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Public trial
 

                                        

                    

                        

                            

                            

                        

                        

                            

                                
RBR-5xg4pk Influence of Motivational Interviewing on body measurements and consumption
diet of women with obesity


                                Date of registration:
                                
                                    09/11/2020                                    (mm/dd/yyyy)
                                
                                

                                Last approval date :
                                
                                    09/11/2020                                    (mm/dd/yyyy)
                                
                                
Study type:


                                
Interventional


                                
 


                                
 


                                
Scientific title:


                                

                                                                        

                                        
en

                                        
Influence of Motivational Interviewing on anthropometric parameters and consumption
diet of women with obesity

                                        

                                        
pt-br

                                        
Influência da Entrevista Motivacional em parâmetros antropométricos e consumo
alimentar de mulheres com obesidade

                                        
                                


                                
 



                                
Trial identification

                                
    
                                    
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                                        UTN code: 
                                        U1111-1254-6957
                                    
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    Public title:
    
                                        
    
                                                                                        
    
                                                    
    en
    
                                                    
    Influence of Motivational Interviewing on body measurements and consumption
diet of women with obesity
    
                                                
    
                                                    
    pt-br
    
                                                    
    Influência da Entrevista Motivacional em medidas corporais e consumo
alimentar de mulheres com obesidade
    
                                                
                                            
    
                                    
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    Scientific acronym:
    
                                        
    
                                                                                                                                
    
                                    
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    Public acronym:
    
                                        
    
                                                                                                                                
    
                                    
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                                        Secondaries identifiers:
                                                                                                                            
      
                                                
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                                                    62117016.8.0000.0096
      
                                                    Issuing authority:
                                                    Plataforma Brasil
                                                
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                                                    3.467.004
      
                                                    Issuing authority:
                                                    Comitê de ética e Pesquisa UFPR - Hospital de Clínicas da Universidade Federal do Paraná
                                                
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Sponsors

                                
    
                                    
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                                        Primary sponsor:
                                        Universidade Federal do Paraná
                                    
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                                        Secondary sponsor:
                                                                                                                                                                                                            
      
                                                
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                                                    Institution:
                                                    Universidade Federal do Paraná
                                                
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                                        Supporting source:
                                                                                                                            
      
                                                
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                                                    Institution:
                                                    Universidade Federal do Paraná
                                                
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Health conditions

                                
    
                                    
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    Health conditions:
    
                                        
    
                                                                                        
    
                                                
    en
    
                                                
    Obesity
    
                                                
    
                                                
    pt-br
    
                                                
    Obesidade
    
                                                
                                            
    
                                    
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    General descriptors for health conditions:
    
                                                                                
    
                                                
    en
    
                                                
    
                                                    C23
                                                    Pathological conditions, signs and symptoms
                                                
    
                                                
    
                                                
    pt-br
    
                                                
    
                                                    C23
                                                    Condições patológicas, sinais e sintomas
                                                
    
                                                
    
                                                
    es
    
                                                
    
                                                    C23
                                                    Condiciones patológicas, signos y síntomas
                                                
    
                                                
                                            
     
    
                                    
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    Specific descriptors:
    
                                                                                
     
    
                                    
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Interventions

                                
    








                                    
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    Interventions:
    
                                        
    
                                                                                        
    
                                                
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    This is a blinded clinical trial conducted at a teaching hospital in Curitiba, Paraná, with 39 women diagnosed with obesity class I and II. These were randomly divided into control (dish-model orientation) and intervention (MI-based and dish-model orientation) groups, with a 3-month nutritional care, with an appointment per month. 
    
                                                
    
                                                
    pt-br
    
                                                
    Trata-se de um ensaio clínico cego realizado em um hospital de ensino em Curitiba, Paraná, com 39 mulheres diagnosticadas com obesidade classe I e II. Estes foram divididos aleatoriamente em grupos de controle (orientação de modelo de prato) e intervenção (orientação de modelo de prato e MI), com um cuidado nutricional de três meses e uma consulta por mês.
    
                                                
                                            
    
                                    
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    Descriptors:
    
                                        
    
                                                    
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                                                        F02.784.176.279.500
                                                        Motivational Interviewing
                                                    
    
                                                    
    
                                                    
    pt-br
    
                                                    
    
                                                        F02.784.176.279.500
                                                        Entrevista Motivacional
                                                    
    
                                                    
    
                                                    
    es
    
                                                    
    
                                                        F02.784.176.279.500
                                                        Entrevista Motivacional
                                                    
    
                                                    
                                            
     
    
                                    
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Recruitment

                                
    
                                    
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                                        Study status:
                                                                                Data analysis completed
                                    
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                                        Countries
                                        
      
                                            
    • Brazil
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                                        Date first enrollment:
                                        
                                                                                        05/01/2017                                            (mm/dd/yyyy)
                                        

                                    
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                                                Target sample size:
                                                Gender:
                                                Minimum age:
                                                Maximum age:
                                            
    
                                            
    
                                                72
                                                F
                                                18 Y
                                                59 Y
                                            
    
                                            
    
                                    
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    Inclusion criteria:
    
                                        
    
                                                                                        
    
                                                
    en
    
                                                
     Adult women aged between 18 and 61 years, all races, with a BMI between 30 and 40 kg/m² 
    
                                                
    
                                                
    pt-br
    
                                                
    Mulheres adultas com idade entre 18 e 61 anos, todas as raças, com IMC entre 30 e 40 kg / m² 
    
                                                
                                            
    
                                    
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    Exclusion criteria:
    
                                        
    
                                                                                        
    
                                                
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    Pregnancy, breastfeeding, inability  to read and interpret dietary prescription or fill food record,  use  of medications for weight reduction, antidepressants, antipsychotics, corticosteroids, lithium, previous diagnosed diabetes, uncontrolled psychiatric diseases, major psychiatric disorders, generalized anxiety, major depression, uncontrolled thyroid diseases.
    
                                                
    
                                                
    pt-br
    
                                                
    Gravidez, amamentação, incapacidade de ler e interpretar prescrição alimentar ou preencher registro alimentar, uso de medicamentos para redução de peso, antidepressivos, antipsicóticos, corticosteróides, lítio, diabetes diagnosticado anteriormente, doenças psiquiátricas não controladas, distúrbios psiquiátricos graves, ansiedade generalizada , depressão maior, doenças não controladas da tireóide. 
    
                                                
                                            
    
                                    
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Study type

                                
    
                                    
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    Study design:
    
                                        
    
                                                                                    
    
                                    
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                                                    Expanded access program
                                                    Purpose
                                                    Intervention assignment
                                                    Number of arms
                                                    Masking type
                                                    Allocation
                                                    Study phase
                                                
    
                                                
                                            
                                            
    
                                                
                                                Treatment
                                                Other
                                                2
                                                Single-blind
                                                Randomized-controlled
                                                N/A
                                            
    
                                                
                                        
    
                                    
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Outcomes

                                
    
                                    
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    Primary outcomes:
    
                                        
    
                                                    
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                                                        To verify the impact of the Motivational Interview applied to the nutritional care of women with obesity in weight reduction.
                                                    
    
                                                    
    
                                                    
    pt-br
    
                                                    
    
                                                        Verificar o impacto da Entrevista Motivacional aplicada ao atendimento nutricional de mulheres com obesidade na redução de peso.
                                                    
    
                                                    
                                            
     
    
                                    
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    Secondary outcomes:
    
                                        
    
                                                
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                                                    To verify the impact of the Motivational Interview, associated with the diet by the model
of the healthy dish, in quality of life of women with obesity. 
                                                
    
                                                
    
                                                
    pt-br
    
                                                
    
                                                     Verificar o impacto da Entrevista Motivacional, associada à dieta pelo modelo
do prato saudável na qualidade de vida de mulheres com obesidade. 
                                                
    
                                                
    
                                                
    en
    
                                                
    
                                                    To verify the impact of the Motivational Interview, associated with the diet by the model
of the healthy dish, in the metabolic of women with obesity. 
                                                
    
                                                
    
                                                
    pt-br
    
                                                
    
                                                    Verificar o impacto da Entrevista Motivacional, associada à dieta pelo modelo
do prato saudável, no perfil metabólico de mulheres com obesidade. 
                                                
    
                                                
    
                                                
    en
    
                                                
    
                                                    To verify the impact of the Motivational Interview, associated with the diet by the model
of the healthy dish, in clinical profile of women with obesity. 
                                                
    
                                                
    
                                                
    pt-br
    
                                                
    
                                                    Verificar o impacto da Entrevista Motivacional, associada à dieta pelo modelo
do prato saudável, no perfil clínico de mulheres com obesidade. 
                                                
    
                                                
    
                                                
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                                                    To verify the impact of the Motivational Interview, associated with the diet by the model
of the healthy dish, in food consumption of women with obesity. S
                                                
    
                                                
    
                                                
    pt-br
    
                                                
    
                                                    Verificar o impacto da Entrevista Motivacional, associada à dieta pelo modelo
do prato saudável, no consumo alimentar de mulheres com obesidade. 
                                                
    
                                                
                                            
     
    
                                    
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Contacts

                                
    

                                    
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                                        Public contact

                                        
      
                                                                                            
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                                                    Full name:
                                                    Regina Maria Vilela
                                                
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                                                            Address:
                                                            Post Graduate Program in Food and Nutrition. Nutrition Department – Federal University of Paraná. Rua Avenida  Lothário Meissner, 3400 –Botanical Garden, Postal Code: 80.210-170, Brazil.
                                                        
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                                                            City: 
                                                            Curitiba / Brazil
                                                        
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                                                            Zip code:
                                                            80.210-17
                                                        
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                                                    Phone:
                                                    +55 41 991115454
                                                
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                                                    Email:
                                                    
                                                
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                                                    Affiliation:
                                                    Universidade Federal do Paraná
                                                
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                                        Scientific contact

                                        
      
                                                                                            
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                                                    Full name:
                                                    Regina  Maria Vilela
                                                
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                                                            Address:
                                                            Rua Avenida  Lothário Meissner, 3400 –Botanical Garden, Postal Code: 80.210-170, Brazil.
                                                        
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                                                            City:
                                                            Curitiba / Brazil
                                                        
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                                                            Zip code:
                                                            80210170
                                                        
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                                                    Phone:
                                                    +55 41 991115454;
                                                
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                                                    Email:
                                                    
                                                
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                                                    Affiliation:
                                                    Universidade Federal do Paraná
                                                
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                                                    Full name:
                                                    Regina Maria Vilela
                                                
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                                                            Address:
                                                            Post Graduate Program in Food and Nutrition. Nutrition Department – Federal University of Paraná. Rua Avenida  Lothário Meissner, 3400 –Botanical Garden, Postal Code: 80.210-170, Brazil.
                                                        
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                                                            City:
                                                            Curitiba / Brazil
                                                        
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                                                            Zip code:
                                                            80.210-17
                                                        
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                                                    Phone:
                                                    +55 41 991115454
                                                
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                                                    Email:
                                                    
                                                
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                                                    Affiliation:
                                                    Universidade Federal do Paraná
                                                
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                                        Site contact

                                        
      
                                                                                            
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                                                    Full name:
                                                    Regina Maria Vilela
                                                
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                                                            Address:
                                                            Post Graduate Program in Food and Nutrition. Nutrition Department – Federal University of Paraná. Rua Avenida  Lothário Meissner, 3400 –Botanical Garden, Postal Code: 80.210-170, Brazil.
                                                        
        • 
                                                        
      • 
                                                            City:
                                                            Curitiba / Brazil
                                                        
        • 
                                                        
      • 
                                                            Zip code:
                                                            80.210-17
                                                        
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      • 
                                                
    • 
                                                    Phone:
                                                    +55 41 991115454
                                                
      • 
                                                
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                                                    Email:
                                                    
                                                
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    • 
                                                    Affiliation:
                                                    Universidade Federal do Paraná
                                                
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Additional links:

                                                                
                            

                        

                    

                    
 

                            

        

        
 

        
    




            
    

    

        


Total de Ensaios Clínicos 16963.



Existem 8361 ensaios clínicos registrados.



Existem 4701 ensaios clínicos recrutando.



Existem 234 ensaios clínicos em análise.



Existem 5771 ensaios clínicos em rascunho.







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