Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000412437p
Ethics application status
Submitted, not yet approved
Date submitted
16/04/2025
Date registered
6/05/2025
Date last updated
6/05/2025
Date data sharing statement initially provided
6/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
LiveBetterSA: Comparing AI-Enhanced Lifestyle Coaching Using a Generative Large Language Model vs. Traditional Telephone Coaching for Adults
Scientific title
LiveBetterSA: A Non-Inferiority Type 2 Hybrid Implementation-Effectiveness Randomised Controlled Trial Comparing AI-Enhanced Lifestyle Coaching Using a Generative Large Language Model vs. Traditional Telephone Coaching for Adults
Secondary ID [1] 314008 0
GNT2031344
Universal Trial Number (UTN)
Trial acronym
LBSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Weight loss 336745 0
Physical activity 336746 0
Dietary habits 336747 0
Condition category
Condition code
Public Health 333237 333237 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the digital health coaching group will engage with a digital health coach for six months via the LiveBetterSA responsive web application. The digital health coaching system, developed using OpenAI's large language model and customised by the University of South Australia and AndMine Pty Ltd, will provide personalised onboarding, guided goal setting, and feedback. The system will be accessible 24/7, allowing participants to interact with the digital health coach at their convenience. Optional Fitbit integration will enable automated step tracking. Participants will receive digital scales and a measuring tape for self-monitoring and outcome reporting.

Participants are encouraged to engage with the platform daily, including asking for advice, responding to coaching prompts, reviewing goals, and receiving personalised feedback. The goal progress check-in schedule is customisable, selected by participants during onboarding, with options ranging from daily, every other day, twice weekly, weekly, or every two weeks.

Personalisation occurs through participant-entered data collected during onboarding, including demographic information, anthropometric measurements, health history, physical activity patterns, dietary habits, eating behaviours, and personal motivations. This data informs tailored goal recommendations, feedback pathways, and support strategies, dynamically adjusted as participants engage with the platform over time.

The guidance provided by the digital health coach is based on comprehensive training content sourced from evidence-based national and international guidelines, educational materials, and reputable health organisations. Key sources informing the AI's content include the Australian Dietary Guidelines (NHMRC) and Australian Physical Activity Guidelines (Department of Health and Aged Care), World Health Organization (WHO) guidelines, as well as educational resources from Diabetes Australia, the Heart Foundation, Cancer Council, Healthy Bones Australia, Exercise and Sports Science Australia (ESSA) and others. This ensures that the support offered is evidence-based, credible, and aligned with national and international public health recommendations. Content includes practical guidance on healthy eating, physical activity, cardiovascular health, digestive health, osteoporosis prevention, stress management, sleep hygiene, and the mental health benefits of exercise.

The digital health coach provides guidance using structured conversational techniques based on participant data, aligned to health guidelines. For example:
-After assessing vegetable intake, the coach offers tailored encouragement compared to the Australian Dietary Guidelines (e.g., highlighting strengths first, then suggesting simple improvements if vegetable serves are below recommendations).
-Following assessment of physical activity levels, the coach compares current behaviour to national activity guidelines and offers achievable next steps (e.g., suggesting an additional walk if a participant is close to but below 150 minutes per week).
-If a participant shares lower confidence or motivation, the coach adapts by suggesting smaller, habit-based goals rather than outcome-based goals (e.g., starting with 5–10 minutes of activity rather than full sessions).

Goal-setting follows a structured process: Up to three goal areas are suggested based on participant priorities and opportunities for improvement, participant's select their preference or propose their own. Goals are personalised to the participant's lifestyle context, such as their available time, preferred activities, and readiness for change.

Participant engagement is monitored through backend system APIs, with automated reporting of usage metrics. Participants with declining engagement patterns are sent supportive re-engagement emails encouraging continued involvement. Strategies to monitor adherence include:
-Login success events (first and subsequent logins),
-Page view tracking across the app,
-Click tracking for key actions such as goal setup, health check completion, and dashboard/menu interactions,
-Monitoring of review of check-in summaries,
-Recording the frequency of check-ins (based on the participant-selected schedule),
-Average session duration calculated from time spent within the platform.
Intervention code [1] 330589 0
Lifestyle
Intervention code [2] 330590 0
Behaviour
Comparator / control treatment
Participants in the telephone coaching group will receive eight structured coaching calls over the six-month intervention period. The initial call, lasting approximately 30 minutes, will focus on rapport building, goal setting, and health history review. Seven follow-up calls, each lasting 10–15 minutes, will incorporate behaviour change strategies, problem-solving, and progress monitoring. The calls will follow standardised coaching protocols addressing physical activity, nutrition, and weight management.

Coaching sessions will be delivered by trained staff, which may include graduate nutritionists, PhD candidates in relevant health fields, or third-year nutrition students under supervision. All coaches will complete mandatory training at least one week prior to commencing delivery of the control treatment. Training will be provided by a PhD-qualified senior member of the research team experienced in health coaching and motivational interviewing.
Training will involve a one-hour workshop, covering: Instruction on the standardised telephone coaching protocol and principles and application of motivational interviewing techniques. Coaches will only commence delivering intervention calls once the trainer is satisfied with their competency to deliver the protocol and apply motivational interviewing techniques appropriately.

In addition, coaches will have access to a structured diet and exercise guide developed by the research team, incorporating content from the Australian Dietary Guidelines, NHMRC, Heart Foundation, and Exercise and Sports Science Australia (ESSA), among others to support consistent, evidence-based coaching discussions.

Participants in this group will also receive digital scales and a measuring tape for self-monitoring and outcome reporting, similar to the digital health coaching group.
Control group
Active

Outcomes
Primary outcome [1] 340816 0
Body weight (kg)
Timepoint [1] 340816 0
Baseline (0 months) — prior to commencement of the intervention, at enrolment. 6 months post-intervention commencement — primary endpoint (completion of intervention period). 12 months post-intervention commencement — follow-up assessment (6 months after completion of intervention).
Secondary outcome [1] 445148 0
Waist circumference (cm)
Timepoint [1] 445148 0
Baseline (0 months) — prior to commencement of the intervention, at enrolment. 6 months post-intervention commencement — at the completion of the intervention period. 12 months post-intervention commencement — at 6 months following the end of the intervention, for follow-up assessment.
Secondary outcome [2] 445149 0
Weekly minutes of moderate-to-vigorous physical activity (MVPA)
Timepoint [2] 445149 0
Baseline (0 months) — prior to commencement of the intervention, at enrolment. 6 months post-intervention commencement — at the completion of the intervention period. 12 months post-intervention commencement — at 6 months following the end of the intervention, for follow-up assessment.
Secondary outcome [3] 445152 0
Dietary intake, including key food groups and total energy intake
Timepoint [3] 445152 0
Baseline (0 months) — prior to commencement of the intervention, at enrolment. 6 months post-intervention commencement — at the completion of the intervention period. 12 months post-intervention commencement — at 6 months following the end of the intervention, for follow-up assessment.
Secondary outcome [4] 445153 0
Health related quality of life
Timepoint [4] 445153 0
Baseline (0 months) — prior to commencement of the intervention, at enrolment. 6 months post-intervention commencement — at the completion of the intervention period. 12 months post-intervention commencement — at 6 months following the end of the intervention, for follow-up assessment.
Secondary outcome [5] 445155 0
Sleep quality
Timepoint [5] 445155 0
Baseline (0 months) — prior to commencement of the intervention, at enrolment. 6 months post-intervention commencement — at the completion of the intervention period. 12 months post-intervention commencement — at 6 months following the end of the intervention, for follow-up assessment.
Secondary outcome [6] 445157 0
Medication use in the last 6 months
Timepoint [6] 445157 0
Baseline (0 months) — prior to commencement of the intervention, at enrolment. 6 months post-intervention commencement — at the completion of the intervention period. 12 months post-intervention commencement — at 6 months following the end of the intervention, for follow-up assessment.
Secondary outcome [7] 446398 0
Body mass index (BMI) (kg/m²)
Timepoint [7] 446398 0
Baseline (0 months) — prior to commencement of the intervention, at enrolment. 6 months post-intervention commencement — at the completion of the intervention period. 12 months post-intervention commencement — at 6 months following the end of the intervention, for follow-up assessment.
Secondary outcome [8] 446399 0
Engagement with digital health coaching (implementation outcome)
Timepoint [8] 446399 0
Engagement metrics will be continuously collected throughout the 6-month intervention period and assessed at the end of the intervention period (6 months post-commencement).
Secondary outcome [9] 446400 0
Engagement with telephone coaching (implementation outcome)
Timepoint [9] 446400 0
Engagement metrics will be continuously collected throughout the 6-month intervention period and assessed at the end of the intervention period (6 months post-commencement).
Secondary outcome [10] 446401 0
Program satisfaction
Timepoint [10] 446401 0
6 months post-intervention commencement — at the completion of the intervention period.
Secondary outcome [11] 446402 0
System usability (digital health coaching group only)
Timepoint [11] 446402 0
6 months post-intervention commencement — at the completion of the intervention period.
Secondary outcome [12] 446403 0
Goal success
Timepoint [12] 446403 0
Data will be continuously collected throughout the 6-month intervention period and assessed at the end of the intervention period (6 months post-commencement).
Secondary outcome [13] 446404 0
Quality adjusted life year (QALY)
Timepoint [13] 446404 0
Baseline (0 months) — prior to commencement of the intervention, at enrolment. 6 months post-intervention commencement — at the completion of the intervention period. 12 months post-intervention commencement — at 6 months following the end of the intervention, for follow-up assessment.
Secondary outcome [14] 446405 0
Hospital admissions in the last 6 months
Timepoint [14] 446405 0
Baseline (0 months) — prior to commencement of the intervention, at enrolment. 6 months post-intervention commencement — at the completion of the intervention period. 12 months post-intervention commencement — at 6 months following the end of the intervention, for follow-up.
Secondary outcome [15] 446406 0
Emergency department presentations in the last 6 months
Timepoint [15] 446406 0
Baseline (0 months) — prior to commencement of the intervention, at enrolment. 6 months post-intervention commencement — at the completion of the intervention period. 12 months post-intervention commencement — at 6 months following the end of the intervention, for follow-up.
Secondary outcome [16] 446409 0
Use of aged care services in the last 6 months
Timepoint [16] 446409 0
Baseline (0 months) — prior to commencement of the intervention, at enrolment. 6 months post-intervention commencement — at the completion of the intervention period. 12 months post-intervention commencement — at 6 months following the end of the intervention, for follow-up.
Secondary outcome [17] 446412 0
General practitioner (GP) visits in the last 6 months
Timepoint [17] 446412 0
Baseline (0 months) — prior to commencement of the intervention, at enrolment. 6 months post-intervention commencement — at the completion of the intervention period. 12 months post-intervention commencement — at 6 months following the end of the intervention, for follow-up.
Secondary outcome [18] 446414 0
Allied health use in the last 6 months
Timepoint [18] 446414 0
Baseline (0 months) — prior to commencement of the intervention, at enrolment. 6 months post-intervention commencement — at the completion of the intervention period. 12 months post-intervention commencement — at 6 months following the end of the intervention, for follow-up.
Secondary outcome [19] 446416 0
Use of government health services in the last 6 months
Timepoint [19] 446416 0
Baseline (0 months) — prior to commencement of the intervention, at enrolment. 6 months post-intervention commencement — at the completion of the intervention period. 12 months post-intervention commencement — at 6 months following the end of the intervention, for follow-up.
Secondary outcome [20] 446418 0
Qualitative feedback on program experience
Timepoint [20] 446418 0
6 months post-intervention commencement — at the completion of the intervention period.

Eligibility
Key inclusion criteria
• BMI equal to or greater than 25 kg/m²
• English speaking
• Internet access
• South Australian resident
Minimum age
18 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Pregnancy/lactation
• Clinical conditions requiring diet modification
• Severe heart conditions e.g. unstable angina (heart conditions allowed with medical clearance)
• Eating disorders
• Severe food allergy (anaphylaxis)
• Diabetes requiring medication
• Use of weight loss drugs
• End-stage organ disease
• Epilepsy
• Severe respiratory disease
• Insufficient technology skills (must be able to send and receive text messages on a smart phone, navigate to a webpage, and upload a photo from a mobile device to a webpage)

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)
The allocation sequence will be implemented through REDCap's secure randomisation module. This centralised electronic system ensures that the allocation sequence remains concealed until the moment of assignment. Researchers conducting participant enrolment will not have access to the randomisation sequence. Once all baseline assessments are completed, the system will reveal the allocated intervention group to the participant and relevant research personnel.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur using stratified block randomisation to ensure balance across groups based on age (= or < 50 years). A computer-generated permuted block design with randomly varied block sizes (4 or 6) will be implemented to minimise allocation predictability. The allocation sequence will be generated by the project manager, using a secure randomisation module within REDCap.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample Size Calculation:
Sample size calculations for the primary outcome, 6-month change in body weight is based on a non-inferiority design with a minimal acceptable difference between groups of -1 kg. With a standard deviation of 3.9kg for weight change, 189 participants per group (378 in total) provide 80% power to ensure the lower limit of a one-sided 95% confidence interval is above the non-inferiority limit. Anticipating dropouts or losses, common in population health trials, this number has been increased by 30%, aiming for 246 participants per group (492 in total)

Statistical Analysis Plan:
-Data will be analysed using repeated measures linear mixed-effects modeling to determine differences between treatment groups over time (group × time interaction) in both primary and secondary outcomes. This approach accounts for within-subject correlations and missing data,
providing a robust framework for longitudinal analysis.
-As recommended for non-inferiority trials, covariates will be added as needed to balance groups based on sociodemographic baseline variables to minimise potential confounding. Analyses will be conducted on an intention-to-treat basis, ensuring all randomised participants are included in the final analysis regardless of adherence to the intervention.
-To confirm non-inferiority of the AI-enhanced treatment, the lower bound of the 95% confidence interval for the difference in weight loss between groups (diffStandardTelephone – diffDigitalHealthCoaching) must not cross the -1kg non-inferiority margin.
-Implementation outcomes will be analysed using descriptive statistics. Engagement in the digital health coaching group will be assessed from digital health coach server logs (e.g., number of check-ins completed, interactions with prompts, number and type of digital health coaching questions).
-Engagement in the telephone group will be determined by the number of coaching sessions completed, cancelled, or rescheduled.
-Economic evaluation will assess cost-effectiveness from a health system perspective, using quality-adjusted life years (QALYs) derived from the AQoL-8D and resource use data from SA-NT DataLink, MBS, PBS, and participant self-report.
-Interview data will be thematically analysed. A minimum of 30 interviews will be conducted, with transcripts coded using an inductive approach to identify key themes related to participant experiences, engagement, and perceived barriers to implementation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2026
Actual
Date of last data collection
Anticipated
30/07/2027
Actual
Sample size
Target
492
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 318514 0
Government body
Name [1] 318514 0
National Health and Medical Research Council (NHMRC) and Department of Health and Aged Care - Medical Research Future Fund (MRFF)– Preventive and Public Health Research Initiative – 2024 Maternal Health and Healthy Lifestyles Grant Opportunity
Country [1] 318514 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Country
Australia
Secondary sponsor category [1] 321179 0
None
Name [1] 321179 0
None
Address [1] 321179 0
Country [1] 321179 0
Other collaborator category [1] 283481 0
Government body
Name [1] 283481 0
Preventive Health SA
Address [1] 283481 0
Country [1] 283481 0
Australia
Other collaborator category [2] 283482 0
University
Name [2] 283482 0
Flinders University
Address [2] 283482 0
Country [2] 283482 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317119 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 317119 0
Ethics committee country [1] 317119 0
Australia
Date submitted for ethics approval [1] 317119 0
16/04/2025
Approval date [1] 317119 0
Ethics approval number [1] 317119 0

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

Contacts
Principal investigator
Name 140058 0
Prof Carol Maher
Address 140058 0
University of South Australia GPO Box 2471. Adelaide SA 5001
Country 140058 0
Australia
Phone 140058 0
+61 8 8302 2315
Fax 140058 0
Email 140058 0
[email protected]
Contact person for public queries
Name 140059 0
Carol Maher
Address 140059 0
University of South Australia GPO Box 2471. Adelaide SA 5001
Country 140059 0
Australia
Phone 140059 0
+61 8 8302 2315
Fax 140059 0
Email 140059 0
[email protected]
Contact person for scientific queries
Name 140060 0
Carol Maher
Address 140060 0
University of South Australia GPO Box 2471. Adelaide SA 5001
Country 140060 0
Australia
Phone 140060 0
+61 8 8302 2315
Fax 140060 0
Email 140060 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Ethical approval and participant consent do not permit external data sharing. Data access is restricted per University of South Australia ethics guidelines and Australian privacy laws, ensuring confidentiality and compliance with data protection policies.



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.