Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000026527
Ethics application status
Approved
Date submitted
7/12/2023
Date registered
12/01/2024
Date last updated
14/06/2024
Date data sharing statement initially provided
12/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Active Women over 50: A randomised controlled trial.
Scientific title
Active Women over 50 program: An effectiveness implementation randomised controlled trial in women seeking support to increase physical activity
Secondary ID [1] 310825 0
None
Universal Trial Number (UTN)
U1111-1299-2794
Trial acronym
AWo50
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 331820 0
Condition category
Condition code
Public Health 328565 328565 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will use a two-arm parallel pragmatic hybrid type I effectiveness-implementation randomised controlled trial (n=1000) to test the effectiveness of the Active Women over 50 program on daily steps at 6 months compared with waitlist control among women aged 50+.

Women participants aged 50 years and over will be randomly allocated in equal numbers to:
a) Immediate participation in the Active Women over 50 program (intervention group), n=500 or
b) Delayed participation in the Active Women over 50 program, waitlist control (control group, n=500)

Intervention components
The intervention group will receive immediate access to the Active Women over 50 program. The Active Women over 50 program is a remotely delivered program designed with input from end-users across urban, regional and rural geographical settings and consists of four parts: 1) telephone-based health coaching, 2) email or SMS behaviour change messages, 3) Active Women over 50 website, and 4) access to the Active Women over 50 private Facebook group.

Health coaching
Participants will receive two health coaching sessions, lasting up to 60 minutes, delivered by telephone or videoconference as preferred by the participant. The health coach will be a tertiary-qualified physiotherapist or other health professional trained and experienced in delivering empowerment-focused coaching to facilitate physical activity behaviour change. The first coaching session will take place within 2 weeks of randomisation, and the second session four weeks after the first. This person-centred health coaching approach will provide information and education about physical activity. The sessions will also draw on evidence-based behaviour change techniques, practice and theories to help participants set goals, action plan, and provide accountability through prompting, monitoring and reinforcement. The coach’s role is to work with participants to make achievable choices, reinforce and evaluate progress, and facilitate accountability. Participants will be encouraged to increase their physical activity as much as they are able to, and to be guided by the recommended dose of activity included in global guidelines. Types of physical activity will be dependent on the individual participant and their needs (e.g. walking, tennis, sit-to-stands).

Email or SMS Behaviour Change Messages
Participants will choose the type of message platform and the frequency at which they would like to receive motivational messages over the 6-month period. Participants will choose between receiving unidirectional email messages that are delivered either weekly (24 emails), fortnightly (12 emails) or monthly (6 emails) frequencies over the 6-month period; or receiving SMS messages that are delivered once per week (24 SMS messages), twice per week (48 SMS messages), or three times per week (72 SMS messages) over the 6-month period. The emails and SMS messages will include several behaviour change techniques (BCTs). Both the email and SMS messages will deliver similar content informed by behaviour change theories. Secure marketing websites will be used to send the email messages and SMS messages. Examples of behaviour change techniques that will be provided in these email or SMS messages include goal setting, planning, self-monitoring and social support.

Active Women over 50 Website
The 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 three main pages “Why be active?”, “How to be active”, and “Be inspired”. The “Why be active?” page includes evidence-based information about the effect of physical activity in middle-age to maintain health, longevity, and prevent disability in older age. The “How to be active” page includes practical suggestions for becoming more active using behaviour change techniques such as SMART goal setting, self-assessment of barriers to physical activity and solution-generation and included links to resources supporting habit formation and behaviour change, and information for different health conditions and services. The “Be inspired” page includes role modelling content to inspire participant’s motivation to be physically active through video case studies and photo stories of “real life” women over 50, external podcasts, and blog posts. Participants will have the ability to access the website at their own discretion. Examples will reflect diversity of participant characteristics and place of residence (i.e., urban, regional, rural, remote). The content on this website has been specifically design for this study. Time participants spend on the website is at their own discretion. Use of the website will be monitored by Google Analytics.

Active Women over 50 private Facebook group
Participants will have access to a private Facebook group to support networking and social support. Participants will be able to post comments to a common page (i.e., the group wall); view and respond to others’ posts; create and post to discussion boards; and post web links, photographs, and videos. The private Facebook group will be moderated daily (Monday to Friday) by a member of the research team to ensure interactions are appropriate and relevant. Participants will be informed of the group rules, which will be both posted in the group, and pinned to the top of the group webpage. Only participants receiving the intervention will be granted access to the private Facebook group. Time participants spend on the private Facebook group is at their own discretion. Use of the Facebook group will be monitored by Facebook engagement analytics.
Intervention code [1] 327237 0
Treatment: Other
Intervention code [2] 327670 0
Behaviour
Comparator / control treatment
Control group
Participants randomised to the control group will have a delayed participation (6 months after randomisation) in the Active Women over 50 program, waitlist control (control group, n=500). Participants in the control group will not be given any educational materials, recommendations or intervention materials during the waitlist period.
Control group
Active

Outcomes
Primary outcome [1] 336372 0
Physical activity (average steps per day).
Timepoint [1] 336372 0
Baseline and 6 months post-randomisation.
Secondary outcome [1] 428080 0
Self-reported physical activity
Timepoint [1] 428080 0
Baseline and 6 months post-randomisation.
Secondary outcome [2] 428081 0
Falls rate
Timepoint [2] 428081 0
Monthly for 6 months - starting at baseline and ending 6 months post-randomisation.
Secondary outcome [3] 428082 0
Mental wellbeing
Timepoint [3] 428082 0
Baseline and 6 months post-randomisation.
Secondary outcome [4] 428083 0
Physical function
Timepoint [4] 428083 0
Baseline and 6 months post-randomisation.
Secondary outcome [5] 428084 0
Quality of life
Timepoint [5] 428084 0
Baseline and 6 months post-randomisation.
Secondary outcome [6] 428085 0
Bodily pain
Timepoint [6] 428085 0
Baseline and 6 months post-randomisation.
Secondary outcome [7] 428086 0
Sleep
Timepoint [7] 428086 0
Baseline and 6 months post-randomisation.
Secondary outcome [8] 428087 0
Balance
Timepoint [8] 428087 0
Baseline and 6 months post-randomisation.
Secondary outcome [9] 428088 0
Fear of falling
Timepoint [9] 428088 0
Baseline and 6 months post-randomisation.
Secondary outcome [10] 428089 0
Proportion achieving light physical activity/week.
Timepoint [10] 428089 0
Baseline and 6 months post-randomisation.
Secondary outcome [11] 428090 0
Action Planning and Coping Planning
Timepoint [11] 428090 0
Baseline and 6 months post-randomisation.
Secondary outcome [12] 428091 0
Individualised goal attainment
Timepoint [12] 428091 0
Baseline and 6 months post-randomisation.
Secondary outcome [13] 428646 0
Proportion of participants who increased 2000+ steps from baseline using ActiGraph GT3X+ over a 7-day period
Timepoint [13] 428646 0
Baseline and 6 months post-randomisation
Secondary outcome [14] 428647 0
Participation in strength and balance training,
Timepoint [14] 428647 0
Baseline and 6 months post-randomisation
Secondary outcome [15] 428648 0
Menopause symptoms
Timepoint [15] 428648 0
Baseline and 6 months post-randomisation
Secondary outcome [16] 430153 0
Health and community service use
Timepoint [16] 430153 0
Monthly for 6 months - starting at baseline and ending 6 months post-randomisation.
Secondary outcome [17] 430154 0
Proportion achieving lower limit MVPA/week
Timepoint [17] 430154 0
Baseline and 6 months post-randomisation.

Eligibility
Key inclusion criteria
The trial will involve consenting women who:
• are aged 50 years and over
• live in the community across NSW
• do not meet the moderate-vigorous physical activity (MVPA) guidelines
• have access to an internet connected device
• want to receive support to be more active
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The trial will exclude adults who:
• have insufficient English language skills to fully participate in the program
• have a medical condition that precludes participation in regular physical activity
• have a cognitive impairment (a diagnosis of dementia or a Memory Impairment Screen score of less than 5)
• have a progressive neurological disease (e.g., Parkinson‘s disease)
• are unable to leave the house independently and walk 10 metres unassisted.

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)
Group allocation will be determined using REDCap (Research Electronic Data Capture), a centralised web-based randomisation system within The University of Sydney. This will ensure concealment of allocation to groups and an auditable process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
4 permuted block stratified by rural/remote and urban locations.
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
Statistical methods / analysis
A sample size of 1000 people will provide 90% power to detect a between-group difference of 1000 steps/day (SD 4200), assuming 25% dropouts, alpha 5%. The sample size calculation was undertaken using the sampsi command in Stata.

The primary outcome will be analysed using generalised linear regression to assess the effect of group allocation, with its corresponding baseline score as a covariate. We will use Poisson regression to determine the between-group difference in the proportion of people increasing daily steps by 2000+. Continuous secondary outcomes will be analysed using linear regression, adjusting for the corresponding baseline measure of the outcome variable as appropriate. Fall rates will be analysed using negative binomial regression models to estimate the difference in rates between groups after 6 months. There will also be pre-defined subgroup analyses included by age, number of medical conditions, geographical location, and baseline fall history.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/04/2024
Date of last participant enrolment
Anticipated
15/01/2026
Actual
Date of last data collection
Anticipated
15/07/2026
Actual
Sample size
Target
1000
Accrual to date
48
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 315072 0
Government body
Name [1] 315072 0
Australian Department of Health and Aged Care, Medical Research Future Fund (MRFF)
Country [1] 315072 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Institute for Musculoskeletal Health, School of Public Health, Faculty of Medicine and Health, Level 10 North, Building 13, King George V Building, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, NSW 2050
Country
Australia
Secondary sponsor category [1] 317090 0
None
Name [1] 317090 0
Address [1] 317090 0
Country [1] 317090 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314019 0
Human Research Ethics Committee (HREC) of The University of Sydney
Ethics committee address [1] 314019 0
Ethics committee country [1] 314019 0
Australia
Date submitted for ethics approval [1] 314019 0
09/10/2023
Approval date [1] 314019 0
21/12/2023
Ethics approval number [1] 314019 0
HREC 2023/803

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

Contacts
Principal investigator
Name 130142 0
Prof Anne Tiedemann
Address 130142 0
Institute for Musculoskeletal Health, PO Box M179, Missenden Road, Camperdown NSW 2050
Country 130142 0
Australia
Phone 130142 0
+61286276233
Fax 130142 0
Email 130142 0
[email protected]
Contact person for public queries
Name 130143 0
Anne Tiedemann
Address 130143 0
Institute for Musculoskeletal Health, PO Box M179, Missenden Road, Camperdown NSW 2050
Country 130143 0
Australia
Phone 130143 0
+61286276233
Fax 130143 0
Email 130143 0
[email protected]
Contact person for scientific queries
Name 130144 0
Anne Tiedemann
Address 130144 0
Institute for Musculoskeletal Health, PO Box M179, Missenden Road, Camperdown NSW 2050
Country 130144 0
Australia
Phone 130144 0
+61286276233
Fax 130144 0
Email 130144 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified participant data underlying published results.
When will data be available (start and end dates)?
The data will be accessible 3 months following the date of publication of the main results related to this trial and will be available for a period of 5 years post-publication.
Available to whom?
Data will be available on a case-by-case basis at the discretion of the Principal Chief Investigator.
Available for what types of analyses?
For meta-analysis.
How or where can data be obtained?
Access subject to approval by the Principal Investigator after providing a methodological proposal directed to the Principal Investigator ([email protected]).


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20812Study protocol  [email protected]
20813Statistical analysis plan  [email protected]
20835Informed consent form  [email protected]
20836Ethical approval  [email protected]


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20812Study protocol  [email protected] 386771-(Uploaded-14-10-2024-14-53-32)-2023_HE000803_v2_01 - AWo50 Protocol_V4_02.10.2024_clean.pdf
20813Statistical analysis plan  [email protected]
20835Informed consent form  [email protected] 386771-(Uploaded-14-10-2024-14-53-32)-AWo50_Consent form_V1_09.10.23.pdf
20836Informed consent form  [email protected] 386771-(Uploaded-14-10-2024-14-53-32)-AWo50_Consent form Extension_V2_02.10.2024_clean.pdf
24275Ethical approval  [email protected] 386771-(Uploaded-14-10-2024-14-54-31)-HE 2023_803 Application Outcome CAT_A.pdf
24276Ethical approval  [email protected] 386771-(Uploaded-14-10-2024-14-54-31)-Decision notification letter_ethics amendment 1_12Jul2024.pdf
24277Ethical approval  [email protected] 386771-(Uploaded-14-10-2024-14-54-31)-Decision notification letter_ethics amendment 2_14Oct2024.pdf

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.