Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000525684
Ethics application status
Approved
Date submitted
9/05/2023
Date registered
19/05/2023
Date last updated
21/05/2024
Date data sharing statement initially provided
19/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of educational workshops for health professionals in behaviour change
Scientific title
Examining the effectiveness and acceptability of training health professionals in behaviour change techniques
Secondary ID [1] 309531 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Education of health-behaviour change 329838 0
Condition category
Condition code
Diet and Nutrition 326740 326740 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Health professionals have shown to rely on providing only education to clients as a way of delivering information and promoting behaviour change. However, while education is important, it is usually ineffective for changing behaviour when used in isolation. Behaviour change theories and techniques can be useful for delivering effective behaviour change interventions. As such, dietary interventions that are informed by behaviour change theoretical models and techniques, have shown to have a greater potential to be more effective than those without. Dietitians have expressed that the training received during dietetics education in behaviour change has been inadequate and that they felt their skills in behaviour change were limited.
A randomised controlled trial, comparing the effectiveness of a behaviour change intervention with a waitlist control group. Participants will be randomised to either the intervention or waitlist control group. Assessments will occur at baseline (T0), Post workshops (T1) and at 3-month follow-up (T2).
The aim of the study is to evaluate the effectiveness of two-2 hour workshops in:
• Increasing the number of behaviour change techniques used and frequency of use of behaviour change techniques in practice.
• Increase dietitians’ capability, opportunity, motivation and preparedness towards delivering behaviour change techniques in practice.
The final aim is to assess the acceptability of the intervention, to dietitians.

The workshops will be delivered by the research team which include a health psychologist and researchers from psychology and nutrition/dietetics who are experienced in health-behaviour change. Workshops will be conducted online via Microsoft Teams. Each workshop will be conducted in groups of up to 15 participants. Workshop 2 will be within 3 months of the first.
The workshops are guided by the Capability, Opportunity, Motivation and Behaviour model (Michie et al., 2011). The workshop will enable dietitians to (1) Understand the importance of using behaviour change in practice, (2) Define the characteristics of the Capability, Opportunity, Motivation, Behaviour Model (COM-B Model), (3) Be able to identify opportunities to use behaviour change techniques in practice and 4) Be able to implement behaviour change techniques in practice. Workshop 1 will focus on outcomes 1 and 2. Workshop 2 will focus on outcomes 3 and 4. Topics will involve understanding behaviour, the COM-B model and behaviour change techniques. In both workshops, there will be an opportunity to work through case studies and group discussions.
Materials & Procedures
Participants will be recruited via social media and newsletters of Australian nutrition and dietetic organisations. After signing up to the study, participants will be asked to complete a baseline measure and will be randomised into either the intervention group or the waitlist control group. Participants allocated into the intervention group will be able to choose their preferred workshop time and access the workshops immediately. Participants in the waitlist control group will be required to wait 3 months before having access to the workshops. Participants will be asked to attend both two 2-hour workshops. Following workshop 2, participants will complete a post-workshop survey and a follow up survey at 3 months. These measures will be completed online via Qualtrics.
Each survey will include questions regarding the use of behaviour change techniques and frequency of use. Participants will also be asked about their capability, opportunity, motivation, and preparedness to use behaviour change techniques in practice.

Process Evaluation:
Process evaluation will be conducted using two methods: (1) a measure of acceptability in the post workshop survey and (2) interviews at the end of 3 months. The measure of acceptability will include two items which were developed by Kothe and Mullan (2014). The first item will ask participants to rate their agreeance on a 5-point Likert scale for 7 keywords related to the two behaviour change workshops. Some examples include: whether the participants felt the workshops were “useful, appropriate, interesting, and worth my time”. Item two explores participant satisfaction with the workshops. This item is rated on a 5-point Likert scale ranging from (1) very dissatisfied to (5) very satisfied.
During the follow-up survey at 3 months, participants will also be invited to attend a 1:1 interview via Microsoft teams. Interviews will explore barriers or enablers following implementation of behaviour change strategies demonstrated in the workshop. These interviews will be guided by the COM-B model (Michie et al., 2011).
Intervention code [1] 325974 0
Behaviour
Comparator / control treatment
The control group is a wait list control group. They will complete all the same measures as the intervention as well as complete both workshops. However, they will have access to the workshops after 3-months following their sign up to the study.
Control group
Active

Outcomes
Primary outcome [1] 334697 0
Behaviour (Use of behaviour change techniques), assessed using one item that asks which techniques have they used in practice. Participants are provided a list of 14 techniques that are covered in the workshops.
Timepoint [1] 334697 0
Baseline (T0), Post second workshop (T1) and 3 month follow up (T2)
Primary outcome [2] 334698 0
Frequency of behaviour, assessed using one item that asks how frequently do participants use behaviour change techniques in practice.
Timepoint [2] 334698 0
Baseline (T0), Post second workshop (T1) and 3 month follow up (T2).
Secondary outcome [1] 421786 0
Capability as assessed using the Capability, Opportunity and Motivation (COM) measure.
Timepoint [1] 421786 0
Baseline (T0), Post second workshop (T1) and 3 month follow up (T2)
Secondary outcome [2] 421787 0
Opportunity as assessed using the Capability, Opportunity and Motivation (COM) measure.
Timepoint [2] 421787 0
Baseline (T0), Post second workshop (T1) and 3 month follow up (T2)
Secondary outcome [3] 421788 0
Motivation as assessed using the Capability, Opportunity and Motivation (COM) measure.
Timepoint [3] 421788 0
Baseline (T0), Post second workshop (T1) and 3 month follow up (T2)
Secondary outcome [4] 421789 0
Preparedness to use Behaviour change techniques, as assessed using the Preparedness scale.
Timepoint [4] 421789 0
Baseline (T0), Post second workshop (T1) and 3 month follow up (T2)
Secondary outcome [5] 421790 0
Acceptability, as assessed using the Acceptability scale (Kothe and Mullan, 2014).
Timepoint [5] 421790 0
Post second workshop (T1)

Eligibility
Key inclusion criteria
Registered and working as a dietitian in Australia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not registered as a Dietitian
Not currently practicing as a dietitian in Australia

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed via individually sealed opaque envelopes numbered 1 to 140 with randomisation determined by an external researcher to the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation will be used with allocation concealment from the active research team via the use of sealed opaque envelopes. The randomisation will be in blocks of four with the randomisation sequence generated prior to the commencement of the study by a biostatistician (external to the research team), using a randomisation table created in Stata.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample Size:
The power analysis is based on a sample size sufficient for a repeated measures ANOVA within-between interaction. Based on a priori analysis (f= .20, power = .80, a.=05), 84 participants in total will be sufficient. This means that there will be 42 participants in each group. Assuming a drop-out rate between 20-50%, a total of 140 participants (70 in each group) will be recruited.

Statistical Analyses:
Descriptive statistics will summarise the demographics of the participants in the study (e.g., age, gender, location of practice, area of practice).
The primary outcome variable is changes in behaviour in terms of the number of behaviour change techniques used in practice and the frequency in that these techniques are used in practice. Secondary outcome variables include changes in the capability, opportunity, motivation, and preparedness of dietitians to use behaviour change techniques in practice.
A series of two-way repeated measures analysis of variance will be conducted to assess differences across the intervention (T0, T1, T2) and between the intervention and waitlist control group. Potential covariates will include age, gender, place of registration, highest education level and dietitian role, area of practice, common mode of delivery.
Intention to treat and per protocol analyses will also be conducted.
Thematic analysis will be used to analyse the process evaluation data collected from the interviews. The analysis of this data will be guided by the COM-B model (Michie et al., 2011).





Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/2023
Actual
20/06/2023
Date of last participant enrolment
Anticipated
1/06/2024
Actual
11/01/2024
Date of last data collection
Anticipated
31/08/2024
Actual
Sample size
Target
140
Accrual to date
Final
160
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313723 0
University
Name [1] 313723 0
Curtin University
Country [1] 313723 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Curtin University, Kent Street, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 315650 0
None
Name [1] 315650 0
Address [1] 315650 0
Country [1] 315650 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312894 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 312894 0
Ethics committee country [1] 312894 0
Australia
Date submitted for ethics approval [1] 312894 0
20/12/2022
Approval date [1] 312894 0
20/01/2023
Ethics approval number [1] 312894 0
HRE2023-0026

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

Contacts
Principal investigator
Name 126250 0
Prof Barbara Mullan
Address 126250 0
Curtin University
Kent Street, Bentley WA 6102
Country 126250 0
Australia
Phone 126250 0
+61892662468
Fax 126250 0
Email 126250 0
[email protected]
Contact person for public queries
Name 126251 0
Hayley Breare
Address 126251 0
Curtin University
Kent Street, Bentley WA 6102
Country 126251 0
Australia
Phone 126251 0
+6189266 2468
Fax 126251 0
Email 126251 0
[email protected]
Contact person for scientific queries
Name 126252 0
Hayley Breare
Address 126252 0
Curtin University
Kent Street, Bentley WA 6102
Country 126252 0
Australia
Phone 126252 0
+6189266 2468
Fax 126252 0
Email 126252 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
Data sharing of individual participant data will not be available due to ethical requirements of the Curtin Human Research Ethics Committee.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19138Ethical approval    385798-(Uploaded-09-05-2023-18-12-20)-Study-related document.pdf



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.