A Bengali Dietary Salt Study to Control Blood Pressure

This study has been completed.
Sponsor:
Collaborator:
St. Bartholomew's Hospital
Information provided by:
Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT00702312
First received: June 19, 2008
Last updated: July 28, 2009
Last verified: July 2009
  Purpose

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 Intervention Phase
Hypertension
Behavioral: Low-salt educational programme
Behavioral: Low-salt Bangladeshi educational programme
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Barts & The London NHS Trust:

Primary Outcome Measures:
  • Reduction in blood pressure [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in dietary salt intake [ Time Frame: Six months ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: June 2008
Study Completion Date: July 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702312

Locations
United Kingdom
The Royal London Hospital
London, United Kingdom, E1 1BB
Sponsors and Collaborators
Barts & The London NHS Trust
St. Bartholomew's Hospital
Investigators
Principal Investigator: Ione Ashurst, BSc, MSc Barts and The London NHS Trust
  More Information

No publications provided by Barts & The London NHS Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ione Ashurst, Barts and The London NHS Trust
ClinicalTrials.gov Identifier: NCT00702312     History of Changes
Other Study ID Numbers: 07/Q0605/13
Study First Received: June 19, 2008
Last Updated: July 28, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Barts & The London NHS Trust:
Blood pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014