Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000485437p
Ethics application status
Submitted, not yet approved
Date submitted
30/04/2025
Date registered
20/05/2025
Date last updated
20/05/2025
Date data sharing statement initially provided
20/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Healthy living for serious mental illness: Co-designing a lifestyle intervention for antipsychotic-associated weight gain
Scientific title
Healthy living for people with severe mental illness: Co-designing a lifestyle intervention for antipsychotic-associated weight gain
Secondary ID [1] 314328 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe mental illness 337280 0
Schizophrenia 337425 0
Bipolar affective disorder 337426 0
Schizoaffective disorder 337427 0
Condition category
Condition code
Mental Health 333678 333678 0 0
Schizophrenia
Mental Health 333802 333802 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase 1 of study: Co-design component will occur before the implementation component. This Phase 1 will take approximately 6 months.
Focus groups will be conducted to develop a lifestyle handout face-to-face or online or over the phone with lead investigator. During the consenting process if participants prefer, they can attend an individual interview instead of a group. Participants (aged 18 to 65 years) will be outpatients Metro South Addiction and Mental Health outpatient clinics, diagnosed with either schizophrenia, schizoaffective, or bipolar affective disorder and taking, or switching to, a weight-inducing antipsychotic. These groups will be conducted online or at a Queensland Health Metro South Community care unit or health clinic. These groups will go for approximately 60 mins, and there will be three groups. Participants can choose how many of these groups to attend. We will use a concept mapping approach to identify the key components of the educational resource. In the focus groups, participants will have the opportunity to discuss the questions that they would have liked to have answered regarding weight management, when they started or switched to an AP medication associated with weight gain (e.g., What do you wish you had been told about physical activity when you first started your medication?). This will be used to gauge ideas on the key components and design of the educational material (e.g., How would you like to have been presented with this information?). Building on the evidence regarding the use of peer support and the unique value imparted by sharing lived experience expertise, participants will be given the chance to answer the key questions that arose during discovery. A focus group/interview will be conducted to hear the personal stories of these consumers which will further inform the development of the educational resource (e.g., What would you like your peers to know about starting or switching to antipsychotic medications that can cause weight gain?). We will prepare a paper-based and digital prototype of the educational resource material and share this with participants for feedback using a focus group/interview format. Participants will have the ability to offer suggestions on the refinement of the prototype. Feedback will also be sought from treating clinicians on the content of the material. Following this, feedback will be implemented, and a final prototype (digital and paper-based) will be developed based on consumer and clinician suggestions. From our consultations with the members of our Consumer Reference Group, we know that people with SMI prefer low-cognitive effort material to aid readability and comprehension (e.g., visual prompts, shorter sentences, question-answer format). A similar preference may be reflected during the co-design process of this current study.

Phase 2 of study: Implementation component
In phase two, we will pilot this resource with 20 new participants with outpatients Metro South Addiction and Mental Health outpatient clinics. To reduce potential bias, participants cannot participate in phase 2 if they have already participated in phase 1. At phase 2 baseline participants will attend a face-to-face appointment to complete some questionnaires about health lifestyle behaviours. These questionnaires were based on the Australian Guidelines for Healthy Eating, and Physical Activity recommendations and developed in consultation with treating clinicians to ensure they were appropriate and relevant to the target population. These questionnaires aim to measure key evidenced-based constructs of health behavior change. Participants will then be provided with a paper-based version of the resource prototype. The researcher will be available to answer any questions participants may have after reading the material. One week later (i.e., 7 days +/- 3 days), participants will attend a second appointment, and the questionnaires will be re-administered by the researcher. These questionnaires are designed to be repeated to show change over a short period of time. We will also ask participants to complete a questionnaire about the acceptability, feasibility, and appropriateness of the resource. It is estimated that each appointment will take approximately 30 mins. The educational resource/handout to be provided by lead investigator face-to-face, individually at a Queensland Health Metro South Community care unit or health clinic. This resource will be provided in 1 x 30 min appointment and then followed up one week later in a second 1 x 30 min appointment.
Intervention code [1] 330935 0
Lifestyle
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341270 0
Intentions towards physical activity and nutrition.
Timepoint [1] 341270 0
baseline and 1 week later.
Primary outcome [2] 341391 0
motivation towards physical activity and nutrition.
Timepoint [2] 341391 0
baseline and 1 week later.
Primary outcome [3] 341392 0
health literacy regarding physical activity and nutrition
Timepoint [3] 341392 0
baseline and 1 week later.
Secondary outcome [1] 446990 0
self-reported nutrition behavior
Timepoint [1] 446990 0
baseline and 1 week later
Secondary outcome [2] 447374 0
self-reported physical activity behavior
Timepoint [2] 447374 0
baseline and 1 week later
Secondary outcome [3] 447375 0
Perceived behavioural control in relation to physical activity and health eating Please note that this outcome is primary.
Timepoint [3] 447375 0
baseline and 1 week later
Secondary outcome [4] 447376 0
Acceptability of resource
Timepoint [4] 447376 0
one week follow up only
Secondary outcome [5] 447377 0
Attitudes surrounding physical activity and nutrition Please note that this outcome is primary.
Timepoint [5] 447377 0
baseline and 1 week later
Secondary outcome [6] 447836 0
Appropriateness of resource
Timepoint [6] 447836 0
one week follow up only
Secondary outcome [7] 447837 0
Feasibility of resource
Timepoint [7] 447837 0
one week follow up only

Eligibility
Key inclusion criteria
For both phases of the study (co-design and implementation) the inclusion criteria are:
Aged 18 to 65 years.
Diagnosed with either schizophrenia, schizoaffective, or bipolar affective disorder.
Taking, or switching to, a weight-inducing antipsychotic; and,
Able to provide informed consent and to read/understand English.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For both phases of the study (co-design and implementation) the exclusion criteria is:
Currently experiencing acute relapse of psychiatric symptoms
For phase 2 of the study (implementation) the exclusion criteria is:
Participated in phase one of the study.

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
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
16/06/2026
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 318846 0
Government body
Name [1] 318846 0
Metro South Hospital and Health Service
Country [1] 318846 0
Australia
Primary sponsor type
Government body
Name
Metro South Hospital and Health Service
Address
Country
Australia
Secondary sponsor category [1] 321299 0
None
Name [1] 321299 0
None
Address [1] 321299 0
Country [1] 321299 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317463 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 317463 0
Ethics committee country [1] 317463 0
Australia
Date submitted for ethics approval [1] 317463 0
13/05/2025
Approval date [1] 317463 0
Ethics approval number [1] 317463 0

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

Contacts
Principal investigator
Name 141118 0
Dr Gabrielle Ritchie
Address 141118 0
Metro South Addiction and Mental Health Service, Woolloongabba Community Health Centre, Level 2, 228 Logan Road Woolloongabba QLD 4102
Country 141118 0
Australia
Phone 141118 0
+61431727352
Fax 141118 0
Email 141118 0
[email protected]
Contact person for public queries
Name 141119 0
Gabrielle Ritchie
Address 141119 0
Metro South Addiction and Mental Health Service, Woolloongabba Community Health Centre, Level 2, 228 Logan Road Woolloongabba QLD 4102
Country 141119 0
Australia
Phone 141119 0
+61431727352
Fax 141119 0
Email 141119 0
[email protected]
Contact person for scientific queries
Name 141120 0
Gabrielle Ritchie
Address 141120 0
Metro South Addiction and Mental Health Service, Woolloongabba Community Health Centre, Level 2, 228 Logan Road Woolloongabba QLD 4102
Country 141120 0
Australia
Phone 141120 0
+61431727352
Fax 141120 0
Email 141120 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.