Protocol summary

Study aim
To investigate the efficacy of Internet-delivered computer-tailored multimedia advice through smartphone on the promotion of a physical activity and quality of life among healthy individuals.
Design
A 12-weeks randomized clinical trial with a control group, single-blinded, with a parallel group design of 148 cases, enrolled between May and December 2017 and outcome assessment.
Settings and conduct
Participants were selected from healthcare workers and patients' company who volunteered to participate in the study. Participants were randomly assigned to case and control groups using a software and participants, data collectors and outcome assessors were blind to it.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18-65 years old physically and mentally healthy individuals with access to Internet and smartphone and basic knowledge of using them. Exclusion criteria: High cardiovascular risk, Uncontrolled hypertension, Valvular heart disease (except MVP), CHF, Peripheral arterial disease, MI or CVA in past 6 months, History of Cancer, Significant unexplained weight loss, Advanced pulmonary disease, Pregnancy, Diseases or conditions preventing patient from increasing his/her physical activity (LBP, Osteoarthritis).
Intervention groups
Participants (intervention and control) are assigned based on their baseline physical activity and cardiovascular risk to mild, moderated and heavy exercise protocols. Both intervention and control groups receive the same exercises and information in multimedia format via website and Telegram® messenger application on their smartphones with the difference that participants in the intervention group receive their program weekly and are required to fill a workbook online at the end of every week and receive appropriate feedbacks and changes in their exercise program for the next week based on their performance on the past week’s assignments. They also receive weekly reminder e-mails, text messages, and instant messages to remind them of their assignments and to submit their workbook at the end of the week (tailored intervention). The control group has access to all the 12-week program consisting of the same exercises and information in multimedia format from the beginning of the study. They neither have to provide a weekly workbook nor receive any feedbacks or reminders.
Main outcome variables
Body Mass Index (kg/m^2) Physical activity (METs.min/week) Minutes of Vigorous to Moderate Physical Activity (min) Quality of life domains (SF-36 Questionnaire)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171016036805N2
Registration date: 2018-02-08, 1396/11/19
Registration timing: retrospective

Last update: 2018-02-08, 1396/11/19
Update count: 0
Registration date
2018-02-08, 1396/11/19
Registrant information
Name
Vahid Sobhani
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8860 0030
Email address
sobhani@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
2017-05-22, 1396/03/01
Actual recruitment end date
2017-07-11, 1396/04/20
Trial completion date
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Scientific title
Efficacy of Internet-delivered computer-tailored multimedia advice through smartphone on physical activity and quality of life among healthy individuals
Public title
Efficacy of multimedia advice through smartphones on physical activity and quality if life
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
18-65 years of age Physically and mentally healthy individuals Access to Internet and smartphone Basic knowledge of working with Internet and smartphone Pass the Physical Activity Readiness Questionnaire (PAR-Q)
Exclusion criteria:
High Cardiovascular Risk (Hx, Lab, Ph/E) History of Cardiovascular Problems (Uncontrolled Hypertension, Valvular Heart Disease except for MVP, CHF, MI or CVA in past 6 months, Peripheral Arterial Disease) History of Cancer Significant Unexplained Weight Loss (more than 10% of weight within 6 months) Advanced Pulmonary Disease (Asthma or COPD) Disability or condition preventing the participant from increasing his/her physical activity (Low Back Pain, Osteoarthritis) Pregnancy
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 148
Actual sample size reached: 155
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using computer software specially designed for this study.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were informed about the study and the possibility that they may be assigned to the intervention or control group randomly (and signed an informed consent form) but were blinded to which group they were assigned. Healthcare providers and investigators who designed and gave tailored feedbacks to participants were aware of group assignments. Data collectors and outcome assessors were blinded to group assignments.
Placebo
Not used
Assignment
Parallel
Other design features
Purpose: Lifestyle change, Physical activity increase

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallh University of Medical Sciences
Street address
Nosrati Ave., Sheykh Bahayi St. Mollasadra Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2015-05-31, 1394/03/10
Ethics committee reference number
IR.BMSU.REC.1394.176

Health conditions studied

1

Description of health condition studied
Healthy Individuals
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Physical Activity (METs.min/week), Moderate to Vigorous Physical Activity (min/week), Body Mass Index (kg/m^2), Quality of Life (SF-36 questionnaire)
Timepoint
Before intervention, 2 weeks after intervention
Method of measurement
World Health Organization's Global Physical Activity Questionnaire (GPAQ), 36-Item Short Form Survey (SF-36), Meter, Weight Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: aerobic, muscle strength, core stability exercises and information and instructions to improve lifestyle in a personally-tailored manner in multimedia format and weekly reminders and feedbacks.
Category
Lifestyle

2

Description
Control group: general aerobic, muscle strength, core stability exercises and information and instructions to improve lifestyle in multimedia format
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Abolfazl Physiotherapy Clinic - Baqiyatallah University of Medical Sciences
Full name of responsible person
Farough Taee
Street address
No.7, 6/39 St., Simetri Nirouye Havayi St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 7717 5788
Email
faroughtaee@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Gholamhossein Alishiri
Street address
Baqiyatallah University of Medical Sciences, Nosrati St., Sheykh Bahayi St., Mollasadra Blvd., Vanak Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
faroughtaee@gmail.com
Web page address
http://www.bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Vahid Sobhani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Baqiyatallah University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8860 0030
Fax
+98 21 8860 0030
Email
faroughtaee@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Vahid Sobhani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Baqiyatallah University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8860 0030
Fax
+98 21 8860 0030
Email
faroughtaee@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Vahid Sobhani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Baqiyatallah University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8860 0030
Fax
+98 21 8860 0030
Email
faroughtaee@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All collected deidentified IPD
When the data will become available and for how long
6 months after publication
To whom data/document is available
Only available for people working in academic institutions
Under which criteria data/document could be used
Relevant researches
From where data/document is obtainable
Farough Taee MD e-Mail: faroughtaee@gmail.com Mobile: 00989033936472 PO: 1396933968
What processes are involved for a request to access data/document
All collected raw deidentified IPD and the parts of analysis that will be published will be available. The best means of contacts is through e-Mail. We shall send you the required data within a month.
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