Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Bengali Dietary Salt Study to Control Blood Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 19, 2008
First Posted Date  ICMJE June 20, 2008
Last Update Posted Date July 29, 2009
Study Start Date  ICMJE June 2008
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2008)
Reduction in blood pressure [ Time Frame: Six months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2008)
Reduction in dietary salt intake [ Time Frame: Six months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Bengali Dietary Salt Study to Control Blood Pressure
Official Title  ICMJE A Multi-method Study of a Low-salt Dietary Approach to Control Blood Pressure in the Bangladeshi Chronic Kidney Disease Population.
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Study group
    Study group that will attend low-salt educational community programme
    Interventions:
    • Behavioral: Low-salt educational programme
    • Behavioral: Low-salt Bangladeshi educational programme
    • Behavioral: Low-salt Bangladeshi educational programme
  • No Intervention: Control group
    Subjects in this arm will have routine medical and dietetic treatment for low-salt reduction.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 28, 2009)
56
Original Estimated Enrollment  ICMJE
 (submitted: June 19, 2008)
54
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult Bengali kidney disease hypertensive patients

Exclusion Criteria:

  • Non-hypertensive Bengali patients and those on dialysis therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00702312
Other Study ID Numbers  ICMJE 07/Q0605/13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ione Ashurst, Barts and The London NHS Trust
Study Sponsor  ICMJE Barts & The London NHS Trust
Collaborators  ICMJE St. Bartholomew's Hospital
Investigators  ICMJE
Principal Investigator: Ione Ashurst, BSc, MSc Barts and The London NHS Trust
PRS Account Barts & The London NHS Trust
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP