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Trial registered on ANZCTR


Registration number
ACTRN12616001331426
Ethics application status
Approved
Date submitted
21/09/2016
Date registered
23/09/2016
Date last updated
12/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial to determine the effectiveness of an intervention combining Motivational Interviewing and Cognitive Behaviour Treatment to increase physical activity in non-admitted patients from a tertiary hospital in regional Australia.
Scientific title
A randomised controlled trial to determine the effectiveness of an intervention combining Motivational Interviewing and Cognitive Behaviour Treatment to increase physical activity in non-admitted patients from a tertiary hospital in regional Australia.
Secondary ID [1] 290105 0
None
Universal Trial Number (UTN)
Trial acronym
H4U
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health related behaviour change. 300199 0
Physical inactivity

300360 0
Quality of life
300361 0
Type 2 diabetes 300362 0
Condition category
Condition code
Public Health 300081 300081 0 0
Health promotion/education
Metabolic and Endocrine 300227 300227 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants enrolling in the project will have to attend a briefing session. The briefing session will be a facilitated learning session based around self-management and behaviour change carried out using the Self-Determination Theory (SDT) framework. This theory is used to support, educate and motivate participants around positive lifestyle choices, as well as the empowerment of individuals over their health care. SDT has been chosen as the framework in which to deliver the briefing session as has been shown to complement MI and CBT integration. The briefing session will be delivered face-to-face in a group setting, with up to 9 participants to a group. The session will last for approximately 45 minutes.

The intervention group will receive the blend of MI and CBT delivered over the telephone. Each participant will receive 8 calls over a 12-week period. Participants will receive 6 calls in the first 8 weeks, and 2 calls in the final 4 weeks. In terms of incorporating MI and CBT, MI will be utilised for sessions 1 to 5. From session 5 to session 8 a blend of MI/CBT will be used. The intervention will begin for participants one week after they have attended the briefing session.

Both the briefing sessions and the MI/CBT intervention will be delivered by an Australian Health Practitioner Regulating Authority (APHRA) registered physiotherapist. He has attended a 2-day workshop on MI and will receive additional coaching from a nationally endorsed Health Psychologist and Sport and Exercise Psychologist.

As part of self-management support, participants, where the intervention is appropriate, may be referred into community programs aimed at lifestyle risk modification. Following the MI/CBT theory, no mandatory referrals will be made to these programs, however the facilitator may highlight the existence of these programs should the situation warrant it. The facilitator will be aware of the programs that are available in the community and can make appropriate consented referrals to the programs on behalf of the participants.

The treatment fidelity will be evaluated and measured prior to the intervention and midway through the intervention time-frame. This will be carried out through the recording of sessions between the facilitator and a nationally endorsed Health Psychologist and having the recordings assessed by an independent assessor who will rate the MI proficiency by using a validate tool the Motivational Interviewing Treatment Integrity (MITI) scale.
Intervention code [1] 295854 0
Lifestyle
Intervention code [2] 295855 0
Prevention
Intervention code [3] 295856 0
Treatment: Other
Comparator / control treatment
The comparator for the Healthy 4U project is termed the minimal intervention arm of the project.

All participants of the minimal intervention group are required to attend the briefing session. As described above, the briefing session will be a facilitated learning session based around self-management and behaviour change carried out using the Self-Determination Theory (SDT) framework. This theory is used to support, educate and motivate participants around positive lifestyle choices, as well as the empowerment of individuals over their health care.

Participants in the minimal intervention group will receive no further behaviour change support from the research team.
Control group
Active

Outcomes
Primary outcome [1] 299563 0
Objectively measured levels of physical activity determined via 7-day accelerometry with activity diary.
Timepoint [1] 299563 0
Baseline, week 13 (1 week post intervention) and at 6 months
Secondary outcome [1] 327511 0
Physical Activity Self-Efficacy, measured via physical activity self-efficacy survey.
Sallis, J.F., Pinski, R.B., Grossman, R.M., Patterson, T.L., and Nader, P.R. The development of self-efficacy scales for health-related diet and exercise behaviors. Health Education Research. 1988; 3, 283-292.
Timepoint [1] 327511 0
Baseline, week 13 (1 week post intervention) and at 6 months
Secondary outcome [2] 327512 0
Quality of Life, measured via SF-12.
Brazier J. Roberts, J. The Estimation of a Preference-Based Measure of Health from the SF-12. Medical Care. 2004; 42(9):851-859
Timepoint [2] 327512 0
Baseline, week 13 (1 week post intervention) and at 6 months
Secondary outcome [3] 327526 0
Type 2 Diabetes risk, assessed via the AUSDRISK tool.
Chen L, Magliano DJ, Balkau B, Colagiuri S, Zimmet PZ, Tonkin AM, Mitchell P, Phillips PJ, Shaw JE. AUSDRISK: an Australian Type 2 Diabetes Risk Assessment Tool based on demographic, lifestyle and simple anthropometric measures. Med J Aust. 2010 Feb 15;192(4):197-202.
Timepoint [3] 327526 0
Baseline, 13 weeks (1 week post intervention) and 6 months.
Secondary outcome [4] 327527 0
Cost-effectiveness of the program determined by an economic analysis
Timepoint [4] 327527 0
6 months

Eligibility
Key inclusion criteria
All participants will be recruited from an elective non-admitted outpatient clinic in Bendigo Health; only non-admitted patients are eligible for participation in this study.

Study participants will be required to be fluent in conversational English, insufficiently physically active (not participating thirty minutes or more of moderate physical activity on at least five days a week; 150 mins/week).

Interested participants will be required to complete a Physical Activity Readiness Questionnaire (PAR-Q). The PAR-Q offers a safe preliminary screening of candidates for exercise testing and prescription. If a participant answers ‘yes’ to one or more questions then they will be required to speak to their doctor regarding the intervention, and the amount of physical activity that they should perform. Clearance to participate from their doctor must be presented to the research team.
The use of the PAR-Q as a screening tool is part of duty of care to the participants. The PAR-Q must be completed before any participant attends a briefing session.
Minimum age
18 Years
Maximum age
69 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The following exclusion criteria will apply: under 18 years and over 69 years; poor comprehension of English language; too physically active (participating in more than thirty minutes of moderate physical activity on at least five days a week); diagnosis of diabetes; deaf/hearing impaired; disabling neurological disorder; severe mental illness such as psychosis, learning disability, dementia and cognitive impairment; registered blind; housebound or resident in nursing home; unable to move about independently or not ambulatory; pregnancy; advanced cancer.

Patients who are categorised as a Category 1 in the hospital surgical wait-list may expect to undergo their surgical procedure within thirty days. For this reason individuals categorised as a Category 1 in the hospital surgical wait-list will be excluded.

Interested participants will be required to complete a Physical Activity Readiness Questionnaire (PAR-Q). The PAR-Q offers a safe preliminary screening of candidates for exercise testing and prescription. If a participant answers ‘yes’ to one or more questions then they will be required to speak to their doctor regarding the intervention, and the amount of physical activity that they should perform. The use of the PAR-Q as a screening tool is part of duty of care to the participants. The PAR-Q must be completed before any participant attends a briefing session

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)
Randomisation: Participants will be randomised to the intervention or the control group using a concealed allocation, block randomisation method with 1:1 allocation. Participants will be randomised using a web-based program (randomization.com) with assignments sealed in sequentially numbered opaque envelopes.
Only after the recruiter determines a participant is eligible, the participant agrees to take part (provided written informed consent) and baseline assessment is completed, will assignment to group be made by opening the next envelope in the sequence

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be generated from a web-based program (randomization.com).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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)
VIC
Recruitment hospital [1] 6630 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment postcode(s) [1] 14251 0
3550 - Bendigo

Funding & Sponsors
Funding source category [1] 294478 0
Hospital
Name [1] 294478 0
Bendigo Health Care Group
Address [1] 294478 0
Bendigo Health
Lucan Street
Bendigo
PO Box 126, Bendigo 3550
Country [1] 294478 0
Australia
Primary sponsor type
Hospital
Name
Bendigo Health Care Group
Address
Bendigo Health
Lucan Street
Bendigo
PO Box 126, Bendigo 3550
Country
Australia
Secondary sponsor category [1] 293348 0
None
Name [1] 293348 0
N/A
Address [1] 293348 0
N/A
Country [1] 293348 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295962 0
Bendigo Health HREC
Ethics committee address [1] 295962 0
Bendigo Health HREC,
CHERC,
PO Box 126,
Bendigo,
VIC,
3552
Ethics committee country [1] 295962 0
Australia
Date submitted for ethics approval [1] 295962 0
30/08/2016
Approval date [1] 295962 0
16/09/2016
Ethics approval number [1] 295962 0
LNR/16/BHCG/42

Summary
Brief summary
Non communicable diseases (NCDs) are the leading cause of illness, disability and death in Australia, accounting for 90% of all deaths in 2011. NCDs have an intricate association with modifiable risk factors such as physical inactivity, poor nutrition, and smoking. Population approaches to NCD management are based around the modification of the associated risk factors- uptake of regular physical activity, smoking cessation and dietary modification.

This research aims to evaluate the effectiveness of a blend of MI/CBT, which are interventions to increase motivation and confidence around behaviour change.
This office based intervention may educate, support and motivate participants through a range of strategies for health related behaviour change.

This intervention will specifically will target adults aged 18 to 69 years from an elective non-admitted hospital clinic in regional Australia. Participants will be required to be insufficiently active (< 150 minutes of moderate physical activity per week), and be fluent in conversational English.

It is hypothesised that by the end of the intervention, compared to the minimal intervention group, the participants in the intervention group will show significant improvements in the primary endpoint physical activity, and in the secondary endpoints: physical activity self-efficacy, quality of life, type 2 diabetes mellitus risk, and anthropometric values.

This office delivered telephone support model may be a cost-effective and relatively straightforward way of promoting health behaviour change. The project aims to test the effectiveness of this in a well-designed and rigorously conducted trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68866 0
A/Prof Michael Kingsley
Address 68866 0
La Trobe Rural Health School,
Edwards Rd,
Flora Hill,
Bendigo, 
Victoria,
3550
Country 68866 0
Australia
Phone 68866 0
+61 3 5444 7589
Fax 68866 0
Email 68866 0
m.kingsley@latrobe.edu.au
Contact person for public queries
Name 68867 0
Mr Stephen Barrett
Address 68867 0
Bendigo Health, 
Lucan St,
PO Box 126,
Bendigo,
3550
Country 68867 0
Australia
Phone 68867 0
+61 3 54549118
Fax 68867 0
Email 68867 0
sbarrett@bendigohealth.org.au
Contact person for scientific queries
Name 68868 0
A/Prof Michael Kingsley
Address 68868 0
La Trobe Rural Health School,
Edwards Rd,
Flora Hill,
Bendigo, 
Victoria,
3550
Country 68868 0
Australia
Phone 68868 0
+61 3 5444 7589
Fax 68868 0
Email 68868 0
m.kingsley@latrobe.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