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- Ensaio Clínico NCT01125202
Intervention to Reduce Dietary Sodium in Hemodialysis (BalanceWise-HD)
14 de agosto de 2017 atualizado por: Mary Ann Sevick, University of Pittsburgh
The purpose of this study is to test, in a randomized clinical trial of 200 hemodialysis patients, a behavioral intervention to reduce dietary sodium intake.
The investigators will assess the impact on weight gain between dialysis treatments, blood pressures, symptoms, and health-related quality of life.
The primary study hypotheses are that participants will gain less weight in between dialysis treatments, and that dietary recalls will demonstrate reduced consumption of dietary sodium.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Cardiovascular disease is the single most common cause of death in hemodialysis (HD) patients.
Most HD patients have left ventricular hypertrophy(LVH), a significant predictor of death in this population.
LVH is related to extracellular volume expansion and hypertension, both of which are amenable to dietary sodium restriction.
However, dietary change is widely known to be difficult to achieve and sustain.
Controlling dietary sodium is particularly difficult for HD because many foods are naturally high in sodium, and most prepared/prepackaged foods have significant amounts of sodium added to enhance taste and shelf-life.
Research on behavioral methods that are effective in reducing dietary sodium intake in HD is very limited.
The purpose of this study is to test, in a randomized clinical trial of 200 HD patients, a behavioral intervention, paired with personal digital assistant (PDA)-based dietary self-monitoring, to enhance adherence to dietary sodium restrictions.
Specifically the investigators will: (a) Assess the impact of the intervention on average daily interdialytic weight gains (IDWG-A).
(b) Examine the impact of the intervention on self-reported dietary sodium intake.
The study hypotheses are that compared to the control group, the intervention group will: (1) demonstrate a statistically significant decline in IDWG-A over the 4-month intervention period, and (2) experience a greater decline in dietary sodium intake.
Secondarily, the investigators will explore the impact of the intervention on: (a) pre-dialysis pulse pressure and mean arterial blood pressure, (b) hemodialysis dietary self-efficacy, and (c) intradialytic and postdialytic symptoms and general health-related quality of life.
In addition, the investigators will characterize the barriers/facilitators to adherence to the HD dietary regimen and patient experience of the intervention through the use of qualitative methods.
The intervention is based on Social Cognitive Theory (SCT).
Self-monitoring within the context of the intervention is operationalized as PDA-based dietary recording using BalanceLog software.
Participants randomized to the attention control will receive computerized dietary education.
Attention control participants will be offered an abbreviated version of the intervention after the 4-month study period concludes.
Differences in IDWG-A, pulse pressure, and mean arterial pressure will be examined using a random intercept linear regression modeling.
Self-reported dietary sodium, self-efficacy, symptoms, and quality of life will be assessed at baseline, 6 weeks, and 4 month and differences will be examined using repeated measures modeling using GEE.
Qualitative analysis of narrative data will be performed.
Tipo de estudo
Intervencional
Inscrição (Real)
179
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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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- University of Pittsburgh School of Medicine
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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
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Individuals with end stage renal disease (ESRD) who are 18 years of age or older,
- Individuals who are literate,
- Community-dwelling adults who have been receiving maintenance dialysis for at least 3 months.
Exclusion Criteria:
- Individuals who cannot read or write,
- Individuals who do not speak English,
- Individuals who plan to move out of the area or change dialysis centers within the next 6 months,
- Individuals who have a life expectancy of less than 12 months,
- Individuals who are scheduled for a living donor transplant,
- Individuals who cannot see the PDA screen or use the stylus to make food selections from the PDA screen, or
- Individuals who live in an institutional setting in which they would have limited control over their dietary intake.
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: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: SCT-based behavioral intervention
Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory.
Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.
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Intervention group continues to receive routine dialysis care.
The intervention duration is 16 weeks.
Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16.
Personal digital assistant dietary records are use to provide targeted counseling and engaged the participant in problem solving around dietary issues.
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Comparador Ativo: Attention control
Attention control participants continue to receive routine dialysis care.
Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet.
The 5 modules evenly over the 4-month study period.
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Attention control participants continue to receive routine dialysis care.
Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet.
The 5 modules evenly over the 4-month study period.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Time Specific Interdialytic Weight Gain (Baseline)
Prazo: Baseline
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Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to baseline measurement.
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Baseline
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Time Specific Interdialytic Weight Gain (8 Weeks)
Prazo: 8 weeks
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Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 8-week measurement time point.
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8 weeks
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Time Specific Interdialytic Weight Gain (12 Weeks)
Prazo: 12 weeks
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Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 12 week measurement time point.
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12 weeks
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Time Specific Interdialytic Weight Gain (16 Weeks)
Prazo: 16 weeks
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Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 16 week measurement time point.
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16 weeks
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Time Specific Dietary Sodium Intake (Baseline)
Prazo: Baseline
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Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day.
Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls.
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Baseline
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Time Specific Dietary Sodium Intake (8 Weeks)
Prazo: 8 weeks
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Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day.
Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls.
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8 weeks
|
Time Specific Dietary Sodium Intake (16 Weeks)
Prazo: 16 weeks
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Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day.
Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls.
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16 weeks
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Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 8 Weeks)
Prazo: Baseline to 8 weeks
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Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day.
Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls.
The difference between measurement time points was determined.
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Baseline to 8 weeks
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Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 16 Weeks)
Prazo: Baseline to 16 weeks
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Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day.
Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls.
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Baseline to 16 weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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
- McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.pub3.
- Sevick MA, Piraino BM, St-Jules DE, Hough LJ, Hanlon JT, Marcum ZA, Zickmund SL, Snetselaar LG, Steenkiste AR, Stone RA. No Difference in Average Interdialytic Weight Gain Observed in a Randomized Trial With a Technology-Supported Behavioral Intervention to Reduce Dietary Sodium Intake in Adults Undergoing Maintenance Hemodialysis in the United States: Primary Outcomes of the BalanceWise Study. J Ren Nutr. 2016 May;26(3):149-58. doi: 10.1053/j.jrn.2015.11.006. Epub 2016 Feb 9.
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
1 de setembro de 2009
Conclusão Primária (Real)
1 de setembro de 2012
Conclusão do estudo (Real)
1 de setembro de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
14 de maio de 2010
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de maio de 2010
Primeira postagem (Estimativa)
18 de maio de 2010
Atualizações de registro de estudo
Última Atualização Postada (Real)
15 de agosto de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de agosto de 2017
Última verificação
1 de agosto de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- PRO08040361
- R01NR010135 (Concessão/Contrato do NIH dos EUA)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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