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Dietary Approach to Stop Hypertension With Sodium (Na) Reduction for Chinese Canadians (DASHNa-CC)

19. oktober 2015 opdateret af: Ping Zou, University of Toronto
The study examined the feasibility of the Dietary Approach to Stop Hypertension with Sodium (Na) Reduction for Chinese Canadian (DASHNa-CC) intervention and its potential effects on blood pressure, health-related quality of life, and health service utilization. Half of participants received usual care while the other half received the DASHNa-CC intervention.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Hypertension has been identified as the most important risk factor for cardiovascular diseases and accounts for a large proportion of stroke, myocardial infarction and heart failure in the Chinese population. While unhealthy diet has been identified as a modifiable risk factor for hypertension, there is a lack of culturally sensitive dietary intervention targeting Chinese Canadians. The 8-week DASHNa-CC intervention incorporated Dietary Approach to Stop Hypertension (DASH) diet, sodium reduction with the food therapy of Traditional Chinese Medicine, and included an intervention manual, two sessions of classroom instruction delivered in Mandarin, and a 20-minute telephone follow-up.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

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

45 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • were at least 45 years old;
  • had a systolic blood pressure 140 to 159 mmHg, or a diastolic blood pressure 90 to 99 mmHg, based on pre-intervention baseline assessment;
  • were able to understand (listen) and speak in Mandarin, read and write in Chinese; and
  • had access to a telephone.

Exclusion Criteria:

  • used antihypertensive medications or other medications that raise or lower blood pressure during the previous three months;
  • used TCM or professional TCM counselling to decrease blood pressure during the previous three months;
  • used insulin or oral hypoglycemic agents during the previous three months;
  • had a history of a cardiovascular event (stroke, myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass surgery, or other arteriosclerotic cardiovascular disease related therapeutic procedure) during the previous three months;
  • had a history of congestive heart failure;
  • had a cancer diagnosis or treatment during the past two years;
  • had special dietary requirements;
  • were pregnant, breast feeding, or planned for pregnancy prior to the anticipated end of study;
  • were a household member of another DASHNa-CC participant; or
  • planned to leave the area prior to the anticipated end of study.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: intervention
The intervention group received usual care plus the DASHNa-CC intervention.
Adfærdsmæssigt: DASHNa-CC
The 8-week DASHNa-CC intervention incorporated Dietary Approach to Stop Hypertension (DASH) diet, sodium reduction with the food therapy of Traditional Chinese Medicine, and included an intervention manual, two sessions of classroom instruction delivered in Mandarin, and a 20-minute telephone follow-up.
Adfærdsmæssigt: usual care
education booklet, encouragement of physician visit, use of public health resources if needed
Aktiv komparator: control
The control group received usual care.
Adfærdsmæssigt: usual care
education booklet, encouragement of physician visit, use of public health resources if needed

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
blood pressure
Tidsramme: 8 weeks post randomization
systolic and diastolic blood pressure
8 weeks post randomization

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
health related quality of life
Tidsramme: 8 weeks post randomization
used SF-36v2
8 weeks post randomization

Samarbejdspartnere og efterforskere

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

Sponsor

University of Toronto

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

1. august 2014

Primær færdiggørelse (Faktiske)

1. december 2014

Studieafslutning (Faktiske)

1. august 2015

Datoer for studieregistrering

Først indsendt

16. oktober 2015

Først indsendt, der opfyldte QC-kriterier

19. oktober 2015

Først opslået (Skøn)

20. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. oktober 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. oktober 2015

Sidst verificeret

1. oktober 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UofT30496

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 DASHNa-CC

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Brazil

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner