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A Bengali Dietary Salt Study to Control Blood Pressure

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ClinicalTrials.gov Identifier: NCT00702312
Recruitment Status : Completed
First Posted : June 20, 2008
Last Update Posted : July 29, 2009
Sponsor:
Collaborator:
St. Bartholomew's Hospital
Information provided by:
Barts & The London NHS Trust

Study Description
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Brief Summary:
The aim of this study is to assess the benefits of using low-salt and healthy eating educational programme, designed specifically for Bangladeshi kidney patients, compared to the usual diet advice given by the clinic dietitians.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Low-salt educational programme Behavioral: Low-salt Bangladeshi educational programme Phase 3

Detailed Description:
We conducted an exploratory study initially to learn about the East London Bangladeshi (ELB) kidney patients salt intake. Furthermore, we assessed their educational needs to inform the development and implementation of an educational programme to reduce dietary salt intake in line with the Department of Health recommendations for a good blood pressure control. The educational programme will be tested in a randomized controlled trial. We are interested in salt because studies have shown that salt is one of the causes of high blood pressure. Scientific studies have also shown that the longer a person has high blood pressure the more the damage to the kidneys.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-method Study of a Low-salt Dietary Approach to Control Blood Pressure in the Bangladeshi Chronic Kidney Disease Population.
Study Start Date : June 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium

Arms and Interventions
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Arm Intervention/treatment
Experimental: Study group
Study group that will attend low-salt educational community programme
 Behavioral: Low-salt educational programme
Subjects will attend a health promotion cooking programme and receive written tailored low-salt Bengali educational tool. This tool has been developed specifically for this population group from Phase 1 and 2 study.
Other Name: Low-salt health education

Behavioral: Low-salt Bangladeshi educational programme
A multi-component low-salt educational programme tailored to the Bangladeshi kidney disease patients delivered in the community.
Other Name: Intervention group

Behavioral: Low-salt Bangladeshi educational programme
A multi-component Low-salt educational programme tailored to the Bangladeshi kidney disease patients residents in Tower Hamlets delivered over 5 months.
Other Name: Intervention group/ Educational group / Low-salt group
No Intervention: Control group
Subjects in this arm will have routine medical and dietetic treatment for low-salt reduction.


Outcome Measures
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Primary Outcome Measures :
  1. Reduction in blood pressure [ Time Frame: Six months ]

Secondary Outcome Measures :
  1. Reduction in dietary salt intake [ Time Frame: Six months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult Bengali kidney disease hypertensive patients

Exclusion Criteria:

  • Non-hypertensive Bengali patients and those on dialysis therapy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00702312


Locations
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United Kingdom
The Royal London Hospital
London, United Kingdom, E1 1BB
Sponsors and Collaborators
Barts & The London NHS Trust
St. Bartholomew's Hospital
Investigators
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Principal Investigator: Ione Ashurst, BSc, MSc Barts and The London NHS Trust
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ione Ashurst, Barts and The London NHS Trust
ClinicalTrials.gov Identifier: NCT00702312    
Other Study ID Numbers: 07/Q0605/13
First Posted: June 20, 2008    Key Record Dates
Last Update Posted: July 29, 2009
Last Verified: July 2009
Keywords provided by Barts & The London NHS Trust:
Blood pressure
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases