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Trial registered on ANZCTR


Registration number
ACTRN12615000564550
Ethics application status
Approved
Date submitted
11/05/2015
Date registered
1/06/2015
Date last updated
22/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the feasibility of a peer-delivered healthy lifestyle intervention to reduce cardiovascular and cancer disease risk for people living with a severe mental illness.
Scientific title
Examining the feasibility of a peer-delivered healthy lifestyle intervention to reduce cardiovascular and cancer disease risk for people living with a severe mental illness: a randomised pilot trial
Secondary ID [1] 286615 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe Mental Illness 294932 0
Cardiovascular Disease 294933 0
Cancer 294934 0
Condition category
Condition code
Cancer 295183 295183 0 0
Any cancer
Cardiovascular 295184 295184 0 0
Coronary heart disease
Mental Health 295185 295185 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The proposed project will be conducted as a randomised controlled pilot study. In addition to completing assessments, and receiving pamphlets and standard care, participants randomised to the intervention will be immediately engaged in the peer delivered Better Health Choices telephone intervention. Better Health Choices was developed to target the specific needs and barriers facing people with Schizophrenia and other severe mental illnesses and aims to help participants decrease their smoking, increase their intake of fruit and vegetables (F&V), and reduce their sedentary behaviour. It incorporates clear health messages, well-established behavioural strategies and can be tailored to the personal goals of each participant. Better Health Choices consists of 8 telephone sessions delivered by trained peer workers over a maximum of 11 weeks. Session 1 will be of 45-60 minutes duration, and consists of feedback from the baseline assessment regarding smoking, activity, screen time, F&V intake and alcohol use with motivational interviewing employed to assist clients in identifying goals for change. A box of F&V will be delivered between sessions 1 and 2 to assist initiation of behaviour change in F&V intake. Sessions 2-8 will be conducted over 15-30 minutes and consist of motivational interviewing, education, and goal setting focused on smoking, F&V consumption, and screen use. Adherence to the intervention will be monitored through a log of telephone sessions. Where clinically appropriate, smokers will be encouraged to access their general practitioner for nicotine replacement therapy (subsidised by the MBS).
Intervention code [1] 291745 0
Prevention
Intervention code [2] 291746 0
Lifestyle
Intervention code [3] 291971 0
Behaviour
Comparator / control treatment
Treatment as usual. Whilst this may vary between participants, it is likely that the person is working with a psychiatrist to address their mental health concerns. They will also likely be working with a Neami support worker who is helping to support their psychosocial goals and needs.
Control group
Active

Outcomes
Primary outcome [1] 294940 0
Number of cigarettes/day as assessed by the Timeline Followback Method.
Timepoint [1] 294940 0
Baseline, 12-weeks and 16-weeks post commencement of intervention.
Secondary outcome [1] 314400 0
Smoking point prevalence abstinence assessed by 7-day smoking point prevalence abstinence self-reported by participants and using the Timeline Followback Method.
Timepoint [1] 314400 0
Baseline, 12-weeks and 16-weeks post commencement of intervention.
Secondary outcome [2] 314401 0
Smoking quit attempts. Participants are asked to report the number of serious quit attempts made since the previous assessment. The following explanation is read to participants to describe serious quit attempts: "By serious attempt I mean you decided that you would try to make sure you never smoked again. Please include any attempt that you are currently making and please include any successful attempt made since we last spoke".
Timepoint [2] 314401 0
Baseline, 12-weeks and 16-weeks post commencement of intervention.
Secondary outcome [3] 314402 0
Use of Nicotine Replacement Therapy assessed by self-reports.
Timepoint [3] 314402 0
Baseline, 12-weeks and 16-weeks post commencement of intervention.
Secondary outcome [4] 314403 0
Readiness to quit smoking assessed using the Smoking Stages of Change (Short Form).
Timepoint [4] 314403 0
Baseline, 12-weeks and 16-weeks post commencement of intervention.
Secondary outcome [5] 314404 0
Fruit & vegetable consumption as assessed by the fruit & vegetable subscales of the Australian Recommended Food Score (ARFS) diet quality index.
Timepoint [5] 314404 0
Baseline, 12-weeks and 16-weeks post commencement of intervention.
Secondary outcome [6] 314405 0
Leisure screen time assessed using Marshall Sedentary questions targeting television viewing and use of computers and other screens at home.
Timepoint [6] 314405 0
Baseline, 12-weeks and 16-weeks post commencement of intervention.
Secondary outcome [7] 314406 0
Minutes spent per day of walking, moderate and vigorous physical activity, assessed using the International Physical Activity Questionnaire (IPAQ).
Timepoint [7] 314406 0
Baseline, 12-weeks and 16-weeks post commencement of intervention.
Secondary outcome [8] 314407 0
Substance use assessed using the Timeline Follow Back Tool (TLFB).
Timepoint [8] 314407 0
Baseline, 12-weeks and 16-weeks post commencement of intervention.
Secondary outcome [9] 314408 0
Quality of life assessed using the WHO-8 Quality of Life Scale.
Timepoint [9] 314408 0
Baseline, 12-weeks and 16-weeks post commencement of intervention.
Secondary outcome [10] 314409 0
Symptom distress as assessed by the Kessler-10.
Timepoint [10] 314409 0
Baseline, 12-weeks and 16-weeks post commencement of intervention.
Secondary outcome [11] 314410 0
Participant satisfactions as assessed by the Client Satisfaction Questionnaire-8.
Timepoint [11] 314410 0
Baseline, 12-weeks and 16-weeks post commencement of intervention.

Eligibility
Key inclusion criteria
(i) registration as a consumer of Neami services; (ii) currently living with a severe mental illness (e.g. schizophrenia, bipolar disorder); (iii) age =18 years or older; (iv) identification of a health related goal.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) currently enrolled in a Neami face-to-face healthy lifestyle peer support intervention; (ii) enrolled in a Neami service that would preclude participation (e.g. homelessness services); (iii) hearing impairment sufficient to prohibit a telephone interview; (iv) acute suicidality; (v) pregnancy; and (vi) acquired brain injury.

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)
Recruitment of participants will occur from Neami services across Australia.
Establishment: Neami staff nationwide will receive education around identification, initial eligibility screening and referral to the project.
Identification: As part of current routine care, Neami support workers conduct regular needs and goal assessments with consumers. For all consumers who identify health needs or goals, support staff will refer the consumer to the study. Participants may also self-refer. Advertising of the study will include flyers in Neami offices, Neami newsletters and via letters mailed to Neami consumers.
Referral: With the consumer’s permission, Neami staff will provide the project officer with the contact details of eligible and interested consumers.
Screening: The project officer will screen referred consumers to determine if they meet inclusion criteria. Non-eligible consumers will be referred to appropriate services, and with permission, feedback regarding ineligibility will be given to their local support worker.
Consent: Eligible and interested participants will provide informed consent. A participant information statement and consent form will be mailed or emailed to the participant. All research activities will take place via phone.
On enrolment to the study, each participant will be allocated a study number. A sealed envelope will be pre-prepared that will include the study number on the outside of the envelope, and the persons treatment condition on the inside of the envelope. Immediately following the initial assessment, the assessment officer will open the envelope and inform the person of their treatment condition. Results of the baseline assessment will be provided to the allocated peer health coach, by the assessment officer, for participants allocated to the intervention. An electronic record of allocations will be kept to verify correct treatment receipt.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be managed independently by a member of our team (RM). Participants will be assigned a unique study number according to a computer-generated randomisation schedule and stratified for smoking status, gender, and duration of illness (<5, 5-10, or 10+ years). Immediately following trial enrolment and baseline assessments, the participant will be informed of their treatment allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Outcome assessment officers who are blind to condition will complete the 12 and 16-week outcome assessments. Assessors will be located within a separate organisation to the peer coaches and will not have any direct contact with the peer workers. Assessors will not have access to treatment files. Participants will be asked not to divulge treatment information. If a participant does divulge their treatment condition, an alternate assessment officer will complete all follow-up assessments for that participant.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The proposed study will be conducted using a randomised controlled pilot study design with intention-to-treat analyses applied. The effect of the treatment condition on the primary outcome measure of number of cigarettes smoked per day will be assessed against the control group using a pre-test vs. post-test by treatment group interaction in a repeated measures random effects regression model (‘xtreg’ in Stata SE version 11.2). The pre- vs. post-test contrast will consist of baseline vs. the two post-test measures together.
Being a pilot trial the study will not be powered to detect a significant treatment effect but it will provide an indication of the size of the treatment effect that we can expect from the intervention and it will allow us to derive a more precise indication of the sample size required to detect a clinically meaningful reduction in smoking in subsequent full-scale trials.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/05/2015
Actual
26/06/2015
Date of last participant enrolment
Anticipated
16/05/2016
Actual
29/06/2016
Date of last data collection
Anticipated
Actual
18/12/2016
Sample size
Target
60
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment postcode(s) [1] 9611 0
2500 - Wollongong
Recruitment postcode(s) [2] 9612 0
2000 - Sydney
Recruitment postcode(s) [3] 9613 0
4000 - Brisbane
Recruitment postcode(s) [4] 9614 0
3000 - Melbourne
Recruitment postcode(s) [5] 9615 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 291183 0
Charities/Societies/Foundations
Name [1] 291183 0
Schizophrenia Fellowship NSW
Country [1] 291183 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Schizophrenia Fellowship NSW
Address
O'Reilly Street, Wagga Wagga NSW, Australia, 2650
Country
Australia
Secondary sponsor category [1] 289863 0
None
Name [1] 289863 0
Address [1] 289863 0
Country [1] 289863 0
Other collaborator category [1] 278442 0
Commercial sector/Industry
Name [1] 278442 0
Neami National
Address [1] 278442 0
247-249 Rosanna Road, Rosanna, VIC 3084
Country [1] 278442 0
Australia
Other collaborator category [2] 278443 0
Charities/Societies/Foundations
Name [2] 278443 0
SANE Australia
Address [2] 278443 0
PO Box 226, South Melbourne, VIC 3205
Country [2] 278443 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292755 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 292755 0
Ethics committee country [1] 292755 0
Australia
Date submitted for ethics approval [1] 292755 0
06/03/2015
Approval date [1] 292755 0
12/03/2015
Ethics approval number [1] 292755 0
HE14/345

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

Contacts
Principal investigator
Name 56870 0
Dr Peter Kelly
Address 56870 0
School of Psychology, University of Wollongong, Northfields Avenue, Wollongong, NSW, 2500
Country 56870 0
Australia
Phone 56870 0
+61 2 42392382
Fax 56870 0
Email 56870 0
pkelly@uow.edu.au
Contact person for public queries
Name 56871 0
Peter Kelly
Address 56871 0
School of Psychology, University of Wollongong, Northfields Avenue, Wollongong, NSW, 2500
Country 56871 0
Australia
Phone 56871 0
+61 2 42392382
Fax 56871 0
Email 56871 0
pkelly@uow.edu.au
Contact person for scientific queries
Name 56872 0
Peter Kelly
Address 56872 0
School of Psychology, University of Wollongong, Northfields Avenue, Wollongong, NSW, 2500
Country 56872 0
Australia
Phone 56872 0
+61 2 42392382
Fax 56872 0
Email 56872 0
pkelly@uow.edu.au

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.