Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000351910
Ethics application status
Approved
Date submitted
5/09/2019
Date registered
12/03/2020
Date last updated
13/07/2021
Date data sharing statement initially provided
12/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of a population-level telephone coaching service on health risk behaviours in people with a mental health condition
Scientific title
The effectiveness of a population-level telephone coaching service on health risk behaviours in people with a mental health condition: a randomised controlled trial
Secondary ID [1] 297622 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor nutrition 311902 0
Inadequate physical activity 311903 0
Mental health 311906 0
Chronic disease 311998 0
Condition category
Condition code
Public Health 310485 310485 0 0
Health service research
Mental Health 310486 310486 0 0
Other mental health disorders
Public Health 310487 310487 0 0
Health promotion/education
Diet and Nutrition 312755 312755 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention participants will receive:

1. Health literature, and
2. An active referral to the NSW Get Healthy Coaching and Information Service

1. Health Literature:
Intervention participants will receive health literature brochures including information on behavioural risks and providing guidance on behaviour change. These brochures were designed by the research team in conjunction with the Mental Health Service for a previous research study.

2. Intervention participants will receive a proactive referral to the NSW Get Healthy Coaching and Information Service: https://www.gethealthynsw.com.au

The NSW Get Healthy Coaching and Information Service is a free, government funded telephone support service that supports people to make healthy lifestyle changes. The service aims to take clients through a 6-month coaching program, providing information on healthy eating, physical activity, healthy weight and weight management, and type-II diabetes prevention. Following the referral, a Healthy Lifestyle Coach from the service will make contact with the participant. Participants can elect to receive ‘information only’ (a single phone call and hard copy resources mailed from the service) or may opt to enrol in the 6-month coaching program.

Coaching program: Participants who choose to commence the program receive up to 10 calls over 6 months, during which they are provided with advice and support to achieve health behaviour change. Calls are delivered by university qualified health coaches (dietitians, exercise physiologists, nurses), who are trained in motivational interviewing. Coaches assist the clients to set their own behavioural goals and provide additional tips and educational materials. During their first call with a coach, participants complete a health assessment with information collected around their current health behaviours, health-related goals, and any current or previous mental health conditions. Participants are allocated to a coaching module (including: the standard program, Aboriginal and Torres Strait Islander cultural adaptation, and diabetes prevention program) based on responses to the health assessment. Each module aims to support health behaviour change. It may also focus on particular health concerns including alcohol reduction, type 2 diabetes prevention or may include tailored modules for specific populations including pregnant women or those who identify as Aboriginal and Torres Strait Islander. Participants enrolled in these specialised programs can receive up to 13 calls.
Intervention code [1] 313865 0
Behaviour
Intervention code [2] 313866 0
Lifestyle
Intervention code [3] 313867 0
Prevention
Comparator / control treatment
Control participants will receive health literature brochures including information on behavioural risks and providing guidance on behaviour change (as per the intervention group). These brochures were designed by the research team in conjunction with the Mental Health Service for a previous research study.
Control group
Active

Outcomes
Primary outcome [1] 319352 0
Self-reported engagement in physical activity (number of minutes of moderate to vigorous exercise over the past 7 days) using the Simple Physical Activity Questionnaire (SIMPAQ). The SIMPAQ measures combined physical activity across all domains including leisure time, domestic, work and transport-related activities and provides an evaluation over a 24-hour period that is representative of the previous week, including sedentary time, walking, structured exercise, and other incidental activities.
Timepoint [1] 319352 0
Assessed at baseline and 6 months (primary endpoint) post recruitment.
Primary outcome [2] 321180 0
Average serves of fruit consumed per day over the last month; assessed using self-report: "Over the last month, on average, how many serves of fruit did you eat a day?"
Timepoint [2] 321180 0
Assessed at baseline and 6 months (primary endpoint) post recruitment.
Primary outcome [3] 322810 0
Average serves of vegetables consumed per day over the last month; assessed using self-report: "Over the last month, on average, how many serves of vegetables did you eat a day?"
Timepoint [3] 322810 0
Assessed at baseline and 6 months (primary endpoint) post recruitment.
Secondary outcome [1] 379848 0
Primary outcome: whether or not participants had attempted to change their physical activity, fruit consumption, vegetable consumption, or other parts of their nutrition in the last 6 months (composite outcome); assessed using self-report during telephone interviews (study-specific survey items).
Timepoint [1] 379848 0
Assessed at baseline and 6 months (primary endpoint) post recruitment.
Secondary outcome [2] 379849 0
Whether or not participants had attempted to change their alcohol consumption in the last 6 months; assessed using self-report during telephone interviews (study-specific survey item).
Timepoint [2] 379849 0
Assessed at baseline and 6 months (primary endpoint) post recruitment.
Secondary outcome [3] 379850 0
Whether or not participants had attempted to change their physical activity levels in the last 6 months; assessed using self-report during telephone interviews (study-specific survey item).
Timepoint [3] 379850 0
Assessed at baseline and 6 months (primary endpoint) post recruitment.
Secondary outcome [4] 379851 0
Whether or not participants had attempted to change their fruit consumption in the last 6 months; assessed using self-report during telephone interviews (study-specific survey item).
Timepoint [4] 379851 0
Assessed at baseline and 6 months (primary endpoint) post recruitment.
Secondary outcome [5] 379852 0
Whether or not participants had attempted to change their vegetable consumption in the last 6 months; assessed using self-report during telephone interviews (study-specific survey item).
Timepoint [5] 379852 0
Assessed at baseline and 6 months (primary endpoint) post recruitment.
Secondary outcome [6] 379853 0
Whether or not participants had attempted to change other parts of their nutrition in the last 6 months; assessed using self-report during telephone interviews (study-specific survey item).
Timepoint [6] 379853 0
Assessed at baseline and 6 months (primary endpoint) post recruitment.
Secondary outcome [7] 379854 0
Weight; assessed using self-report during telephone interviews (study-specific survey item).
Timepoint [7] 379854 0
Assessed at baseline and 6 months (primary endpoint) post recruitment.
Secondary outcome [8] 379855 0
Body Mass Index (BMI) (calculated using self-report of weight and height). Assessed using self-report during telephone interviews (study-specific survey item)
Timepoint [8] 379855 0
Assessed at baseline and 6 months (primary endpoint) post recruitment.
Secondary outcome [9] 379856 0
Uptake of referral to the NSW Get Healthy Information and Coaching service
Timepoint [9] 379856 0
Assessed at service completion or withdrawal (using records from the NSW Get Healthy Coaching and Information Service)
Secondary outcome [10] 379857 0
Number of calls completed with the NSW Get Healthy Information and Coaching service
Timepoint [10] 379857 0
Assessed at service completion or withdrawal (using records from the NSW Get Healthy Coaching and Information Service)
Secondary outcome [11] 379858 0
Retention/attrition rates in the NSW Get healthy Information and Coaching service program
Timepoint [11] 379858 0
Assessed at service completion or withdrawal (using records from the NSW Get Healthy Coaching and Information Service)
Secondary outcome [12] 379859 0
Length of time with the NSW Get Healthy Information and Coaching service
Timepoint [12] 379859 0
Assessed at service completion or withdrawal (using records from the NSW Get Healthy Coaching and Information Service)

Eligibility
Key inclusion criteria
Participants will be recruited from mental health services across several local health districts and community managed organisations in New South Wales, Australia.

To be eligible, participants must:
- Have a working telephone number
- Currently be currently receiving care or have received care in the past 12 months for a mental health condition from one of the participating mental health services or community managed organisations
- Upon contact, confirm a willingness to engage with or be contacted by a telephone-based support service.
Minimum age
18 Years
Maximum age
No limit
Sex
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. Clients who self-report being currently enrolled in the Get Healthy service coaching program or having used the service in the previous 4 months will be excluded.

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)
A statistician independent of the project will generate a random allocation sequence prior to commencement of recruitment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomised allocation tables will be sent from the statistician to an independent REDCap consultant who will then upload the allocation sequence into the REDCap database. This will ensure all researchers are blinded to the group allocation until after the participant has completed the baseline survey. Participants will be allocated to either the intervention group or to the control group at a ratio of 4:1 respectively with separate randomisation tables for each site.
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
Regression models will be used to compare the primary outcomes between the health literature and telephone coaching referral conditions at the primary end point of the study: the 6 month follow-up, adjusting for baseline confounding factors such as age, sex, and diagnosis. Similar analyses will be conducted for secondary outcomes.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
10/10/2019
Date of last participant enrolment
Anticipated
30/06/2020
Actual
19/01/2021
Date of last data collection
Anticipated
13/08/2021
Actual
Sample size
Target
675
Accrual to date
Final
683
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 302165 0
Government body
Name [1] 302165 0
Cancer Institute NSW
Country [1] 302165 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 302005 0
Government body
Name [1] 302005 0
Hunter New England Population Health
Address [1] 302005 0
Longworth Ave, Wallsend, NSW 2287
Country [1] 302005 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302846 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 302846 0
Ethics committee country [1] 302846 0
Australia
Date submitted for ethics approval [1] 302846 0
04/09/2018
Approval date [1] 302846 0
29/10/2018
Ethics approval number [1] 302846 0
2018/ETH00377
Ethics committee name [2] 302897 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 302897 0
Ethics committee country [2] 302897 0
Australia
Date submitted for ethics approval [2] 302897 0
22/01/2019
Approval date [2] 302897 0
24/01/2019
Ethics approval number [2] 302897 0
H-2019-0013

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

Contacts
Principal investigator
Name 91590 0
Prof Jenny Bowman
Address 91590 0
School of Psychology, Building W, University of Newcastle
University Drive
Callaghan NSW 2308
Country 91590 0
Australia
Phone 91590 0
+61249215958
Fax 91590 0
Email 91590 0
[email protected]
Contact person for public queries
Name 91591 0
Jenny Bowman
Address 91591 0
School of Psychology, Building W, University of Newcastle
University Drive
Callaghan NSW 2308
Country 91591 0
Australia
Phone 91591 0
+61249215958
Fax 91591 0
Email 91591 0
[email protected]
Contact person for scientific queries
Name 91592 0
Jenny Bowman
Address 91592 0
School of Psychology, Building W, University of Newcastle
University Drive
Callaghan NSW 2308
Country 91592 0
Australia
Phone 91592 0
+61249215958
Fax 91592 0
Email 91592 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7225Study protocol    Study protocol citation will be provided when publ... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of referral to a population-level telephone coaching service for improving health risk behaviours in people with a mental health condition: study protocol for a randomised controlled trial.2022https://dx.doi.org/10.1186/s13063-021-05971-6
N.B. These documents automatically identified may not have been verified by the study sponsor.