Reducing Chronic Kidney Disease Burden in an Underserved Population
25 de novembro de 2020 atualizado por: Baylor Research Institute
A Prospective, Randomized Two Group Study to Evaluate the Feasibility and Initial Efficacy of a Community-engaged Screening, Identification, and F&V Intervention to Improve F&V Intake and CKD Outcomes in 140 AA Adults
To evaluate a scalable population health strategy to 1) screen, 2) identify, and 3) intervene with individuals at high risk of CKD progression to ESRD that could be implemented in other high risk communities and health care systems.
This novel study will evaluate the feasibility and preliminary efficacy of providing F&V to individuals identified at high risk study for CKD and ESRD through community health screenings.
Further, it will evaluate whether providing education as to how to prepare F&V for consumption, the latter being done for all F&V recipients in PI's preliminary published studies but its efficacy was not specifically tested, increases F&V intake and thereby reduces CKD progression risk as well as related clinical outcomes.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Descrição detalhada
"Fruits and Veggies for Health" is a prospective, randomized two group study to evaluate a community-engaged screening, identification, and F&V intervention to improve CKD outcomes in 140 AA adults (greater than 18 years).
Participants will be randomized to a 1) F&V only (F&V Only), or 2) F&V plus a nutrition/cooking program (F&V + Cook).
Tipo de estudo
Intervencional
Inscrição (Real)
142
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Texas
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Dallas, Texas, Estados Unidos, 75210
- Baylor Research Institute
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Willingness to participate in 6 month F&V study
- Positive urine dipstick.
- African American (self declared) race
- Access to internet via personal computer or mobile device
- Ability to read and write in English
Exclusion Criteria:
- Negative urine dipstick
- Currently receiving dialysis or needing dialysis (stage 5 Kidney disease)
- Have received or need kidney transplant
- Pregnant or plan to become pregnant in the next 6 months
- Baseline urine potassium > 60 mEq/g creatinine
- Nephrotic proteinuria demonstrated on urine ACR measurement
- Lacking access to the internet via personal computer or mobile device
- Unable to read or write in English
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Fruits and Vegetables Only
This group will receive a prescribed amount of free fruits and vegetables (F & V) for 6 weeks through pick-up at a farm stand, or direct delivery.
After 6 weekly pick-up/deliveries, participants will be provided vouchers and reminders to obtain F&V at farm stands for an additional 18 weeks with minimal contact
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Fruits and vegetables delivery, once/week for 24 weeks
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Experimental: Fruits and Vegetables and Cook
In addition to the prescribed amount of free F&V, participants will receive 6 weekly, group nutrition and cooking education classes based on "The Happy Kitchen" curriculum.
Participants will also receive free ingredients to complete the recipe from each weekly session at home.
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Fruits and vegetables delivery, once/week for 24 weeks
Nutrition education and cooking instruction class, one class/week for 6 weeks
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from baseline concentration of Urine angiotensinogen (AGT) at 6 weeks and 6 months
Prazo: Baseline; 6 weeks; 6 months
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Primary surrogate marker of eGFR
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Baseline; 6 weeks; 6 months
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Change from baseline of Urine albumin-to-creatinine ratio (ACR) at 6 weeks and 6 months
Prazo: Baseline; 6 weeks; 6 months
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Measure of renal damage
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Baseline; 6 weeks; 6 months
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Changes from baseline in fruit and vegetable intake at 6 weeks and 6 months
Prazo: Baseline; 6 weeks; 6 months
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Track changes in fruit and vegetable intake via ASA24 food diary
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Baseline; 6 weeks; 6 months
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Changes from baseline in dietary fat intake at 6 weeks and 6 months
Prazo: Baseline; 6 weeks; 6 months
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Track changes in fat (g) intake via ASA24 food diary
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Baseline; 6 weeks; 6 months
|
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Changes from baseline in caloric intake at 6 weeks and 6 months
Prazo: Baseline; 6 weeks; 6 months
|
Track changes in total caloric(kcal) intake via ASA24 food diary
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Baseline; 6 weeks; 6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Changes from baseline in systolic and diastolic Blood pressure at 6 weeks and 6 months
Prazo: Baseline; 6 weeks; 6 months
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Measure changes in systolic/diastolic blood pressure (mm Hg) to assess cardiovascular disease risk (CVD)
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Baseline; 6 weeks; 6 months
|
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Changes from baseline in serum Lipoprotein levels at 6 weeks and 6 months
Prazo: Baseline; 6 weeks; 6 months
|
Measure changes in total cholesterol, HDL, and LDL (mg/dL) by fingerstick to assess CVD risk
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Baseline; 6 weeks; 6 months
|
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Changes from baseline in serum Glycosolated hemoglobin A1C (HgA1C) levels at 6 weeks and 6 months
Prazo: Baseline; 6 weeks; 6 months
|
Measure changes in HgA1C (mg/dL) by fingerstick as a marker of diabetes and to assess CVD risk
|
Baseline; 6 weeks; 6 months
|
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Changes from baseline in Blood glucose at 6 weeks and 6 months
Prazo: Baseline; 6 weeks; 6 months
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Measure fasting glucose(mg/dL) as a marker of diabetes and to assess CVD risk
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Baseline; 6 weeks; 6 months
|
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Changes from baseline in Body mass index (BMI) at 6 weeks and 6 months
Prazo: Baseline; 6 weeks; 6 months
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Measure body mass index(lb/inches squared) to assess CVD risk
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Baseline; 6 weeks; 6 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Donald Wesson, MD, MBA, Baylor RI
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
24 de janeiro de 2019
Conclusão Primária (Real)
13 de junho de 2020
Conclusão do estudo (Real)
14 de julho de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
1 de fevereiro de 2019
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de fevereiro de 2019
Primeira postagem (Real)
6 de fevereiro de 2019
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de novembro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de novembro de 2020
Última verificação
1 de julho de 2020
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 1R21DK113440-01A1 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
All IPD that underlie results in a publication
Prazo de Compartilhamento de IPD
Data will be available within 6 mths of outcome publication
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- ANALYTIC_CODE
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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