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: | 2019 |
Outros Autores: | , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UNESP |
Texto Completo: | http://dx.doi.org/10.1590/1678-9865201932e180234 http://hdl.handle.net/11449/186052 |
Resumo: | 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 +/- 46.8 mg/dL and GI93.1 +/- 16.9 mg/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 Clinicos (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 SystemObjective 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 +/- 46.8 mg/dL and GI93.1 +/- 16.9 mg/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 Clinicos (Brazilian Clinical Trials Registry), RBR-775y3d.Coordenacao do Aperfeicoamento de Pessoal do Ensino SuperiorUniv Estadual Paulista, Dept Alimentos & Nutr, Fac Ciencias Farmaceut, Araraquara, SP, BrazilUniv Metodista Piracicaba, Fac Ciencias Saude, Programa Posgrad Ciencias Movimento Humano, Piracicaba, SP, BrazilUniv Estadual Paulista, Programa Posgrad Saude Colet, Fac Med Botucatu, Botucatu, SP, BrazilUniv Estadual Paulista, Ctr Ciencia & Tecnol Soberania & Seguranca Alimen, Inst Biociencias, R Prof Dr Antonio Celso Wagner Zanin S-N, BR-18618970 Botucatu, SP, BrazilCtr Univ Rio Preto, Curso Nutr, Unidade Univ 1, Sao Jose Do Rio Preto, SP, BrazilUniv Estadual Paulista, Dept Alimentos & Nutr, Fac Ciencias Farmaceut, Araraquara, SP, BrazilUniv Estadual Paulista, Programa Posgrad Saude Colet, Fac Med Botucatu, Botucatu, SP, BrazilUniv Estadual Paulista, Ctr Ciencia & Tecnol Soberania & Seguranca Alimen, Inst Biociencias, R Prof Dr Antonio Celso Wagner Zanin S-N, BR-18618970 Botucatu, SP, BrazilCoordenacao do Aperfeicoamento de Pessoal do Ensino Superior: 001Pontificia Universidade Catolica CampinasUniversidade Estadual Paulista (Unesp)Univ Metodista PiracicabaCtr Univ Rio PretoEvangelista, Mayara Martins [UNESP]Crisp, Alex HarleyRossato, Sinara Laurini [UNESP]Vieira, Carla Maria [UNESP]Bossa, RayliOliveira, Maria Rita Marques de [UNESP]2019-10-04T12:40:51Z2019-10-04T12:40:51Z2019-01-01info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article13application/pdfhttp://dx.doi.org/10.1590/1678-9865201932e180234Revista De Nutricao-brazilian Journal Of Nutrition. Campinas: Pontificia Universidade Catolica Campinas, v. 32, 13 p., 2019.1415-5273http://hdl.handle.net/11449/18605210.1590/1678-9865201932e180234S1415-52732019000100522WOS:000481865000001S1415-52732019000100522.pdf23230898490825164793746890315015Web of Sciencereponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengRevista De Nutricao-brazilian Journal Of Nutritioninfo:eu-repo/semantics/openAccess2024-01-15T06:23:39Zoai:repositorio.unesp.br:11449/186052Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-01-15T06:23:39Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)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 Evangelista, Mayara Martins [UNESP] 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 |
Evangelista, Mayara Martins [UNESP] |
author_facet |
Evangelista, Mayara Martins [UNESP] Crisp, Alex Harley Rossato, Sinara Laurini [UNESP] Vieira, Carla Maria [UNESP] Bossa, Rayli Oliveira, Maria Rita Marques de [UNESP] |
author_role |
author |
author2 |
Crisp, Alex Harley Rossato, Sinara Laurini [UNESP] Vieira, Carla Maria [UNESP] Bossa, Rayli Oliveira, Maria Rita Marques de [UNESP] |
author2_role |
author author author author author |
dc.contributor.none.fl_str_mv |
Universidade Estadual Paulista (Unesp) Univ Metodista Piracicaba Ctr Univ Rio Preto |
dc.contributor.author.fl_str_mv |
Evangelista, Mayara Martins [UNESP] Crisp, Alex Harley Rossato, Sinara Laurini [UNESP] Vieira, Carla Maria [UNESP] Bossa, Rayli Oliveira, Maria Rita Marques de [UNESP] |
dc.subject.por.fl_str_mv |
Bariatric surgery Clinical trial Obesity Public Health System |
topic |
Bariatric surgery Clinical trial Obesity Public Health System |
description |
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 +/- 46.8 mg/dL and GI93.1 +/- 16.9 mg/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 Clinicos (Brazilian Clinical Trials Registry), RBR-775y3d. |
publishDate |
2019 |
dc.date.none.fl_str_mv |
2019-10-04T12:40:51Z 2019-10-04T12:40:51Z 2019-01-01 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://dx.doi.org/10.1590/1678-9865201932e180234 Revista De Nutricao-brazilian Journal Of Nutrition. Campinas: Pontificia Universidade Catolica Campinas, v. 32, 13 p., 2019. 1415-5273 http://hdl.handle.net/11449/186052 10.1590/1678-9865201932e180234 S1415-52732019000100522 WOS:000481865000001 S1415-52732019000100522.pdf 2323089849082516 4793746890315015 |
url |
http://dx.doi.org/10.1590/1678-9865201932e180234 http://hdl.handle.net/11449/186052 |
identifier_str_mv |
Revista De Nutricao-brazilian Journal Of Nutrition. Campinas: Pontificia Universidade Catolica Campinas, v. 32, 13 p., 2019. 1415-5273 10.1590/1678-9865201932e180234 S1415-52732019000100522 WOS:000481865000001 S1415-52732019000100522.pdf 2323089849082516 4793746890315015 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
Revista De Nutricao-brazilian Journal Of Nutrition |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
13 application/pdf |
dc.publisher.none.fl_str_mv |
Pontificia Universidade Catolica Campinas |
publisher.none.fl_str_mv |
Pontificia Universidade Catolica Campinas |
dc.source.none.fl_str_mv |
Web of Science reponame:Repositório Institucional da UNESP instname:Universidade Estadual Paulista (UNESP) instacron:UNESP |
instname_str |
Universidade Estadual Paulista (UNESP) |
instacron_str |
UNESP |
institution |
UNESP |
reponame_str |
Repositório Institucional da UNESP |
collection |
Repositório Institucional da UNESP |
repository.name.fl_str_mv |
Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP) |
repository.mail.fl_str_mv |
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1799965627233861632 |