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Effectiveness of specialist-delivered lifestyle interventions in severe mental illness

Effectiveness of specialist-delivered lifestyle interventions in severe mental illness

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000641796
Enrollment
46
Registered
2022-05-02
Start date
2022-05-16
Completion date
2022-09-12
Last updated
2022-05-16

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

Conditions

None listed

Brief summary

People experiencing mental illness experience poor physical health at disproportionate rates when compared with the general population. The research goal is to improve the cardiometabolic health of young people living with severe mental illness. The study objectives are to determine whether a specialist-delivered intervention improves cardiometabolic outcomes of people living with severe mental illness and to determine whether a specialist-delivered intervention improves global functioning, dietary intake, physical activity level, neuromuscular and cardiorespiratory fitness, eating behaviours and nutrition knowledge of people living with severe mental illness.

Interventions

This trial will use a traditional paralleled RCT design. Participants will be randomly allocated to either standard mental healthcare (control group) or standard mental healthcare plus a lifestyle (nutrition and exercise) intervention at baseline. Nutrition Intervention (delivered by an Accredited Practising Dietitian): • Nutrition intervention will be delivered over 12 weeks. Participants will attend 6 X 60 minute consults with the dietitian. All consults will be conducted one-on-one. • Consu

This trial will use a traditional paralleled RCT design. Participants will be randomly allocated to either standard mental healthcare (control group) or standard mental healthcare plus a lifestyle (nutrition and exercise) intervention at baseline. Nutrition Intervention (delivered by an Accredited Practising Dietitian): • Nutrition intervention will be delivered over 12 weeks. Participants will attend 6 X 60 minute consults with the dietitian. All consults will be conducted one-on-one. • Consults will be conducted fortnightly basis, patients will also have access to the dietitian via telephone/email during weeks where there is no face to face contact if extra support is required. The face-to-face consults will take place at the Specialist Youth Mental Health Outreach Office. • Nutrition care plans will be individualised utilising behaviour change therapy and goal setting. Nutrition consults will cover multiple areas prioritised based on the patients needs. o Areas included but not limited to: o Healthy eating (Australian Guide to Healthy Eating) (NHMRC, 2017) o Label reading (simplified) o Energy density o Non-hungry eating o Maintenance of healthy eating and changes in activity levels o Food security o Budget for food (after money from disability pension (DSP) spent on smoking) o Food storage and cooking facilities at home o Binge eating/night eating o Cooking/shopping skill ability and confidence o Building a day of eating, how to prepare for it. • Participants will also be offered 3 cooking sessions to improve confidence and ability to prepare healthy meals on a budget. These sessions we be conducted in the kitchen at the University of Canberra. These sessions will be offered in week 3, 6 and 9 of the 12-week intervention. These sessions will be conducted in a group setting, the number of participants at the session will be dependent on the number of participants enrolled in the trial at that time – multiple sessions can be offered if required. Each cooking session will be run over a 2-hour period, and participants will be taught about food safety, storage and preparation. Participants will be cooking healthy meals, which are achievable on a budget. Cooking sessions may also involve families for the younger participants. Exercise intervention (planning and programming of individualised exercise sessions will be delivered by an Accredited Exercise Physiologist (AEP)), the part of the intervention will be conducted concurrently with the nutrition intervention: • All participants will be required to get medical clearance from their GP and then will be screened using the ESSA pre-exercise participation-screening tool to inform the individual exercise prescription during the intervention. • Participants will complete a 12-week combined intervention program, engaging in two exercise sessions per week for a total of 24 exercise sessions. Exercise sessions will take place at the AXM Exercise Physiology Clinic for the first nine weeks. From weeks 10-12, the second session, that will take place at the BlocHaus Bouldering Canberra where the participants will transition from the strength training sessions at the AXM Exercise Physiology Clinic to climbing (bouldering) sessions at the BlocHaus. • Exercise session will be conducted over 60 minutes, participants will be offered 2 sessions each week. Session One • The first session in the week will include a facilitated exercise session that will comprise of a variety of different exercise modes and education. This session will be supervised by an AEP and supported by university exercise physiology students. Exercise education will include: how to use fitness equipment, how to self-monitor exercise intensity and progression, and appropriate exercise training techniques (American College of Sports Medicine, 2018). Activities will include: circuit training, cardiovascular exercise, weight training, Tai Chi, yoga, Pilates, power walking, and small team games (e.g. badminton, basketball and handball). Exercise sessions will be designed to: a) educate participants on how to exercise safely and effectively; and b) improve physical activity self-efficacy and autonomous motivation by using a variety of exercises in different settings (fitness equipment, group training, small team games) (Stubbs et al. 2018). Utilizing a broad range of mastery experiences (opportunities to successfully achieve a goal), vicarious experiences (witnessing someone who is similar performing a task), and positive verbal persuasion (providing feedback on task performance) during exercise may improve self-efficacy and influence sustained behaviour change (Artinian et al. 2010). Perceived variation of exercises with a range of tasks in different social contexts may improve individual’s felt experience and perception leading to increased autonomous motivation (Dimmock et al. 2012). Session Two • The second session will be a facilitated exercise session that focuses specifically on motor learning, neuromuscular co-ordination exercise and the development of whole-body strength using resistance exercise training (RET). • The available empirical evidence supports RET as an alternative or adjuvant therapy for mental illness (including depression and anxiety). In addition, the inclusion of motor learning, neuromuscular co-ordination exercises and RET is based on an underlying hypothesis relating to the sensorimotor, neuromuscular and movement abnormalities associated with psychoses and antipsychotic medication (Peralta et al. 2017, Walther at al. 2020). Whilst the session one education and exercise content will focus on exposing the participants to a variety of behaviour change, physical activities and exercise techniques aimed at improving cardiometabolic health, the exercises in session two will be individualised to focus on the specific movement and strength limitations of the participants. Specifically, the aim of these sessions will be to rehabilitate the symptoms associated with mental illness and side effects of medication and poor lifestyle. These symptoms that will be “treated” using the second session exercises include psychomotor agitation or retardation, muscle stiffness/tension, loss of muscle tone, muscle weakness and imbalance (Tomasi et al. 2019). Throughout the intervention the needs of the participants will be considered with modifications to the program to ensure that sessions are individualised. For example, it is anticipated that some participants will prefer to perform one-on-one exercise sessions with the exercise physiologist rather than performing sessions in a group session. It is anticipated that the individualised nature of the program will maximise enjoyment, benefits and adherence. • Incorporated within the two sessions/week discussed above, participants will be requested to attend a minimum of five short (15 minute) exercise program review sessions that occur just before their scheduled exercise session (week 1, week 3, week 6, week 8, week 10).. These sessions will be used as exercise programming/planning sessions (e.g. adjusting intensity/load/mode of exercises). Each program will be tailored to meet the physical capacity of the individual (based on baseline fitness testing), their needs, desires and strengths. • These individual sessions will allow programs to be modified throughout the intervention period in response to changes in fitness levels, motivation and fluctuations in psychiatric symptomatology. • Exercise capacity, measured with a range of fitness assessments, will be performed on a separate day during the first week of the intervention, at 3 months (end trial) and 6 months (post trial) For both components of the intervention we will be using session attendance checklists to encourage attendance. For the trial we will also be using peer support workers to help with attendance, participants will also have their transport costs covered to attend all sessions.

Sponsors

University of Canberra
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
14 Years to 24 Years
Healthy volunteers
No

Inclusion criteria

Diagnosed with a psychotic disorder according to DSM-V or ICD-10 criteria, or a first-episode of psychosis according to assessment criteria. Prescribed equal to or greater than 1 therapeutic dose antipsychotic medication; Aged between 14-24 Engaged with SYHMO or the Adults Mental health service (Woden, Tuggeranong or Gungahlin) Patients may be prescribed additional medication including other psychotropic medications; Physically able to complete physical activity (GP approval); Ability to provide written informed consent or consent provided by a legal guardian (treating team advice); Participants’ with English as a second language will be engaged in the study using translating and interpreting service (TIS).

Exclusion criteria

Currently or previously diagnosed with an eating disorder; Currently enrolled in a regular exercise program; Already receiving nutritional advice from an Accredited Practising Dietitian; Currently medically unwell; Not currently pregnant or lactating

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026