RBR-9cht5w7 Nutrition intervention based on behavior change theories in overweight non-dialysis dependent chronic kidney disease wom...

Date of registration: 09/15/2021 ^(mm/dd/yyyy)
Last approval date : 09/15/2021 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1212-9896

• Public title:

  en

  Nutrition intervention based on behavior change theories in overweight non-dialysis dependent chronic kidney disease women

  pt-br

  Intervenção nutricional com foco em mudança de comportamento em mulheres com excesso de peso e doença renal crônica na fase não dialítica

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 67219417.2.0000.5505 - CAAE
    Issuing authority: Plataforma Brasil
  • 0402/2017- CEP
    Issuing authority: Comitê de Ética em Pesquisa da Unifesp
  • 67219417.2.0000.5505
    Issuing authority: Plataforma Brasil
  • U1111-1212-9896
    Issuing authority: Universal Trial Number
  • 2.070.316
    Issuing authority: Comitê de Ética em Pesquisa do Hospital São Paulo
  • U1111-1212-9896
    Issuing authority: Universal Trial Number

Sponsors

• Primary sponsor: Universidade Federal de São Paulo
• Secondary sponsor:
  • Institution: Fundação Oswaldo Ramos/Hospital do Rim
• Supporting source:
  • Institution: Fundação de Amparo a Pesquisa do Estado de São Paulo

Health conditions

• Health conditions:

  en

  Chronic kidney disease, obesity.

  pt-br

  Insuficiencia renal cronica/doença renal crônica, obesidade.

• General descriptors for health conditions:

  en

  E00-E90 IV - Endocrine, nutritional and metabolic diseases

  pt-br

  E00-E90 IV - Doenças endócrinas, nutricionais e metabólicas

• Specific descriptors:

  en

  C18.654.726.500 Obesity

  pt-br

  C18.654.726.500 Obesidade

  es

  C18.654.726.500 Obesidad

  en

  C12.777.419.780.750 Renal Insufficiency, Chronic

  pt-br

  C12.777.419.780.750 Insuficiência Renal Crônica

  es

  C12.777.419.780.750 Insuficiencia Renal Crónica

Interventions

• Interventions:

  en

  A 15 week or biweekly (of 90 minutes each meeting) nutritional intervention based on behavior change theories conducted in groups of up to 10 patients(women) with chronic kidney disease.The subjects approached are related to different aspects of food and eating, weight / body image, quality of life, and chronic kidney disease. 33 patients initiated the intervention and 23 completed it. No control group.

  pt-br

  Intervenção nutricional com abordagem baseada em teorias de mudança de comportamento, realizada em grupos de até 10 pacientes (mulheres)com doença renal crônica abordando diferentes temáticas relacionadas aos aspectos da comida e do comer, peso/imagem corporal, qualidade de vida, e da doença renal crônica. Trata-se de 15 encontros semanais ou quinzenais de aproximadamente 90 minutos cada. 33 pacientes iniciaram e 23 finalizaram o estudo. Sem grupo controle.

• Descriptors:

  en

  C12.777.419.780.750 Renal Insufficiency, Chronic

  pt-br

  C12.777.419.780.750 Insuficiência Renal Crônica

  es

  C12.777.419.780.750 Insuficiencia Renal Crónica

  en

  F01.145.113.547 Feeding Behavior

  pt-br

  F01.145.113.547 Comportamento Alimentar

  es

  F01.145.113.547 Conducta Alimentaria

  en

  E02.642.249 Diet Therapy

  pt-br

  E02.642.249 Dietoterapia

  es

  E02.642.249 Dietoterapia

  en

  F02.784.176 Counseling

  pt-br

  F02.784.176 Aconselhamento

  es

  F02.784.176 Consejo

  en

  C18.654.726.500 Obesity

  pt-br

  C18.654.726.500 Obesidade

  es

  C18.654.726.500 Obesidad

Recruitment

• Study status: Data analysis completed
• Countries
  • Brazil
• Date first enrollment: 08/10/2017 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  33	F	0	0

• Inclusion criteria:

  en

  Women aged 25 to 75 years body mass index greater than or equal to 27 kg / m²; Estimated Glomerular Filtration Rate between 15 to 45 ml / min / 1.73m²; who have had at least three previous medical appointments and at least two previous dietitian appointments.

  pt-br

  Serão elegíveis pacientes do sexo feminino com idade entre 25 a 75 anos; índice de massa corporal > ou igual 27 kg/m²; Taxa de Filtração Glomerular estimada entre 15 a 45 ml/min/1,73m²; que tenham passado por ao menos três consultas médicas prévias e ao menos duas consultas prévias com nutricionista.

• Exclusion criteria:

  en

  Illiterate patients with cognitive or visual impairment, terminal cancer, acquired immunodeficiency syndrome (AIDS), on steroids, pregnant women, severe psychiatric disorders and autoimmune diseases will be considered ineligible.

  pt-br

  Os pacientes analfabetos, portadores de deficiência cognitiva ou visual, câncer terminal, síndrome da imunodeficiência adquirida (AIDS), em uso de esteroides, gestantes, distúrbios psiquiátricos graves e doenças autoimunes serão considerados inelegíveis.

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Single-group	1	Open	Single-arm-study	N/A

Outcomes

• Primary outcomes:

  en

  We expect that patients who participate in the group intervention will be more motivated for lifestyle changes and therefore positively impact eating attitudes and behavior.

  pt-br

  Espera-se que os pacientes que aderirem à intervenção em grupo estarão mais motivados para mudanças e obterão impacto positivo em atitudes e comportamentos alimentares.

  en

  The group intervention can impact positively patients' quality of life, diet quality, clinical and nutritional aspects.

  pt-br

  A intervenção poderá exercer impacto positivo na qualidade de vida, qualidade da dieta, aspectos clínicos e nutricionais.

• Secondary outcomes:

  en

  Impacts on motivation for change are expected to improve overall self-care, and thus may benefit the control of clinical markers of renal disease progression.

  pt-br

  Espera-se que os impactos na motivação para mudança auxiliem a melhorar o autocuidado em geral, portanto, podendo beneficiar o controle dos marcadores clínicos de progressão da doença renal.

  en

  We hope that the intervention can impact better acceptance of the disease and contribute to better mental health conditions if they need dialysis.

  pt-br

  Esperamos que a intervenção possa impactar em melhor aceitação da doença e contribuir para as melhores condições de saúde mental caso necessitem de diálise.

Contacts

• Public contact
  • Full name:
  • • Address:
    • City: /
    • Zip code:
  • Phone:
  • Email:
  • Affiliation:
  • Full name: Raíssa Antunes Pereira
  • • Address: Rua Ouvidor Peleja, 611
    • City: São Paulo / Brazil
    • Zip code: 04128-001
  • Phone: +55(11)981625869
  • Email: raissa.antunes17@gmail.com
  • Affiliation: Universidade Federal de São Paulo
   
• Scientific contact
  • Full name:
  • • Address:
    • City: /
    • Zip code:
  • Phone:
  • Email:
  • Affiliation:
  • Full name: Raíssa Antunes Pereira
  • • Address: Rua Ouvidor Peleja, 611
    • City: São Paulo / Brazil
    • Zip code: 04128-001
  • Phone: +55(11)981625869
  • Email: raissa.antunes17@gmail.com
  • Affiliation: Universidade Federal de São Paulo
   
• Site contact
  • Full name: Lilian Cuppari
  • • Address: Rua Pedro de Toledo, 282
    • City: São Paulo / Brazil
    • Zip code: 04039-000
  • Phone: 1159048499
  • Email: lcuppari@uol.com.br
  • Affiliation: Fundação Oswaldo Ramos/Hospital do Rim
  • Full name: Raíssa Antunes Pereira
  • • Address: Rua Ouvidor Peleja, 611
    • City: São Paulo / Brazil
    • Zip code: 04128-001
  • Phone: +55(11)981625869
  • Email: raissa.antunes17@gmail.com
  • Affiliation: Universidade Federal de São Paulo
   

Additional links:

• Download in ICTRP format