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Trial registered on ANZCTR


Registration number
ACTRN12613000087752
Ethics application status
Approved
Date submitted
9/01/2013
Date registered
23/01/2013
Date last updated
7/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of using pedometer-driven walking to promote physical activity, and improve health-related quality of life among meat processing workers: randomized controlled trial.
Scientific title
Feasibility of using pedometer-driven walking to promote physical activity, and improve health-related quality of life among meat processing workers: randomized controlled trial.
Secondary ID [1] 281739 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal disorders 288045 0
Promoting physical activity and improving health-related quality of life among meat processing workers 288046 0
Condition category
Condition code
Public Health 288423 288423 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After randomization all participants will be attended a 30 min education session on the health benefits of being physically active, then participants in the intervention group will be received another 70 min session including 10 min walk efficacy by pedometer, 30 min exercise behaviour change and 30 min about PA booklet. This session will be based on back 2 activity protocols and conducted by a physiotherapist and student researcher.Participants in the intervention group will use a Yamax Digi-walker W200 pedometer from the beginning of the intervention. They will be instructed on how to wear and use the pedometer (to record steps taken) by doing the following: wear the pedometer at the assigned location over the hip; wear the pedometer during all waking hours (except when bathing, swimming or going to bed at night); reset the pedometer to zero at the beginning of each day, and remove it at the end of each day, record on their step calendar the date, the total number of steps displayed on the pedometer, and the strategies used to increase physical activity that week. Participants will receive weekly e-mail reminders about his or her week’s step-count goal which aimed to gradually increase the level of activities by 5% with an additional increase from previous goal setting to reach at least 10000 steps/day at the end of the 12 week period as weel as information about the importantce of PA for health benefits . The 12 weeks pedometer-driven walking intervention will be used in this study based on self-regulation theory (SRT) and will include goal setting, feedback, educational material, and the use of a step calendar for self-monitoring. Walking will be performed for at least 5 days/week according to evidence based international guidelines that recommend adults to accumulate at least 30 min of moderate intensity activity, on at least 5 days/week, to achieve optimal health benefits Participants in both the walking (intervention) and control groups will also receive standardised educational material that consists of written and graphic information describing the importance of walking as a PA for health benefits and prevention of different diseases. At the completion of the 12 weeks both groups will again use the pedometer for one week to establish a weekly step count for comparison to baseline scores
Intervention code [1] 286277 0
Lifestyle
Intervention code [2] 286278 0
Prevention
Comparator / control treatment
Participants randomly allocated to the control group will be encouraged to read the educational activity material from the booklet as well as weekly email, and will be asked to record any exercise they perform over the 12 weeks.At the completion of the 12 weeks participants will again wear the pedometer for one week and also one week during week 24 post-intervention to establish a weekly step count for comparison to baseline
Control group
Active

Outcomes
Primary outcome [1] 288590 0
1. Quality of life will be measured using The Short Form 36 Version2 (SF-36v2)

Timepoint [1] 288590 0
At baseline, 12-week, and the follow-up measurement (3 months after the intervention).
Primary outcome [2] 288698 0
Physical activity levels PAL will be measured using International Physical Activity Questionnaire (IPAQ-Short Form) and pedometer
Timepoint [2] 288698 0
At baseline, 12-week, and 3 months follow-up
Primary outcome [3] 288699 0
Functional capacity will be measured using The Six Minute Walk Test
Timepoint [3] 288699 0
At baseline, 12-week, and 3 months follow-up
Secondary outcome [1] 300544 0
- Blood pressure will be measured using Omron MX3 plus Blood Pressure Monitor
Timepoint [1] 300544 0
At baseline, 12-week, and the follow-up measurement (3 months after the intervention).
Secondary outcome [2] 300784 0
- Body Mass Index will be calculated as weight divided by height squared
Timepoint [2] 300784 0
At baseline, 12-week, and 3 moths follow-up
Secondary outcome [3] 300785 0
Functional exercise capacity will be measured using the Six Minute Walk Test (6MWT).
Timepoint [3] 300785 0
At baseline, 12-week, and 3 months follow-up
Secondary outcome [4] 300786 0
-Body Fat Percentage BF will be measured using Skinfold thickness
Timepoint [4] 300786 0
At baseline, 12-week, and 3 months follow-up
Secondary outcome [5] 300787 0
Waist Circumference WC will be measured using plastic tape
Timepoint [5] 300787 0
At baseline, 12-week, and 3 months follow-up

Eligibility
Key inclusion criteria
Currently working with Silver Fern Farms (SFF) Company-Balclutha/ Otago male or female aged 18-65 years
Having a sedentary lifestyle
Able to walk continuously for at least 10 minutes
Able to read and sign an informed consent and questionnaires
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion if they participation in PA program during the last 6 months, pregnant women will be also excluded

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will initially be screened for eligibility for entry into the randomized control trial by wearing the pedometer (Yamax Digi-walker SW-200) for 7 consecutive days. In addition, the ability of the participant to be physically able to participate in walking program will be based on the results of the physical activity readiness questionnaire (PAR-Q)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After successfully completing the baseline assessment and signing the informed consent, randomization will be performed by using sealed envelopes to one of two groups. Participants will be invited to choose an envelope each containing the group name and the timetable of the study from a basket containing envelopes a half for the intervention and the other half for the control groups. Researchers and participants will be not be blinded to group allocation. The assessor for outcome measurements will be blinded to group allocation until the final assessment is achieved
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Statistical analysis will be performed using SPSS software 20.0, and will include descriptive data and means, confidence intervals and the standard deviation.
A repeated-measures two-way analysis of variance ANOVA will be performed to compare between the groups for the primary outcome measurements at different time periods (baseline, 12-week, and 24-week follow-up)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/01/2013
Actual
23/01/2013
Date of last participant enrolment
Anticipated
8/03/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
58
Accrual to date
Final
Recruitment outside Australia
Country [1] 4782 0
New Zealand
State/province [1] 4782 0
Dunedin

Funding & Sponsors
Funding source category [1] 286527 0
University
Name [1] 286527 0
University of Otago
Country [1] 286527 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
University of Otago
Clocktower Building
364 Leith Walk
Dunedin, 9016
Country
New Zealand
Secondary sponsor category [1] 285317 0
None
Name [1] 285317 0
Address [1] 285317 0
Country [1] 285317 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288603 0
University of Otago Human Ethics Committee
Ethics committee address [1] 288603 0
Ethics committee country [1] 288603 0
New Zealand
Date submitted for ethics approval [1] 288603 0
Approval date [1] 288603 0
23/11/2012
Ethics approval number [1] 288603 0

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

Contacts
Principal investigator
Name 36882 0
Mr Suliman Mansi
Address 36882 0
School of Physiotherapy
University of Otago
Level 3
325 Gt King Street
Dunedin 9016
New Zealand
Country 36882 0
New Zealand
Phone 36882 0
+64 (0)3 479 9619
Fax 36882 0
Email 36882 0
almsu521@student.otago.ac.nz
Contact person for public queries
Name 36883 0
Suliman
Address 36883 0
School of Physiotherapy
University of Otago
Level 3
325 Gt King Street
Dunedin 9016
New Zealand
Country 36883 0
New Zealand
Phone 36883 0
+64 (0)3 479 9619
Fax 36883 0
Email 36883 0
almsu521@student.otago.ac.nz
Contact person for scientific queries
Name 36884 0
Suliman
Address 36884 0
School of Physiotherapy
University of Otago
Level 3
325 Gt King Street
Dunedin 9016
New Zealand
Country 36884 0
New Zealand
Phone 36884 0
+64 (0)3 479 9619
Fax 36884 0
Email 36884 0
almsu521@student.otago.ac.nz

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
SourceTitleYear of PublicationDOI
EmbaseUse of pedometer-driven walking to promote physical activity and improve health-related quality of life among meat processing workers: A feasibility trial.2013https://dx.doi.org/10.1186/1477-7525-11-185
EmbaseInvestigating the effect of a 3-month workplace-based pedometer-driven walking programme on health-related quality of life in meat processing workers: a feasibility study within a randomized controlled trial.2015https://dx.doi.org/10.1186/s12889-015-1736-z
N.B. These documents automatically identified may not have been verified by the study sponsor.