Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001152718
Ethics application status
Approved
Date submitted
17/08/2022
Date registered
23/08/2022
Date last updated
22/09/2024
Date data sharing statement initially provided
23/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Can text messages engage healthier lifestyle choices in participants with heart disease or at high risk for heart disease?
Scientific title
Utilising the 45 and Up Study as a Framework for a Digital Mobile Health Intervention: A Randomised Controlled Trial in participants with heart disease or who are at high risk for heart disease
Secondary ID [1] 307207 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 326784 0
Diabetes 327418 0
Hypertension 327419 0
High cholesterol levels 327420 0
Condition category
Condition code
Cardiovascular 324003 324003 0 0
Coronary heart disease
Metabolic and Endocrine 324548 324548 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive the 45 and Up Mobile Health Study program delivered over a 12-week time period via text messages that are designed to engage and educate participants about healthy lifestyles on quitting smoking, eating a heart-healthy diet, and increasing exercise levels. The messages will provide education, motivation and reminders customised to individual characteristics (current smoking, vegetarian, diabetic, and physical disability status). These will be delivered 4 times per week and will provide varying information to support participants with health education, such as embedded educational videos, self-reported surveys, and information to engage in healthy nutrition and exercise such as recipes and examples of physical activity.

Examples of text messages may include: "Hi $PrefName, change doesn't come all at once. A little progress is still progress and needs to be celebrated. Keep up the good work!", "Try interval training with cycling. Cycle for 30 seconds at your highest effort, followed by 30 seconds of gentle cycling. Repeat 4-6 times", "Here's a recipe idea - wrap fish fillets in foil parcels with lemon, garlic & herbs and place in the oven. Serve with steamed veggies for a yummy, healthy meal", "A lot of meat substitutes have high amounts of salt. Healthier options include tofu, lentils and beans, or wholegrains such quinoa and buckwheat", "Hi $PrefName, you're doing great! Any movement is good movement. Regular exercise can improve your blood pressure & cholesterol".

Message content has been reviewed and created by a team of healthcare professionals and researchers. Some messages have been designed specifically for this study and some will contain educational materials that are accessible via public links to online reliable sources such as the Heart Foundation Australia, American College of Sports Medicine, and European Society of Cardiology prevention guidelines.

Participants cannot respond to their daily text message and will only receive messages. These messages will be sent on random days of the week (Monday to Friday) and at random times during the day (9:00am, 12noon, 3:00pm, 5:00pm). Messages are drawn from 4 message banks per week (one from general cardiovascular health, one from diet, one from physical activity, and one from smoking cessation). Non-smokers will receive two general messages, one diet message, and one physical activity per week. Smokers will receive one general message, one diet message, one physical activity, and one smoking per week.

The messaging will be monitored in an automated, unidirectional manner using the TextCare software engine, designed and established by our team the University of Sydney. This message delivery software utilises computerised algorithms to generate and automatically send personalised texts. All messages delivered to the participants will be recorded by the TextCare software messaging engine, for example the logs on the timing of the sent messages and proportion of successful message deliveries.
Intervention code [1] 323865 0
Lifestyle
Comparator / control treatment
Participants in the control group will not receive the 45 and Up Mobile Health Study program. Control participants will only receive an introductory text stating they are in the control group and will be contacted at baseline and then 12-weeks follow up to complete the baseline/final follow up surveys via a text message and/or email.
Control group
Active

Outcomes
Primary outcome [1] 331799 0
The proportion in each group who meet all 3 healthy lifestyle factors of not smoking, being physically active and consuming key heart-healthy dietary foods. All outcomes will be self-reported.

Smoking cessation will be defined as not having a cigarette for the preceding 7 days as reported in a study-specific questionnaire. Being physically active is defined as exercising on 5 or more days per week for at least 30 minutes using the WHO Global Physical Activity Questionnaire.

Diet will be measured using questions on key heart-healthy dietary foods from the WHO steps instrument and the European Society of Cardiology prevention guidelines. This includes meeting daily recommendations for fruit and vegetable intake, legumes and beans, healthy fats (avocado, nuts and seeds, olive oil, and oily fish such as salmon), and avoiding ultra-processed foods and sugar-sweetened beverages.
Timepoint [1] 331799 0
Baseline and 12-week post-intervention commencement.
Secondary outcome [1] 411196 0
Quality of life will be assessed by the EQ-5D-3L survey.
Timepoint [1] 411196 0
12-week post-intervention commencement.
Secondary outcome [2] 411197 0
Brief acceptability questionnaire for the intervention group to determine the acceptability of the programs, barriers, and enables. This was designed specifically for this study.
Timepoint [2] 411197 0
12-weeks post-intervention commencement.
Secondary outcome [3] 413227 0
Smoking cessation will be defined by not having a cigarette for the preceding 7 days using a study-specific self-reported questionnaire.
Timepoint [3] 413227 0
Baseline and 12 weeks post-intervention commencement.
Secondary outcome [4] 413228 0
Diet will be assessed using questions on key heart-healthy dietary foods from the WHO steps instrument and the European Society of Cardiology prevention guidelines. This will be self-reported.
Timepoint [4] 413228 0
Baseline and 12 weeks post-intervention commencement.
Secondary outcome [5] 413229 0
Being physically active as defined as exercising on 5 or more days per week for at least 30 minutes using the WHO Global Physical Activity Questionnaire. This will be self-reported.
Timepoint [5] 413229 0
Baseline and 12 weeks post-intervention commencement.
Secondary outcome [6] 413230 0
Calculated body mass index (BMI)<25 using self-reported weight and height in a study-specific questionnaire.
Timepoint [6] 413230 0
Baseline and 12 weeks post-intervention commencement.
Secondary outcome [7] 413231 0
Alcohol levels will be self-reported in a study-specific questionnaire according to national standards.
Timepoint [7] 413231 0
Baseline and 12 weeks post-intervention commencement.
Secondary outcome [8] 413236 0
Medication use will be self-reported, as reported in a study-specific questionnaire. Medication use will also be validated through prescription data obtained via the Pharmaceutical Benefits Scheme (PBS).
Timepoint [8] 413236 0
Baseline and 12 weeks post-intervention commencement.
Secondary outcome [9] 413237 0
Hospitalisations as determined through data linkage to medical records.
Timepoint [9] 413237 0
1-year post-intervention commencement.
Secondary outcome [10] 413238 0
Major cardiovascular events (defined as cardiovascular death, non-fatal acute myocardial infarction) as determined through data-linkage to medical records.
Timepoint [10] 413238 0
1-year post-intervention commencement.
Secondary outcome [11] 413239 0
All-cause mortality as determined through data-linkage to medical records.
Timepoint [11] 413239 0
1-year post-intervention commencement.

Eligibility
Key inclusion criteria
Participants from the 45 and Up Study Cohort will be eligible if they have self-reported heart disease and/or are aged >60 years with any of the following (all self-reported): Diabetes mellitus, High blood pressure/hypertension, Treatment for high cholesterol, and/or Current smoking.

Further inclusion criteria includes: ability to provide informed consent, sufficient skill in English language to read and understand text messages, and own an active mobile phone that can receive text messages.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they do not meet the eligibility/inclusion requirements and do not own a working mobile phone.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants who meet the eligibility/inclusion criteria and have consented will be enrolled into the study. Research staff will store participant details and baseline data required to personalise the intervention program onto a secure password-protected computer. Allocation concealment will be ensured using data management systems (REDCap, Research Electronic Data Capture). Participants will be allocated by central randomisation by computer in a uniform 1:1 allocation ratio (control:intervention) and details of randomisation will be concealed from study personnel until the completion of the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be managed through REDCap. Participants will be automatically allocated to either the control or intervention group, according to randomisation sequence generated in R using the randomiseR package. The random allocation sequence will be a uniform 1:1.
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
Completed
Date of first participant enrolment
Anticipated
6/11/2023
Actual
17/07/2023
Date of last participant enrolment
Anticipated
4/12/2023
Actual
16/02/2024
Date of last data collection
Anticipated
Actual
25/07/2024
Sample size
Target
1000
Accrual to date
Final
582
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 311507 0
Government body
Name [1] 311507 0
National Health and Medical Research Council (NHMRC)
Country [1] 311507 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 312918 0
None
Name [1] 312918 0
N/A
Address [1] 312918 0
N/A
Country [1] 312918 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310969 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 310969 0
Ethics committee country [1] 310969 0
Australia
Date submitted for ethics approval [1] 310969 0
Approval date [1] 310969 0
13/05/2022
Ethics approval number [1] 310969 0
2022/036

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

Contacts
Principal investigator
Name 119534 0
Prof Clara Chow
Address 119534 0
The University of Sydney, Faculty of Medicine and Health, Westmead Applied Research Centre. Level 6, Block K | Entrance 10, Westmead Hospital | Hawkesbury Road Westmead, NSW, 2145
Country 119534 0
Australia
Phone 119534 0
+61 2 86273580
Fax 119534 0
Email 119534 0
[email protected]
Contact person for public queries
Name 119535 0
Sarah Zaman
Address 119535 0
The University of Sydney, Faculty of Medicine and Health, Westmead Applied Research Centre. Level 6, Block K | Entrance 10, Westmead Hospital | Hawkesbury Road Westmead, NSW, 2145
Country 119535 0
Australia
Phone 119535 0
+61 414365523
Fax 119535 0
Email 119535 0
[email protected]
Contact person for scientific queries
Name 119536 0
Anushriya Pant
Address 119536 0
The University of Sydney, Faculty of Medicine and Health, Westmead Applied Research Centre. Level 6, Block K | Entrance 10, Westmead Hospital | Hawkesbury Road Westmead, NSW, 2145
Country 119536 0
Australia
Phone 119536 0
+61 457385686
Fax 119536 0
Email 119536 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.