Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000882426p
Ethics application status
Not yet submitted
Date submitted
18/07/2025
Date registered
13/08/2025
Date last updated
13/08/2025
Date data sharing statement initially provided
13/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of an Integrated Peer-Supported Physical Health Service (IPPHS) on physical health outcomes for adults living with persistent mental illness
Scientific title
No body left behind trial: The effect of an Integrated Peer-Supported Physical Health Service (IPPHS) on physical health outcomes for adults living with persistent mental illness
Secondary ID [1] 314907 0
none
Universal Trial Number (UTN)
Trial acronym
IPPHS Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 338254 0
Psychoses 338469 0
Bipolar disorder 338470 0
Condition category
Condition code
Cardiovascular 334552 334552 0 0
Normal development and function of the cardiovascular system
Mental Health 334639 334639 0 0
Schizophrenia
Mental Health 334640 334640 0 0
Psychosis and personality disorders
Physical Medicine / Rehabilitation 334641 334641 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Name: Integrated Peer-Supported Physical Health Service (IPPHS)
The IPPHS is designed for adults who receive care from community mental health services and live a diagnosis of schizophrenia, psychosis or bipolar disorder. It aims to improve people’s physical health and includes three components:
- Peer worker provision of physical health coaching and support to navigate physical health services
- Primary care providers employed within the adult community mental health service to complete comprehensive physical health checks (aligned with routine care and minimum standards for physical health screening of adults living with persistent mental illness) and provide guideline-adherent physical health interventions according to the Positive Cardiometabolic Health Resource. Primary Care Providers will work to link participants to a community general practice based on consumer needs and preference of a provider and general practice location. The Primary Care Providers will utilise existing referral processes and communication channels between their Adult Community Mental Health Service and local general practices.
- A mobile health app (TeleClinical Care) for self-management of physical health at home. The app includes physical health questionnaires and an exercise program which is developed within and accessed within the app. The app is linked to the health service for remote monitoring of physical health risks.

The intervention will be delivered in six adult community mental health services across Tasmania and south eastern Sydney. Intervention staff will be employed within the mental health service and receive training and access to Mindgardens developed physical health resources and the Positive Cardiometabolic Health Framework.

Peer workers will utilise the Mindgardens ‘Consumer Learning Modules’ to provide health coaching. Health coaching will include assisting consumers in the development of goals, tracking goal achievement, and providing guidance on how to achieve goals using the ‘nutrition’, ‘physical activity’, ‘drugs and alcohol ', and ‘general health’ Mindgardens Modules. Peer workers will also support consumers in navigating services to meet their physical health needs and goals. This includes providing information on available services and how to access services, including:
- Nutrition and dietetics
- Physical activity programs and exercise physiologists
- Lifestyle support, including sleep specialists and smoking cessation programs
- Diabetes services
- Primary Care
- Chronic disease services
Peer workers will utilise existing service information for their local health service site, and services will be located within a suitable area as deemed by the consumer. Peer workers will discuss with consumers their preferences and needs, such as travel distance, provider choice, and circumstances, e.g., transport, ability to travel independently, or availability of a carer to assist with travel.
Peer workers will undertake the ‘Health Coaching Conversations’ training developed by Imperial College London and available on Coursera. The training is online, and 5 hours of self-paced modules.

Peer workers and primary care providers will be provided with the ‘Keeping the Body in Mind(gardens) training videos (nutrition, physical activity and tobacco treatment). The videos are available online and 10 minutes each.

Primary care providers will be provided with a one-day training workshop facilitated by two members of the research team who have backgrounds as psychiatrists. The training will cover the Positive Cardiometabolic Health Resource, minimum requirements for physical health screening of people living with persistent mental illness and guideline-appropriate physical health interventions.

Peer workers will also be provided with a one-day training workshop facilitated by two members of the research team who have experience delivering health coaching training and working as a peer health coach. The GROW Coaching Model will be used for the training workshop.

Participants will receive a baseline physical health check according to routine care and NSW Guidelines for minimum physical health screening of people living with persistent mental illness. If a participant has a physical health check recorded less than 13-weeks before trial intake then they will not be offered the baseline health check to avoid unnecessary screening.

Participants will choose which IPPHS components they would like to engage with based on their physical health goals. Participants will receive 13-week individualised interventions and have a physical health check at IPPHS discharge and 6-month follow-up.
• Intervention occurs at Adult Community Mental Health Services across South Eastern Sydney and Tasmania.
• The service is delivered face-to-face at community mental health clinics by staff employed within the adult community mental health service.
• The mobile health app is used individually at home, supported by clinicians at the health service.
• The service is person-centered: participants set their own health goals and decide which parts of the IPPHS they want to engage with.
Frequency, Duration, and Intensity
• Each participant receives a 13-week intervention
• There is no fixed number of sessions — participants can meet with peer workers and primary care providers as needed during this time.
• The mobile app can be used daily at home, and health checks occur at the start, end, and 6 months after the intervention.
• Typical support might involve weekly check-ins, with more frequent contact in the first month depending on participant goals.
Adherence and Fidelity Monitoring
• Participant engagement will be monitored by the adult community mental health service staff and a secure project log and participant tracker maintained.
• The research team will monitor service delivery through regular check-ins and data collection tools.
Community Mental Health Services will receive access to Mindgardens 'Keeping the Body in Mind' education resources for health providers. Implementation strategies to support the sites will be tailored based on the site context and include opportunities for continuing professional development via Primary Health Network webinar events, audit and feedback performance reports, educational and out-reach visits to provide guidance on the Positive Cardiometabolic Monitoring Resource and TCC app, problem solving support via phone for TCC technology, community of practice online meeting support with peer work health coach trainers, identification of health service champions to remind service staff of the trial aims and to support resistance or address challenges.
Intervention code [1] 331536 0
Lifestyle
Intervention code [2] 331537 0
Prevention
Intervention code [3] 331538 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342223 0
Abdominal obesity
Timepoint [1] 342223 0
Intake, intervention discharge and 6-month follow-up.
Primary outcome [2] 342224 0
Blood pressure
Timepoint [2] 342224 0
Intake, intervention discharge and 6-month follow-up
Primary outcome [3] 342225 0
Health related quality of life
Timepoint [3] 342225 0
Intake, intervention discharge and 6-month follow-up
Secondary outcome [1] 450007 0
Type of guideline-adherent physical health interventions offered to patients.
Timepoint [1] 450007 0
Intake and intervention discharge
Secondary outcome [2] 450008 0
Number of patients who take up guideline-adherent physical health interventions
Timepoint [2] 450008 0
Intake and intervention discharge
Secondary outcome [3] 450009 0
Number of patients who complete guideline-adherent physical health interventions.
Timepoint [3] 450009 0
Intervention discharge
Secondary outcome [4] 450351 0
Glucose (primary outcome)
Timepoint [4] 450351 0
Intake, intervention discharge, 6-month follow up
Secondary outcome [5] 450353 0
Blood lipids (primary outcome)
Timepoint [5] 450353 0
Intake, intervention discharge, 6-month follow-up
Secondary outcome [6] 450354 0
Sleep quality (primary)
Timepoint [6] 450354 0
Intake, intervention discharge, 6-month follow-up
Secondary outcome [7] 450355 0
Physical activity (primary outcome)
Timepoint [7] 450355 0
Intake, intervention discharge, 6-month follow up
Secondary outcome [8] 450356 0
Nutrition
Timepoint [8] 450356 0
Intake, intervention discharge, 6-month follow up
Secondary outcome [9] 450357 0
Smoking (primary)
Timepoint [9] 450357 0
Intake, intervention discharge, 6-month follow up
Secondary outcome [10] 450358 0
Number of guideline-adherent physical health interventions offered to patients
Timepoint [10] 450358 0
Intervention discharge
Secondary outcome [11] 450360 0
Number of patients who retain guideline-adherent physical health interventions
Timepoint [11] 450360 0
6-month follow up

Eligibility
Key inclusion criteria
• Adults aged between 18-65 years of age
• Able to provide informed consent (as assessed by ACMHS staff during intake process)
• Diagnosis defined as schizophrenia and/or related psychoses, and/or bipolar disorder, as per the International Classification of Diseases and Related Health Problems version 10 (ICD 10) (codes F20 to F31):
o F20-F29 Schizophrenia, schizotypal & delusional
o F 30-31 Mood Disorders (manic episode and bipolar affective disorder)
• Community dwelling within the geographical boundaries of the study sites
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Have a diagnosis of severe mental illness codes F32-F39 (Depressive episode, recurrent depressive disorder, persistent mood disorders other mood disorders, and unspecified mood disorder) without comorbid diagnosis of codes F20 to F31
- Engaged with Adult Acute Mental Health Inpatient Service, Inpatient Rehabilitation Services, Mental Health Intensive Care Units, Child and Adolescent Mental Health Services, Older Persons Mental Health Service.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2026
Actual
Date of last participant enrolment
Anticipated
31/03/2027
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
370
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,TAS

Funding & Sponsors
Funding source category [1] 319468 0
Government body
Name [1] 319468 0
National Health and Medical Research Council
Country [1] 319468 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 321987 0
None
Name [1] 321987 0
Address [1] 321987 0
Country [1] 321987 0
Other collaborator category [1] 283594 0
University
Name [1] 283594 0
University of Tasmania
Address [1] 283594 0
Country [1] 283594 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 318042 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 318042 0
Ethics committee country [1] 318042 0
Australia
Date submitted for ethics approval [1] 318042 0
01/10/2025
Approval date [1] 318042 0
Ethics approval number [1] 318042 0

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

Contacts
Principal investigator
Name 142938 0
Prof Jackie Curtis
Address 142938 0
Neuroscience Research Australia, 139 Barker St, Randwick, NSW, 2031
Country 142938 0
Australia
Phone 142938 0
+61 02 9348 2163
Fax 142938 0
Email 142938 0
[email protected]
Contact person for public queries
Name 142939 0
Jackie Curtis
Address 142939 0
Neuroscience Research Australia, 139 Barker St, Randwick, NSW, 2031
Country 142939 0
Australia
Phone 142939 0
+61 02 9348 2163
Fax 142939 0
Email 142939 0
[email protected]
Contact person for scientific queries
Name 142940 0
Jackie Curtis
Address 142940 0
Neuroscience Research Australia, 139 Barker St, Randwick, NSW, 2031
Country 142940 0
Australia
Phone 142940 0
+61 02 9348 2163
Fax 142940 0
Email 142940 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.