Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000511932
Ethics application status
Approved
Date submitted
16/05/2011
Date registered
17/05/2011
Date last updated
11/12/2019
Date data sharing statement initially provided
11/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Blood pressure and salt intake: Translating the benefits of salt reduction into practice
Scientific title
A randomised parallel study to assess the effect of dietary education about salt intake compared with usual care in individuals with hypertension who have lost weight following laparoscopic adjustable gastric banding.
Secondary ID [1] 262180 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 265861 0
Condition category
Condition code
Diet and Nutrition 266017 266017 0 0
Other diet and nutrition disorders
Cardiovascular 266021 266021 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Usual salt intake in overweight and obese people is approximately 11 g salt/day in men and 8 g salt/day in women which is much higher than the NHMRC population target of 6g salt/day. In this study patients will be educated to reduce their salt intake using the simple strategy to choose foods defined according to the Food Standards Australia and New Zealand (FSANZ) guideline of 120 mg sodium/100g food. They will also be given general guidelines regarding reducing sodium intake. This advice will be given on an individual basis by a dietitian at the start of the study and participants will have access to the dietitian for advice and support regarding dietary changes throughout the study. Interventions will require three visits of about 30 minutes duration at the start of the study, and at three and six months, where blood pressure will be taken and height and weight measured. A 24 hour urine sample will also be collected on each occasion. Compliance will be assessed by sodium excretion measurement.
Intervention code [1] 264585 0
Treatment: Other
Intervention code [2] 264588 0
Lifestyle
Intervention code [3] 264590 0
Prevention
Comparator / control treatment
This is a randomised parallel study of two groups - salt reduction to a target 100mmol Na/day (approximately 6g salt/day) compared with usual care. Usual care is defined as dietary education with no specific advice on sodium reduction. At the end of the study patients in the usual care arm will be given the same information about reducing salt intake as the intervention arm.
Control group
Active

Outcomes
Primary outcome [1] 266758 0
Blood Pressure measured by automated sphygmomanometer (mean of three measurements)
Timepoint [1] 266758 0
Baseline, three and six months
Secondary outcome [1] 276330 0
24 hour urinary sodium and potassium excretion
Timepoint [1] 276330 0
Baseline, three and six months
Secondary outcome [2] 276331 0
Weight measured by weighing scales
Timepoint [2] 276331 0
Baseline, three and six months

Eligibility
Key inclusion criteria
People who have lost weight following laparoscopic adjustable gastric banding who have hypertension
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with known metabolic disease such as liver or kidney disease. Use of non-steroidal anti-inflammatory drugs because of their effect on sodium retention.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be invited to participate in the study and provided with written information. Following their consent they will be randomised to either usual care or sodium reduction. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random numbers will be generated using a computer program
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
13/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 267081 0
Other Collaborative groups
Name [1] 267081 0
Australian Institute of Weight Control
Country [1] 267081 0
Australia
Funding source category [2] 267087 0
Other Collaborative groups
Name [2] 267087 0
Baker IDI
Country [2] 267087 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Baker IDI
Address
Level 3, 193-195 North Terrace
Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 264175 0
None
Name [1] 264175 0
Address [1] 264175 0
Country [1] 264175 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267061 0
Alfred Hospital
Ethics committee address [1] 267061 0
Ethics committee country [1] 267061 0
Australia
Date submitted for ethics approval [1] 267061 0
Approval date [1] 267061 0
23/06/2010
Ethics approval number [1] 267061 0
1/10/0187

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32612 0
Address 32612 0
Country 32612 0
Phone 32612 0
Fax 32612 0
Email 32612 0
Contact person for public queries
Name 15859 0
Dr. Jennifer Keogh
Address 15859 0
University of South Australia
School of Pharmacy and Medical Sciences
GPO Box 2471
Adelaide, SA 5000
Country 15859 0
Australia
Phone 15859 0
+61 8 8302 2579
Fax 15859 0
Email 15859 0
[email protected]
Contact person for scientific queries
Name 6787 0
Dr. Jennifer Keogh
Address 6787 0
University of South Australia
School of Pharmacy and Medical Sciences
GPO Box 2471
Adelaide, SA 5000
Country 6787 0
Australia
Phone 6787 0
+61 8 8302 2579
Fax 6787 0
Email 6787 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.