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Trial registered on ANZCTR


Registration number
ACTRN12618001781235
Ethics application status
Approved
Date submitted
25/10/2018
Date registered
30/10/2018
Date last updated
23/09/2021
Date data sharing statement initially provided
30/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Testing the effectiveness of supported referral to healthy lifestyle interventions in reducing the number of modifiable risk factors among primary care patients.
Scientific title
Testing the effectiveness of supported referral to healthy lifestyle interventions in reducing the number of modifiable risk factors among primary care patients.
Secondary ID [1] 293334 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic diseases 305425 0
Cardiovascular disease 305426 0
Diabetes 305427 0
Cancer 305428 0
Condition category
Condition code
Public Health 304705 304705 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible general practice patients will complete a brief (approximately 10 minute) touchscreen computer survey on a tablet device while in the waiting room prior to their appointment. The survey will assess whether the patient has modifiable risk factors related to: smoking, alcohol consumption and overweight or obesity using validated tools. Those who indicate that they have at least one of these risk factors will be eligible to participate in the trial. Patients who are randomised to the intervention condition will receive:
(i) Tailored written feedback. A patient feedback sheet that is tailored based on the participants responses to the baseline survey will be automatically printed upon completion of the assessment using a dedicated printer located in the reception area. The feedback sheet will be handed to the patient when they return the tablet computer to the research assistant. The feedback sheet will include information about recommended preventive healthcare actions based on answers to the baseline survey.
(ii) GP endorsement of feedback. The GP will emphasise the importance of preventive care in the patient’s appointment and will recommend that the patient book at reception for a face-to-face nurse consultation. If the patient forgets to make the appointment, the nurse will phone the patient to make the appointment.
(iii) Face-to-face consultation with a practice nurse, involving risk counselling, motivational interviewing and provision of referral to evidence-based services. The nurse will provide a face-to-face consultation which comprises: 1) Review of identified risk factors including brief advice. The nurse will provide a brief verbal overview of what their feedback means, for example, how their risk factors compare to relevant guideline recommendations; the potential adverse health consequences associated with these, and what level of change would needed to make a difference to their health.
2) Assessment of patient interest in reducing their risk factors. To establish the patient’s motivation and confidence to make changes the nurse will ask how patients feel about making a change (e.g. quitting smoking, losing weight). The nurse will affirm and encourage patients interested in making a change. If the patient is not willing address their risk factors at this time, the nurse will arrange to follow-up with the patient in 4 weeks by telephone to see if they would be willing to consider a referral at this time.
3) Assessment of barriers/enablers to addressing risk factors. For those who are interested in addressing one or more risk factors, the nurse will elicit patient views about factors that may help or hinder them in making lifestyle changes. For example, knowledge about what strategies will work, social support, environmental triggers etc.
4) Referrals to external support services. The nurse will refer the patient to the “Get Healthy Service” call back service for overweight / obesity and/ or risky alcohol consumption. The ‘call back’ service involves the patient receiving a proactive telephone call from the service rather than the patient initiating contact.
The Get Healthy Information and Coaching Service® (Get Healthy Service) is a free telephone service (phone: 1300 806 258) staffed by qualified health coaches that provides information and ongoing support to people in NSW aimed at changing an individual’s behaviour regarding healthy eating, physical activity, and how to reach and maintain a healthy weight. The Get Healthy Service has two streams: 1) information only (a one-time coaching call and printed information); or 2) 6 month coaching program (10 coaching calls over 6 months). The Get Healthy service will assign participants to the most appropriate stream dependent on participant preference and the health coach's recommendation.

A Quitline call back referral will be made for those who report current smoking. Quitline is a telephone service (phone: 13 78 48) that provides information and advice or counselling to people in NSW who want to quit smoking. A free Quit Pack can be requested which includes: a Quit Book containing information on: the best way to quit, coping with withdrawal symptoms, proactive telephone counselling, and local organisations that can provide help and counselling; and a pocket guide with hints on how to stay a non-smoker.
Participants with internet access will also be provided with information about QuitCoach, a free online tool to assist in quitting smoking. This service includes the development of a personalised quitting plan based on participant responses to questions about motivation, confidence and past attempts. http://www.quitcoach.org.au/

A referral to the GP may also be made if there are health conditions that need to be considered when making lifestyle changes (e.g. mobility issues, heart condition), and/or if a pharmacological intervention to assist with smoking cessation should be considered. For example, nicotine replacement therapy can be prescribed where appropriate.

Post-consultation follow-up (two-weeks later)
The nurse will also arrange a follow-up visit or phone call two weeks post face-to-face consultation to review how the plan is going, any issues experienced and if patient has received a call back or phoned the referral services suggested to them e.g. the Get Healthy Service or Quitline.
Intervention code [1] 299591 0
Prevention
Intervention code [2] 299592 0
Lifestyle
Intervention code [3] 299593 0
Behaviour
Comparator / control treatment
Participants in the control condition will not receive feedback about their identified risk factors. Those allocated to the control condition will receive standard care. This includes any care the GP and/or practice nurse would normally deliver to treat any chronic or acute conditions.
Control group
Active

Outcomes
Primary outcome [1] 303919 0
Number of risk factors (smoking, drinking alcohol at levels above Australian guidelines, and overweight/obesity). Smoking and alcohol intake will be assessed by a study-specific questionnaire, overweight/obesity will be assessed by stadiometer and digital scales.
Timepoint [1] 303919 0
3 and 6 [primary timepoint] months after baseline survey
Secondary outcome [1] 340458 0
Smoking status as assessed by study-specific questionnaire and verified by breath carbon monoxide.
Timepoint [1] 340458 0
3 and 6 month after baseline survey
Secondary outcome [2] 340459 0
Alcohol intake as assessed by study-specific questionnaire
Timepoint [2] 340459 0
3 and 6 months after baseline survey
Secondary outcome [3] 340460 0
Weight as assessed by digital scales.
Timepoint [3] 340460 0
3 and 6 months after baseline survey

Eligibility
Key inclusion criteria
Patients aged 18 to 75 years who are attending a participating primary care clinic and who have at least one of the following health risk factors will be eligible to participate: current smoker; consumes alcohol above levels recommended by health guidelines; or categorised as overweight (BMI is between 25 kg/m2 and 29.99 kg/m2) or obese (BMI is equal to or greater than 30 kg/m2).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients aged less than 18 years of age or above 75 years of age. Patients who are considered by practice staff to be too unwell to participate. Patients that are unable to complete the touchscreen survey on their own (e.g. vision-impaired, non-English speaking).

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Separate computer-generated randomisation tables will be generated for each clinic. Each session that recruitment takes place in a participating clinic will be randomly allocated to either the intervention or control condition.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

For each of the risk factors of interest, baseline and follow-up measures will be compared to determine if the patient has successfully achieved a reduction in each risk factor. The following be used to define a reduction in each of the risk factors:
Smoking cessation: Those who are classified as a smoker at baseline via self-reported smoking status will report being a non-smoker at follow-up.
Alcohol: Those who report drinking above the levels reported in the NHMRC guidelines will report a reduction at or below the levels recommended by the NHMRC at follow-up.
Weight loss: For those who are classified as overweight or obese at baseline, a reduction of 5% of their measured body weight at follow-up will be considered a successful outcome. A 5% weight reduction was deemed appropriate as it is at this amount of weight loss that important health benefits are experienced, and a weight loss goal of 5-10% of initial body weight is recommended. In addition, weight change as a percentage of baseline weight was chosen as the outcome measure instead of absolute weight loss.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/10/2018
Date of last participant enrolment
Anticipated
30/09/2021
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
120
Accrual to date
88
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 297958 0
Charities/Societies/Foundations
Name [1] 297958 0
Cancer Council NSW
Country [1] 297958 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive, Callaghan
NSW 2308
Country
Australia
Secondary sponsor category [1] 297053 0
None
Name [1] 297053 0
Address [1] 297053 0
Country [1] 297053 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299000 0
University of Newcastle Human Research Ethics Committee (EC00144)
Ethics committee address [1] 299000 0
Ethics committee country [1] 299000 0
Australia
Date submitted for ethics approval [1] 299000 0
01/09/2017
Approval date [1] 299000 0
14/12/2017
Ethics approval number [1] 299000 0
H-2017-0290

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

Contacts
Principal investigator
Name 78954 0
A/Prof Mariko Carey
Address 78954 0
Level 4 West, HMRI Building
University of Newcastle
University Drive
Callaghan, NSW, 2308
Country 78954 0
Australia
Phone 78954 0
+61 2 4042 0702
Fax 78954 0
Email 78954 0
mariko.carey@newcastle.edu.au
Contact person for public queries
Name 78955 0
Mariko Carey
Address 78955 0
Level 4 West, HMRI Building
University of Newcastle
University Drive
Callaghan, NSW, 2308
Country 78955 0
Australia
Phone 78955 0
+61 2 4042 0702
Fax 78955 0
Email 78955 0
mariko.carey@newcastle.edu.au
Contact person for scientific queries
Name 78956 0
Mariko Carey
Address 78956 0
Level 4 West, HMRI Building
University of Newcastle
University Drive
Callaghan, NSW, 2308
Country 78956 0
Australia
Phone 78956 0
+61 2 4042 0702
Fax 78956 0
Email 78956 0
mariko.carey@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The conditions of our ethics approval prohibit release of individual data and only allow sharing of aggregate data.


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.