the results of an intervention on the waiting list for bariatric surgery |
title_full |
Randomized controlled trial protocol: A quanti-quali approach for analyzing the results of an intervention on the waiting list for bariatric surgery |
title_fullStr |
Randomized controlled trial protocol: A quanti-quali approach for analyzing the results of an intervention on the waiting list for bariatric surgery |
title_full_unstemmed |
Randomized controlled trial protocol: A quanti-quali approach for analyzing the results of an intervention on the waiting list for bariatric surgery |
title_sort |
Randomized controlled trial protocol: A quanti-quali approach for analyzing the results of an intervention on the waiting list for bariatric surgery |
author |
Martins EVANGELISTA, Mayara |
author_facet |
Martins EVANGELISTA, Mayara Harley CRISP, Alex Laurini ROSSATO, Sinara VIEIRA, Carla Maria BOSSA, Rayli Marques de OLIVEIRA, Maria Rita |
author_role |
author |
author2 |
Harley CRISP, Alex Laurini ROSSATO, Sinara VIEIRA, Carla Maria BOSSA, Rayli Marques de OLIVEIRA, Maria Rita |
author2_role |
author author author author author |
dc.contributor.author.fl_str_mv |
Martins EVANGELISTA, Mayara Harley CRISP, Alex Laurini ROSSATO, Sinara VIEIRA, Carla Maria BOSSA, Rayli Marques de OLIVEIRA, Maria Rita |
dc.subject.por.fl_str_mv |
Bariatric surgery Clinical trial Obesity Public Health System |
topic |
Bariatric surgery Clinical trial Obesity Public Health System |
description |
ObjectiveThis 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. MethodsA 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. ResultsOf 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). ConclusionThis 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. |
publishDate |
2023 |
dc.date.none.fl_str_mv |
2023-03-06 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://periodicos.puc-campinas.edu.br/nutricao/article/view/7584 |
url |
https://periodicos.puc-campinas.edu.br/nutricao/article/view/7584 |
dc.language.iso.fl_str_mv |
por |
language |
por |
dc.relation.none.fl_str_mv |
https://periodicos.puc-campinas.edu.br/nutricao/article/view/7584/5125 |
dc.rights.driver.fl_str_mv |
https://creativecommons.org/licenses/by/4.0 info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
https://creativecommons.org/licenses/by/4.0 |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
Núcleo de Editoração – PUC-Campinas |
publisher.none.fl_str_mv |
Núcleo de Editoração – PUC-Campinas |
dc.source.none.fl_str_mv |
Brazilian Journal of Nutrition; Vol. 32 (2019): Revista de Nutrição Revista de Nutrição; Vol. 32 (2019): Revista de Nutrição Revista de Nutrição; v. 32 (2019): Revista de Nutrição 1678-9865 reponame:Revista de Nutrição instname:Pontifícia Universidade Católica de Campinas (PUC-CAMPINAS) instacron:PUC_CAMP |
instname_str |
Pontifícia Universidade Católica de Campinas (PUC-CAMPINAS) |
instacron_str |
PUC_CAMP |
institution |
PUC_CAMP |
reponame_str |
Revista de Nutrição |
collection |
Revista de Nutrição |
repository.name.fl_str_mv |
Revista de Nutrição - Pontifícia Universidade Católica de Campinas (PUC-CAMPINAS) |
repository.mail.fl_str_mv |
||sbi.submissionrn@puc-campinas.edu.br |
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1799126067782352896 |