Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000641796
Ethics application status
Approved
Date submitted
11/04/2022
Date registered
2/05/2022
Date last updated
2/05/2022
Date data sharing statement initially provided
2/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of specialist-delivered lifestyle interventions in severe mental illness
Scientific title
Effectiveness of specialist-delivered lifestyle interventions in severe mental illness
Secondary ID [1] 300457 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe Mental Illness 316124 0
Early onset psychosis 316125 0
Condition category
Condition code
Mental Health 314412 314412 0 0
Schizophrenia
Mental Health 314413 314413 0 0
Psychosis and personality disorders
Mental Health 314414 314414 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 323295 0
Lifestyle
Intervention code [2] 323402 0
Treatment: Other
Comparator / control treatment
Control group will continue to receive standard mental health care. Standard health care for the purpose of this study is the current mental health care each client already has in place i.e. continue sessions with the mental health team and medication regime.
Control group
Active

Outcomes
Primary outcome [1] 330980 0
Weight will be measured using calibrated scales.
Timepoint [1] 330980 0
Baseline, and 3 (primary endpoint), 6 & 12 months post-intervention commencement.
Primary outcome [2] 331120 0
Waist Circumference, will be measured at the approximate midpoint between the lower margin of the last palpable rib and the top of the iliac crest
Timepoint [2] 331120 0
Baseline, and 3 (primary endpoint), 6 & 12 months post-intervention commencement.
Primary outcome [3] 331121 0
Percent body fat/lean muscle mass/visceral fat assessed using a DEXA scan.
Timepoint [3] 331121 0
Baseline, and 3 (primary endpoint), 6 & 12 months post-intervention commencement.
Secondary outcome [1] 408331 0
Global functioning assessed using the Global Assessment of Function.
Timepoint [1] 408331 0
Baseline, and 3, 6 & 12 months post-intervention commencement.
Secondary outcome [2] 408332 0
Dietary intake (Multi-pass 24-hour food record)
Timepoint [2] 408332 0
Baseline, and 3, 6 & 12 months post-intervention commencement.
Secondary outcome [3] 408333 0
Physical activity level (International Physical Activity Questionnaire-short form)
Timepoint [3] 408333 0
Baseline, and 3, 6 & 12 months post-intervention commencement.
Secondary outcome [4] 408334 0
Cardiorespiratory fitness (sub-maximal VO2 test adopting the Astrand-Rhyming protocol on a cycle ergometer)
Timepoint [4] 408334 0
Baseline, and 3, 6 & 12 months post-intervention commencement.
Secondary outcome [5] 408335 0
Muscle Endurance will be assessed using YMCA 1 minute crunch test protocol (Lawrence & Coldin, 2000)
Timepoint [5] 408335 0
Baseline, and 3, 6 & 12 months post-intervention commencement.
Secondary outcome [6] 408336 0
Eating behaviours and nutrition knowledge (General Nutrition Knowledge Questionnaire)
Timepoint [6] 408336 0
Baseline, and 3, 6 & 12 months post-intervention commencement.
Secondary outcome [7] 408337 0
Quality of life (AQoL-8D multi-attribute questionnaire)
Timepoint [7] 408337 0
Baseline, and 3, 6 & 12 months post-intervention commencement.
Secondary outcome [8] 408832 0
Resting Heart Rate (Primary Outcome) will be assessed using a Whoop band to monitor throughout the duration of the intervention.
Timepoint [8] 408832 0
Baseline, and 3 (primary endpoint), 6 & 12 months post-intervention commencement.
Secondary outcome [9] 408834 0
Heart Rate Variability (Primary Outcome) will be assessed using R-R intervals recorded with a Polar H10 monitor system using a chest belt that transmits the R-R interval data to a wristwatch (Polar Electro Oy, Kempele, Finland)
Timepoint [9] 408834 0
Baseline, and 3 (primary endpoint), 6 & 12 months post-intervention commencement.
Secondary outcome [10] 408835 0
Blood Pressure (Primary Outcome) will be assessed using a sphygmomanometer.
Timepoint [10] 408835 0
Baseline, and 3 (primary endpoint), 6 & 12 months post-intervention commencement.
Secondary outcome [11] 408836 0
Blood Lipids (Primary Outcome) (LDL, HDL, total cholesterol, triglycerides) will be measured using Spectrophotometry.
Timepoint [11] 408836 0
Baseline, and 3 (primary endpoint), 6 & 12 months post-intervention commencement.
Secondary outcome [12] 408837 0
Fasting Blood Glucose (Primary Outcome) will be measured using a glucose hexokinase method on a Roche automated analyzer. The fasting insulin and glucose will be used to calculate HOMA-%b, HOMA%S and HOMAIR.
Timepoint [12] 408837 0
Baseline, and 3 (primary endpoint), 6 & 12 months post-intervention commencement.
Secondary outcome [13] 408838 0
Fasting Serum Insulin (Primary Outcome) will be measured by radioimmunoassay. The fasting insulin and glucose will be used to calculate HOMA-%b, HOMA%S and HOMAIR.
Timepoint [13] 408838 0
Baseline, and 3 (primary endpoint), 6 & 12 months post-intervention commencement.
Secondary outcome [14] 408839 0
Blood sample to check C-Reactive Protein (Primary Outcome) will be assessed using enzyme-linked immunosorbent assay (ELISA)
Timepoint [14] 408839 0
Baseline, and 3 (primary endpoint), 6 & 12 months post-intervention commencement.
Secondary outcome [15] 408840 0
Muscle Strength will be assessed using TTM Original handgrip Dynamometer (Baumgartner et al., 2002)
Timepoint [15] 408840 0
Baseline, and 3, 6 & 12 months post-intervention commencement.
Secondary outcome [16] 408841 0
Muscle Flexibility will be assessed using YMCA sit and reach test (Lawrence & Coldin, 2000)
Timepoint [16] 408841 0
Baseline, and 3, 6 & 12 months post-intervention commencement.
Secondary outcome [17] 408842 0
Global functioning assessed using the Social and Occupational Functioning Assessment Scale.
Timepoint [17] 408842 0
Baseline, and 3, 6 & 12 months post-intervention commencement
Secondary outcome [18] 409110 0
Muscle Strength will be assessed using YMCA push-up test protocol (Baumgartner et al., 2002)
Timepoint [18] 409110 0
Baseline, and 3, 6 & 12 months post-intervention commencement

Eligibility
Key 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).
Minimum age
14 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Who is / are masked / blinded?



Intervention assignment
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
16/05/2022
Actual
Date of last participant enrolment
Anticipated
12/09/2022
Actual
Date of last data collection
Anticipated
29/02/2024
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 304872 0
Government body
Name [1] 304872 0
ACT Health Research and Innovation Fund
Country [1] 304872 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
11 Kirinari St, Bruce ACT 2617
Country
Australia
Secondary sponsor category [1] 305211 0
None
Name [1] 305211 0
Address [1] 305211 0
Country [1] 305211 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305280 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 305280 0
Ethics committee country [1] 305280 0
Australia
Date submitted for ethics approval [1] 305280 0
03/02/2020
Approval date [1] 305280 0
04/04/2021
Ethics approval number [1] 305280 0
2019/ETH13341

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

Contacts
Principal investigator
Name 99870 0
A/Prof Andrew McKune
Address 99870 0
University of Canberra,
11 Kirinari St, Bruce ACT 2617
Country 99870 0
Australia
Phone 99870 0
+61 2 62012122
Fax 99870 0
Email 99870 0
[email protected]
Contact person for public queries
Name 99871 0
Andrew McKune
Address 99871 0
University of Canberra,
11 Kirinari St, Bruce ACT 2617
Country 99871 0
Australia
Phone 99871 0
+61 2 62012122
Fax 99871 0
Email 99871 0
[email protected]
Contact person for scientific queries
Name 99872 0
Andrew McKune
Address 99872 0
University of Canberra,
11 Kirinari St, Bruce ACT 2617
Country 99872 0
Australia
Phone 99872 0
+61 2 62012122
Fax 99872 0
Email 99872 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to the population group of the study and privacy reasons only the research team will be able to access the individual participant data.


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.