Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000723189
Ethics application status
Approved
Date submitted
3/05/2019
Date registered
14/05/2019
Date last updated
14/05/2019
Date data sharing statement initially provided
14/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Lifestyle Intervention: Pilot Study for people with schizophrenia treated with either clozapine or another antipsychotic medication
Scientific title
Pilot study to evaluate the effect of a lifestyle intervention: on quality of physical and mental health in people with schizophrenia treated with either clozapine or another antipsychotic medication who are overweight/obese
Secondary ID [1] 298144 0
Nil
Universal Trial Number (UTN)
nil
Trial acronym
No
Linked study record
No

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 312684 0
Overweight/obesity 312757 0
Condition category
Condition code
Mental Health 311183 311183 0 0
Schizophrenia
Diet and Nutrition 311250 311250 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A lifestyle intervention including a combination of low grade physical activity and targeted dietary modification would be supported and monitored by the research team together with clients’ Mental Health case manager, clozapine coordinators, consumer volunteers, and/or their NDIS or Community managed organisation support worker. The lifestyle intervention will run for three months.

Dietary component
The dietary intervention will consist of an individualised dietary assessment using online the Australian Eating Survey (AES) which identifies key areas that require change. Intake from each of the food groups is subsequently used to calculate an individual's macronutrient and micronutrient intake.

At the end of the dietary assessment participants will be provided with feedback which will be delivered face to face by a dietician with three goals: a) reducing sweetened drinks, b) reduction in discretionary foods and snacks c) increase core food intake. These factors have been shown to be prevalent issues in this population group and will lead to a reduction in total energy intake.

Those in the control group will only be provided with this feedback and no other lifestyle intervention. They will continue to be case managed by the mental health service and receive ongoing psychiatric treatment for schizophrenia.

Those in the intervention group will receive the three individual sessions delivered face to face by either dietician or clinical psychologist, at baseline, 2 months and 3 months which come from Food Fix programs. The dietician has over 10 of experience in delivering dietary interventions as well as having experience in delivering the Food Fix Program. The clinical psychologist has over 10 years of experience in providing clinical and lifestyle interventions to people with mental health problems

The dietary sessions consist of:
Session 1 consists of provision of feedback from the online survey and development of dietary goals and encouraging the participant to make dietary changes.

Session 2 will occur at 2 months and will utilise motivational interview techniques to help the participant explore barriers to change and provide coping strategies to help the client overcome some of the barriers.

Session 3 last session will occur at 3 months, and will be used as a check in to see how the participant is traveling

Physical fitness component
The physical fitness will be assessed using a 6 minute walk test, which counts the number of times a person is able to walk between two witches’ hats. All participants will be assessed. The fitness test will be done by clinical psychologist who has over 10 years’ experience in physical fitness assessments and provision of lifestyle interventions.

Those in the intervention group will be encouraged to join a walking group which will be run from the community managed organisation by the support workers. The intervention will involve supervised walking groups, 40 minutes per day three times per week. As participants get fitter a 20 minutes supervised brisk walk or going up and down stairs, once a week, will be incorporated into the 40 minute walk. The walking groups will be delivered face to face under the supervision of two support workers.

Weekly support group sessions will be used to motivate clients, discuss any barriers and difficulties in adhering to the dietary and physical intervention. These sessions will occur straight after the walking group. These groups will be run by the clinical psychologist in collaboration with the support workers involved in the walking groups. The clinical psychologist has over 10 years of experience in providing clinical and lifestyle interventions to people with mental health problems. The support workers have at least 6 years of experience in support to people with mental health issues.

The intervention adherence will be assessed by keeping attendance log which will record the number of times participants attended the walking groups and number of dietary sessions attended. The records will be kept by the support worker involved in walking groups and dietician delivering the dietary intervention.

Intervention code [1] 314362 0
Lifestyle
Comparator / control treatment
Control group will receive usual care consisting of ongoing treatment for schizophrenia through case management often involving close monitoring of the medication adherence.
Control group
Active

Outcomes
Primary outcome [1] 319946 0
Metabolic,risk factors measured by blood test (liver function, urea electrolytes and creatinine, a fasting lipid profile test , fasting blood glucose test ). This is a composite primary outcome
Timepoint [1] 319946 0
Baseline and 3 months
Primary outcome [2] 319996 0
Cardiovascular risk measure by blood test (The troponin test)
Timepoint [2] 319996 0
Baseline and 3 months
Primary outcome [3] 319997 0
Quality of life measured by self report Quality of life and General Health measure (AQol-8D)
Timepoint [3] 319997 0
Baseline and 3 months
Secondary outcome [1] 369958 0
Overweight/obesity measured by BMI. BMI will be measured by collecting the weight and height of the participants. The weight will be meausred using a digital scale and the height will be measured using stadiometer.
Timepoint [1] 369958 0
Baseline and 3 months

Eligibility
Key inclusion criteria
• Age -18-65 years
• Taking clozapine for at least 18 weeks and are in maintenance phase or
• have been taking another antipsychotic medication for at least 6 months
• Are overweight or obese – BMI greater than 25
• Have access to transport – either by having their own car, or living in the area and near a bus stop, or have an NDIS support worker who can bring them
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Women who are pregnant
• Acutely unwell (psychotic) or an intellectual disability with severe cognitive impairment which would prevent them from participating in the behavioural program
• Are currently taking medications that may interfere with intervention ( for example metformin, diuretics, any other weight loss medication).
• Persons who are unable to read or write and understand the information statement, consent form, and self-report measures are ineligible. Informed consent must be obtained to be eligible for the study. As part of the dietary intervention, participants will learn about reading labels so that the right food products can be chosen. Basic level of reading and writing is required for this research.

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)
Randomisation will be carried out by the clinicians and participants will be allocated by selecting a sealed envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer program was used to generate a block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
No
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Chi-square tests (for categorical variables) and analyses of variance (for continuous variables) were used to examine differences between groups for the demographic variables, diagnostic and blood profiles. In addition, community contacts and admissions were expressed as rates per year for the purposes of describing the data. Univariate and multivariate logistic regressions will be used to examine primary and secondary outcome.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/05/2019
Actual
Date of last participant enrolment
Anticipated
31/07/2019
Actual
Date of last data collection
Anticipated
31/10/2019
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 302669 0
Commercial sector/Industry
Name [1] 302669 0
Pfizer Australia
Country [1] 302669 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Mental Health Local health District
Address
PO Box 833
Newcastle, NSW 2300
Country
Australia
Secondary sponsor category [1] 302603 0
None
Name [1] 302603 0
Address [1] 302603 0
Country [1] 302603 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303292 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 303292 0
Ethics committee country [1] 303292 0
Australia
Date submitted for ethics approval [1] 303292 0
17/12/2018
Approval date [1] 303292 0
12/02/2019
Ethics approval number [1] 303292 0
2018/ETH00365

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

Contacts
Principal investigator
Name 93158 0
Dr Agatha Conrad
Address 93158 0

Research, Evaluation, Analysis & Dissemination (MH-READ)
Centre for Brain and Mental Health Research (CBMHR)
Hunter New England Mental Health
Level 5 McAuley Centre, The Mater
Address: PO Box 833 Newcastle NSW 2300
Country 93158 0
Australia
Phone 93158 0
+61 02 4033 5708
Fax 93158 0
+61 02 4033 5692
Email 93158 0
[email protected]
Contact person for public queries
Name 93159 0
Agatha Conrad
Address 93159 0
Research, Evaluation, Analysis & Dissemination (MH-READ)
Centre for Brain and Mental Health Research (CBMHR)
Hunter New England Mental Health
Level 5 McAuley Centre, The Mater
Address: PO Box 833 Newcastle NSW 2300
Country 93159 0
Australia
Phone 93159 0
+61 02 4033 5708
Fax 93159 0
+61 02 4033 5692
Email 93159 0
[email protected]
Contact person for scientific queries
Name 93160 0
Agatha Conrad
Address 93160 0
Research, Evaluation, Analysis & Dissemination (MH-READ)
Centre for Brain and Mental Health Research (CBMHR)
Hunter New England Mental Health
Level 5 McAuley Centre, The Mater
Address: PO Box 833 Newcastle NSW 2300
Country 93160 0
Australia
Phone 93160 0
+61 02 4033 5708
Fax 93160 0
+61 02 4033 5692
Email 93160 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
Only group results will be available


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.