Determine the Effect of Training and Use of the Smartphone Pedometer Program on Sedentary behavior and physical activity in students
Design
A randomized clinical trial with a intervention and control group, double blind, stratified randomization, the sample of this research is a total of 100 people.
Settings and conduct
This study is a randomized clinical trial study.Samples will be selected from among non-medical students of Tehran University in a continuous sampling method based on entry and exit criteria,and after obtaining informed written consent,will be classified into two groups of control and intervention by stratified random allocation.double blinding will be done on the researcher and the participants.This intervention involves installing pedometer software and training on the use of its capabilities,as well as intervention team will daily receive 7 short messages each week from the researcher.
Participants/Inclusion and exclusion criteria
The criteria for entering the study include the first or second year students studying at comprehensive universities in Tehran;inadequate physical activity according to the WHO guidelines
Non-entry criteria include obvious disability and physical disability which affects the person's ability to exercise physically Also the active use of Pedometer Software.
Intervention groups
The intervention will take place for one month.This intervention involves installing pedometer software and training on the use of the program's capabilities.The intervention team will daily receive 7 short messages each week from the researcher,including 5 messages with informative content and 2 messages with motivational content.At the end of the study,the content of texting and teaching the use of pedometer program capabilities in the form of pamphlets will be provided to the control group.
Main outcome variables
Physical Activity, Sedentary Behavior
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190710044170N1
Registration date:2019-07-16, 1398/04/25
Registration timing:prospective
Last update:2019-07-16, 1398/04/25
Update count:0
Registration date
2019-07-16, 1398/04/25
Registrant information
Name
Adel Alizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5273 5114
Email address
alizadeh-a@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-07, 1398/06/16
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Training and Using the Capabilities of the Smartphone Pedometer Program on Sedentary Behavior and Physical Activity in Students
Public title
Effect of Training and Using the Capabilities of the Smartphone Pedometer Program on Sedentary Behavior and Physical Activity in Students
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Students of the first or second year of studying at comprehensive universities in Tehran
inadequate physical activity according to the WHO guidelines (at least 150 minutes of moderate intensity or 75 minutes of intense activity per week)
Owning a smartphone that owns the student and has a continuous presence
Internet access via smartphone
Ability to read and write in Persian language
run the pedometer application completely by researcher
Exclusion criteria:
Manifest disability and physical disability that affecting the individual's ability to exercise physically
Psychological disorder such as depression is a psychiatric diagnosis and a student statement that lowers his desire for mobility
Active use of pedometer software
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be randomly Stratified assign into two groups of control and intervention; in this type of allocation, people will be placed in two layers of software installation without active use and no installation of the software on the smartphone. Then samples of each layer in the method Blocks will be divided into two groups of intervention and control; random sequences will be created based on web-based randomization and will be used to hide random assignments from sealed non-transparent envelopes that are numbered.
Blinding (investigator's opinion)
Double blinded
Blinding description
The double blinding will be implemented in the participants and the researcher in such a way that the participants will be provided with the questionnaire after knowing the goals of the study and willing to participate in the study and signing informed written consent.Participants are unaware that they will be in the intervention group or in the control group.The researcher does not know whether the participant is in the intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Qods St., Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
7434115761
Approval date
2019-05-15, 1398/02/25
Ethics committee reference number
IR.TUMS.VCR.REC.1398.143
Health conditions studied
1
Description of health condition studied
Educational intervention in the field of healthy lifestyle
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
To determine the physical activity of students, a short form of the International Physical Activity Questionnaire will be used. This questionnaire measures the physical activity of individuals in the past 7 days and based on the formula for the participants' energy consumption (METs-min / week) during activity Light, moderate and severe, and individuals will take place in three groups with low physical, moderate, and high levels of physical activity.
Timepoint
Before the intervention and one month after the intervention
Method of measurement
International Questionnaire of Physical Activity (Short Form)
Secondary outcomes
1
Description
Sedentary behavior in this research is a score that a person takes from the ASAQ questionnaire. Using this questionnaire, student sitting sessions (watching TV, watching a movie, using a computer, etc.) that are grouped into five general categories during a The week is measured in min / day and then the sitting behavior of individuals will be accumulated over a week.
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Adolescent Sedentary Activity Questionnaire
Intervention groups
1
Description
Intervention group: For the test group, the intervention will take place for one month. This intervention involves installing step-by-step software and training on the use of the program's capabilities. The intervention team will receive 7 short messages each week from the researcher who will send them on a daily basis, including 5 messages with informative content and 2 messages with motivational content.
Category
Lifestyle
2
Description
Control group: The control group will not receive training during the intervention but at the end of the study, the content of texting and teaching the use of step-by-step program capabilities in the form of pamphlets will be provided to the control group.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University
Full name of responsible person
Adel Alizadeh
Street address
Tehran University, 16 Azar Street, Enghelab Street, Enghelab Square
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۸
Phone
+98 21 6640 0273
Email
alizadeh-a@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali sahraeian
Street address
Deputy Head of Research and Technology, 6th floor, Central Organization of the University, Ghods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 8163 3685
Email
alizadeh-a@razi.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Adel Alizadeh
Position
Master of Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 7, 4th Floor, Atoosa Building, Alley 19, Paeez Street, Pasargad Boulevard, South Bahonar
City
Shiraz
Province
Fars
Postal code
7177974376
Phone
+98 71 5273 5114
Email
alizadeh-a@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Negarandeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing & Midwifery Care Research Center, School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6642 1685
Email
negarandeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Adel Alizadeh
Position
Master of Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 7, 4th Floor, Atoosa Building, Alley 19, Paeez Street, Pasargad Boulevard, South Bahonar
City
Shiraz
Province
Fars
Postal code
7177974376
Phone
+98 71 5273 5114
Email
alizadeh-a@razi.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Some of the information, such as a sample demographic profile form without personal information of individuals, as well as some information on the primary consequences (primary and secondary), can be shared.
When the data will become available and for how long
Start the access period 9 months after printing results
To whom data/document is available
Researchers working in academic and scientific institutions, students as well as people working in the industry
Under which criteria data/document could be used
After the publication of the article, the use of the results of the study by reference to the article in question or the use of the results with respect to the author in the industry is not permitted.
From where data/document is obtainable
Adel Alizadeh by email alizadeh-a@razi.tums.ac.ir or mobile number
09174457463
What processes are involved for a request to access data/document
After the call by applicant the documentation will be provided by researcher; authorize researcher is important.