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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.

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001331426
Acronym
H4U
Enrollment
72
Registered
2016-09-23
Start date
2016-10-10
Completion date
2017-06-13
Last updated
2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 sessio

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.

Sponsors

Bendigo Health Care Group
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to 69 Years
Healthy volunteers
No

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 23, 2026