Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000485336
Ethics application status
Approved
Date submitted
30/03/2017
Date registered
4/04/2017
Date last updated
12/08/2019
Date data sharing statement initially provided
12/08/2019
Date results information initially provided
12/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised trial to evaluate the effect of an education program on the physical activity of University female staff aged 50 years and over
Scientific title
A randomised trial to evaluate the effect of an education program on the physical activity of University female staff aged 50 years and over
Secondary ID [1] 291369 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 302357 0
Condition category
Condition code
Public Health 301944 301944 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After gaining informed consent, eligible participants will complete a baseline survey of their current physical activity level and wear an Actigraph accelerometer for 7 days, issued by the research assistant. Participants randomised to the intervention group will attend a one-hour workshop, held at the University of Sydney or Royal Prince Alfred Hospital.
The workshop will be delivered by one of the investigators (CS, AT, CC, LH or RS), who are also University academic staff members and registered Physiotherapists. Information will be given about the importance of physical activity for maximising physical and mental health and preventing disability in women and to provide information about existing opportunities to participate in and enhance physical activity participation. Video interviews will be shown at the workshop of 4 current and retired University female staff who are over 50 and manage to fit physical activity into their busy lives and experience the benefits. The COM-B behaviour change framework, which focuses on capability opportunity and motivation, will be used to guide the design of the intervention. Workshop materials will be made freely available at the completion of the workshop. Existing physical activity opportunities that will be referred to include the a) on-campus activities and facilities b) websites providing information and programmes, for example the Active and Healthy website, a freely-available database of physical activity opportunities for the over 50s run by the NSW Ministry of health, the Get Healthy coaching service run by the NSW Ministry of health and the Global Corporate Challenge supported by the University; c) suggestions of some free applications for smartphone devices that enhance physical activity (for example, "Couch 2 5K", "Map my run").
Participants who are unable to physically attend the workshops will be offered attendance via video-conferencing facilities or via an online recording of the workshop with the opportunity to ask any questions to the presenters by email or telephone.
An on-line discussion group will be set up for those who wish to remain in contact, and fortnightly emails supporting behaviour change will be sent to those who wish to receive these. Workshop participants will also be offered the use of a pedometer or internet-connected activity tracker (Fitbit) for the duration of the study (3 months), to provide motivation and feedback to increase activity levels. Participants will be re-evaluated by survey and Actigraph accelerometer 3 months after the workshop, and will be asked about their goals attained, and which additional activities and support approaches were undertaken.
Intervention code [1] 297393 0
Prevention
Intervention code [2] 297394 0
Behaviour
Intervention code [3] 297668 0
Lifestyle
Comparator / control treatment
Participants randomised to the control group will be allocated to a waiting list and receive access to the intervention after the 3-month follow-up period.
Control group
Active

Outcomes
Primary outcome [1] 301362 0
The proportion of people achieving an average of at least 10,000 daily steps, measured objectively with an Actigraph accelerometer.
Timepoint [1] 301362 0
Actigraph measures collected over 7 consecutive days at baseline, and 3 months after randomisation
Secondary outcome [1] 332425 0
1) the proportion of people achieving adequate physical activity levels as recommended by national physical activity guidelines, measured using an Actigraph accelerometer;
Timepoint [1] 332425 0
Actigraph measures collected over 7 consecutive days at baseline, and 3 months after randomisation
Secondary outcome [2] 333405 0
2) the average total number of hours of physical activity per week as measured by the International Physical Activity Questionnaire (IPAQ);
Timepoint [2] 333405 0
Participant survey at baseline, and 3 months after randomisation
Secondary outcome [3] 333406 0
3) change in perceived benefits of and barriers to exercise participation, as measured by the Exercise Benefits and Barriers Scale;
Timepoint [3] 333406 0
Participant survey at baseline, and 3 months after randomisation
Secondary outcome [4] 333407 0
4) physical functioning as measured by the function component of the Late Life Function and Disability Instrument (LLFDI);
Timepoint [4] 333407 0
Participant survey at baseline, and 3 months after randomisation
Secondary outcome [5] 333408 0
5) mood as measured with the positive and negative subscales of the Positive and Negative Affect Schedule (PANAS).
Timepoint [5] 333408 0
Participant survey at baseline, and 3 months after randomisation

Eligibility
Key inclusion criteria
Eligible participants will be aged 50 years and over and female and be staff of The University of Sydney or Royal Prince Alfred Hospital, Concord Repatriation General Hospital, Balmain Hospital or Canterbury Hospital, Sydney.
Minimum age
50 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
a) have insufficient English language skills to fully participate in the program;
b) have a medical condition that precludes participation in regular physical activity;
c) are already sufficiently active in accordance with the Australian Physical Activity guidelines.

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)
For eligible people who consent to participate in the study, a baseline assessment will be conducted. At the end of the assessment group allocation will be determined using concealed allocation. Concealed allocation will be achieved by the randomisation schedule being embedded in a secure online database (REDCap).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A variable block randomisation schedule will be prepared from a computer-generated list of random numbers by a researcher not involved in the recruitment of participants in the trial. The randomisation schedule will incorporate stratification for University campus.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analysis will be blinded, by intention-to-treat and guided by a detailed statistical analysis plan. Analysis and interpretation (also performed blinded) on the primary and key secondary outcomes will be conducted by the research team. A p-value of < 0.05 will be considered statistically significant. A full Statistical Analysis Plan will be devised by the lead investigator prior to completion of recruitment.
Odds ratios will be calculated to assess the effect of group allocation on the dichotomously-scored primary outcome (proportion of people achieving 10,000 steps/ day) and secondary outcome (proportion of people achieving physical activity in accordance with national guidelines). General linear models will assess the effect of group allocation on the continuously-scored secondary outcomes (weekly hours of physical activity, function and mood), adjusting for baseline scores.
A total of 50 participants per group (i.e. 100 participants) will provide 80% power to detect 30% more people in the intervention group reaching the recommended 10,000 steps/ day than the control group. This calculation assumed a proportion of 27% compliance with the 10,000 steps/ day activity level in the control group, dropout rate of 15% and alpha of 5%. The estimates of mean proportion of people achieving 10,000 steps/ day activity level was taken from the baseline results of the University of Sydney staff participating in the Global Corporate Challenge, Analyses will be pre-planned, conducted while masked to group allocation and will use an intention-to-treat approach. Analyses will be conducted using the Stata 13 software package.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/04/2017
Actual
29/05/2017
Date of last participant enrolment
Anticipated
7/09/2018
Actual
4/07/2018
Date of last data collection
Anticipated
23/12/2018
Actual
7/11/2018
Sample size
Target
100
Accrual to date
Final
126
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11808 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 11809 0
Concord Repatriation Hospital - Concord
Recruitment hospital [3] 11810 0
Balmain Hospital - Balmain
Recruitment hospital [4] 11811 0
Canterbury Hospital - Campsie
Recruitment postcode(s) [1] 15506 0
1825 - Lidcombe
Recruitment postcode(s) [2] 15505 0
2006 - The University Of Sydney
Recruitment postcode(s) [3] 23937 0
2041 - Balmain
Recruitment postcode(s) [4] 23935 0
2050 - Camperdown
Recruitment postcode(s) [5] 23936 0
2139 - Concord
Recruitment postcode(s) [6] 23938 0
2194 - Campsie

Funding & Sponsors
Funding source category [1] 295841 0
University
Name [1] 295841 0
The study is being funded through a Healthy Sydney University seed funding grant.
Country [1] 295841 0
Australia
Funding source category [2] 300618 0
University
Name [2] 300618 0
Musculoskeletal Health Sydney Collaborative Research Scheme, The University of Sydney
Country [2] 300618 0
Australia
Funding source category [3] 300619 0
University
Name [3] 300619 0
Musculoskeletal Health Sydney Academic Research Group Postgraduate Scholarship
Country [3] 300619 0
Australia
Primary sponsor type
University
Name
School of Public Health, The University of Sydney
Address
University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 294691 0
University
Name [1] 294691 0
Faculty of Health Sciences, The University of Sydney
Address [1] 294691 0
THE UNIVERSITY OF SYDNEY
PO Box 170,
Lidcombe, NSW, 1825
Country [1] 294691 0
Australia
Secondary sponsor category [2] 294694 0
University
Name [2] 294694 0
Healthy Sydney University
Address [2] 294694 0
Level 3, Margaret Telfer (K07) and Level 4 The Quadrangle (A14) L4.05
The University of Sydney
NSW 2006
Country [2] 294694 0
Australia
Secondary sponsor category [3] 300123 0
Hospital
Name [3] 300123 0
Royal Prince Alfred Hospital
Address [3] 300123 0
Missenden Road
Camperdown
NSW 2050
Country [3] 300123 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297123 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 297123 0
Ethics and Research Integrity
Margaret Telfer Building (K07)
University of Sydney
NSW 2006
Ethics committee country [1] 297123 0
Australia
Date submitted for ethics approval [1] 297123 0
28/02/2017
Approval date [1] 297123 0
13/04/2017
Ethics approval number [1] 297123 0
Ethics committee name [2] 301406 0
Sydney Local Health District Ethics Review Committee (RPAH Zone) [EC00113]
Ethics committee address [2] 301406 0
Royal Prince Alfred Hospital
Camperdown
NSW 2050
Ethics committee country [2] 301406 0
Australia
Date submitted for ethics approval [2] 301406 0
07/09/2017
Approval date [2] 301406 0
26/09/2017
Ethics approval number [2] 301406 0
X17-0316

Summary
Brief summary
This randomised waiting list controlled trial aims to test the impact of an intervention designed to enhance ongoing physical activity participation in women aged over 50.
100 female University staff aged 50 years and older will be recruited via University newsletters and websites. Exclusion criteria are limited English skills, a medical condition precluding participation in regular exercise, or currently meeting physical activity guidelines.
Upon giving informed consent participants will complete a baseline survey on physical activity knowledge, attitudes and behaviour, physical functioning and mood. Current physical activity level will be measured with an accelerometer, worn on the hip for 7 consecutive days to determine the average daily step count.
Participants will then be randomised to attend a workshop immediately, or after 3 months. At 3 months post randomisation, similar surveys and wearing the accelerometer will be repeated.
The intervention will be a one-hour workshop to give information about the importance of physical activity for maximising physical and mental health and preventing disability in women, and to provide information about existing opportunities to participate in and enhance physical activity.
An email list and on-line discussion group will be set up for those wishing to remain in contact. Workshop materials will be made freely available at the completion of the project, and participants will also be offered the use of a pedometer or internet-connected activity tracker (Fitbit) for the duration of the study, to provide motivation and feedback to increase activity levels.
Participants randomised to the control group will be allocated to a waiting list and receive access to the intervention after the 3-month follow-up period.
The primary outcome will be the proportion of people achieving an average of at least 10,000 daily steps, measured with an accelerometer.
The secondary outcomes will be the proportion of people achieving adequate physical activity levels as recommended by national physical activity guidelines, average total number of hours of physical activity per week, change in perceived benefits of and barriers to exercise participation, physical functioning, mood.
Analyses will be pre-planned, conducted while masked to group allocation and will use an intention-to-treat approach.
50 participants per group (i.e. 100 participants) will provide 80% power to detect 30% more people in the intervention group reaching the recommended 10,000 steps/day than the control group. This calculation assumed a proportion of 27% compliance with the 10,000 steps/day activity level in the control group, 15% dropout rate and 5% alpha.
This sample size is also expected to be sufficient to detect between-group differences in the order of 10-15% for the secondary outcome measures.
If shown to be effective, this study is an approach that could be implemented more broadly to increase the population health impact.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73054 0
Prof Cathie Sherrington
Address 73054 0
School of Public Health
University of Sydney
NSW 2006
Country 73054 0
Australia
Phone 73054 0
+61418225929
Fax 73054 0
Email 73054 0
cathie.sherrington@sydney.edu.au
Contact person for public queries
Name 73055 0
Prof Cathie Sherrington
Address 73055 0
School of Public Health
University of Sydney
NSW 2006
Country 73055 0
Australia
Phone 73055 0
+61418225929
Fax 73055 0
Email 73055 0
cathie.sherrington@sydney.edu.au
Contact person for scientific queries
Name 73056 0
Prof Cathie Sherrington
Address 73056 0
School of Public Health
University of Sydney
NSW 2006
Country 73056 0
Australia
Phone 73056 0
+61418225929
Fax 73056 0
Email 73056 0
cathie.sherrington@sydney.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
SourceTitleYear of PublicationDOI
EmbaseActive Women over 50. Promoting Physical Activity in Women Over 50: A Randomized Trial.2022https://dx.doi.org/10.1177/08901171211045678
N.B. These documents automatically identified may not have been verified by the study sponsor.