Dietary Counseling to Reduce Salt Intake in Patients With High Blood Pressure
Assessment of Effectiveness of Counseling by a Registered Dietician on Low Salt Diet in Patients With Hypertension: A Pragmatic Clinical Trial.
High salt diet increases risk of development of hypertension. In hypertensive patients, low salt diet decreases blood pressure. Not surprisingly public health authorities endorse low salt diet in hypertensive patients. But, surprisingly, average salt intake among adults in Canada remains stubbornly high. Low effectiveness of "fast counselling" by physicians and nurses on dietary salt is partly the culprit. Methods used in successful clinical trials (eg. provision of meals, community cooking sessions, many hours of counselling by dieticians) cannot be used in routine clinical practice. Hence the investigators propose a study on a pragmatic dietary counselling method suitable for clinical practice.
Hypertensive patients will be randomized to receive standard care (which includes counselling by the usual healthcare team, including doctors and nurses) or to receive additional counselling from a registered dietician. This counselling will include two components: a one hour counselling session, and 4, once-weekly telephone calls.
Effectiveness of this counselling will be measured by checking sodium in the urine from a 24 hour collection (which is a measure of dietary salt intake) at baseline and at 4 weeks. In addition, the investigators will also measure urinary sodium at 1 year, to assess if this effect of counselling persists over a longer time.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The study is a pragmatic clinical trial, to test if additional counseling provided by a dietician results in a reduction in dietary sodium intake as compared to usual care.
The hypothesis is that additional individualized and focused counseling provided by a dietician will result in true change in dietary habits which will result in reduction of dietary salt intake at 4 weeks. Usual care has been shown in the past to be ineffective in actual reduction in dietary salt intake.
In the current model of treatment of hypertension, no funding is available for this additional counseling. Also, usual care has been shown to be ineffective in reducing salt intake. If positive, this study will help make the case for provision of dietary counseling, which can be made to funding bodies.
This will be a prospective, open-label with blinded endpoints, randomized controlled trial.
The intervention: One focused dietary counseling session, one hour long, with a registered dietician. In addition, this will be followed by four, once-weekly phone calls to provide reinforcement, and provide advice and support. This will be additional to usual care.
The control group will receive usual care, which is advice provided during their clinic visit by the hypertension specialists clinic registered nurses and hypertension specialist physicians.
Both groups will have additional measurements as follows:
- Baseline, 4 week and 12 month measurement of 24 hour urinary sodium and potassium
- Baseline, 4 week and 12 month measurement of 24 hour ambulatory blood pressure monitoring
The randomization process will consist of a computer generated random listing of the treatment allocations in variable permuted blocks of 4 and 6 with concealment of allocation. Though blinding of the patients is not possible for a behavioral intervention such as this, the assessment of the outcome, which is an objective measurement, will be done in a blinded fashion. All the study personnel collating and analyzing this data will be blinded to the treatment assignment. In addition, the lab personnel who will be measuring the urinary sodium (which is the primary outcome) will be blinded to treatment assignment.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Ontario
-
Ottawa, Ontario, Canadá, K1H7W9
- Ottawa Hospital Research Institute
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
Adult patients (>18 years) with hypertension defined as
- daytime BP readings above 140/90 mmHg (as assessed from 24-hr ABPM)) without treatment and/or
- any patient with treated hypertension irrespective of BP load based on 24-hr ABPM.
Exclusion Criteria:
- Pregnant patients and
- patients with following conditions:
- glomerular filtration rate <45 ml/min/1.75 m2,
- active infection,
- acute coronary syndrome,
- severe liver disease;
- psychiatric disorders and/or otherwise unable to sign consent;
- patients with clinically manifested generalized and/or cardiac volume overload who may require immediate changes in diuretic therapy (at the discretion of treating hypertension specialist).
Plano de estudo
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: Dietary Counseling
Apart from standard care, an additional one on one (family members allowed) one hour long counseling by certified dietician who will assess the patient's dietary habits, endorse and describe the Dietary Approach to Stop Hypertension (DASH) diet, and will establish four weekly half an hour follow ups by telephone to address compliance and any question raised by patient and family members.
|
a standard endorsement of low salt diet and other non-pharmacological interventions such as moderation of alcohol intake, optimal body weight, daily exercise by hypertension nurse and physician AND an additional one on one (family members allowed) one hour long counseling by certified dietician who will assess the patient's dietary habits, endorse and describe the Dietary Approach to Stop Hypertension (DASH) diet, and will establish four weekly half an hour follow ups by telephone to address compliance and any question raised by patient and family members.
|
|
Outro: Control: Standard Care
A standard endorsement of low salt diet and other non-pharmacological interventions such as moderation of alcohol intake, optimal body weight, daily exercise by hypertension nurse and physician
|
a standard endorsement of low salt diet and other non-pharmacological interventions such as moderation of alcohol intake, optimal body weight, daily exercise by hypertension nurse and physician
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in 24 hour urinary sodium excretion
Prazo: 4 weeks
|
Change in 24-hour urine sodium at 4 weeks
|
4 weeks
|
|
Change in 24 hour urinary sodium excretion
Prazo: 12 months
|
Change in 24-hour urine sodium at 12 months
|
12 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in 24 hour ambulatory blood pressure
Prazo: 4 weeks and 12 months
|
Changes in daytime average systolic BP by 24-hr Ambulatory Blood Pressure Machine
|
4 weeks and 12 months
|
|
Change in 24 hour urinary potassium
Prazo: 4 weeks and 12 months
|
Changes in dietary potassium intake assessed from 24-hour urinary potassium
|
4 weeks and 12 months
|
|
Change in body weight
Prazo: 4 weeks and 12 months
|
Change in body weight
|
4 weeks and 12 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Marcel Ruzicka, MD PhD, Ottawa Hospital research Insititute
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 20142641
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 .
Ensaios clínicos em Dietary Counseling
-
The University of Tennessee, KnoxvilleColorado State UniversityAtivo, não recrutandoTranstorno por Uso de Cannabis, Leve | Transtorno por Uso de Cannabis, Moderado | Transtorno do Uso de Cannabis, GraveEstados Unidos