Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
12/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Emma Mast

ORCID ID

Contact details

Blood Pressure unit
St George's Hospital
University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom
+44 020 8266 6498

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

1. 1996 results in http://www.ncbi.nlm.nih.gov/pubmed/8634621

Publication citations

  1. 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.

Additional files

Editorial Notes