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| Sponsors and Collaborators: |
Barts & The London NHS Trust St. Bartholomew's Hospital |
|---|---|
| Information provided by: | Barts & The London NHS Trust |
| ClinicalTrials.gov Identifier: | NCT00702312 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Multi-method Study of a Low-salt Dietary Approach to Control Blood Pressure in the Bangladeshi Chronic Kidney Disease Population. |
| 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 |
|---|---|
|
Study group: Experimental
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.
Behavioral: Low-salt Bangladeshi educational programme
A multi-component low-salt educational programme tailored to the Bangladeshi kidney disease patients delivered in the community.
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.
|
|
Control group: No Intervention
Subjects in this arm will have routine medical and dietetic treatment for low-salt reduction.
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United Kingdom | |
| The Royal London Hospital | |
| London, United Kingdom, E1 1BB | |
| Principal Investigator: | Ione Ashurst, BSc, MSc | Barts and The London NHS Trust |
More Information
| Responsible Party: | Barts and The London NHS Trust ( Ione Ashurst ) |
| Study ID Numbers: | 07/Q0605/13 |
| Study First Received: | June 19, 2008 |
| Last Updated: | July 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00702312 History of Changes |
| Health Authority: | United Kingdom: Research Ethics Committee |
|
Blood pressure |
|
Renal Insufficiency, Chronic Vascular Diseases Kidney Failure, Chronic Kidney Diseases Hypertension |
|
Vascular Diseases Cardiovascular Diseases Hypertension |
