Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001065189p
Ethics application status
Submitted, not yet approved
Date submitted
13/05/2019
Date registered
31/07/2019
Date last updated
31/07/2019
Date data sharing statement initially provided
31/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The analysis of the incidence of mobile phone use in quality of life, physical condition and labour satisfaction in officer workers
Scientific title
The incidence of mobile phone use in quality of life, physical condition and labour satisfaction in office workers: a cross-sectional study
Secondary ID [1] 297526 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sedentary behaviour 312801 0
poor diet 312860 0
Condition category
Condition code
Musculoskeletal 311303 311303 0 0
Normal musculoskeletal and cartilage development and function
Mental Health 311360 311360 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
For this cross-sectional office workers will be assessed by means of different questionnaires to determine their physical fitness, physical activity, nutrition habits and job satisfaction. The questionnaires can be completed in 40 minutes. In the first phase, during one week, information about mobile phone use (7 days), and the number of steps will be determined. On the second phase, quality of life and physical fitness will be assessed by a different fitness tests whose duration is 60 minutes per person.
Intervention code [1] 314448 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320043 0
Mobile phone use will be measured by an App (YourHour)
Timepoint [1] 320043 0
The App (YourHour) will be installed in workers mobile phone. The App will measure the mobile phone time use during 7 days, 24 hours/day.
Primary outcome [2] 320114 0
Physical activity level and sitting time will be measured by IPAQ (short version)
Timepoint [2] 320114 0
IPAQ will be complete in 5 minutes the last day (day 8) on Google Form.
Secondary outcome [1] 370345 0
Number of steps will be measured by an App (Google Fit)
Timepoint [1] 370345 0
The App (Google Fit) will be installed in workers mobile phone. The App will measure the mobile phone time use during 7 days, 24 hours/day.
Secondary outcome [2] 370557 0
Quality of life will be measured by SF-36
Timepoint [2] 370557 0
SF-36 will be complete in 5 minutes the last day (day 8) on Google Form.
Secondary outcome [3] 370558 0
Nutrition will be measured by a food diary
Timepoint [3] 370558 0
Workers must complete the diary with all the food they eat on thursday, friday and saturday this week.
Secondary outcome [4] 370559 0
Sleep Quality will be measured by SPQI
Timepoint [4] 370559 0
SPQI will be complete in 5 minutes the last day (day 8) on Google Form.
Secondary outcome [5] 370560 0
Tobacco and alcohol consumption will be measured by Spanish Health Questionaire (Statistics National Institute, 1989)
Timepoint [5] 370560 0
Health Questionaire will be complete in 5 minutes during day 7 on Google Form.
Secondary outcome [6] 370561 0
Cognitive Flexibility will be measured by Stroop Test
Timepoint [6] 370561 0
Stroop Test will be performed the last day (day 8)
Secondary outcome [7] 370562 0
Waist circumference and hip circumference will be assessed by means of a measuring tape and then the Waist-to-Hip ratio will be determined
Timepoint [7] 370562 0
Waist Hip Index (WHI) will be meadured the last day (day 8)
Secondary outcome [8] 370563 0
Basal heart rate and systolic and diastolic blood pressure will be measure by blood pressure monitor (Beurer 08)
Timepoint [8] 370563 0
They will be measured the last day (day 8)
Secondary outcome [9] 370564 0
Body composition will be made by bioimpedance eléctrica (BodyStat 1500)
Timepoint [9] 370564 0
It will be measured the last day (day 8)
Secondary outcome [10] 370565 0
Flexibility will be measure by Sit and Reach test
Timepoint [10] 370565 0
It will be measured the last day (day 8)
Secondary outcome [11] 370566 0
Static balance with open and close eyes will be made by an App (Lockhart Monitor) in iphone 5.
Timepoint [11] 370566 0
It will be made the last day (day 8)
Secondary outcome [12] 370567 0
Hand grip strength will be measured by Camry EH101 dynamometer
Timepoint [12] 370567 0
We will measure left hand strenght two times and right hand strenght two times the last day (day 8)
Secondary outcome [13] 370568 0
Lower limb strength will be made by sit and stand test
Timepoint [13] 370568 0
It will measure the last day (day 8)
Secondary outcome [14] 370569 0
Lower limb strength will be estimate by countermovement jump
Timepoint [14] 370569 0
Every subject will must do three countermovement jumps the last day (day 8)
Secondary outcome [15] 370570 0
Cardiorespiratory fitness will be measured by 6 minutes walking test
Timepoint [15] 370570 0
It will measure the last day (day 8)
Secondary outcome [16] 370571 0
Job Satisfaction will be measured by Overall Job Satisfaction Questionaires
Timepoint [16] 370571 0
It will masure the first day (day 1)
Secondary outcome [17] 370572 0
Resilient Organization Questionaire (HERO). This is a composite outcome to assess the engagement, self-efficacy, resilience, optimism and hope of the workers.
Timepoint [17] 370572 0
It will be made the first day (day 1)
Secondary outcome [18] 371629 0
Clinic history (Latest diseases or accidents and chronic diseases). It has been designed for this study, even though we have chosen some questions of Spanish Health Questionnaire. It is measured with a questionnaire that asks about latest diseases or accidents and chronic diseases
Timepoint [18] 371629 0
It will masure the first day (day 1)

Eligibility
Key inclusion criteria
Being employee in whose municipal company will be done the research
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not being a sedentary worker

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
SPSS will be use to perform all statistical analyses. Anova will be performed to test the different between groups (groups with different activity, work, sedentary behavour etc.). The association between variables will be analyzed using Spearman's correlation coefficients. Finally, we will perform a linear regression analyses between variables.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2019
Actual
Date of last participant enrolment
Anticipated
1/10/2019
Actual
Date of last data collection
Anticipated
1/12/2019
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 21466 0
Spain
State/province [1] 21466 0
Seville

Funding & Sponsors
Funding source category [1] 302750 0
University
Name [1] 302750 0
University of Seville
Country [1] 302750 0
Spain
Primary sponsor type
University
Name
University of Seville
Address
Pabellón de Brasil.
Paseo de las Delicias s/n.
Seville
Country
Spain
Secondary sponsor category [1] 302685 0
None
Name [1] 302685 0
None
Address [1] 302685 0
None
Country [1] 302685 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302765 0
Investigación Biomédica de Andalucía
Ethics committee address [1] 302765 0
Ethics committee country [1] 302765 0
Spain
Date submitted for ethics approval [1] 302765 0
13/02/2019
Approval date [1] 302765 0
Ethics approval number [1] 302765 0

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

Contacts
Principal investigator
Name 91322 0
Dr Borja Sañudo
Address 91322 0
University of Seville
19 Pirotecnia Street
Sevilla, Spain
41013
Country 91322 0
Spain
Phone 91322 0
+34 652 387 090
Fax 91322 0
Email 91322 0
[email protected]
Contact person for public queries
Name 91323 0
Laura Velasco
Address 91323 0
University of Seville
19 Pirotecnia Street
Sevilla, Spain
41013
Country 91323 0
Spain
Phone 91323 0
+34 658 074 539
Fax 91323 0
Email 91323 0
[email protected]
Contact person for scientific queries
Name 91324 0
Laura Velasco
Address 91324 0
University of Seville
19 Pirotecnia Street
Sevilla, Spain
41013
Country 91324 0
Spain
Phone 91324 0
+34 658 074 539
Fax 91324 0
Email 91324 0
[email protected]

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?

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.