Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001262796p
Ethics application status
Submitted, not yet approved
Date submitted
14/09/2022
Date registered
21/09/2022
Date last updated
21/09/2022
Date data sharing statement initially provided
21/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Online personalised salt education: examining the effect on salt intake in adults with high blood pressure
Scientific title
Acceptability and effectiveness of the online personalised salt education on salt intake in adults with high blood pressure: SaltED intervention.
Secondary ID [1] 307970 0
NIL
Universal Trial Number (UTN)
Trial acronym
SaltED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High blood pressure 327631 0
Condition category
Condition code
Cardiovascular 324719 324719 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active intervention group: an online computer-tailored intervention that provides personalised feedback based on participants' food choices.

The intervention includes 6 modules of personalised salt intake advice delivered over 6 weeks. Participants will be directed to the platform website (salted.org.au) to register. Weekly email notifications with a link to the SaltED page will be sent to participants.

Participants will be asked to spend at least 1 hour every week (for 6 weeks) on the Module content and complete the activities. Module content will be personalised based on the participant's current salt intake (measured using a validated short Score Sodium Questionnaire at week 1) and knowledge and use of food labels. The personalised feedback will be on commercial food groups/items that are high in salt and how to choose alternatives by reading labels. Each week they will receive personalised feedback on selected groups of commercial foods (e.g. bread, cereals, biscuits and baking products). They will also receive weekly mini quiz games (approximately 2 minutes to complete per quiz) based on the content of the previous week. They will also receive feedback on these quizzes. Web-portal analytics will be used to monitor adherence to the intervention.
Intervention code [1] 324429 0
Lifestyle
Comparator / control treatment
Waitlist control group: participants in this group will be invited to access the full intervention materials similar to the Active group after six weeks.
Control group
Active

Outcomes
Primary outcome [1] 332541 0
Changes in sodium score measured using Score Sodium Questionnaire.
Timepoint [1] 332541 0
At baseline and post-intervention (week 6)
Primary outcome [2] 332542 0
Changes in dietary sodium intake, measured using 24-hour diet recall (online ASA24 diet recall)
Timepoint [2] 332542 0
At baseline and post-intervention (week 6)
Primary outcome [3] 332567 0
Changes in food label reading behaviour, measured using a short questionnaire designed specifically for this study.
Timepoint [3] 332567 0
At baseline and post-intervention (week 6)
Secondary outcome [1] 413855 0
Changes in 24-hour ambulatory blood pressure measurements using ambulatory blood pressure monitors
Timepoint [1] 413855 0
At baseline and post-intervention (week 6)
Secondary outcome [2] 413858 0
Changes in 24-hour urinary sodium measurements
Timepoint [2] 413858 0
At baseline and post-intervention (week 6)
Secondary outcome [3] 413883 0
Participants' use, perception and satisfaction with using SaltED platform will be assessed together as the "acceptability" composite secondary outcome using a short questionnaire developed for this study.
Timepoint [3] 413883 0
Post-intervention (Week 6)

Eligibility
Key inclusion criteria
Adults (18 years of age and older) with medically diagnosed hypertension or those with consistent systolic blood pressure greater than or equal to 130 mmHg and/or diastolic blood pressure greater than or equal to 85 mmHg who are able to access the Internet via a computer, tablet, laptop or smartphone and consent to the study will be eligible to participate in this project.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who are pregnant or those who are following strict medical nutrition therapy for conditions other than hypertension (e.g. chronic kidney disease, cirrhosis, chemotherapy, heart failure, etc.) will be excluded.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer block randomisation at the point of registration
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created
by computer software
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
Based on previous salt intake reduction interventions, 1 – 2 grams reduction in daily salt intake is expected from the proposed intervention (1). This is to reduce the risk of
cardiovascular events by around 20% (2). Considering a baseline salt intake of 9 grams and a standard deviation of 2.5 grams (3) using GPower software (v3.0), an effect size of 0.4 was calculated for a 1-gram salt reduction in the intervention group. With 80% power, a = 0.05, and 20% attrition rate, we aim to recruit a total of 184 (Active intervention n=92; Waitlisted control n=92) adults with increased blood pressure.

References:
1- Ireland, D.M., et al, Achieving the salt intake target of 6 g/day in the current food supply in free-living adults using two dietary education strategies. J Am Diet Assoc, 2010.(5): p. 763-7.
2- He, F.J. and G.A. MacGregor, Salt reduction lower CVD risk: a meta-analysis. Lancet, 2011. (9789): p. 380-2.
3- Land, M.A., et al., Salt consumption by Australian adults: a systematic review and meta-analysis. Med J Aust, 2018.(2): p. 75-81.

Assessments:
Primary outcome: A survey including a sodium score questionnaire; 24 h dietary recall, and questions about food label reading will be used to collect dietary behaviour information and salt score at baseline and post-intervention. Participants' demographic variables of age, gender, medical history, education, living and cooking status and anthropometric variables will also be collected at baseline. Changes in salt score and intake, and food label reading behaviour will be the primary outcome of the study.

Secondary outcomes: Participants' use, perception and satisfaction with the online intervention will also be collected at the post-intervention as secondary outcomes. Participants will also be invited to complete a 24-hour ambulatory blood pressure measurement and a 24-hour urinary sodium measurement at baseline and post-intervention (two points). 24-hour ambulatory blood pressure and urinary sodium measurements are optional. Participants who do not wish to complete these additional tasks will still be able to participate in this study.

Data analysis:
Bivariate analysis and a Linear mixed model will be used to explore changes in outcome measures and Intervention effects. Hierarchical model regression analysis and structural equation modelling will be used to assess the impact of moderators (e.g., demographic and anthropometric) on intervention effectiveness. Analysis of variance will also be used to compare changes in outcomes throughout this study. User satisfaction, compliance and acceptability will be evaluated.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2022
Actual
Date of last participant enrolment
Anticipated
1/04/2023
Actual
Date of last data collection
Anticipated
15/06/2023
Actual
Sample size
Target
184
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312238 0
Charities/Societies/Foundations
Name [1] 312238 0
National Heart Foundation of Australia
Country [1] 312238 0
Australia
Funding source category [2] 312239 0
University
Name [2] 312239 0
Central Queensland University
Country [2] 312239 0
Australia
Primary sponsor type
Individual
Name
Dr Saman Khalesi
Address
Appleton Institute, Central Queensland University, Brisbane Campus, 160 Ann St, Brisbane City, QLD 4000
Country
Australia
Secondary sponsor category [1] 313775 0
Individual
Name [1] 313775 0
Prof Corneel Vandelanotte
Address [1] 313775 0
Appleton Institute, Central Queensland University, Rockhampton Campus, Building 7, Bruce Highway, Rockhampton, Qld 4702
Country [1] 313775 0
Australia
Other collaborator category [1] 282423 0
Individual
Name [1] 282423 0
Professor David Johnson
Address [1] 282423 0
Princess Alexandra Hospital, Ambulatory Renal and Transplant Services (ARTS) Building
199 Ipswich Road, Woolloongabba, Qld 4102
Country [1] 282423 0
Australia
Other collaborator category [2] 282424 0
Individual
Name [2] 282424 0
Professor Jacqui Webster
Address [2] 282424 0
The George Institute for Global Health, Level 5, 1 King St, Newtown, NSW 2042
Country [2] 282424 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311615 0
CQUniversity Human Research Ethics Committee
Ethics committee address [1] 311615 0
Ethics committee country [1] 311615 0
Australia
Date submitted for ethics approval [1] 311615 0
12/08/2022
Approval date [1] 311615 0
Ethics approval number [1] 311615 0

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

Contacts
Principal investigator
Name 121726 0
Dr Saman Khalesi
Address 121726 0
Central Queensland University, Level 21, 160 Ann St, Brisbane, QLD 4000, Australia
Country 121726 0
Australia
Phone 121726 0
+61730234153
Fax 121726 0
Email 121726 0
[email protected]
Contact person for public queries
Name 121727 0
Saman Khalesi
Address 121727 0
Central Queensland University, Level 21, 160 Ann St, Brisbane, QLD 4000, Australia
Country 121727 0
Australia
Phone 121727 0
+61730234153
Fax 121727 0
Email 121727 0
[email protected]
Contact person for scientific queries
Name 121728 0
Saman Khalesi
Address 121728 0
Central Queensland University, Level 21, 160 Ann St, Brisbane, QLD 4000, Australia
Country 121728 0
Australia
Phone 121728 0
+61730234153
Fax 121728 0
Email 121728 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data from individual participants who are included in the published results.
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following all results publication.
Available to whom?
Data will be available case-by-case and only to researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Data will be available for analysis to achieve the aims in the approved proposal. Additionally, researchers who require additional information for further analysis (e.g. meta-analysis of published studies) will be able to access the information required upon request.
How or where can data be obtained?
Access subject to approvals by Principal Investigator, Dr Saman Khalesi ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17122Ethical approval  [email protected]



Results publications and other study-related documents

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

Documents added automatically
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