Protocol summary

Summary
This is a community-based study of randomized, controlled trial to evaluate the effectiveness of health promotion interventions to prevent the decline of regular physical activity and promoting that among adolescent girls in Hamedan. To change the behavior will be used the determinants of physical activity based on Hybrid model of behavior change according to a previous study. Method: 8 secondary schools will be selected by simple random sampling and then a class will be randomly selected from each school and they will be divided randomly into intervention and control groups. A total of 270 students, 13 years old in Hamadan's schools will participate in the study voluntarily. Inclusion criteria included: students at a girls' school in Hamadan; Absence of disease or physical disability that prevents of moderate to vigorous physical activity and Exclusion criteria will be included: Completion of scanty information and the absence in half of training sessions. The control group will be received regular training and the intervention group, in addition to the usual training will be received training based on a hybrid model and possibly environmental changes. Before and after intervention, demographic data, knowledge, structures of hybrid model and performance will be measured using a questionnaire. The results of this study will be used to provide a solution to prevent the decline of regular physical activity in adolescents and offer educational programs and policies designed to improve the lifestyle of adolescents.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015042921155N2
Registration date: 2015-05-28, 1394/03/07
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-05-28, 1394/03/07
Registrant information
Name
masomeh rostami moez
Name of organization / entity
hamadan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3822 3272
Email address
ma.rostami@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of community-based intervention program on promoting regular physical activity and preventing of its decline among Hamadan city adolescent girls: Applying combined model
Public title
Effect of community-based intervention program on promoting regular physical activity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria included: students at a girls' school in Hamadan; Absence of disease or physical disability that prevents of moderate to vigorous physical activity and Exclusion criteria will be included: Completion of scanty information and the absence in half of training sessions.
Age
From 13 years old to 14 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 270
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Av,Hamadan,Iran.
City
Hamadan
Postal code
6517838678
Approval date
2015-01-20, 1393/10/30
Ethics committee reference number
p/16/35/9/5301

Health conditions studied

1

Description of health condition studied
Regular Physical Activity
ICD-10 code
Z72.3
ICD-10 code description
Lack of physical exercise

Primary outcomes

1

Description
Knowledge
Timepoint
Before and after intervention
Method of measurement
Questionnaire

2

Description
Constructs of combined health education and health promotion model
Timepoint
Before and after intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Practice
Timepoint
Before and after intervention
Method of measurement
Questionnair

Intervention groups

1

Description
Intervention Group: Interventions for 6 months included: education; distribution of educational aids such as pamphlet, booklet, view video, banner installation; holding group discussion; coordinate with relevant agencies and probably environmental change in order to promote regular physical activity
Category
Prevention

2

Description
Control Group: For the control group will not perform any of the action that will be taken for the intervention group.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Secondary Schools in Hamadan
Full name of responsible person
Masomeh Rostami Moez
Street address
Health Faculty,Hamadan University of Medical Sciences, Shahid Fahmideh Av,Hamadan,Iran.
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Hamadan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Av, Hamadan, Iran.
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Seyed Mohammad Mahdi Hazavehei
Position
PhD, Head of Department of Public Health
Other areas of specialty/work
Street address
Hamadan university of Medical sciences, shahid Fahmideh Av, Hamadan, Iran
City
Hamadan
Postal code
Phone
+98 81 3838 1642
Fax
Email
hazavehei@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Seyed Mohammad Mahdi Hazavehei
Position
PhD, Head of Department of Public Health
Other areas of specialty/work
Street address
Hamadan university of Medical sciences, shahid Fahmideh Av, Hamadan, Iran
City
Hamadan
Postal code
Phone
+98 81 3838 1642
Fax
Email
hazavehei@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Masomeh Rostami Moez
Position
Master of Sciences\PhD Student
Other areas of specialty/work
Street address
Hamadan university of Medical sciences, shahid Fahmideh Av, Hamadan, Iran
City
Hamadan
Postal code
Phone
+98 81 3822 3272
Fax
Email
ma.rostami@umsha.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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