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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
Date results information 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] 294590 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inactivity 307389 0
sedentary behaviour 307390 0
Condition category
Condition code
Public Health 306565 306565 0 0
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] 300883 0
Lifestyle
Intervention code [2] 300884 0
Behaviour
Intervention code [3] 300885 0
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] 305501 0
Physical activity in minutes measured via Actigraph accelerometers worn for one week.
Timepoint [1] 305501 0
At baseline and week 12 post baseline (primary time point).
Primary outcome [2] 305502 0
Physical activity minutes in the previous week measured via the Active Australia Survey
Timepoint [2] 305502 0
At baseline, week 6, 12 (primary time point) and 24 post baseline.
Secondary outcome [1] 345490 0
Patient reported resistance exercise as a composite outcome determined by the number of sessions, sets and repetitions of resistance exercises per week.
Timepoint [1] 345490 0
At baseline, week 6, 12 and 24. post baseline
Secondary outcome [2] 345492 0
Sedentary behaviour measured via the Workforce Sitting Questionnaire
Timepoint [2] 345492 0
At baseline, week 6, 12 and 24 post baseline
Secondary outcome [3] 345494 0
Sleep duration measured via actigraph accelerometers
Timepoint [3] 345494 0
At baseline and week 12 post baseline
Secondary outcome [4] 345496 0
Functional Status measured via the Functional Status Questionnaire
Timepoint [4] 345496 0
At baseline, week 12 post baseline
Secondary outcome [5] 345497 0
Social support measured via the Duke Social Support Index
Timepoint [5] 345497 0
At baseline, week 12 post baseline
Secondary outcome [6] 345498 0
Quality of life measured via the SF-12
Timepoint [6] 345498 0
At baseline, week 12 post baseline
Secondary outcome [7] 345499 0
Satisfaction with life measured via the Satisfaction with Life Scale
Timepoint [7] 345499 0
At baseline, week 12 post baseline
Secondary outcome [8] 345778 0
Number of sessions of balance and flexibility activities (composite outcome).
Timepoint [8] 345778 0
At baseline, week 6, 12 and 24 post baseline
Secondary outcome [9] 345924 0
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] 345924 0
At baseline, week 6, 12 and 24 post baseline
Secondary outcome [10] 345925 0
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] 345925 0
At baseline, week 6, 12 and 24 post baseline
Secondary outcome [11] 345926 0
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] 345926 0
At baseline, week 6, 12 and 24 post baseline
Secondary outcome [12] 345927 0
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] 345927 0
At baseline, week 6, 12 and 24 post baseline
Secondary outcome [13] 345928 0
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] 345928 0
12 weeks post baseline
Secondary outcome [14] 345929 0
Engagement with the intervention assessed through website usage statistics
Timepoint [14] 345929 0
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
Gender
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
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)
QLD,SA

Funding & Sponsors
Funding source category [1] 299206 0
University
Name [1] 299206 0
Central Queensland University
Address [1] 299206 0
Central Queensland University, Bruce Hwy, Rockhampton, QLD, 4702, Australia.
Country [1] 299206 0
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] 298470 0
None
Name [1] 298470 0
Address [1] 298470 0
Country [1] 298470 0
Other collaborator category [1] 280056 0
University
Name [1] 280056 0
Catholic University of Leuven
Address [1] 280056 0
Oude Markt 13, 3000 Leuven, Belgium
Country [1] 280056 0
Belgium

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300130 0
Central Queensland University Human Ethics Committee
Ethics committee address [1] 300130 0
Central Queensland University Human Ethics Committee
Central Queensland University
554-700 Yaamba Rd
Norman Gardens QLD 4701
AUSTRALIA
Ethics committee country [1] 300130 0
Australia
Date submitted for ethics approval [1] 300130 0
31/01/2017
Approval date [1] 300130 0
21/02/2017
Ethics approval number [1] 300130 0

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 82662 0
Dr Stephanie Alley
Address 82662 0
Central Queensland University, Building 7, Bruce Hwy, Rockhampton, QLD, 4702
Country 82662 0
Australia
Phone 82662 0
+61 7 4923 2263
Fax 82662 0
Email 82662 0
s.alley@cqu.edu.au
Contact person for public queries
Name 82663 0
Ms Deb Power
Address 82663 0
Central Queensland University, Building 7, Bruce Hwy, Rockhampton, QLD, 4702
Country 82663 0
Australia
Phone 82663 0
+61 7 4930 6456
Fax 82663 0
Email 82663 0
activeforlife@cqu.edu.au
Contact person for scientific queries
Name 82664 0
Dr Stephanie Alley
Address 82664 0
Central Queensland University, Building 7, Bruce Hwy, Rockhampton, QLD, 4702
Country 82664 0
Australia
Phone 82664 0
+61 7 4923 2263
Fax 82664 0
Email 82664 0
s.alley@cqu.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?
Study protocol
How or where can supporting documents be obtained?
Type [1] 6858 0
Study protocol
Citation [1] 6858 0
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).
Email [1] 6858 0
Other [1] 6858 0
Attachment [1] 6858 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary