Comparison of the Effectiveness of Individualized internet-based physical activity intervention with nonindividualized program in increasing physical activity in the general population
The aim of this study was to evaluate the effectiveness an individualized computer-tailored physical activity program in Iranian population.
Design
Randomised controlled trial, community based, parallel group
Settings and conduct
Participants will be randomly assigned to two groups including intervention and control by a randomization computerized program and then given an id to have access to exercises on the website. The website includes an interactive computer tailored exercise program that generates individualized progressing PA advice and a fixed progressing exercise program in control group. Physical activity level will be assessed before and after intervention via GPAQ.
Participants/Inclusion and exclusion criteria
Inclusion criteria includes age between 18 and 65 years, internet access and having the eligible computer based skills to interact via internet. Exclusion criteria includes history of cardiovascular disease, uncontrolled hypertension, chronic lung disease or heart stroke in the past six months, pregnancy and any condition which is a barrier to physical activity.
Intervention groups
Intervention group has an individualized exercise program based on their progression process. They will have access to ten week exercises program week by week .By the end of each week if each participant completes the log book, will have the access to next week exercises with appropriate increasing intensity according to the logbook answers. Exercise program includes aerobic exercises, resistance exercises, flexibility and core stability exercises. Control group exercises includes the same ten week exercise program non individualized, which they will have access to the whole program from the beginning and no logbook completion is mandated.
Main outcome variables
physical activity level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180129038545N1
Registration date:2018-02-18, 1396/11/29
Registration timing:prospective
Last update:2018-02-18, 1396/11/29
Update count:0
Registration date
2018-02-18, 1396/11/29
Registrant information
Name
Maryam Selk Ghaffari
Name of organization / entity
Sports Medicine Research Center Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 0228
Email address
selk1360@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Individualized internet-based physical activity intervention with nonindividualized program in increasing physical activity in the general population
Public title
Efficacy of individualized internet-based physical activity intervention in increasing physical activity.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age is between 18 and 65 years.
Having internet access (including e-mail access) either at home or at work .
Having the eligible computer based skills to interact via internet.
Exclusion criteria:
Having history of cardiovascular disease, uncontrolled hypertension, chronic lung disease or heart stroke in the past six months.
Being pregnant.
Having unwanted weight loss (exceeding ten percent of the total body weight) in the past six months.
Having any condition which is a barrier to physical activity
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
152
Randomization (investigator's opinion)
Randomized
Randomization description
They will be randomly assigned to two groups including intervention and control by a randomization automatic computerized numbered program.
Blinding (investigator's opinion)
Not blinded
Blinding description
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
16th Azar St., Enghelab Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417466191
Approval date
2015-03-21, 1394/01/01
Ethics committee reference number
86100078
Health conditions studied
1
Description of health condition studied
physical activity
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Total physical activity level
Timepoint
At the beginning and end of intervention.
Method of measurement
GPAQ
Secondary outcomes
1
Description
Physical activity at work.
Timepoint
At the beginning and end of intervention.
Method of measurement
GPAQ
2
Description
Physical activity during travel
Timepoint
At the beginning and end of intervention
Method of measurement
GPAQ
3
Description
Sedentary behavior level
Timepoint
At the beginning and end of intervention
Method of measurement
GPAQ
Intervention groups
1
Description
Intervention group: individualized computer-tailored physical activity program
Category
Prevention
2
Description
Control group: nonindividualized computer-tailored physical activity program
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sports medicine research center Tehran university of medical sciences
Full name of responsible person
Maryam Selk Ghaffari
Street address
No.7,Jalal Al Ahmad Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1411734143
Phone
+98 21 8863 0228
Email
selk1360@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ramin Kordi
Street address
16th Azar St., Enghelab Sq., Tehran, Iran
City
Tehran
Province
Chahar-Mahal-va-Bakhtiari
Postal code
1417466191
Phone
+98 21 6111 3411
Email
international@ut.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
Sports Medicine Research Center Tehran University of Medical Sciences
Full name of responsible person
Maryam Selk Ghaffari
Position
Sports medicine specialist
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
No 7, Jalal Al Ahmad Ave, Sports medicine research center Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1411734143
Phone
+98 21 8863 0228
Fax
Email
selk1360@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sports Medicine Research Center Tehran University of Medical Sciences
Full name of responsible person
Maryam Selk Ghaffari
Position
Sports medicine specialist
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
No 7, Jalal Al Ahmad Ave, Sports medicine research center Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1411734143
Phone
+98 21 8863 0228
Fax
Email
selk1360@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sports Medicine Research Center Tehran University of Medical Sciences
Full name of responsible person
Maryam Selk Ghaffari
Position
Sports medicine specialist
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
No 7, Jalal Al Ahmad Ave, Sports medicine research center Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1411734143
Phone
+98 21 8863 0228
Fax
Email
selk1360@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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information including outcome suach as physical activity level will be shared.
When the data will become available and for how long
The data will be available starting 6 months after publication
To whom data/document is available
people working in academic institutions can apply to receive it.
Under which criteria data/document could be used
No limitation is set.
From where data/document is obtainable
contact the e mail selk1360@gmail.com.
What processes are involved for a request to access data/document
The data will be available starting 6 months after publication by contacting
selk1360@gmail.com for 6 month after obtaining contact information of the researcher.