Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0236169544
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Nutritional, Metabolic, Endocrine
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The difference in 24 sodium content in the experimental group versus the control group
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2005
Overall trial end date
01/09/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
40
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/09/2005
Recruitment end date
01/09/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Blood Pressure unit
London
SW17 0RE
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
St George's Healthcare NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 1996 results in http://www.ncbi.nlm.nih.gov/pubmed/8634621
Publication citations
-
Results
MacGregor GA, Sever PS, Salt--overwhelming evidence but still no action: can a consensus be reached with the food industry? CASH (Consensus Action on Salt and Hypertension), BMJ, 1996, 312, 7041, 1287-1289.