Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001268730
Ethics application status
Not required
Date submitted
4/09/2022
Date registered
26/09/2022
Date last updated
16/02/2024
Date data sharing statement initially provided
26/09/2022
Date results provided
16/02/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Train to sustain: A randomised controlled trial evaluation of a vitality training employing behaviour-change techniques.
Scientific title
Train to sustain: A randomised controlled trial evaluation of a vitality training employing behaviour-change techniques.
Secondary ID [1] 307858 0
None
Universal Trial Number (UTN)
U1111-1282-1116
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Work-related stress 327475 0
Burnout 327476 0
Condition category
Condition code
Public Health 324602 324602 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention was a vitality training employing scientifically-tested behaviour-change techniques. The intervention consisted of five two-hour group sessions that were performed in-house, on the organisations’ premises, which were held fortnightly over a nine-week period. A maximum of 12 participants could participate in a group session. The sessions included the following topics: 1. Personal energy balance analysis; 2. Physical and mental energy; 3. Working from qualities, values, and goals; 4. Personal vitality strategy; and 5. Evaluation and maintenance. The vitality training employed a specially designed ‘method’, which required that participants worked through assignments employing evidence-based behaviour-change techniques, including self-persuasion, implementation intentions, and self-efficacy techniques. This approach allowed participants to identify their own areas of concern, to set a limited number of personally relevant and meaningful goals, and to develop personalised strategies for change. The intervention was delivered by the (independent) developer of the training, who holds a PhD in clinical psychology and works as a researcher, university lecturer, and vitality trainer. Session content was delivered via workbooks; that is, participants completed assignments in their workbooks individually, following instructions from the trainer, and then a short group discussion took place after each assignment. Halfway through each 2-hour session there was a short 10-minute break. Adherence to the intervention method was controlled for, across sessions and participant groups, using a checklist, which was reviewed following each session. During the maintenance phase, the intervention group was not required to complete any activities nor were they contacted by the trainer. The duration of the maintenance phase was approximately 3 months after the completion of the final group session.
Intervention code [1] 324327 0
Behaviour
Intervention code [2] 324328 0
Lifestyle
Comparator / control treatment
The comparator group was a no-treatment / wait-list control treatment.
The intervention group commenced the vitality training during Phase 1 and the control group was put on a waiting list for the training during this time (i.e., the wait-list control period was 9 weeks). During Phase 2, the control group completed the training and the intervention group was on a maintenance phase.
Control group
Active

Outcomes
Primary outcome [1] 332419 0
Energy: Three items designed specifically for this study established participants’ subjective energy levels, which assessed the extent to which participants reported feeling i) energetic, ii) physically fit, and iii) mentally fit. Responses were made using visual analogue scales ranging from 0 to 100 (never to always). 'Energy’ was a mean of these three items. All measures were assessed in Dutch.
Timepoint [1] 332419 0
Baseline, post-intervention (primary timepoint), and follow-up.
Baseline data were collected up to two weeks prior to the commencement of the training. Post-intervention data was collected up to two weeks following the completion of the training. Follow-up was approximately 3-months following the completion of training for the intervention group (this was associated with the completion of the training for the wait-list control group).
Primary outcome [2] 332420 0
Stress: Two items designed specifically for this study established participants’ subjective stress levels, which assessed the extent to which participants reported feeling i) stressed and ii) overloaded. Responses were made using visual analogue scales ranging from 0 to 100 (never to always). 'Stress' was a mean of these two items. All measures were assessed in Dutch.
Timepoint [2] 332420 0
Baseline, post-intervention (primary timepoint), and follow-up.
Baseline data were collected up to two weeks prior to the commencement of the training. Post-intervention data was collected up to two weeks following the completion of the training. Follow-up was approximately 3-months following the completion of training for the intervention group (this was associated with the completion of the training for the wait-list control group).
Secondary outcome [1] 413442 0
Daily life satisfaction: Four items designed specifically for this study established participants’ subjective daily life satisfaction, which assessed the extent to which participants reported being i) satisfied with their daily life, ii) paying attention to the activities in their daily life, as well as being iii) motivated towards and iv) inspired by the activities in their daily life. Responses were made using visual analogue scales ranging from 0 to 100 (never to always). ‘Daily life satisfaction’ was a mean of these four items. All measures were assessed in Dutch.
Timepoint [1] 413442 0
Baseline, post-intervention, and follow-up.
Baseline data were collected up to two weeks prior to the commencement of the training. Post-intervention data was collected up to two weeks following the completion of the training. Follow-up was approximately 3-months following the completion of training for the intervention group (this was associated with the completion of the training for the wait-list control group).
Secondary outcome [2] 413443 0
Work capacity: Six items designed specifically for this study established participants’ subjective work capacity, which assessed the extent to which participants reported feeling i) motivated, ii) productive, and iii) efficient at work, felt iv) inspired by their work, and the extent to which they felt capable of v) concentrating and vi) achieving their goals at work. Responses were made using visual analogue scales ranging from 0 to 100 (never to always). ‘Work capacity’ was a mean of these six items. All measures were assessed in Dutch.
Timepoint [2] 413443 0
Baseline, post-intervention, and follow-up.
Baseline data were collected up to two weeks prior to the commencement of the training. Post-intervention data was collected up to two weeks following the completion of the training. Follow-up was approximately 3-months following the completion of training for the intervention group (this was associated with the completion of the training for the wait-list control group).
Secondary outcome [3] 413546 0
Self-efficacy was included as a possible process measure: Five items designed specifically for this study established participants’ subjective ability to manage their work-life balance, which assessed the extent to which participants reported an ability to i) change their work-life balance, ii) influence on having a good work-life balance, iii) make choices, and iv) set boundaries regarding their work-life balance, and the extent to which v) their goals regarding their work-life balance are achievable. Responses were made using visual analogue scales ranging from 0 to 100 (never to always). ‘Self-efficacy’ was a mean of these five items. All measures were assessed in Dutch.
Timepoint [3] 413546 0
Baseline, post-intervention, and follow-up.
Baseline data were collected up to two weeks prior to the commencement of the training. Post-intervention data was collected up to two weeks following the completion of the training. Follow-up was approximately 3-months following the completion of training for the intervention group (this was associated with the completion of the training for the wait-list control group).

Eligibility
Key inclusion criteria
Employees of all age groups who worked at one of the three participating organisations during the trial period were eligible to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No further exclusion criteria of participant characteristics were required following recruitment.
Participants were retained in the analysis to evaluate the intervention if they attended a minimum of three out of the five training sessions.

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 was concealed (central randomisation by computer was performed).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation to either an intervention group or a wait-list control group was performed by simple randomisation using a computerised sequence generator.
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
The sample size was determined on a pragmatic basis, including employees across participating organisations who elected to complete the training and participate in the study.

The effects of the intervention on quantitative outcomes were examined using a mixed MANOVA and univariate ANOVA procedures. Mediation effects were explored using bootstrapping procedures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/12/2014
Date of last participant enrolment
Anticipated
Actual
26/01/2015
Date of last data collection
Anticipated
Actual
30/06/2015
Sample size
Target
100
Accrual to date
Final
84
Recruitment outside Australia
Country [1] 24986 0
Netherlands
State/province [1] 24986 0

Funding & Sponsors
Funding source category [1] 312136 0
University
Name [1] 312136 0
Behavioural Science Institute, Radboud University
Country [1] 312136 0
Netherlands
Funding source category [2] 312168 0
University
Name [2] 312168 0
Institute for Management Research, Radboud University
Country [2] 312168 0
Netherlands
Primary sponsor type
University
Name
Behavioural Science Institute, Radboud University
Address
Behavioural Science Institute
Radboud University
6500 HE Nijmegen
The Netherlands

Postal address:
Behavioural Science Institute
Radboud University
P.O. Box 9104
6500 HE Nijmegen
The Netherlands
Country
Netherlands
Secondary sponsor category [1] 313656 0
University
Name [1] 313656 0
Institute for Management Research, Radboud University
Address [1] 313656 0
Institute for Management Research
Radboud University
6500 HK Nijmegen
The Netherlands

Postal address:
Institute for Management Research
Radboud University
P.O. Box 9108
6500 HK Nijmegen
The Netherlands
Country [1] 313656 0
Netherlands

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 311530 0
Ethics Committee Social Science (ECSS), Radboud University
Ethics committee address [1] 311530 0
Ethics committee country [1] 311530 0
Netherlands
Date submitted for ethics approval [1] 311530 0
Approval date [1] 311530 0
Ethics approval number [1] 311530 0

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

Contacts
Principal investigator
Name 121426 0
Dr Mattheis van Leeuwen
Address 121426 0
Behavioural Science Institute
Radboud University
6500 HE Nijmegen
The Netherlands
Country 121426 0
Netherlands
Phone 121426 0
+31 24 361 00 80
Fax 121426 0
Email 121426 0
[email protected]
Contact person for public queries
Name 121427 0
Mattheis van Leeuwen
Address 121427 0
Behavioural Science Institute
Radboud University
6500 HE Nijmegen
The Netherlands
Country 121427 0
Netherlands
Phone 121427 0
+31 24 361 00 80
Fax 121427 0
Email 121427 0
[email protected]
Contact person for scientific queries
Name 121428 0
Bernice Plant
Address 121428 0
BehaviourWorks Australia
8 Scenic Blvd
Monash University
Clayton
Victoria, 3800
Country 121428 0
Australia
Phone 121428 0
+613 9905 9656
Fax 121428 0
Email 121428 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified survey data underlying the published results will be shared only.
When will data be available (start and end dates)?
Immediately following publication, for a minimum of 5 years following publication.
Available to whom?
The de-identified data that support the findings of this study are available to researchers on reasonable request.
Available for what types of analyses?
De-identified survey data will be available for research purposes only (e.g., to replicate key findings or for meta-analyses).
How or where can data be obtained?
Applications for survey data can be made by contacting the Contact person for scientific queries (Dr Bernice Plant, [email protected]).


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.