Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000517471
Ethics application status
Approved
Date submitted
18/04/2016
Date registered
21/04/2016
Date last updated
29/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Designing physical activity interventions based on user’s need for cognition: impact on attention and persuasion among healthy adults
Scientific title
Designing physical activity interventions based on user’s need for cognition: impact on attention and persuasion among healthy adults
Secondary ID [1] 289035 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
physical inactivity 298450 0
Condition category
Condition code
Public Health 298551 298551 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 - Physical activity module designed to persuade via central route information processing (i.e., deep and critical thinking):

The module in this condition consists of 12 slides., Participants are asked to sit in front of the computer in the laboratory and view the slides in their own time . Participants can only view the slides once and can not view a previous slide once they click 'next', Topics covered include the benefits of physical activity, the physical activity guidelines for Australian adults (published by the Department of health and ageing) and how to get started and stay committed to physical activity. The slide content was developed by the lead researcher, drawing from content developed for previous intervention research (e.g., http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4594649/).

The materials in this condition emphasise facts relating to physical activity and physical activity behaviour change. Strong arguments are presented in a clear and direct manner. No weak arguments are presented and emotional appeals are not used (including humour and emotive language).
Intervention code [1] 294516 0
Behaviour
Comparator / control treatment
Arm 2 - Physical activity module designed to persuade via peripheral route information processing (i.e., feelings, heuristics):

The module in this condition consists of 16 slides, Participants are asked to sit in front of the computer in the laboratory and view the slides in their own time . Topics covered include the benefits of physical activity, what physical activity is recommended and how to get started and stay committed to physical activity.

In contrast to arm 1, the materials in this condition utilize positive images (e.g., sunsets, fun physical activity) and narratives to convey key messages and to increase associations between physical activity and positive feelings. Text is used to create a narrative that people can identify with, rather than to emphasise facts.
Control group
Active

Outcomes
Primary outcome [1] 298034 0
Average gaze duration per slide assessed using eye tracking device and software.
Timepoint [1] 298034 0
Continuous monitoring from start of first slide to the final slide.
Secondary outcome [1] 322980 0
Physical Activity intentions

The following 3-items (Courneya et al., 1999; Courneya, 1994; Rhodes & Courneya, 2003) will be used to assessed physical activity intentions:

1) In the next week, my goal is to be physically active (response option 1- not at all to 7 every day)
2)Over the next week, I intend to engage in physical activity __ times per week (open response option)
3)I intent to engage in physical activity at least every other day over the next week ( (response option 1- not at all to 7 every day)

Responses are summed together to form overall intention score, with higher scores equating to higher intentions.
Timepoint [1] 322980 0
Immediate post-intervention
Secondary outcome [2] 322981 0
Perceived message effectiveness
A 3-item perceived effectiveness scale, adapted from Fishbein et al (2002) and Jensen (2012) will be used to assess the perceived persuasiveness of the messages. The three items are “were the materials convincing”, “would people your age who are not already active be more likely to become active after viewing the materials?” and “Would the materials be helpful for convincing your friends and family to become more physically active?” with 4-point response options: definitely no, no, yes, and definitely yes.
Timepoint [2] 322981 0
Immediate post-intervention
Secondary outcome [3] 323054 0
Need for cognition will be assessed so that it can be examined as an effect modifier

The 18-Item Need for Cognition Scale developed by Cacioppo, Feng Kao and Petty (1984) will be utilised. It is based on the original work by Cacioppo and Petty (1982) and is a shortened form scale of the original 34-item scale and was deemed to be more efficient than the 34-item scale. Item examples include ‘I would prefer complex to simple problems’ and ‘thinking is not my idea of fun’
Timepoint [3] 323054 0
Baseline

Eligibility
Key inclusion criteria
English proficient adults between the ages of 18-60, who can read and write in English, who can attend the University of Adelaide testing site during business hours (9am-5pm Monday-Friday), who can clearly view a computer screen without the assistance of glasses (contact lenses permitted), who are not already participating in recommended physical activity levels (i.e., 30 minutes of moderate-vigorous physical activity on five or more days per week) and who had not had laser eye surgery are eligible to participate.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
laser eye surgery

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Individuals interested in participating are asked to complete a screening questionnaire online. All individuals are assigned a unique identification number, Algorithms are used to determine if individuals are eligible. If eligible they are denoted as such in the database. The file is then downloaded from the website and uploaded into R. The allocation script that was developed a priori is then run for eligible individuals only to randomise them into study groups on a ratio of 1:1 using random block sizes. This is carried out by a statistician with de-identified data. The statistician then provides the research team with the allocation sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number generator is used.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear regression examining interaction between group allocation, need for cognition and outcomes of interest (gaze duration, intentions, message effectiveness).

Assuming that high (low) NFC individuals have 5 min (3 min) attention spans when matched with website (ie central vs peripheral) and 1 min (1 min) spans when mis-matched, and assuming normally distributed attention spans with a common standard deviation of 2 min, then simulations indicate that with 50 individuals (25 in each group) there is at least 80% power to detect an interaction between NFC (high v low) and treatment (central v peripheral) when the prevalence of high NFC is between 30% and 70% of the randomized population.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2016
Date of last participant enrolment
Anticipated
30/04/2016
Actual
30/04/2016
Date of last data collection
Anticipated
Actual
13/05/2016
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 293402 0
University
Name [1] 293402 0
University of Adelaide
Country [1] 293402 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
North Terrace, University of Adelaide
Adelaide, SA. 5000
Country
Australia
Secondary sponsor category [1] 292231 0
None
Name [1] 292231 0
nil
Address [1] 292231 0
nil
Country [1] 292231 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294853 0
School of Psychology HREC sub-committee, University of Adelaide
Ethics committee address [1] 294853 0
Ethics committee country [1] 294853 0
Australia
Date submitted for ethics approval [1] 294853 0
21/09/2015
Approval date [1] 294853 0
28/09/2015
Ethics approval number [1] 294853 0
H-2015/94

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

Contacts
Principal investigator
Name 65246 0
Dr Camille Short
Address 65246 0
Level 7, South Australia Health Medical Research Institute, North terrace,
Adelaide, SA, 5000
Country 65246 0
Australia
Phone 65246 0
+61, 8, 83130532
Fax 65246 0
Email 65246 0
[email protected]
Contact person for public queries
Name 65247 0
Camille Short
Address 65247 0
Level 7, South Australia Health Medical Research Institute, North terrace,
Adelaide, SA, 5000
Country 65247 0
Australia
Phone 65247 0
+61, 8, 83130532
Fax 65247 0
Email 65247 0
[email protected]
Contact person for scientific queries
Name 65248 0
Camille Short
Address 65248 0
Level 7, South Australia Health Medical Research Institute, North terrace,
Adelaide, SA, 5000
Country 65248 0
Australia
Phone 65248 0
+61, 8, 83130532
Fax 65248 0
Email 65248 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.