Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000301066
Ethics application status
Approved
Date submitted
13/04/2010
Date registered
15/04/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Walking to Wellness in an ageing sedentary university community
Scientific title
The effect of a work-site based physical activity intervention on daily walking steps, health and work-ability in a university community with an ageing workforce
Secondary ID [1] 1605 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical activity 257147 0
Work ability 257148 0
Condition category
Condition code
Public Health 257303 257303 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to the intervention group will participate in a 12-week worksite-based physical activity intervention based around increasing their average daily work day steps. The intervention will comprise 2 distinct treatment phases targeting behaviour adoption (weeks 1-4) and adherence (weeks 5-12) using ‘Stages of Behaviour Change’ principles. The adoption phase of the walking intervention will consist of individually targeted supervised 60-minute education/information group sessions of 5-6 participants held once per week. The adoption pahase group sessions will be facilitated by a physiotherapist or exercise physiologist. Participants will discuss the benefits of becoming more active; how to initiate behaviours to achieve activity goals; how to identify strategies for overcoming lapses etc); how to set individual steps per day goals; and how to self monitor progress using the pedometer and a walking diary to record work day steps. Each session will conclude with a 20 minute group walk. The adherence phase of the walking intervention will be self-directed and remotely monitored to encourage participant compliance and progression. Participants will select their own preferred walking option(s) from three alteratives, depending on their own life circumstances or individual preference with the intention of progressively increasing average work day steps. The first of these walking options, termed “walking routes” will use prescribed walks around the campus over which participants will be asked to complete at least 20-30 minutes of continuous, brisk walking every work day. The second walking option, termed “walking within tasks” will encourage participants to accumulate step counts throughout the working day. Rather than prescribed routes, the office, lectures and seminars will be targeted as environments where tasks could be completed standing and walking, rather than sitting, for example “walk and talk” tutorials or meetings. The third walking option, termed “walking for transport” will provide participants with an information pack to facilitate safe walking to and/or from work, using identified walking paths and public transport facilities. Particpiants will be encouraged to select a mix the options from day-to-day depending on their preferences.
Intervention code [1] 256301 0
Behaviour
Intervention code [2] 256314 0
Lifestyle
Intervention code [3] 256315 0
Prevention
Comparator / control treatment
Participants allocated to the control group will receive no intervention for the 12-week treatment period during which they will be encouraged to continue with normal behaviour and refrain from commencing any new physical activity or exercise program.
Control group
Active

Outcomes
Primary outcome [1] 258213 0
Average work day step count: will be measured by pedometer (Yamax SW-200) and averaged over five working days at each time point
Timepoint [1] 258213 0
Pre-intervention (baseline), end adoption phase (end week 4) and post-intervention (end week 12).
Secondary outcome [1] 263862 0
Physical health status: will be measured by three standard measures of cardiovascular and metabolic health
1. Blood pressure: duplicate measures of systolic and diastolic blood pressure (BP) will be taken two minutes apart using an automated device Microlife BP A 100; Microlife AG, Widnau, Switzerland) after the participant has rested in a seated position for five minutes.
2. Waist circumference: duplicate measurements of the waist circumference will be made at the level of the trunk where the girth is minimal (i.e. where there is a noticeable indentation of the trunk), usually 1 inch or 2.5 cm above the umbilicus, or if there is no noticeable indentation the tape will be located at the umbilicus. A steel tape measure KDS F10-02 (KDS Corporation, Japan) will be used to ensure the tape does not stretch during measurement.
3. Body fat percentage will be assessed by bioelectrical impedance analysis procedures using an electronic body composition analyzer (Tanita BF 350; Tanita Corporation, Tokyo Japan) following recommended procedures.
Timepoint [1] 263862 0
Pre-intervention (baseline), and post-intervention (end week 12).
Secondary outcome [2] 263863 0
Mental health status: The psychological wellbeing of participants will be measured by a validated self-administered questionnaire; Kessler-10.
Timepoint [2] 263863 0
Pre-intervention (baseline), and post-intervention (end week 12).
Secondary outcome [3] 263864 0
Physical activity participation: will be measured by the validated Active Australia Survey
Timepoint [3] 263864 0
Pre-intervention (baseline), and post-intervention (end week 12).
Secondary outcome [4] 263865 0
Work ability - will be measured by two self administered questionnaires: the Work Ability Index (Australia) which is an adaption of the Work Ability Index (WAI); and by the Work Ability Survey (WAS).
Timepoint [4] 263865 0
Pre-intervention (baseline), and post-intervention (end week 12).

Eligibility
Key inclusion criteria
Volunteers will be eligible to participate if they are:
1. employed at the Australian Catholic University on a part-time or full time basis in either an academic or administrative job designation
2. work at one of three of the university’s campuses located in Sydney and Melbourne
Minimum age
45 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Volunteers will be excluded from participation if they have a:
1. physically active lifestyle as defined as compliance with current physical activity guidelines (i.e. participating in > 150 minutes of moderate intensity physical activity per week)
2. cardiovascular, neurological or musculoskeletal contraindication to exercise as determined by the Physical Activity Readiness Questionnaire (PAR-Q) or subsequent certification by a medical practitioner.

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)
Participants will be randomly allocated to treatment group using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The computer program generated allocation sequence will be produced by a researcher not involved in recruitment or assessment of participants at baseline prior to group allocation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
25/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
156
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2821 0
2060
Recruitment postcode(s) [2] 2822 0
2135
Recruitment postcode(s) [3] 2826 0
3065

Funding & Sponsors
Funding source category [1] 256804 0
Government body
Name [1] 256804 0
Australian Research Council: ARC (Industry) Linkage Grant
Country [1] 256804 0
Australia
Primary sponsor type
Individual
Name
Dr Martin Mackey
Address
Ageing, Work and Health Research Unit, Faculty of Health Sciences,
The University of Sydney
PO Box 170 LIDCOMBE, NSW 2141
Country
Australia
Secondary sponsor category [1] 256084 0
Individual
Name [1] 256084 0
Professor Philip Taylor
Address [1] 256084 0
Business Work and Ageing Centre for Research, Faculty of Business and Enterprise
H23 Swinburne University of Technology, PO Box 218 Hawthorn Victoria 3122
Country [1] 256084 0
Australia
Other collaborator category [1] 1205 0
Individual
Name [1] 1205 0
Professor Philip Bohle
Address [1] 1205 0
Ageing, Work and Health Research Unit, Faculty of Health Sciences,
The University of Sydney
PO Box 170 LIDCOMBE, NSW 2141
Country [1] 1205 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258823 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 258823 0
Ethics committee country [1] 258823 0
Australia
Date submitted for ethics approval [1] 258823 0
Approval date [1] 258823 0
15/01/2009
Ethics approval number [1] 258823 0
01-2009/11535

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

Contacts
Principal investigator
Name 31045 0
Address 31045 0
Country 31045 0
Phone 31045 0
Fax 31045 0
Email 31045 0
Contact person for public queries
Name 14292 0
Dr Martin Mackey
Address 14292 0
Ageing Work and Health Research Unit, Faculty of Health Sciences,
The University of Sydney,
PO Box 170 Lidcombe NSW 2141
Country 14292 0
Australia
Phone 14292 0
+61 2 93519374
Fax 14292 0
+61 2 93519601
Email 14292 0
[email protected]
Contact person for scientific queries
Name 5220 0
Dr Martin Mackey
Address 5220 0
Ageing Work and Health Research Unit, Faculty of Health Sciences,
The University of Sydney,
PO Box 170 Lidcombe NSW 2141
Country 5220 0
Australia
Phone 5220 0
+61 2 93519374
Fax 5220 0
+61 2 93519601
Email 5220 0
[email protected]

No information has been provided regarding IPD availability


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.