NCT00702312

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

July 29, 2009

Status Verified

July 1, 2009

Enrollment Period

10 months

First QC Date

June 19, 2008

Last Update Submit

July 28, 2009

Conditions

Keywords

Blood pressure

Outcome Measures

Primary Outcomes (1)

  • Reduction in blood pressure

    Six months

Secondary Outcomes (1)

  • Reduction in dietary salt intake

    Six months

Study Arms (2)

Study group

EXPERIMENTAL

Study group that will attend low-salt educational community programme

Behavioral: Low-salt educational programmeBehavioral: Low-salt Bangladeshi educational programme

Control group

NO INTERVENTION

Subjects in this arm will have routine medical and dietetic treatment for low-salt reduction.

Interventions

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.

Also known as: Low-salt health education
Study group

A multi-component low-salt educational programme tailored to the Bangladeshi kidney disease patients delivered in the community.

Also known as: Intervention group
Study group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult Bengali kidney disease hypertensive patients

You may not qualify if:

  • Non-hypertensive Bengali patients and those on dialysis therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal London Hospital

London, E1 1BB, United Kingdom

Location

Related Publications (2)

  • McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.pub3.

  • de Brito-Ashurst I, Perry L, Sanders TA, Thomas JE, Dobbie H, Varagunam M, Yaqoob MM. The role of salt intake and salt sensitivity in the management of hypertension in South Asian people with chronic kidney disease: a randomised controlled trial. Heart. 2013 Sep;99(17):1256-60. doi: 10.1136/heartjnl-2013-303688. Epub 2013 Jun 13.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Ione Ashurst, BSc, MSc

    Barts and The London NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 19, 2008

First Posted

June 20, 2008

Study Start

June 1, 2008

Primary Completion

April 1, 2009

Study Completion

July 1, 2009

Last Updated

July 29, 2009

Record last verified: 2009-07

Locations