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Trial registered on ANZCTR


Registration number
ACTRN12616001519448
Ethics application status
Approved
Date submitted
31/10/2016
Date registered
3/11/2016
Date last updated
29/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effectiveness of a healthy lifestyle clinician in addressing the chronic disease risk behaviours of community mental health clients
Scientific title
Evaluating the effectiveness of a healthy lifestyle clinician in addressing the chronic disease risk behaviours of community mental health clients: a randomised controlled trial
Secondary ID [1] 290391 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 300695 0
Poor nutrition 300696 0
Inadequate physical activity 300697 0
Harmful alcohol consumption 300698 0
Provision of care (assessment, advice and referral) to address the chronic disease risk behaviours of community mental health clients 300774 0
Chronic disease 300778 0
Chronic disease prevention 300779 0
Condition category
Condition code
Public Health 300540 300540 0 0
Health service research
Mental Health 300615 300615 0 0
Other mental health disorders
Public Health 300616 300616 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A healthy lifestyle clinician will be embedded in one community-based mental health service in a regional area in the state of New South Wales (NSW), Australia, with the specific role of providing assessment, advice and referral to evidence based behaviour change services to modify the chronic disease risk behaviours of clients (smoking, poor nutrition, inadequate physical activity and harmful alcohol consumption). The clinician will be a mental health clinician with experience in delivering mental health care in a community setting.

Clients allocated to the intervention condition will receive a 40-minute face-to-face consultation and follow-up call with the healthy lifestyle clinician, in addition to care they might receive in the context of their routine mental health consultations.

The intervention will be implemented according to a manualised protocol based on motivational interviewing principles, with the aims of fostering client motivation for modification of risk behaviours and uptake of telephone coaching services (NSW Quitline (smoking) and NSW Get Healthy Information and Coaching Service (poor nutrition, physical inactivity, alcohol consumption and weight management)). The manual will guide the healthy lifestyle clinician to:
1) Assess risk.
The healthy lifestyle clinician will assess the client’s chronic disease risk behaviours through a structured questionnaire evaluating the clients risk status in accordance with national guidelines. The clinician will assess abdominal adiposity as a sequelae of physical inactivity and inadequate fruit and vegetable consumption. The clinician will also ask the client if they have any concerns in relation to their weight or nutrition more broadly than fruit and vegetable consumption.
2) Advise.
The clinician will provide brief feedback to the client in a non-judgemental manner as to how their behaviours compare against national guidelines. Clients identified as meeting the national guidelines for one or more of the behaviours will be provided positive feedback on the health benefits of their behaviour. If the client is identified as being at-risk according to the national guidelines for any one or more of the behaviours, the healthy lifestyle clinician will provide brief advice to modify the behaviour. Further intervention based on motivational interviewing techniques will be provided for the risk behaviours, which is designed to address any ambivalence regarding the current behaviour and motivate for change. Specific strategies utilised and content discussed will be tailored to each client and may include: education about current levels of behaviour and associated health impacts; further information about guidelines and recommendations reinforcing positive intentions to change behaviour; consideration of the barriers to change; and building self-efficacy.
3) Refer.
Clients who are at-risk for smoking will be offered a referral to the NSW Quitline and in line with care offered by the NSW Get Healthy Information and Coaching Service, clients who are at-risk and/or express concern about their physical activity, weight, nutrition or alcohol consumption will be offered a referral to the Get Healthy Information and Coaching Service. If appropriate, clients will be offered a referral to both telephone services. The NSW Get Healthy Information and Coaching Service offers ten free individual coaching sessions over a six-month period to support individuals in setting and achieving weight-related behaviour change goals. The NSW Quitline offers six free individual telephone coaching sessions to support individuals to stop smoking. In line with clinical practice guidelines, all clients will be referred to their general practitioner for assessment of metabolic risks.

Approximately one week following the consultation with the healthy lifestyle clinician, the clinician will call the client to follow-up on any referrals made and briefly discuss their progress. The call will take approximately 20 minutes. Positive feedback will be provided to clients who have had contact with the telephone services and/or attended the appointment with their GP, to further encourage behaviour change. Where clients have not yet taken up referrals made, the clinician will provide encouragement to do so and seek to identify and address any barriers the client may have.

To monitor adherence, a checklist will be used by the healthy lifestyle clinician to record the aspects of the intervention that were delivered. In addition, the clinician will have regular supervision and feedback from a senior clinician with expertise in motivational interviewing.
Intervention code [1] 296223 0
Lifestyle
Intervention code [2] 296269 0
Prevention
Intervention code [3] 296270 0
Behaviour
Comparator / control treatment
Participants allocated to the control condition will receive care for chronic disease risk behaviours as is normally provided in routine consultations. In line with the current policy of the health district, this care should include: assessment of chronic disease risk behaviours (including smoking, fruit and vegetable consumption, physical activity and alcohol use), brief advice relating to the health behaviour, and offer of referral as appropriate.
Control group
Active

Outcomes
Primary outcome [1] 299959 0
The number of referrals made by the community mental health service to the NSW Quitline and NSW Get Healthy Information and Coaching Service (data provided by the respective services).
Timepoint [1] 299959 0
Assessed at a baseline and a six month follow-up (for the previous six month period).
Primary outcome [2] 299960 0
The number of participants that had telephone contact with the NSW Quitline and NSW Get Healthy Information and Coaching Service (data provided by the respective services).
Timepoint [2] 299960 0
Assessed at a baseline and a 6 month follow-up (for the previous six month period).
Primary outcome [3] 299961 0
The number of participants that engaged in a behaviour change program offered by the telephone service. For the NSW Get Healthy Information and Coaching Service, this includes enrolling in a six month coaching program. For the NSW Quitline, this includes accepting at least one follow-up coaching call from the service (data provided by the respective services).
Timepoint [3] 299961 0
Assessed at a baseline and a 6 month follow-up (for the previous six month period).
Secondary outcome [1] 328675 0
Participant reported health risk behaviour status (smoking, poor nutrition, harmful alcohol consumption and inadequate physical activity). Assessed during telephone interviews.
Timepoint [1] 328675 0
Baseline and one and six month post-baseline follow-ups.
Secondary outcome [2] 328679 0
Participant reported interest in changing the chronic disease risk behaviors (smoking, poor nutrition, inadequate physical activity and harmful alcohol consumption), rated on a 1 to 10 scale. Assessed during telephone interviews.
Timepoint [2] 328679 0
Baseline and one and six month post-baseline follow-ups.
Secondary outcome [3] 328841 0
Participant reported confidence to change the chronic disease risk behaviors (smoking, poor nutrition, inadequate physical activity and harmful alcohol consumption), rated on a 1 to 10 scale. Assessed during telephone interviews.
Timepoint [3] 328841 0
Baseline and one and six month post-baseline follow-ups
Secondary outcome [4] 328847 0
Participant reported perceived importance of changing the chronic disease risk behaviors (smoking, poor nutrition, inadequate physical activity and harmful alcohol consumption), rated on a 1 to 10 scale. Assessed during telephone interviews.
Timepoint [4] 328847 0
Baseline and one and six month post-baseline follow-ups
Secondary outcome [5] 328927 0
Participant reported receipt of assessment from the mental health service for the chronic disease risk behaviours (smoking, poor nutrition, inadequate physical activity and harmful alcohol consumption). Assessed during telephone interviews.
Timepoint [5] 328927 0
Baseline and one month post-baseline follow-up.
Secondary outcome [6] 328928 0
Participant reported receipt of advice from the mental health service for the chronic disease risk behaviours (smoking, poor nutrition, inadequate physical activity and harmful alcohol consumption). Assessed during telephone interviews.
Timepoint [6] 328928 0
Baseline and one month post-baseline follow-up
Secondary outcome [7] 328929 0
Participant reported receipt of referral from the mental health service for the chronic disease risk behaviours (smoking, poor nutrition, inadequate physical activity and harmful alcohol consumption). Assessed during telephone interviews.
Timepoint [7] 328929 0
Baseline and one month post-baseline follow-up
Secondary outcome [8] 328930 0
Participant reported satisfaction with any care received for the chronic disease risk behaviors (smoking, poor nutrition, inadequate physical activity and harmful alcohol consumption) from the mental health service. Assessed during telephone interviews.
Timepoint [8] 328930 0
Baseline and one month post-baseline follow-up

Eligibility
Key inclusion criteria
Participants will be all new and existing clients of one community mental health service in Australia.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clients who are under the age of 18 or identified by mental health staff to be too unwell or clinically inappropriate to contact will be ineligible for inclusion.

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)
Central randomisation by a computer with assistance by a statistician uninvolved in any other aspect of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Prior to commencement of the trial, a random allocation sequence using permuted-block randomisation will be generated by a statistician independent of the project. Eligible clients will be randomly allocated in a 1:1 ratio to receive usual care (control condition) or usual care plus a face-to-face consultation and follow-up call with the healthy lifestyle clinician (intervention condition).
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
Logistic regression models will be used to compare the primary outcomes between the intervention and usual care conditions at the six month follow-up point, adjusting for baseline use of the telephone services and other potential confounders such as, age, gender and number of visits to the mental health service. Similar analyses will be used for secondary outcomes. All analyses will be conducted on an intention-to-treat basis.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 14527 0
2300 - Newcastle

Funding & Sponsors
Funding source category [1] 294792 0
Other Collaborative groups
Name [1] 294792 0
The Australian Prevention Partnership Centre
Address [1] 294792 0
10, 235 Jones St, Ultimo NSW 2007
Country [1] 294792 0
Australia
Funding source category [2] 294834 0
Government body
Name [2] 294834 0
Population Health, Hunter New England Local Health District
Address [2] 294834 0
Longworth Ave, Wallsend, NSW 2287,
Country [2] 294834 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive. Callaghan NSW 2308.
Country
Australia
Secondary sponsor category [1] 293677 0
Government body
Name [1] 293677 0
Hunter New England Population Health
Address [1] 293677 0
Longworth Ave. Wallsend. NSW 2287
Country [1] 293677 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296183 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 296183 0
Locked Bag No 1. New Lambton. NSW 2305.
Ethics committee country [1] 296183 0
Australia
Date submitted for ethics approval [1] 296183 0
03/02/2016
Approval date [1] 296183 0
29/03/2016
Ethics approval number [1] 296183 0
16/02/17/4.09
Ethics committee name [2] 296220 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 296220 0
University Drive
Callaghan NSW 2308
Ethics committee country [2] 296220 0
Australia
Date submitted for ethics approval [2] 296220 0
18/04/2016
Approval date [2] 296220 0
26/04/2016
Ethics approval number [2] 296220 0
H-2016-0123

Summary
Brief summary
People with a mental illness have significantly poorer physical health and shorter life expectancy than the general population, primarily due to chronic diseases. A higher prevalence of modifiable health risk behaviours such as poor nutrition, inadequate physical activity, harmful alcohol consumption and smoking contribute substantially to this disparity. Evidence based guidelines recommend that mental health services routinely provide care to address these risk behaviours, however, the provision of such care is consistently reported to be low in Australia and internationally.

A randomised controlled trial will be conducted to determine the effectiveness, acceptability and feasibility of allocating a designated clinician within a community mental health service to the specific role of providing assessment, advice and referral for clients' chronic disease risk behaviours. Clients of one community mental health service in NSW, Australia will be randomly allocated to receive either usual care for chronic disease risk behaviours, or usual care plus an additional face-to-face consultation and follow-up telephone call with a ‘healthy lifestyle clinician’. The role of the clinician will be to assess clients’ chronic disease risk behaviours, provide advice to change behaviours, and refer at-risk clients with free government telephone coaching services (NSW Quitline and NSW Get Healthy Information and Coaching Service) for ongoing care.

The primary outcomes, referral to and uptake of the NSW Quitline and NSW Get Healthy Information and Coaching Service, will be obtained from the respective services. Telephone interviews of clients will be conducted at baseline and one and six month post baseline follow-up to assess secondary outcomes: self-reported chronic disease risk behaviour status, self-reported receipt of any assessment, advice and referral from the mental health service, satisfaction with the receipt of such care, and interest, confidence and perceived importance of changing risk behaviours.
Trial website
Trial related presentations / publications
Publication: Caitlin Fehily, Kate Bartlem, John Wiggers, Paula Wye, Richard Clancy, David Castle, Sonia Wutzke, Chris Rissel, Andrew Wilson, Paul McCombie, Fionna Murphy, Jenny Bowman. Evaluating the effectiveness of a healthy lifestyle clinician in addressing the chronic disease risk behaviours of community mental health clients: study protocol for a randomised controlled trial. Trials. 2017. 18:276.

Oral presentation: Caitlin Fehily, Kate Bartlem, John Wiggers, Paula Wye, Richard Clancy, David Castle, Sonia Wutzke, Chris Rissel, Andrew Wilson, Paul McCombie, Fionna Murphy, Jenny Bowman. Embedding a healthy lifestyle clinician in a mental health service: an RCT. Public Health Prevention Conference. Sydney, NSW, Australia. 2-4 May 2018.

Poster presentation: Caitlin Fehily, Kate Bartlem, John Wiggers, Paula Wye, RIchard Clancy, David Castle, Sonia Wutzke, Chris Rissel, Andrew Wilson, Paul McCombie, Fionna Murphy and Jenny Bowman. EVALUATING THE EFFECTIVENESS OF A HEALTHY LIFESTYLE CLINICIAN IN ADDRESSING THE CHRONIC DISEASE RISK BEHAVIOURS OF COMMUNITY MENTAL HEALTH CLIENTS: A STUDY PROTOCOL FOR A RANDOMISED CONTROLLED TRIAL. International Congress of Behavioural Medicine, Melbourne, VIC, Australia. 7-11 Dec 2016.
Public notes

Contacts
Principal investigator
Name 69894 0
A/Prof Jenny Bowman
Address 69894 0
School of Psychology, Building W, University of Newcastle
University Drive
Callaghan
NSW
2308
Country 69894 0
Australia
Phone 69894 0
+612 49215958
Fax 69894 0
Email 69894 0
jenny.bowman@newcastle.edu.au
Contact person for public queries
Name 69895 0
A/Prof Jenny Bowman
Address 69895 0
School of Psychology, Building W, University of Newcastle
University Drive
Callaghan
NSW
2308
Country 69895 0
Australia
Phone 69895 0
+612 49215958
Fax 69895 0
Email 69895 0
jenny.bowman@newcastle.edu.au
Contact person for scientific queries
Name 69896 0
A/Prof Jenny Bowman
Address 69896 0
School of Psychology, Building W, University of Newcastle
University Drive
Callaghan
NSW
2308
Country 69896 0
Australia
Phone 69896 0
+612 49215958
Fax 69896 0
Email 69896 0
jenny.bowman@newcastle.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary