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Healthy living for serious mental illness: Co-designing a lifestyle intervention for antipsychotic-associated weight gain

Healthy living for people with severe mental illness: Co-designing a lifestyle intervention for antipsychotic-associated weight gain

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000485437
Enrollment
35
Registered
2025-05-20
Start date
2025-07-01
Completion date
2026-06-16
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project will address the significant impact of antipsychotic-induced weight gain among people with serious mental illness (SMI) by co-designing an evidence-based, easily understandable, and low-cost, educational resource on diet and physical activity. This study will use a co-production methodology to co-design the lifestyle resource with individuals with SMI and their treating clinicians. We will identify the key components required for this educational resource, and then develop, and refine this resource by running three focus groups (N = 5 per group) with Metro South Addiction and Mental Health Service (MSAMHS) case-managed out-patients (18-65 years) with lived experience of SMI. We will then pilot this lifestyle self-management intervention with MSAMHS consumers (N=20). We expect that this resource will lead to positive changes in consumer intentions, attitudes, perceived behavior control, motivation and health literacy in relation to their physical activity and nutrition. We also expect that this will lead to a change in consumer health behavior (i.e., increased physical activity and healthy eating).

Interventions

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

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.

Sponsors

Metro South Hospital and Health Service
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026