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Dietary Counseling to Reduce Salt Intake in Patients With High Blood Pressure

2 marzo 2021 aggiornato da: Ottawa Hospital Research Institute

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

105

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H7W9
        • Ottawa Hospital Research Institute

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: Dietary Counseling
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.
Altro: 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
Altro: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in 24 hour urinary sodium excretion
Lasso di tempo: 4 weeks
Change in 24-hour urine sodium at 4 weeks
4 weeks
Change in 24 hour urinary sodium excretion
Lasso di tempo: 12 months
Change in 24-hour urine sodium at 12 months
12 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in 24 hour ambulatory blood pressure
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 4 weeks and 12 months
Change in body weight
4 weeks and 12 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ottawa Hospital Research Institute

Collaboratori

The Ottawa Hospital Academic Medical Association

Investigatori

  • Investigatore principale: Marcel Ruzicka, MD PhD, Ottawa Hospital research Insititute

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 settembre 2015

Completamento primario (Effettivo)

1 dicembre 2020

Completamento dello studio (Effettivo)

1 dicembre 2020

Date di iscrizione allo studio

Primo inviato

2 novembre 2014

Primo inviato che soddisfa i criteri di controllo qualità

4 novembre 2014

Primo Inserito (Stima)

5 novembre 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 marzo 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 marzo 2021

Ultimo verificato

1 marzo 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 20142641

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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