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Trial registered on ANZCTR

Registration number

ACTRN12618000646246

Ethics application status

Approved

Date submitted

13/04/2018

Date registered

23/04/2018

Date last updated

11/02/2020

Date data sharing statement initially provided

11/02/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Increasing older adults' physical activity through 'Active For Life', an online intervention
with personalised advice

Scientific title

The effectiveness of a web-based physical activity intervention with tailored advice at increasing older adults' physical activity levels.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Inactivity

sedentary behaviour

Condition category

Condition code

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The first intervention group (tailored advice only) will receive the Active For Life Program. The 12-week program consists of six, 30 minute fortnightly sessions of personally tailored advice on the Active For Life website. The personally relevant advice in each session will be based on older adults’ responses to a brief online survey and will use computer algorithms to immediately provide feedback based on participants’ responses. The intervention content will be underpinned by components of the Theory of Planned Behaviour and Social Cognitive Theory as both theories have demonstrated their effectiveness in changing health behaviours in older adults. As such, the sessions will deliver physical activity advice tailored to psychosocial correlates (e.g., self-efficacy, social support, barriers), participants’ current physical activity level, participants’ demographics (e.g., age, gender) and health status. In addition to the six personalised sessions, the website will include an optional exercise library with beginner strength, balance and flexibility exercise programs. An optional action planning tool that allows users to create their own physical activity plans will also be included. There will also be a contact and help page where users can ask questions about physical activity or the study. A second intervention group will be given access to the same program, but with Fitbit activity trackers to objectively track their activity. Their personalised physical activity advice will be based on Fitbit data, rather than self-reported physical activity.

Intervention code [1]

Lifestyle

Intervention code [2]

Behaviour

Intervention code [3]

Prevention

Comparator / control treatment

The control group will be a wait-list control group. They will be given access to the Active For Life website to complete the research surveys, however the program features (personalised advice, action plans and exercise library) will be turned off for the duration of the trial. The control participants will be given access to all program features after they complete the last research survey.

Control group

Active

Outcomes

Primary outcome [1]

Physical activity in minutes measured via Actigraph accelerometers worn for one week.

Timepoint [1]

At baseline and week 12 post baseline (primary time point).

Primary outcome [2]

Physical activity minutes in the previous week measured via the Active Australia Survey

Timepoint [2]

At baseline, week 6, 12 (primary time point) and 24 post baseline.

Secondary outcome [1]

Patient reported resistance exercise as a composite outcome determined by the number of sessions, sets and repetitions of resistance exercises per week.

Timepoint [1]

At baseline, week 6, 12 and 24. post baseline

Secondary outcome [2]

Sedentary behaviour measured via the Workforce Sitting Questionnaire

Timepoint [2]

At baseline, week 6, 12 and 24 post baseline

Secondary outcome [3]

Sleep duration measured via actigraph accelerometers

Timepoint [3]

At baseline and week 12 post baseline

Secondary outcome [4]

Functional Status measured via the Functional Status Questionnaire

Timepoint [4]

At baseline, week 12 post baseline

Secondary outcome [5]

Social support measured via the Duke Social Support Index

Timepoint [5]

At baseline, week 12 post baseline

Secondary outcome [6]

Quality of life measured via the SF-12

Timepoint [6]

At baseline, week 12 post baseline

Secondary outcome [7]

Satisfaction with life measured via the Satisfaction with Life Scale

Timepoint [7]

At baseline, week 12 post baseline

Secondary outcome [8]

Number of sessions of balance and flexibility activities (composite outcome).

Timepoint [8]

At baseline, week 6, 12 and 24 post baseline

Secondary outcome [9]

Sleep duration measured via 1 question from the Behavioral Risk Factor Surveillance System Survey, as follows:
“On average, how many hours of sleep do you get in a 24-hour period? Think about the time you actually spend sleeping or napping, not just the amount of sleep you think you should get (categorized as <7 hours and =7 hours).”

Timepoint [9]

At baseline, week 6, 12 and 24 post baseline

Secondary outcome [10]

Snoring measured via 1 question from the Behavioral Risk Factor Surveillance System Survey, as follows:
“Do you snore? (can have been told by spouse or someone else; categorized as yes or no)?”

Timepoint [10]

At baseline, week 6, 12 and 24 post baseline

Secondary outcome [11]

Sleepiness measured via 1 question from the Behavioral Risk Factor Surveillance System Survey, as follows:
During the past 30 days, for about how many days did you find yourself unintentionally falling asleep during the day (categorized as none or at least 1 day reported)?”

Timepoint [11]

At baseline, week 6, 12 and 24 post baseline

Secondary outcome [12]

Dangerous Sleepiness measured via 1 question from the Behavioral Risk Factor Surveillance System Survey, as follows:
“During the past 30 days, have you ever nodded off or fallen asleep, even just for a brief moment, while driving (categorized as yes or no)?”

Timepoint [12]

At baseline, week 6, 12 and 24 post baseline

Secondary outcome [13]

Acceptability of the intervention assessed through a number of questionnaires: Fitbit use, (survey designed for this study), Physical activity advice acceptability (survey designed for this study), Fitbit Integration (survey designed for this study), and Systems Usability Scale.

Timepoint [13]

12 weeks post baseline

Secondary outcome [14]

Engagement with the intervention assessed through website usage statistics

Timepoint [14]

Continuous ongoing measurement from the time participants use the website the first time to the end of the study at 12 weeks post-baseline.

Eligibility

Key inclusion criteria

Eligible people will be adults aged 65+ years who have Internet access, basic computer skills, are not currently meeting the national physical activity guidelines, are not currently participating in a physical activity program, have not used a Fitbit or similar in the previous 12 months and either pass the Physical Activity Readiness Questionnaire or have GP clearance to become more active.

Minimum age

65 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Does not speak or read the English language and does not reside in Australia

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)

Allocation is not concealed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation using a randomisation table created by computer software in blocks of 9.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Participants in the four following categories were randomly assigned separately to ensure equal representation of each across the three trial conditions:
Males under 75,
Males over 75,
Females under 75,
Females over 75.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

For the primary outcomes, generalized linear mixed models (GLMM) will be used, on an intention-to-treat basis (to account for missing data), to test for differences in physical activity by group, across the time points. The GLMMs provide unbiased estimates of the treatment effect under the assumption that data are missing at random.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

24/04/2018

Actual

24/04/2018

Date of last participant enrolment

Anticipated

Actual

31/03/2019

Date of last data collection

Anticipated

Actual

12/11/2019

Sample size

Target

300

Accrual to date

Final

243

Recruitment in Australia

Recruitment state(s)

QLD,SA

Funding & Sponsors

Funding source category [1]

University

Name [1]

Central Queensland University

Address [1]

Central Queensland University, Bruce Hwy, Rockhampton, QLD, 4702, Australia.

Country [1]

Australia

Primary sponsor type

University

Name

Central Queensland University

Address

Central Queensland University, Bruce Hwy, Rockhampton, QLD, 4702, Australia.

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

Catholic University of Leuven

Address [1]

Oude Markt 13, 3000 Leuven, Belgium

Country [1]

Belgium

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Queensland University Human Ethics Committee

Ethics committee address [1]

Central Queensland University Human Ethics Committee
Central Queensland University
554-700 Yaamba Rd
Norman Gardens QLD 4701
AUSTRALIA

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/01/2017

Approval date [1]

21/02/2017

Ethics approval number [1]

Summary

Brief summary

The purpose of the study is to determine the effectiveness of personally-tailored, web-based physical activity intervention, with and without Fitbit syncing, targeted to inactive older adults (65+ years of age) in a 6-month randomised controlled trial . It is hypothesised that increases in objectively measured physical activity will be greater in both intervention groups compared to the control group and greater in the Fitbit and tailored advice group compared to the tailored advice only group at 12 weeks.

Trial website

https://www.activeforlife.net.au/eng/pages/homepage

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Stephanie Alley

Address

Central Queensland University, Building 7, Bruce Hwy, Rockhampton, QLD, 4702

Country

Australia

Phone

+61 7 4923 2263

Fax

[email protected]

Contact person for public queries

Name

Deb Power

Address

Central Queensland University, Building 7, Bruce Hwy, Rockhampton, QLD, 4702

Country

Australia

Phone

+61 7 4930 6456

Fax

[email protected]

Contact person for scientific queries

Name

Stephanie Alley

Address

Central Queensland University, Building 7, Bruce Hwy, Rockhampton, QLD, 4702

Country

Australia

Phone

+61 7 4923 2263

Fax

[email protected]

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
6858	Study protocol	Alley, S., van Uffelen, J. G. Z., Schoeppe, S., Parkinson, L., Hunt, S., Power, D., Duncan, M. J., Schneiders, A., Vandelanotte, C (2019). The efficacy of a computer-tailored web-based physical activity intervention using Fitbits for older adults: a randomised controlled trial protocol, BMJ Open, 9(12).	https://bmjopen.bmj.com/content/9/12/e033305

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The Effectiveness of a Computer-Tailored Web-Based Physical Activity Intervention Using Fitbit Activity Trackers in Older Adults (Active for Life): Randomized Controlled Trial.	2022	https://dx.doi.org/10.2196/31352
Embase	Engagement, acceptability, usability and satisfaction with Active for Life, a computer-tailored web-based physical activity intervention using Fitbits in older adults.	2023	https://dx.doi.org/10.1186/s12966-023-01406-4

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

Trial Review

Documents added manually

Documents added automatically