Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000674336
Ethics application status
Approved
Date submitted
5/05/2017
Date registered
10/05/2017
Date last updated
11/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The health effects of mobile phone use while walking
Scientific title
Mood effects of mobile phone use while walking in adult volunteers
Secondary ID [1] 291831 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mood 303077 0
Condition category
Condition code
Mental Health 302536 302536 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomized to either the mobile phone or control condition. All will be asked to do a walking route around Auckland Domain for approximately 12 minutes. The walking route is on grass over park-like grounds. Those randomized to the mobile phone condition will be asked to read information about the Auckland Domain on a mobile phone while they are walking. All participants will receive verbal and visual instructions about the route for the walking task and will be fitted with the wrist worn fitness and heart rate monitor (Garmin vivosmart HR) to record heart rate, step count and walking speed. During the walking task a stationary digital video recorder will video each participant on the same stretch of the walking loop. These behavioural data will later be analysed for information on adherence to the assigned condition, posture and gaze behaviour.
Intervention code [1] 297945 0
Other interventions
Comparator / control treatment
Those in the control condition will complete the walking task without looking at a phone.
Control group
Active

Outcomes
Primary outcome [1] 301956 0
Overall mood, assessed with a visual analogue scale (VAS)
Timepoint [1] 301956 0
baseline and post walking
Secondary outcome [1] 334355 0
Affect, measured with The Affect Valuation Index (AVI)
Timepoint [1] 334355 0
baseline and post walking
Secondary outcome [2] 334356 0
Current positive mood, assessed with a visual analogue scale
Timepoint [2] 334356 0
baseline and post walking
Secondary outcome [3] 334358 0
Current negative mood, assessed with a visual analogue scale
Timepoint [3] 334358 0
baseline and post walking
Secondary outcome [4] 334359 0
Feelings of power, assessed by four items adapted from Cuddy, Wilmuth, and Carney (2012). Participants rate how "dominant", "in control", "powerful" and "confident" they feel on a scale ranging from "not at all" to "extremely"
Timepoint [4] 334359 0
baseline and post walking
Secondary outcome [5] 334360 0
Trait contentedness with nature, measured with the Inclusion of Nature in Self Scale (Schultz, 2002), an adaption from the Inclusion of Self in Other Scale (Aron, Aron, & Smollan, 1992). Participants rate their general connectedness with nature on a single-item pictorial measure. Seven different response options show two circles (self and nature) with different amounts of overlap, representing different levels of connectedness.
Timepoint [5] 334360 0
baseline
Secondary outcome [6] 334361 0
State connectedness with nature, measured with the Inclusion of Nature in Self Scale (Schultz, 2002), an adaption from the Inclusion of Self in Other Scale (Aron, Aron, & Smollan, 1992). Participants rate their momentary connectedness with nature on a single-item pictorial measure.
Timepoint [6] 334361 0
Baseline and post walking
Secondary outcome [7] 334499 0
walking time
Timepoint [7] 334499 0
at the end of the walking route
Secondary outcome [8] 334500 0
heart rate measured on the Garmin vivosmart HR
Timepoint [8] 334500 0
during the walking task
Secondary outcome [9] 334501 0
blood pressure using sphygmomanometer
Timepoint [9] 334501 0
change from before to after the walking tasks
Secondary outcome [10] 334609 0
Posture assessed using computer software analysis of body angles from still frames taken from video of the participant walking. We are interested in head angle, eye angle, and the size of arm swing.
Timepoint [10] 334609 0
mid-way during the walking route
Secondary outcome [11] 334610 0
Stride-length. We will know the number of steps taken from the Garmin Vivosmart HR and the distance walked is the same for everyone since they walk the same route Distance walked/number of steps = stride length
Timepoint [11] 334610 0
over the course of the walk

Eligibility
Key inclusion criteria
Able to understand and read English
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they are under 16 years of age, if they are not fluent in English, if they have impaired vision that disables them from reading a text off a smart phone, or if they are unable to walk unaided for about 12 minutes.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using randomization table created by a computer software (i.e. computerized sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
An ANCOVA with between subject factor of group allocation (mobile phone or not) will be used to analyze the data, controlling for baseline scores of measured variables.
Hackford (2015) found an effect size of partial eta squared =.06 of posture (slumped versus. upright) on both low arousal negative affect and high arousal affect during walking in a standardized stressful situation. G power indicates that to find a similar intermediate sized effect, using power of .80, alpha of .05 and an ANCOVA controlling for baseline measures, 125 participants would be required overall.
Other relevant studies which also found medium size effects are Andrews-Smith (2016), who found an effect size of partial eta squared of =.073 of eye gaze direction on overall mood in a non stressful situation, and Miller & Krizan (2016) who found an effect size of d=.57 of walking on positive affect.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/05/2017
Actual
24/05/2017
Date of last participant enrolment
Anticipated
31/07/2017
Actual
25/09/2017
Date of last data collection
Anticipated
31/07/2017
Actual
25/09/2017
Sample size
Target
125
Accrual to date
Final
125
Recruitment outside Australia
Country [1] 8863 0
New Zealand
State/province [1] 8863 0
Auckland

Funding & Sponsors
Funding source category [1] 296329 0
University
Name [1] 296329 0
University of Auckland
Country [1] 296329 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
The University of Auckland
Private Bag 92019, Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 295257 0
None
Name [1] 295257 0
none
Address [1] 295257 0
none
Country [1] 295257 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297559 0
The University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 297559 0
Ethics committee country [1] 297559 0
New Zealand
Date submitted for ethics approval [1] 297559 0
27/02/2017
Approval date [1] 297559 0
24/03/2017
Ethics approval number [1] 297559 0
018789

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

Contacts
Principal investigator
Name 74438 0
A/Prof Elizabeth Broadbent
Address 74438 0
Department of Psychological Medicine,
University of Auckland
Private Bag 92019, Auckland 1142
Country 74438 0
New Zealand
Phone 74438 0
+64 9 3737599 Ext 86756
Fax 74438 0
Email 74438 0
[email protected]
Contact person for public queries
Name 74439 0
Elizabeth Broadbent
Address 74439 0
Department of Psychological Medicine,
University of Auckland
Private Bag 92019, Auckland 1142
Country 74439 0
New Zealand
Phone 74439 0
+64 9 3737599 Ext 86756
Fax 74439 0
Email 74439 0
[email protected]
Contact person for scientific queries
Name 74440 0
Elizabeth Broadbent
Address 74440 0
Department of Psychological Medicine,
University of Auckland
Private Bag 92019, Auckland 1142
Country 74440 0
New Zealand
Phone 74440 0
+64 9 3737599 Ext 86756
Fax 74440 0
Email 74440 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.