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Trial registered on ANZCTR


Registration number
ACTRN12618001222235
Ethics application status
Approved
Date submitted
17/07/2018
Date registered
20/07/2018
Date last updated
18/07/2024
Date data sharing statement initially provided
18/07/2024
Date results provided
18/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of involving a physical health nurse in the care of young people with a first episode of psychosis on the prevention of weight gain
Scientific title
Effect of involving a physical health nurse in the care of young people with a first episode of psychosis on the prevention of weight gain compared to treatment as usual: A randomised trial
Secondary ID [1] 295388 0
None
Universal Trial Number (UTN)
U1111-1216-6816
Trial acronym
PHAstER (Physical Health Assistance in Early Recovery of Psychosis)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Weight gain during first episode of psychosis 308639 0
Condition category
Condition code
Mental Health 307584 307584 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Physical health nurse

Description: Participants allocated to the intervention group will have a physical health nurse as part of their treating team for a 12-week period. The purpose of the physical health nurse is to provide coordination of the physical health services for the young people who attend the Early Psychosis Prevention and Intervention Centre (EPPIC) at Orygen Youth Health. This role includes performing physical health screening (metabolic monitoring) and facilitating clients attending the services at Orygen Youth Health that have been established to address the physical health of young people, including but not limited to exercise physiologists, dieticians, gym group, yoga group, and 'Tackling tobacco' intervention in conjunction with QUIT Victoria. The physical health nurse will have weekly contact with participants via a combination of face-to-face and telephone contact, typically separate to the treating team appointments.
Intervention code [1] 301758 0
Prevention
Intervention code [2] 301759 0
Lifestyle
Comparator / control treatment
The control group will be "treatment as usual". That is, a physical health nurse will not be assigned to their treating team (so it will consist of a case manager and doctor). All people in this group will still have access to all of the physical health interventions available to the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 306630 0
proportion of individuals who gain >7% of body weight
Timepoint [1] 306630 0
at commencement of intervention, and at 4 weeks, 8 weeks, 12 weeks (primary time point), and 26 weeks post-commencement
Secondary outcome [1] 349064 0
proportion of participants with components of metabolic syndrome, assessed via BMI (using a stadiometer and digital scale to measure height and weight), waist circumference (tape measure), blood pressure (digital sphygmomanometer), and fasting glucose, HbA1c and fasting cholesterol (determined via a fasting blood test that will be sent to a pathology lab).
Timepoint [1] 349064 0
height, fasting glucose, HbA1c, fasting cholesterol: at commencement of intervention, and at 12 weeks and 26 weeks post-commencement
weight, waist circumference, blood pressure: at commencement of intervention, and at 4 weeks, 8 weeks, 12 weeks, and 26 weeks post-commencement
Secondary outcome [2] 349066 0
level of physical activity assessed using the Simple Physical Activity Questionnaire (SIMPAQ) and an actigraph that will measure number of steps and quantity of exercise
Timepoint [2] 349066 0
at commencement of intervention, and at 12 weeks and 26 weeks post-commencement
Secondary outcome [3] 349068 0
level of symptomology assessed via the Brief Psychiatric Rating Scale (BPRS) and the Schedule for Assessment of Negative Symptoms (SANS)
Timepoint [3] 349068 0
at commencement of intervention, and at 12 weeks and 26 weeks post-commencement
Secondary outcome [4] 349069 0
level of psychological functioning assessed via the Social and Occupational Functioning Assessment Scale (SOFAS)
Timepoint [4] 349069 0
at commencement of intervention, and at 12 weeks and 26 weeks post-commencement
Secondary outcome [5] 349070 0
level of sexual health and contraceptive use, assessed via an internal questionnaire developed at Orygen Youth Health
Timepoint [5] 349070 0
at commencement of intervention, and at 12 weeks and 26 weeks post-commencement
Secondary outcome [6] 349071 0
level of substance use assessed via the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Timepoint [6] 349071 0
at commencement of intervention, and at 12 weeks and 26 weeks post-commencement
Secondary outcome [7] 349072 0
quality of sleep assessed via an actigraph, the Pittsburgh Sleep Quality index (PSQI), the Insomnia Severity Index (ISI), and the Morningness-Eveningness questionnaire (MEQ)
Timepoint [7] 349072 0
at commencement of intervention, and at 12 weeks and 26 weeks post-commencement
Secondary outcome [8] 349073 0
satisfaction with services assessed via the Youth (Mental Health) Service Satisfaction Scale (YSSS)
Timepoint [8] 349073 0
at commencement of intervention, and at 12 weeks and 26 weeks post-commencement

Eligibility
Key inclusion criteria
- Eligible for EPPIC and this involves: residing within the geographically defined catchment area, be aged between 15 and 24 and experiencing a first episode of psychosis, defined as experiencing at least one positive psychotic symptom on a daily basis for at least one week,
- Ability to provide informed consent.
- Have at least 12 weeks of care remaining at EPPIC
Minimum age
15 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- More than 30 days total exposure to the minimum effective dose for a psychotic disorder (reference – Maudsley guidelines)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The researchers involved in the diagnosis and eligibility screening of participants will not be privy to the allocation sequence, which will be centrally randomised by a separate statistician who will allocate on a per-participant basis following informed consent.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation), stratified according to sex and BMI.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SAMPLE SIZE ESTIMATION & JUSTIFICATION
A total of 88 participants will be recruited, which will allow for attrition of just over 10%. The power analysis conducted to obtain this sample size is presented below.

POWER CALCULATIONS
It has been demonstrated that at least 50% of young people with a first episode of psychosis will gain >7% of their body weight in the first 12 weeks of treatment, even with medications that have been marketed as ‘weight neutral’. The HeAL declaration sets out a target of no more than 25% of young people with a first episode of psychosis gaining >7% of their body weight following treatment for a first episode of psychosis. Therefore, with an estimated proportion of 50% in the non-intervention group and 20% in the intervention group gaining clinically significant weight gain (>7% body weight), with 80% power at 95% significance level would require a total sample size of 78 with 39 in each group. Therefore, this study will aim to recruit a total of 88 participants with a first episode of psychosis from the Early Psychosis Prevention and Intervention Centre (EPPIC) at Orygen Youth Health to allow for approximately 10% attrition. Disengagement rates can be as high as 30% in those with a first episode of psychosis, however this tends to occur in the periods six months after initial presentation. Furthermore, the primary outcome of weight gain is measured routinely by the treating team and therefore it will be possible to obtain information on individuals for the intention to treat analysis.

STATISTICAL METHODS TO BE UNDERTAKEN
The primary outcome will be determined using chi-square analysis comparing the two expected vs observed outcome of proportion of individuals who gained >7% of body weight in the two groups.

In order to control for some potential confounders, which may not have been addressed by randomization, a further binary logistic regression analysis will be performed, with all of the potential confounders (such as age and medication prescribed ) in the first block and the treatment allocation in the second block.

Chi-square analysis will also be conducted for certain secondary outcomes (components of metabolic syndrome, tobacco use, contraception use). Descriptive statistics will be calculated for all measures. Key sleep measures will be compared to actigraph measures using Bland-Altman concordance analysis.

Young people who become pregnant during the course of the study can still remain involved in the study and can complete the study intervention and follow-up assessments. However they will be excluded from the primary outcome analysis, as their expected weight gain during the pregnancy would confound the primary outcome. However, the data collected from any participant who becomes pregnant will contribute towards secondary outcomes (excluding contraception use).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/07/2018
Actual
22/08/2018
Date of last participant enrolment
Anticipated
Actual
14/04/2021
Date of last data collection
Anticipated
Actual
19/10/2021
Sample size
Target
88
Accrual to date
Final
88
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11329 0
Orygen Youth Health - Sunshine - Sunshine
Recruitment postcode(s) [1] 23226 0
3020 - Sunshine

Funding & Sponsors
Funding source category [1] 299980 0
University
Name [1] 299980 0
University of Melbourne Early Career Researcher Grant
Country [1] 299980 0
Australia
Funding source category [2] 300138 0
Charities/Societies/Foundations
Name [2] 300138 0
Morris Family Foundation
Country [2] 300138 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Orygen, the National Centre of Excellence in Youth Mental Health
Address
Centre for Youth Mental Health
The University of Melbourne
35 Poplar Rd, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 299360 0
Individual
Name [1] 299360 0
Dr Brian O'Donoghue
Address [1] 299360 0
Centre for Youth Mental Health
The University of Melbourne
35 Poplar Rd, Parkville VIC 3052
Country [1] 299360 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300837 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 300837 0
Ethics committee country [1] 300837 0
Australia
Date submitted for ethics approval [1] 300837 0
Approval date [1] 300837 0
24/05/2018
Ethics approval number [1] 300837 0
HREC/18/MH/77

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

Contacts
Principal investigator
Name 84978 0
Dr Brian O'Donoghue
Address 84978 0
St Vincent's University Hospital
Elm Park
Dublin 4
Country 84978 0
Ireland
Phone 84978 0
+353876301145
Fax 84978 0
Email 84978 0
brian.odonoghue@ucd.ie
Contact person for public queries
Name 84979 0
Orygen Research office
Address 84979 0
Orygen, 35 Poplar Rd, Parkville VIC 3052
Country 84979 0
Australia
Phone 84979 0
+61 0399669100
Fax 84979 0
Email 84979 0
research@orygen.org.au
Contact person for scientific queries
Name 84980 0
Orygen Research office
Address 84980 0
Orygen, 35 Poplar Rd, Parkville VIC 3052
Country 84980 0
Australia
Phone 84980 0
+61 03 99669100
Fax 84980 0
Email 84980 0
research@orygen.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data, anonymised
When will data be available (start and end dates)?
Data are available immediately for an indefinite time.
Available to whom?
Data will potentially be available to researchers from not-for profit organisations, commercial organisations or other based in any location. All data requests will be considered by the data custodian and the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see Orygen data management policy.
Available for what types of analyses?
To any type of analyses. Assessed on a case-by-case basis.
How or where can data be obtained?
Access can be requested via the Health Data Australia catalogue (https://researchdata.edu.au/health). Search for the ANZTRN number in the catalogue to find datasets associated with this trial.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23661Study protocol https://onlinelibrary.wiley.com/doi/10.1111/eip.12884 



Results publications and other study-related documents

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