Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001217796
Ethics application status
Approved
Date submitted
5/11/2013
Date registered
5/11/2013
Date last updated
30/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Keeping the Body Mind: A lifestyle intervention for young people with first episode psychosis
Scientific title
In young people experiencing a first episode of psychosis (FEP) what is the effect of a lifestyle intervention in addition to usual care, on physical health parameters such as body weight.
Secondary ID [1] 283518 0
Nil
Universal Trial Number (UTN)
Trial acronym
KBIM (Keeping the Body In Mind)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
First Episode Psychosis 290435 0
Condition category
Condition code
Mental Health 290826 290826 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A cluster-controlled trial will be conducted across early psychosis programs at two sites, one active site in which the intervention will be delivered, and one site that will act as a usual care control. Participants will be young FEP clients. The lifestyle intervention involves a 12-week program consisting of both dietetic and exercise physiology based interventions. The specific program each participant receives is individualised using best practice principles from both disciplines, and aimed at increasing physical activity and improving dietary choices and nutritional understanding. In addition to lifestyle interventions, young people referred to the KBIM project will be assessed for suitability for pharmacological interventions, such as medication switching, metformin and statins.
Health coaching
Health coaching will be provided by the CNC who will oversee both the diet and exercise interventions and provide a motivational framework to assist clients with adherence. Specifically the CNC will utilize goal identification and structured motivational interviewing involving four-core components 1.expressing empathy 2. Developing discrepancy 3. Rolling with resistance 4. Supporting self-efficacy.
Diet
Dietetic consultations will be offered on a weekly basis focusing on nutritional adequacy and energy balance in order to ensure requirements for key nutrients are met while promoting weight loss or the attenuation of weight gain. A diet history or 24-hour nutritional recall will be conducted during each consultation using non-leading questions. The diet history or 24-hour recall aims to obtain an accurate description of all food and drink consumed in the last day, and will be used for comparison against Australian Guide to Healthy Eating Food Group recommendations for nutritional adequacy. Weekly 2-hour cooking classes will also be facilitated in conjunction with an occupational therapist or case worker.
Exercise
The American College of Sports Medicine aerobic and resistance training guidelines will be used to guide exercise programming within the KBIM project. Whilst these public health recommendations will be used to structure the exercise prescriptions, the exercise physiologist will tailor individual programmes to cater for variations in motivation, time and access to services. Clients involved in the KBIM lifestyle intervention will have access to a supervised gym within the community health centre up to four days per week.
The duration of each session and total sessions per week is varied and dependent upon engagement with individual clients.
Intervention code [1] 288221 0
Lifestyle
Comparator / control treatment
cluster-controlled trial will be conducted across two sites in Sydney, Australia. The first site at The Bondi Centre, South Eastern Sydney Local Health District will act as the active site in which the KBIM lifestyle intervention will be delivered. The second site at Liverpool Hospital, South Western Sydney Local Health District will act as a control site providing best-practice usual care.
Usual care involves individual mental health case management with medical assessment, and anti-psychotic prescription based upon mental health needs.
Control group
Active

Outcomes
Primary outcome [1] 290822 0
body weight (kg) is measured whilst clients are barefoot using digital scales.
Timepoint [1] 290822 0
baseline, week 12
Secondary outcome [1] 305365 0
Waist circumference (cm) will be measured using a tape measure with clients wearing loose fitting clothing
Timepoint [1] 305365 0
baseline, week 12
Secondary outcome [2] 305366 0
body mass index (BMI) will be calculated using height and weight. A stadiometer will be used to record weight with clients bare-foot
Timepoint [2] 305366 0
baseline, week 12
Secondary outcome [3] 305367 0
blood pressure (mmHg) will be recorded manually using a sphygmomanometer and stethoscope
Timepoint [3] 305367 0
baseline, week 12
Secondary outcome [4] 305368 0
lipid profile (HDL,LDL, triglycerides, total cholesterol); all participants will be provided with pathology forms to be taken to private pathology collection facilities
Timepoint [4] 305368 0
baseline, week 12
Secondary outcome [5] 305369 0
blood glucose levels (mmol/L); all participants will be provided with pathology forms to be taken to private pathology collection facilities
Timepoint [5] 305369 0
baseline, week 12

Eligibility
Key inclusion criteria
All clients referred to the Bondi Early Psychosis Program meeting required eligibility criteria will be automatically referred to the KBIM lifestyle intervention. To be eligible for referral to KBIM clients must be experiencing a FEP, defined as a schizophreniform psychosis schizophrenia, schizoaffective disorder, delusional disorder, brief psychotic disorder, substance induced psychotic disorder or affective disorders (bipolar, depression) with psychotic features according to DSM-IV-TR criteria, and receiving treatment with anti-psychotic medication.
Minimum age
15 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clients will be ineligible to participate in the trial if they are medically unfit to exercise, or if they have had previous anti-psychotic exposure greater than or equivalent to four weeks.

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)
All clients referred to the Bondi Early Psychosis Program meeting required eligibility criteria will be automatically referred to the KBIM lifestyle intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A cluster-controlled trial will be conducted across early psychosis programs at two sites, one active site in which the intervention will be delivered, and one site that will act as a usual care control.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study is a pilot study and as such no power calculations have been completed. The study aims to evaluate the effectiveness and subsequent acceptability of a pragmatic lifestyle intervention

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/03/2013
Actual
26/03/2013
Date of last participant enrolment
Anticipated
1/11/2013
Actual
1/11/2013
Date of last data collection
Anticipated
Actual
1/05/2014
Sample size
Target
30
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1658 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 1659 0
Liverpool Hospital - Liverpool

Funding & Sponsors
Funding source category [1] 288218 0
Government body
Name [1] 288218 0
Mental Health Drug and Alcohol Office (MHDAO) of New South Wales
Country [1] 288218 0
Australia
Primary sponsor type
Hospital
Name
Bondi Early Pscyhosis Programme
Address
26 Llandaff st
Bondi Junction
NSW 2022
Country
Australia
Secondary sponsor category [1] 286941 0
None
Name [1] 286941 0
Address [1] 286941 0
Country [1] 286941 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290127 0
Prince of Wales Human Research Ethics Committee
Ethics committee address [1] 290127 0
Ethics committee country [1] 290127 0
Australia
Date submitted for ethics approval [1] 290127 0
Approval date [1] 290127 0
20/03/2013
Ethics approval number [1] 290127 0
13/040

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

Contacts
Principal investigator
Name 44086 0
Dr Jackie Curtis
Address 44086 0
Bondi Early Psychosis Programme
26 Llandaff St
Bondi Junction
NSW 2022
Country 44086 0
Australia
Phone 44086 0
+61 2 9366 8610
Fax 44086 0
Email 44086 0
[email protected]
Contact person for public queries
Name 44087 0
Jackie Curtis
Address 44087 0
Bondi Early Psychosis Programme
26 Llandaff St
Bondi Junction
NSW 2022
Country 44087 0
Australia
Phone 44087 0
+61 2 9366 8610
Fax 44087 0
Email 44087 0
[email protected]
Contact person for scientific queries
Name 44088 0
Jackie Curtis
Address 44088 0
Bondi Early Psychosis Programme
26 Llandaff St
Bondi Junction
NSW 2022
Country 44088 0
Australia
Phone 44088 0
+61 2 9366 8610
Fax 44088 0
Email 44088 0
[email protected]

No information has been provided regarding IPD availability


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.