Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000036112
Ethics application status
Approved
Date submitted
19/12/2018
Date registered
11/01/2019
Date last updated
23/09/2021
Date data sharing statement initially provided
11/01/2019
Date results provided
25/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Integrated motivational interviewing and cognitive behaviour treatment to increase physical activity in non-admitted patients from a tertiary hospital in regional Australia: the Healthy 4U-2 randomised controlled trial
Scientific title
Integrated motivational interviewing and cognitive behaviour treatment to increase physical activity in non-admitted patients from a tertiary hospital in regional Australia: the Healthy 4U-2 randomised controlled trial
Secondary ID [1] 296518 0
NA
Universal Trial Number (UTN)
Trial acronym
H4U-2
Linked study record
The H4U-2 trial is a follow-up study of the Healthy 4U trial ACTRN12616001331426

Health condition
Health condition(s) or problem(s) studied:
Health behaviour change 310300 0
Physical inactivity 310301 0
Quality of life 310302 0
Condition category
Condition code
Public Health 309031 309031 0 0
Health service research
Public Health 309032 309032 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants enrolling in the project will 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 Motivational Interviewing (MI) and Cognitive Behaviour Therapy (CBT) delivered over the telephone. Each participant will receive 5 calls over a 12-week period, each lasting up to 20 minutes. Participants will receive 4 calls in the first 6 weeks, and a booster call at 12 weeks. In terms of incorporating MI and CBT, MI will be utilised for sessions 1 to 3. From session 3 to session 5 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.

For measurement of fidelity, 10% of counselling sessions in the study will be digitally recorded. The recorded sessions will be assessed for adherence to MI-CBT principles using the MI-CBT fidelity scale and coded by an expert independent coding group.
Intervention code [1] 312830 0
Lifestyle
Intervention code [2] 312831 0
Prevention
Comparator / control treatment
The comparator for the H4U-2 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] 307993 0
The primary outcome is minutes per day of moderate-to-vigorous physical activity objectively measured via 7-day accelerometry.
Timepoint [1] 307993 0
Baseline, week 13 (1 week post intervention) and at 9 months (primary endpoint).
Secondary outcome [1] 353590 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] 353590 0
Baseline, week 13 (1 week post intervention) and at 9 months (primary endpoint).
Secondary outcome [2] 353591 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] 353591 0
Baseline, week 13 (1 week post intervention) and at 9 months (primary endpoint).
Secondary outcome [3] 353592 0
Body mass index (BMI).
Body mass will be recorded to the nearest 0.1 kg using a calibrated scale (model 813; Seca, Germany). Free standing stature will recorded to the nearest 0.1 cm using a calibrated equipment with the participant barefoot (Portable stadiometer; Seca, Germany). BMI will be calculated by dividing body mass by the square of height.
Timepoint [3] 353592 0
Baseline, week 13 (1 week post intervention) and at 9 months (primary endpoint).
Secondary outcome [4] 353593 0
Cost-effectiveness of the program determined by an economic analysis.
Cost effectiveness of the intervention will be evaluated from a health system perspective. Data for resource use associated with the intervention will be calculated, as well as costs derived from hospital admissions. Quality of life measured using SF-12 at baseline, 13 weeks and 9 months will allow calculation of differences in Quality Adjusted Life Years (QALYs) between groups.

We will calculate the cost per QALY for each treatment comparison as the difference in mean costs divided by the difference in mean outcomes over the duration of the trial.
Timepoint [4] 353593 0
Baseline, week 13 (1 week post intervention) and at 9 months (primary endpoint).
Secondary outcome [5] 365172 0
Waist Circumference.
Waist circumference (WC) was measured to the nearest 0.1 cm using a rigid anthropometric measuring tape (Lufkin, US)
Timepoint [5] 365172 0
Baseline, week 13 (1 week post intervention) and at 9 months (primary endpoint).

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, and to self-report as 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
Sex
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); 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
Not Applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To compare differences in our outcome measures a series of 3 x 2 mixed model ANOVAs will be undertaken. Utilizing data from the H4U study [Barrett et al, 2018; 18:1166], to detect an effect size of 0.35 or greater, with the alpha set at .05, and the power set at .90, a sample size of 50 participants per arm will be required. Protecting against a drop-out rate of 20% over the 9 month period, 60 participants will be recruited and randomized into each arm. The total study sample will therefore be 120.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/01/2019
Actual
28/02/2019
Date of last participant enrolment
Anticipated
2/12/2019
Actual
13/09/2019
Date of last data collection
Anticipated
3/08/2020
Actual
9/04/2021
Sample size
Target
120
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12363 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment postcode(s) [1] 24623 0
3550 - Bendigo

Funding & Sponsors
Funding source category [1] 301105 0
Hospital
Name [1] 301105 0
Bendigo Health Care Group
Country [1] 301105 0
Australia
Primary sponsor type
Hospital
Name
Bendigo Health Care Group
Address
Bendigo Health
Lucan Street
Bendigo
PO Box 126,
Bendigo,
VIC.
3550
Country
Australia
Secondary sponsor category [1] 300716 0
None
Name [1] 300716 0
Address [1] 300716 0
Country [1] 300716 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301855 0
Bendigo Health Care Group HREC
Ethics committee address [1] 301855 0
Ethics committee country [1] 301855 0
Australia
Date submitted for ethics approval [1] 301855 0
25/10/2018
Approval date [1] 301855 0
01/11/2018
Ethics approval number [1] 301855 0
LNR/18/BHCG/44121

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

Contacts
Principal investigator
Name 88330 0
A/Prof Michael Kingsley
Address 88330 0
La Trobe Rural Health School,
Edwards Rd,
Flora Hill,
Bendigo,
Victoria,
3550
Country 88330 0
Australia
Phone 88330 0
+61 3 5444 7589
Fax 88330 0
Email 88330 0
[email protected]
Contact person for public queries
Name 88331 0
Stephen Barrett
Address 88331 0
Bendigo Health,
Lucan St,
PO Box 126,
Bendigo,
VIC
3550
Country 88331 0
Australia
Phone 88331 0
+61 3 54549118
Fax 88331 0
Email 88331 0
[email protected]
Contact person for scientific queries
Name 88332 0
Michael Kingsley
Address 88332 0
La Trobe Rural Health School,
Edwards Rd,
Flora Hill,
Bendigo,
Victoria,
3550
Country 88332 0
Australia
Phone 88332 0
+61 3 5444 7589
Fax 88332 0
Email 88332 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
At present individual participant data (IPD) for this trial be not be made available.


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
SourceTitleYear of PublicationDOI
EmbaseA physical activity coaching intervention can improve and maintain physical activity and health-related outcomes in adult ambulatory hospital patients: the Healthy4U-2 randomised controlled trial.2020https://dx.doi.org/10.1186/s12966-020-01063-x
EmbaseThe effect of a physical activity coaching intervention on accelerometer-measured sedentary behaviours in insufficiently physically active ambulatory hospital patients.2021https://dx.doi.org/10.3390/ijerph18115543
EmbasePhysical activity telephone coaching intervention for insufficiently physically active ambulatory hospital patients: Economic evaluation of the Healthy 4U-2 randomised controlled trial.2022https://dx.doi.org/10.1371/journal.pone.0270211
N.B. These documents automatically identified may not have been verified by the study sponsor.