Educational session, salt intake, patients of African-Caribbean origin

ISRCTN ISRCTN76445926
DOI https://doi.org/10.1186/ISRCTN76445926
Secondary identifying numbers N0236169544
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
12/04/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Emma Mast
Scientific

Blood Pressure unit
St George's Hospital
University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom

Phone +44 020 8266 6498

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesThe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedNutritional, Metabolic, Endocrine
InterventionAll 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 typeOther
Primary outcome measureThe difference in 24 sodium content in the experimental group versus the control group
Secondary outcome measuresNot provided at time of registration
Overall study start date01/09/2005
Completion date01/09/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants40
Key inclusion criteriaThe 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.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/09/2005
Date of final enrolment01/09/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Blood Pressure unit
London
SW17 0RE
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

St George's Healthcare NHS Trust (UK)

No information available

NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 18/05/1996 Yes No