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ISRCTN
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ISRCTN76445926
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ClinicalTrials.gov identifier
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Public title
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Educational session, salt intake, patients of African-Caribbean origin
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0236169544
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Study hypothesis
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The target limiting salt intake to 6g per day is important for all adults, but in particularly so for people of African and Caribbean origin. These groups are more likely to develop - and are more susceptible to the effects of - raised blood pressure and hence heart attack, stroke and heart failure. Traditionally the biggest proportion of salt intake in people of African Caribbean descent in the UK is from salt added to cooking. However, components such as sauces used to prepare ethnic meals at home also have a high salt content.
A previous study for Salt Awareness Day 2005 stowed in individuals with high blood pressure that, in spite of claiming that they reduced salt intake by half, the 24 hour urine analysis of salt was still high - around 10g/day, illustrating that the public are very confused about where salt is in the diet and how sodium relates to salt. The same study showed that most people (69%) find nutrition labels incomprehensible.
Therefore, the aim of this study is to see whether education and advice for people of African-Caribbean descent in the form of a one-to-one training session addressing how to read a label and general education about how sodium relates to salt will result in a reduction in salt intake (as assessed by 24 hour urine collection). A control group comprising patients who claim to be making lifestyle changes, but who will not receive the educational session, will also be recruited.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Nutritional, Metabolic, Endocrine
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Participants - inclusion criteria
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The recruits will be adults (aged 18 years and over) of African Caribbean origin. They will be patients with hypertension referred to the blood Pressure Unit at St Georges Hospital, Tooting, London. The participants can be on or off blood pressure treatment, but they must say they have been trying to make lifestyle changes with respect to reducing their blood pressure.
We have targeted people of African or Caribbean origin because these groups are more likely to develop - and are more susceptible to the effects of - raised blood pressure and hence heart attack, stroke and heart failure, than their Caucasian counterparts.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/09/2005
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Anticipated end date
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01/09/2006
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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40
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Interventions
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All visits will be at the Blood Pressure Unit. At the first hospital visit patients will be asked if they want to take part in this study. They will be given at least 24 hours to make this decision. If they agree (we call them to confirm this) we will arrange their first visit where they will bring back their signed consent form.
Next patients will be randomised to either the experimental (n=20) or control (n=20) group by a person independent to the study. Both groups need to collect their urine for 48 hours from visit 1 (day 1) and from day 17 (visit 3) where they will be shown a wide variety of fresh and processed foods, taught how to read a label, taught what salt is and how sodium relates to salt etc. The patients will also be taught how to adapt recipes to include less salt.
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Primary outcome measure(s)
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The difference in 24 sodium content in the experimental group versus the control group
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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St George's Healthcare NHS Trust (UK)
NHS R&D Support Funding
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Trial website
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Publications
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1. 1996 results in http://www.ncbi.nlm.nih.gov/pubmed/8634621
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Contact name
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Dr
Emma
Mast
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Address
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Blood Pressure unit
St George's Hospital
University of London
Cranmer Terrace
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City/town
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London
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Zip/Postcode
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SW17 0RE
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Country
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United Kingdom
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Tel
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+44 020 8266 6498
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Fax
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+44 020 8725 2959
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Email
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Sponsor
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Record Provided by the NHSTCT Register - 2006 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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29/09/2006
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Last edited
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12/04/2012
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Date ISRCTN assigned
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29/09/2006
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