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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]

None

Universal Trial Number (UTN)

U1111-1227-1779

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Physical inactivity

Condition category

Condition code

Public Health

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]

Prevention

Intervention code [2]

Behaviour

Intervention code [3]

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]

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]

3 months post-randomisation

Secondary outcome [1]

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]

Actigraph measures will be collected over a 7 consecutive day period at baseline and at 3 months post-randomisation

Secondary outcome [2]

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]

Actigraph measures will be collected over a 7 consecutive day period at baseline, and at 3 months post-randomisation

Secondary outcome [3]

3) Exercise perceptions as measured by the Exercise Benefits and Barriers Scale

Timepoint [3]

Participant survey at baseline, and 3 months after randomisation

Secondary outcome [4]

4) Mood measured with the positive and negative subscales of the Positive and Negative Affect Schedule (PANAS)

Timepoint [4]

Participant survey at baseline, and 3 months after randomisation

Secondary outcome [5]

5) Current self-reported physical activity levels as measured by International Physical Activity Questioinnaire (IPAQ)

Timepoint [5]

Participant survey at baseline, and 3 months after randomisation

Secondary outcome [6]

6) Physical functioning as measured by the function component of the Late Life Function and Disability Instrument (LLFDI)

Timepoint [6]

Participant survey at baseline and 3 months after randomisation

Secondary outcome [7]

7) Health related quality of life as measured by the EQ-5D-5L survey

Timepoint [7]

Participant survey at baseline and 3 months after randomisation

Secondary outcome [8]

8) Percentage of screened participants who agree to participate in the study, measured by (1) study screening forms, (2) consent forms

Timepoint [8]

Participant baseline assessment

Secondary outcome [9]

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]

Participant assessment: baseline and 3 months post-randomisation

Secondary outcome [10]

10) Percentage of participants who completed self-report survey assessments, measured by completed questionnaires at the assessment intervals.

Timepoint [10]

Participant assessment: baseline and 3 months post-randomisation

Secondary outcome [11]

11) Percentage of participants who engaged in follow-up telephone support, measured by study records.

Timepoint [11]

3 months post-randomisation

Secondary outcome [12]

12) Percentage of participants who used the website, recorded by Google analytics

Timepoint [12]

3 months post-randomisation

Secondary outcome [13]

13) Proportion of people screened who met the inclusion crieteria, recorded via the study screening forms.

Timepoint [13]

Participant baseline assessment

Secondary outcome [14]

14) Number of participants who withdraw consent or participation, recorded via the study records

Timepoint [14]

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

Sex

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

26/03/2019

Actual

Date of last participant enrolment

Anticipated

26/07/2019

Actual

Date of last data collection

Anticipated

29/11/2019

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

Charles Perkins Centre Active Ageing Research Node seed grant, The University of Sydney

Address [1]

Camperdown
Sydney
NSW 2050

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Sydney Human Research Ethics Committee

Ethics committee address [1]

Ethics and Research Integrity
Margaret Telfer Building (K07)
University of Sydney
NSW 2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/01/2019

Approval date [1]

08/03/2019

Ethics approval number [1]

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

A/Prof Anne Tiedemann

Address

Institute for Musculoskeletal Health
The University of Sydney
PO Box M179
Missenden Rd
Camperdown
NSW, 2050

Country

Australia

Phone

+61 2 8627 6233

Fax

+61 2 8627 6262

anne.tiedemann@sydney.edu.au

Contact person for public queries

Name

Anne Tiedemann

Address

Institute for Musculoskeletal Health
The University of Sydney
PO Box M179
Missenden Rd
Camperdown
NSW, 2050

Country

Australia

Phone

+61 2 8627 6233

Fax

+61 2 8627 6262

anne.tiedemann@sydney.edu.au

Contact person for scientific queries

Name

Anne Tiedemann

Address

Institute for Musculoskeletal Health
The University of Sydney
PO Box M179
Missenden Rd
Camperdown
NSW, 2050

Country

Australia

Phone

+61 2 8627 6233

Fax

+61 2 8627 6262

anne.tiedemann@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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		Wallbank G et al. Acceptability and feasibility of... [More Details]
Study results article	Yes		Wallbank G et al. Acceptability and feasibility of... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Active Women over 50 online information and support to promote physical activity behaviour change: Study protocol for a pilot trial.	2020	https://dx.doi.org/10.1186/s40814-020-00627-9

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically