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Trial registered on ANZCTR


Registration number
ACTRN12619000490178
Ethics application status
Approved
Date submitted
19/03/2019
Date registered
26/03/2019
Date last updated
26/03/2019
Date data sharing statement initially provided
26/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Active Women over 50 Online: a pilot trial
Scientific title
Active Women over 50 online information and support to promote physical activity behaviour change: a feasibility pilot trial
Secondary ID [1] 297155 0
None
Universal Trial Number (UTN)
U1111-1227-1779
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 311187 0
Condition category
Condition code
Public Health 309808 309808 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Upon giving informed consent and completing baseline measurements, eligible participants will be randomised to receive the intervention immediately or after the 3 month follow-up measurements. The intervention group will receive access to the Active Women over 50 website, one follow-up telephone contact from a research physiotherapist and a choice of either 24 follow-up SMS or 8 follow-up email messages over a 3 month period. Frequency of use of the Active Women over 50 website will be at the discretion of the participant. The follow-up telephone contact will encourage goal setting and physical activity behaviour change, based on evidence-based theoretically grounded behaviour change principles. The follow up email and SMS messages will be similar in content. The purpose of the messages is to support physical activity behaviour change through behaviour change techniques. These techniques include providing practical tips, addressing barriers, providing motivation by social modelling and reminders of the benefits of physical activity, assisting with action planning and problem solving and time management. These messages will also link participants back to the website.The Active Women over 50 website will emphasise the importance of becoming active from middle age for maintenance of health and physical function and prevention of falls in older age. Content will include evidence-based information about the impact of even small increases in physical activity on health and longevity as well as inspirational video case studies of “success stories”; people who have managed to increase their physical activity levels in the face of mobility/ health/ practical difficulties and the benefits that they have experienced. Guidance on the setting of SMART (Specific, Measurable, Achievable, Realistic and Time-related) goals and self-assessment of barriers to physical activity participation and solution generation will be an important inclusion on the website. The website will link to other sources of support/ information, such as the NSW Ministry of Health-funded Get Healthy free health coaching service and the Active and Healthy online directory of physical activity opportunities.
Intervention code [1] 313416 0
Prevention
Intervention code [2] 313417 0
Behaviour
Intervention code [3] 313418 0
Lifestyle
Comparator / control treatment
Participants randomised to the control group will be allocated to a waiting list and receive access to the website and follow-up support after the 3-month follow-up period.
Control group
Active

Outcomes
Primary outcome [1] 318770 0
Participant acceptability and feasibility of the intervention and study methods. A global measure whether or not a participant would be to recommend participation in the study to someone else like themselves on a 3 point scale (yes, unsure, no).
Timepoint [1] 318770 0
3 months post-randomisation
Secondary outcome [1] 365972 0
1) Average number of steps per day, measured by a matchbox-sized accelerometer (Actigraph) worn on a belt at the hip during waking hours, assessed over 7 days. Accelerometer data will be analysed using ActiLife 6 software. Acceptable wear time will be defined as 4 days or more of 10 hours or more per day.
Timepoint [1] 365972 0
Actigraph measures will be collected over a 7 consecutive day period at baseline and at 3 months post-randomisation
Secondary outcome [2] 365973 0
2) Proportion of participants taking part in at least 150 minutes of moderate intensity physical activity or at least 75 minutes of vigorous intensity physical activity (as recommended by the Australian Physical Activity Guidelines), assessed by accelerometer (Actigraph) worn on a belt at the hip during waking hours, assessed over 7 consecutive days
Timepoint [2] 365973 0
Actigraph measures will be collected over a 7 consecutive day period at baseline, and at 3 months post-randomisation
Secondary outcome [3] 365974 0
3) Exercise perceptions as measured by the Exercise Benefits and Barriers Scale
Timepoint [3] 365974 0
Participant survey at baseline, and 3 months after randomisation
Secondary outcome [4] 365975 0
4) Mood measured with the positive and negative subscales of the Positive and Negative Affect Schedule (PANAS)
Timepoint [4] 365975 0
Participant survey at baseline, and 3 months after randomisation
Secondary outcome [5] 365977 0
5) Current self-reported physical activity levels as measured by International Physical Activity Questioinnaire (IPAQ)
Timepoint [5] 365977 0
Participant survey at baseline, and 3 months after randomisation
Secondary outcome [6] 365980 0
6) Physical functioning as measured by the function component of the Late Life Function and Disability Instrument (LLFDI)
Timepoint [6] 365980 0
Participant survey at baseline and 3 months after randomisation
Secondary outcome [7] 366145 0
7) Health related quality of life as measured by the EQ-5D-5L survey
Timepoint [7] 366145 0
Participant survey at baseline and 3 months after randomisation
Secondary outcome [8] 367412 0
8) Percentage of screened participants who agree to participate in the study, measured by (1) study screening forms, (2) consent forms
Timepoint [8] 367412 0
Participant baseline assessment
Secondary outcome [9] 367416 0
9) Percentage of participants who complied with wearing the accelerometer (Actigraph) for the 7-day period, measured by the recorded accelerometer data at the assessment intervals
Timepoint [9] 367416 0
Participant assessment: baseline and 3 months post-randomisation
Secondary outcome [10] 367420 0
10) Percentage of participants who completed self-report survey assessments, measured by completed questionnaires at the assessment intervals.
Timepoint [10] 367420 0
Participant assessment: baseline and 3 months post-randomisation
Secondary outcome [11] 367424 0
11) Percentage of participants who engaged in follow-up telephone support, measured by study records.
Timepoint [11] 367424 0
3 months post-randomisation
Secondary outcome [12] 367425 0
12) Percentage of participants who used the website, recorded by Google analytics
Timepoint [12] 367425 0
3 months post-randomisation
Secondary outcome [13] 367429 0
13) Proportion of people screened who met the inclusion crieteria, recorded via the study screening forms.
Timepoint [13] 367429 0
Participant baseline assessment
Secondary outcome [14] 367432 0
14) Number of participants who withdraw consent or participation, recorded via the study records
Timepoint [14] 367432 0
3 months post-randomisation

Eligibility
Key inclusion criteria
Eligible participants will be aged 50 years and over, female, community dwelling in New South Wales, Australia.
Minimum age
50 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People will be excluded if they:
i) have insufficient English language skills to fully participate in the program;
ii) do not have access to the internet
iii) have a medical condition that precludes participation in regular physical activity;
iv) are already sufficiently active in accordance with the Australian Physical Activity guidelines.

Study design
Purpose of the study
Treatment
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.
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 will be analysed descriptively to guide the design of a larger trial. Between-group differences in secondary outcomes, analysed with general linear models, will estimate effect sizes for sample size calculations for a larger trial and will provide an indication of likely intervention effect.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 301709 0
University
Name [1] 301709 0
Charles Perkins Centre Active Ageing Research Node seed grant, The University of Sydney
Address [1] 301709 0
Camperdown
Sydney
NSW 2050
Country [1] 301709 0
Australia
Primary sponsor type
University
Name
School of Public Health, The University of Sydney
Address
Level 10, North
KGV Building
Missenden Road
Camperdown, 2050
Country
Australia
Secondary sponsor category [1] 301713 0
None
Name [1] 301713 0
Address [1] 301713 0
Country [1] 301713 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302428 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 302428 0
Ethics and Research Integrity
Margaret Telfer Building (K07)
University of Sydney
NSW 2006
Ethics committee country [1] 302428 0
Australia
Date submitted for ethics approval [1] 302428 0
28/01/2019
Approval date [1] 302428 0
08/03/2019
Ethics approval number [1] 302428 0
2019/075

Summary
Brief summary
We have designed a simple intervention aimed at increasing physical activity in females aged 50+. Stage 1 of the Active Women over 50 project involved a pilot RCT (ACTRN12617000485336) to test the impact of a one hour face-to-face education session about physical activity, as well as access to follow-up support strategies (goal setting, email prompts) for promoting behaviour change. In the Active Women over 50 stage 1 pilot RCT (n=130) the education session was well-received among university and hospital employees, with 100% of attendees subsequently investigating the suggested physical activity resources further (e.g. physical activity websites, local facilities, Fitbit device) to increase activity. In order to broaden the reach of the program and to enable implementation to a more varied population of women from different geographical areas, we now plan to develop and evaluate the impact of an online resource in phase 2 of the Active Women over 50 project.

Active ageing is at the core of this highly innovative project that targets women aged 50 years and older. To our knowledge there currently exists no other online resource that specifically targets physical activity information and resources in a way that is relevant to the needs of women aged 50+ years. Women in this age group have unique barriers to becoming more active and hence a targeted and supported approach to ensure behaviour change is sustainable is particularly important. Women aged 50+ years may struggle to increase physical activity participation due to factors such as lack of time, carer responsibilities, demands of work, chronic health conditions, chronic pain and disability. By taking a tailored and supported approach to the provision of physical activity information, our innovative project has the potential to substantially increase physical activity participation in people aged 50+. The use of video case studies of real women who have managed to become active in the face of many barriers is a particularly innovative aspect of our program since it provides relevance and familiarity to the target audience. This approach also allows for the targeting of key messages to a broad range of women 50+ from all geographical areas and socioeconomic backgrounds.

This project aims to assess the feasibility and acceptability of an online physical activity behaviour change resource with follow-up support and to pilot test the proposed methods for a planned large RCT to assess the impact of the intervention on physical activity among women aged 50 years and over.
Trial website
www.activewomenover50.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90210 0
A/Prof Anne Tiedemann
Address 90210 0
Institute for Musculoskeletal Health
The University of Sydney
PO Box M179
Missenden Rd
Camperdown
NSW, 2050
Country 90210 0
Australia
Phone 90210 0
+61 2 8627 6233
Fax 90210 0
+61 2 8627 6262
Email 90210 0
anne.tiedemann@sydney.edu.au
Contact person for public queries
Name 90211 0
A/Prof Anne Tiedemann
Address 90211 0
Institute for Musculoskeletal Health
The University of Sydney
PO Box M179
Missenden Rd
Camperdown
NSW, 2050
Country 90211 0
Australia
Phone 90211 0
+61 2 8627 6233
Fax 90211 0
+61 2 8627 6262
Email 90211 0
anne.tiedemann@sydney.edu.au
Contact person for scientific queries
Name 90212 0
A/Prof Anne Tiedemann
Address 90212 0
Institute for Musculoskeletal Health
The University of Sydney
PO Box M179
Missenden Rd
Camperdown
NSW, 2050
Country 90212 0
Australia
Phone 90212 0
+61 2 8627 6233
Fax 90212 0
+61 2 8627 6262
Email 90212 0
anne.tiedemann@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results