Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000186550
Ethics application status
Approved
Date submitted
5/02/2015
Date registered
25/02/2015
Date last updated
14/06/2019
Date data sharing statement initially provided
14/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Incentivising physical activity for nurses: protocol for a quasi-experimental trial
Scientific title
Incentivising physical activity for nurses: a pedometer-based intervention, with and without an incentive, to promote physical activity in nurses.
Secondary ID [1] 286113 0
none
Universal Trial Number (UTN)
U1111-1166-9569
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
promoting physical activity to reduce the risk of non-communicable diseases in nurses. 294111 0
Condition category
Condition code
Cardiovascular 294426 294426 0 0
Coronary heart disease
Public Health 294427 294427 0 0
Epidemiology
Public Health 294559 294559 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants in the Intervention hospital will be given a Yamax SW 200 pedometer and weekly log sheets. Participants will be requested to wear the pedometer every day during all waking hours, and record their daily step counts on the log sheets that will be collected each week, by research staff. Each participant will recieve a bi-weekly text message encouraging them to increase their steps per day. Nurses will receive a monetary incentive at the end of the 10-week intervention. The value of the incentive will be scaled, based on the percentage increase in accelerometer measured step counts. For example, if a nurse has increased his/her daily steps counts by 3000 steps or more since baseline, he/she will receive $120. Nurses who increase their steps counts by 2000 and 1000 steps per day will receive $60 and $30, respectively. The nurses will then be invited to keep the pedometer for a further 10-weeks. They will not receive any text messages or incentive during this period, and will not be required to record their weekly pedometer counts.

Bi-weekly text messages:
Week 1:
Well done on starting the nurse’s intervention! Your daily average steps were **** and your 10-week goal is *** steps per day


Week 3:
We hope that you are keeping track of your daily steps. Why not aim for a weekend walk? A 30-minute walk is about 3500 steps! :)


Week 5:
Meeting goal:
You should aim to achieve at least [insert goal steps] steps per day to meet your goal and receive the $110! Your average step count last week was [insert week 4 steps] which shows that you are already achieving this goal. Keep it up

Close to goal:
You should aim to achieve at least [insert goal steps] steps per day to meet your goal and receive the $110! Your average step count last week was [insert week 4 steps] showing that you are making good progress. Keep it up

Far from goal
You should aim to achieve at least [insert goal steps] steps per day to meet your goal and receive the $110! Your average step count last week was [insert week 4 steps] Every step counts, so try to walk an extra 10 minutes every day this week.

Week 7:
We've passed the halfway mark! Every step counts. You average steps per day over the last two weeks were [insert week 5 and 6 steps]. Keep looking for opportunities to be active. Take the stairs instead of the escalator; go for a lunchtime walk; aim for a longer week end walk over the next two weeks.


Week 9:
One more week to go! Keeping on clocking up those steps. Remember your goal is to walk an average of [insert goal steps] steps per day. Its getting light earlier and earlier, how about an early morning walk?

On track:
One more week to go! Keeping on clocking up those steps. You are on track for achieving your goal of [insert goal steps] steps per day! How about adding an early morning or evening walk to your day?

Close to goal:
One more week to go! Keeping on clocking up those steps. You are close to achieving your goal of [insert goal steps] steps per day! How about adding an early morning or evening walk to your day?

Far from goal:
One more week to go! Keeping on clocking up those steps. Every step counts so keep on aiming to get as close to your goal of [insert goal steps] steps per day as possible. How about adding an early morning or evening walk to your day?
Intervention code [1] 291108 0
Lifestyle
Intervention code [2] 291109 0
Behaviour
Intervention code [3] 291217 0
Prevention
Comparator / control treatment
Participants in the control hospital will also be given a pedometer and will be requested to record their daily step counts for 10 weeks on the log sheets that will be collected weekly by research staff. Like the intervention group, these step counts will be used to tailor bi-weekly text messages that will be sent to participants to encourage them to increase their physical activity. However, these nurses will not receive the incentive for increasing physical activity. These nurses will also be invited to wear the pedometer for a further 10-weeks, during which time they will not need to record their steps and will not receive any text messages.

Bi-weekly text messages:
Week 1:
Well done on starting the nurses intervention! Your daily average steps were **** and your 10-week goal is *** steps per day


Week 3:
We hope that you are keeping track of your daily steps. Why not aim for a weekend walk? A 30-minute walk is about 3500 steps! :)


Week 5:
Meeting goal:
You should aim to achieve at least [insert goal steps] steps per day to meet your goal. Your average step count last week was [insert week 4 steps] which shows that you are already achieving this goal. Keep it up

Close to goal:
You should aim to achieve at least [insert goal steps] steps per day to meet your goal! Your average step count last week was [insert week 4 steps] showing that you are making good progress. Keep it up

Far from goal
You should aim to achieve at least [insert goal steps] steps per day to meet your goal! Your average step count last week was [insert week 4 steps] Every step counts, so try to walk an extra 10 minutes every day this week.

Week 7:
We've passed the halfway mark! Every step counts. You average steps per day over the last two weeks were [insert week 5 and 6 steps]. Keep looking for opportunities to be active. Take the stairs instead of the escalator; go for a lunchtime walk; aim for a longer week end walk over the next two weeks.


Week 9:
One more week to go! Keeping on clocking up those steps. Remember your goal is to walk an average of [insert goal steps] steps per day. Its getting light earlier and earlier, how about an early morning walk?

On track:
One more week to go! Keeping on clocking up those steps. You are on track for achieving your goal of [insert goal steps] steps per day! How about adding an early morning or evening walk to your day?

Close to goal:
One more week to go! Keeping on clocking up those steps. You are close to achieving your goal of [insert goal steps] steps per day! How about adding an early morning or evening walk to your day?

Far from goal:
One more week to go! Keeping on clocking up those steps. Every step counts so keep on aiming to get as close to your goal of [insert goal steps] steps per day as possible. How about adding an early morning or evening walk to your day?

Control group
Active

Outcomes
Primary outcome [1] 294226 0
The main outcome will be a change in daily step counts, according to the accelerometer measures. The acceleroemter will be worn for 8 consectutive days at each time point.
Timepoint [1] 294226 0
Baseline to 10 weeks and 11 weeks to 21 weeks
Secondary outcome [1] 312823 0
Light intensity physical activity based on accelerometer measures. The acceleroemter will be worn for 8 consectutive days at each time point. Accelerometer counts that are less than <2020 per minute will be classified as light intensity physical activity. This is based on the cutpoints of Troiano et al., 2008. (Troiano RP, Berrigan D, Dodd KW, Masse LC, Tilert T, McDowell M. Physical activity in the United States measured by accelerometer. Med Sci Sports Exerc 2008;40(1):181-188)
Timepoint [1] 312823 0
Baseline to 10 weeks and 11-21 weeks.
Secondary outcome [2] 313061 0
Moderate intensity physical activity based on accelerometer measures. The acceleroemter will be worn for 8 consectutive days at each time point. Accelerometer counts betweeen 2020 and 5998 per minute will be classified as moderate intensity physical activity. This is based on the cutpoints of Troiano et al., 2008. (Troiano RP, Berrigan D, Dodd KW, Masse LC, Tilert T, McDowell M. Physical activity in the United States measured by accelerometer. Med Sci Sports Exerc 2008;40(1):181-188)
Timepoint [2] 313061 0
Baseline to 10 weeks, and 11-21 weeks based on accelerometer measures. The acceleroemter will be worn for 8 consectutive days at each time point.
Secondary outcome [3] 313062 0
Vigorous intensity physical activity based on accelerometer measures. The acceleroemter will be worn for 8 consectutive days at each time point. Moderate intensity physical activity based on accelerometer measures. The acceleroemter will be worn for 8 consectutive days at each time point. Accelerometer counts bmore than or equal to 5999 per minute will be classified as vigorous intensity physical activity. This is based on the cutpoints of Troiano et al., 2008. (Troiano RP, Berrigan D, Dodd KW, Masse LC, Tilert T, McDowell M. Physical activity in the United States measured by accelerometer. Med Sci Sports Exerc 2008;40(1):181-188)
Timepoint [3] 313062 0
Baseline to 10 week, and 11-21 weeks
Secondary outcome [4] 313063 0
Sedentary behaviour based on accelerometer measures. The acceleroemter will be worn for 8 consectutive days at each time point.
Timepoint [4] 313063 0
baseline to 10 weeks, and 11-21 weeks
Secondary outcome [5] 313064 0
Self-reported physical activity which will be measured using the Global Physical Activity Questionniare. This questionnaire forms part of the Nurse's Health Survey.
Timepoint [5] 313064 0
baseline, 10 and 21 weeks.
Secondary outcome [6] 313065 0
Chrono-type: Horne-Ostberg Morning-Evening Personality Questionnaire
This questionnaire (part of nurse health survey) will be used to measure self-reported diurnal preference or chrono-type. It comprises 19 questions related to time of waking, how refreshed participants feel on waking and whether they use an alarm clock to wake up.
Timepoint [6] 313065 0
Baseline

Eligibility
Key inclusion criteria
All nurses who work shifts will be eligible to participate
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The only exclusion criteria are that nurses should not be pregnant or wheelchair bound.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The main outcome will be a change in daily step counts, according to the accelerometer measures, from baseline to 11 and 22 weeks. We determined sample size by examining outcome statistics from a comparable study by Baker et al. that assessed changes in daily step counts in participants who received physical activity goals and counseling and compared them to a control group. In order to detect a between-group difference in change in step counts of 3000 steps per day, with an expected standard deviation of this change of 1700 steps per day, the required sample size is 29 nurses per group, based on a significance level a=0.05 and 80% power. However, the Baker et al. (2008) study had a mean dropout rate of 19%, therefore the sample size will be increased by 20% to 35 nurses per hospital, for a total of 70 nurses.

Descriptive statistics (mean, standard deviation for the continuous variables and proportions for the categorical variable) will be used to describe baseline characteristics, with t tests and chi square tests to determine group differences for continuous and categorical variables, respectively. Generalised linear models will be used to compare group differences in changes in accelerometer derived average steps per day and in other variables. Sub-group analyses will be used to examine differences between day and night shift workers. Significance will be accepted when p < 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2014
Actual
6/10/2014
Date of last participant enrolment
Anticipated
23/03/2015
Actual
1/02/2017
Date of last data collection
Anticipated
Actual
30/06/2017
Sample size
Target
70
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3399 0
Toowong Private Hospital - Toowong
Recruitment hospital [2] 3400 0
St Vincent's Hospital Brisbane - Kangaroo Point

Funding & Sponsors
Funding source category [1] 290691 0
University
Name [1] 290691 0
University of Queensland
Country [1] 290691 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
The School of Human Movement Studies
Level 5, Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 289384 0
None
Name [1] 289384 0
Address [1] 289384 0
Country [1] 289384 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292325 0
Behavioural and Social Sciences Ethical Review Committee at the University of Queensland
Ethics committee address [1] 292325 0
Ethics committee country [1] 292325 0
Australia
Date submitted for ethics approval [1] 292325 0
Approval date [1] 292325 0
30/09/2014
Ethics approval number [1] 292325 0
2014001049

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

Contacts
Principal investigator
Name 54694 0
Dr Tracy Kolbe-Alexander
Address 54694 0
Centre for Research on Exercise, Physical Activity and Health
School of Human Movement Studies
Blair Drive
St Lucia, 4072
University of Queensland
Brisbane
Country 54694 0
Australia
Phone 54694 0
+ 61 7 3665 6981
Fax 54694 0
Email 54694 0
[email protected]
Contact person for public queries
Name 54695 0
Tracy Kolbe-Alexander
Address 54695 0
Centre for Research on Exercise, Physical Activity and Health
School of Human Movement Studies
Blair Drive
St Lucia, 4072
University of Queensland
Brisbane
Country 54695 0
Australia
Phone 54695 0
+ 61 7 3665 6981
Fax 54695 0
Email 54695 0
[email protected]
Contact person for scientific queries
Name 54696 0
Tracy Kolbe-Alexander
Address 54696 0
Centre for Research on Exercise, Physical Activity and Health
School of Human Movement Studies
Blair Drive
St Lucia, 4072
University of Queensland
Brisbane
Country 54696 0
Australia
Phone 54696 0
+ 61 7 3665 6981
Fax 54696 0
Email 54696 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 will only be made available should peer-review journals request that it be shared.


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.