Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001395325
Ethics application status
Approved
Date submitted
21/09/2017
Date registered
3/10/2017
Date last updated
27/05/2019
Date data sharing statement initially provided
27/05/2019
Date results provided
27/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Activity for Wellbeing: Promoting wellbeing through physical activity in aged care workers.
Scientific title
Activity for Wellbeing: A randomised, controlled trial of a need-supportive, person-centred physical activity intervention for aged care workers
Secondary ID [1] 292947 0
Nil Known
Universal Trial Number (UTN)
U1111-1202-3589
Trial acronym
Not applicable
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Physical activity behaviour and wellbeing 304840 0
Public Health 304841 0
Condition category
Condition code
Public Health 304141 304141 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial aims to study the efficacy of using a need-supportive, person-centred physical activity program for improving and maintaining physical activity participation and psychological wellbeing in frontline aged care workers. A mixed-methods design will also evaluate the perceived effectiveness and limitations of the program for this population. Potential participants that respond to recruitment information will be contacted to obtain informed consent, confirm eligibility for inclusion, and undertake pre-exercise health screening (Adult Pre-Exercise Screening System) and baseline measures. Once participants have undertaken baseline measures and inclusion is confirmed, participants will be block randomised at the individual level to intervention or wait-list control. The intervention will be delivered by an Accredited Exercise Physiologist and will consist of 12 weeks of active need-support (support of the basic needs of competence, autonomy and relatedness) using a Self Determination theory-based approach. For more information see publications by Ryan and Deci or http://selfdeterminationtheory.org/theory/).

The need-support will be applied through the following strategies:
• One initial face-to-face motivational interviewing-based session (approximately 1 hour), which will be used to investigate individual barriers and preferences for physical activity, and for the collaborative development of a person-centred activity plan (aimed at assisting the participant to meet ACSM recommendations for physical activity). During this session participants will also be taught how to use affect and ratings of perceived exertion to regulate exercise intensity, and the use of a pedometer and interactive website for monitoring step counts.
• Weekly contacts via the dashboard page of the program website for providing feedback on goal-setting, motivational statements and active encouragement and support (12 contacts over the course of 12-weeks), or email contacts (where preferred to the website). These contacts will occur as comments or messages that will appear on the participant's dashboard (unscheduled - will generally be in response to goal-setting or to prompt goal-setting)
• Monthly informational newsletters
• Free access to gyms located at various sites of the funding organisation (the number of gym sessions logged will be counted to indicate participant engagement)

The website that will be used in this study has been previously piloted (Frensham et al. 2014) and will include a page with general nutritional guidelines, links to informational websites, local community activities and resources, a forum where participants can interact with the researchers and other participants, a personal dashboard where they can input step counts for self-monitoring, tiered goal-setting, and a space where researchers can input feedback and motivational statements. Participants will be free to access the website as regularly as they like to input step goals and view information on the dashboard. The intervention will be structured to gradually shift participants from high levels of researcher input to low levels of researcher input and increased autonomy over the period of the 12-week intervention. Adherence to the program will be evaluated through participant engagement with the website, frequency of goal-setting, uploading of step counts, number of gym sessions logged and change in and maintenance of physical activity behaviour (primary outcomes). Participant experiences (perceived effectiveness and limitations of the program) will be investigated qualitatively, post-intervention.
Intervention code [1] 299186 0
Lifestyle
Intervention code [2] 299187 0
Behaviour
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303458 0
Physical activity behaviour will be measured by 7 days of accelerometry (GENEactiv accelerometers).
Timepoint [1] 303458 0
Baseline, 12 weeks (post-intervention) and 6-month follow-up (9 months post baseline - PRIMARY TIMEPOINT)
Primary outcome [2] 303459 0
2 day activity recall over the telephone using the Adult version of the Multimedia Activity Recall for Children and Adolescents (MARCA) software
Timepoint [2] 303459 0
Baseline, 12 weeks (post-intervention) and 6-month follow-up (9 months post baseline - PRIMARY TIMEPOINT)
Primary outcome [3] 303460 0
Quality of life (well-being) as measured via the Assessment of Quality of Life Questionnaire (AQOL-8D)
Timepoint [3] 303460 0
Baseline, 12 weeks (post-intervention) and 6-month follow-up (9 months post baseline - PRIMARY TIMEPOINT)
Secondary outcome [1] 338982 0
Negative psychological states (psychological distress) as measured by the Kessler 10-point Psychological Distress Scale (K-10)
Timepoint [1] 338982 0
Baseline, 12 weeks (post-intervention) and 6-month follow-up (9 months post baseline - PRIMARY TIMEPOINT)
Secondary outcome [2] 338983 0
Six Minute Walk distance
Timepoint [2] 338983 0
Baseline, 12 weeks (post-intervention) and 6-month follow-up (9 months post baseline - PRIMARY TIMEPOINT)
Secondary outcome [3] 338984 0
Resting blood pressure using an automatic blood pressure monitor
Timepoint [3] 338984 0
Baseline, 12 weeks (post-intervention) and 6-month follow-up (9 months post baseline - PRIMARY TIMEPOINT)
Secondary outcome [4] 339193 0
Body mass assessed using a standard weighing scale
Timepoint [4] 339193 0
Baseline, 12 weeks (post-intervention) and 6-month follow-up (9 months post baseline - PRIMARY TIMEPOINT)
Secondary outcome [5] 339194 0
Behavioural regulations (BREQ-3)
Timepoint [5] 339194 0
Baseline, 12 weeks (post-intervention) and 6-month follow-up (9 months post baseline - PRIMARY TIMEPOINT)
Secondary outcome [6] 339195 0
Psychological need satisfaction in exercise (PNSE)
Timepoint [6] 339195 0
Baseline, 12 weeks (post-intervention) and 6-month follow-up (9 months post baseline - PRIMARY TIMEPOINT)
Secondary outcome [7] 339196 0
Exercise causality orientations (ECOS)
Timepoint [7] 339196 0
Baseline only
Secondary outcome [8] 347567 0
the Healthcare Climate Questionnaire (HCCQ) will evaluate the perceived autonomy support given by the exercise physiologist during the implementation of the program (i.e. the exercise physiologist supported participant input into their activity plan and respected participant views and opinions).
Timepoint [8] 347567 0
Post-intervention
Secondary outcome [9] 347568 0
Reach survey - this is a short, customised survey that will be sent out to all invited employees. This will assess the level of awareness of the program and investigate reasons why potential participants choose or choose not to participate in the program.
Timepoint [9] 347568 0
Post-intervention (once all participants have completed the post-intervention timepoint)
Secondary outcome [10] 347569 0
Implementer survey - this is a short survey that will be sent to implementers of the program within the organisation (i.e. line managers, site co-ordinators, gym staff) to assess their perceptions and support of the program.
Timepoint [10] 347569 0
Post-intervention (once all participants in a given site or area have completed the post-intervention timepoint).

Eligibility
Key inclusion criteria
The inclusion criteria for the trial are:
• Current employee of ACH Group
• Able to speak fluent English
• At least 18 years of age
• Ability to engage in moderate physical activity (as defined by the American College of Sports Medicine (ACSM)) and complete all outcome measures (including the Six Minute Walk)
• Not currently meeting ASCM recommendations for physical activity (Greater than or equal to 30 minutes of moderate cardio-respiratory exercise per day, 5 days per week)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria, but volunteers who have previously diagnosed conditions or signs or symptoms of disease as indicated on the Adult Pre-exercise Screening System will need to provide medical clearance prior to participation in the study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Non-randomised
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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
Efficacy
Statistical methods / analysis
The results of quantitative outcome measures will be analysed using a random effects mixed-model which will compare baseline, post-intervention and six-month follow-up measures. However the statistical analysis will be limited by the small sample size (an a-priori power analysis indicated that a minimum of 60 participants would be needed). The data will be analysed using an intention-to-treat analysis where baseline data will be used in place of post-intervention and six-month follow-up data for participants who withdraw from the study prior to undertaking these outcome assessments. A large focus of the project will be the perceived effectiveness and limitations of the program in this population which will be investigated using qualitative methods. A process evaluation will be undertaken to assess the fidelity of the implementation and the reach of the program.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2017
Actual
9/11/2017
Date of last participant enrolment
Anticipated
30/06/2018
Actual
14/06/2018
Date of last data collection
Anticipated
1/02/2019
Actual
15/04/2019
Sample size
Target
30
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 297573 0
Other
Name [1] 297573 0
ACH Group
Country [1] 297573 0
Australia
Funding source category [2] 297574 0
University
Name [2] 297574 0
University of South Australia
Country [2] 297574 0
Australia
Primary sponsor type
Individual
Name
Merilyn Lock
Address
Alliance for Research in Exercise, Nutrition and Activity, School of Health Sciences. Playford Bldg. City East Campus, University of South Australia, Adelaide, SA, 5001
Country
Australia
Secondary sponsor category [1] 296588 0
University
Name [1] 296588 0
University of South Australia
Address [1] 296588 0
GPO Box 2471, Adelaide, SA 5001 – School of Health Sciences, CEA – 14
Country [1] 296588 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298667 0
University of South Australia, Human Research Ethics Committee
Ethics committee address [1] 298667 0
Ethics committee country [1] 298667 0
Australia
Date submitted for ethics approval [1] 298667 0
03/07/2017
Approval date [1] 298667 0
22/08/2017
Ethics approval number [1] 298667 0
0000036767

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

Contacts
Principal investigator
Name 77830 0
Ms Merilyn Lock
Address 77830 0
Alliance for Research in Exercise, Nutrition and Activity, School of Health Sciences. Playford Bldg. City East Campus, University of South Australia, Adelaide, SA, 5001
Country 77830 0
Australia
Phone 77830 0
+61 8 8302 1752
Fax 77830 0
Email 77830 0
merilyn.lock@mymail.unisa.edu.au
Contact person for public queries
Name 77831 0
Merilyn Lock
Address 77831 0
Alliance for Research in Exercise, Nutrition and Activity, School of Health Sciences. Playford Bldg. City East Campus, University of South Australia, Adelaide, SA, 5001
Country 77831 0
Australia
Phone 77831 0
+61 8 8302 1752
Fax 77831 0
Email 77831 0
merilyn.lock@mymail.unisa.edu.au
Contact person for scientific queries
Name 77832 0
Merilyn Lock
Address 77832 0
Alliance for Research in Exercise, Nutrition and Activity, School of Health Sciences. Playford Bldg. City East Campus, University of South Australia, Adelaide, SA, 5001
Country 77832 0
Australia
Phone 77832 0
+61 8 8302 1752
Fax 77832 0
Email 77832 0
merilyn.lock@mymail.unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.