Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

2. marts 2021 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

105

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Andet: 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
Andet: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in 24 hour urinary sodium excretion
Tidsramme: 4 weeks
Change in 24-hour urine sodium at 4 weeks
4 weeks
Change in 24 hour urinary sodium excretion
Tidsramme: 12 months
Change in 24-hour urine sodium at 12 months
12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in 24 hour ambulatory blood pressure
Tidsramme: 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
Tidsramme: 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
Tidsramme: 4 weeks and 12 months
Change in body weight
4 weeks and 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ottawa Hospital Research Institute

Samarbejdspartnere

The Ottawa Hospital Academic Medical Association

Efterforskere

  • Ledende efterforsker: Marcel Ruzicka, MD PhD, Ottawa Hospital research Insititute

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2015

Primær færdiggørelse (Faktiske)

1. december 2020

Studieafslutning (Faktiske)

1. december 2020

Datoer for studieregistrering

Først indsendt

2. november 2014

Først indsendt, der opfyldte QC-kriterier

4. november 2014

Først opslået (Skøn)

5. november 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. marts 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. marts 2021

Sidst verificeret

1. marts 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20142641

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Forhøjet blodtryk

Kliniske forsøg med Dietary Counseling

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Equatorial Guinea

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner