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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]

NIL

Universal Trial Number (UTN)

Trial acronym

SaltED

Linked study record

Health condition

Health condition(s) or problem(s) studied:

High blood pressure

Condition category

Condition code

Cardiovascular

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]

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]

Changes in sodium score measured using Score Sodium Questionnaire.

Timepoint [1]

At baseline and post-intervention (week 6)

Primary outcome [2]

Changes in dietary sodium intake, measured using 24-hour diet recall (online ASA24 diet recall)

Timepoint [2]

At baseline and post-intervention (week 6)

Primary outcome [3]

Changes in food label reading behaviour, measured using a short questionnaire designed specifically for this study.

Timepoint [3]

At baseline and post-intervention (week 6)

Secondary outcome [1]

Changes in 24-hour ambulatory blood pressure measurements using ambulatory blood pressure monitors

Timepoint [1]

At baseline and post-intervention (week 6)

Secondary outcome [2]

Changes in 24-hour urinary sodium measurements

Timepoint [2]

At baseline and post-intervention (week 6)

Secondary outcome [3]

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]

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]

Charities/Societies/Foundations

Name [1]

National Heart Foundation of Australia

Address [1]

1 Abbotsford Rd, Bowen Hills QLD 4006

Country [1]

Australia

Funding source category [2]

University

Name [2]

Central Queensland University

Address [2]

554-700 Yaamba Rd, Norman Gardens QLD 4701

Country [2]

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]

Individual

Name [1]

Prof Corneel Vandelanotte

Address [1]

Appleton Institute, Central Queensland University, Rockhampton Campus, Building 7, Bruce Highway, Rockhampton, Qld 4702

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Professor David Johnson

Address [1]

Princess Alexandra Hospital, Ambulatory Renal and Transplant Services (ARTS) Building
199 Ipswich Road, Woolloongabba, Qld 4102

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Professor Jacqui Webster

Address [2]

The George Institute for Global Health, Level 5, 1 King St, Newtown, NSW 2042

Country [2]

Australia

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

CQUniversity Human Research Ethics Committee

Ethics committee address [1]

Central Queensland University Human Research Ethics Committee, Building 32, Bruce Highway, Rockhampton, QLD 4702

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/08/2022

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

This project aims to investigate the effectiveness of an online, personalised intervention on salt reduction (called SaltED) in adults with high blood pressure. It hypothesises that SaltED is effective in reducing salt intake. Participants will be automatically randomised into two groups (active intervention or wait-listed control) by a computer algorithm to conceal allocation the first time they access the SaltED website. The intervention includes 6 modules of personalised salt intake advice delivered over 6 weeks. Module content will be personalised based on the participant's current salt intake (measured using a short questionnaire at week 1) and knowledge and use of food labels. Participants in the active intervention group will receive the intervention content from week 1. Participants in the control group will not receive the personalised intervention materials, until after their post-intervention measures, when they will be invited to access the intervention materials. Participants' sodium score and dietary sodium intake will be measured as primary outcomes at week 1 (baseline) and week 6 (post-intervention). Participants will also be invited (optional) to complete the 24-hour ambulatory blood pressure and urinary sodium measurements at baseline and post-intervention as secondary outcomes. Participants' acceptability and use of the platform will also be investigated using a survey post-intervention.

Trial website

salted.org.au

Trial related presentations / publications

Public notes

The prevalence of hypertension in Australia is high (~34%). High salt intake is a well-known risk factor for high blood pressure. Australians consume too much salt. Almost twice the recommended intake to reduce the risk of heart diseases. Salt intake reduction is proposed as an effective therapy to prevent and manage high blood pressure. But the majority (%75) of salt consumed is ‘hidden salt’ coming from discretionary and processed foods. Many people are not aware of the hidden salt and how to reduce them. In our recent study, we have shown that behaviour change interventions focusing on salt education can be effective in reducing salt intake. But a majority of these interventions use face-to-face delivery, with a low response rate at the follow-up stage (5%). These methods require the physical presence of participants and have limited reach. Therefore, there is a pressing need for innovative and effective salt reduction interventions that can affordably reach large numbers of people. Web-based interventions have been demonstrated to effectively produce health behaviour changes for other behaviours (e.g., physical activity) if they are personalised to individual needs. In our previous study, we engaged a sample of Australian adults with high blood pressure in a discussion around strategies to help reduce salt intake. We have also explored the acceptability and usability of online dietary tools, including apps and websites in a sample of Australian adults. Using the findings of these studies, we have developed a web-based intervention that provides personalised education and feedback on choosing lower salt foods (called SaltED) to adults with high blood pressure. The current study aims to explore the acceptability and effectiveness of this intervention in a sample of Australian adults with elevated blood pressure.

Contacts

Principal investigator

Name

Dr Saman Khalesi

Address

Central Queensland University, Level 21, 160 Ann St, Brisbane, QLD 4000, Australia

Country

Australia

Phone

+61730234153

Fax

Email

[email protected]

Contact person for public queries

Name

Saman Khalesi

Address

Central Queensland University, Level 21, 160 Ann St, Brisbane, QLD 4000, Australia

Country

Australia

Phone

+61730234153

Fax

Email

[email protected]

Contact person for scientific queries

Name

Saman Khalesi

Address

Central Queensland University, Level 21, 160 Ann St, Brisbane, QLD 4000, Australia

Country

Australia

Phone

+61730234153

Fax

Email

[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.	Type	Citation	Link	Email	Other Details	Attachment
17122	Ethical approval			[email protected]

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.