Protocol summary

Summary
In this quasi-experimental study 200 students in grade two in Tabriz high schools divide into two groups of 100 students by cluster Sampling method. Data gathering tool is a manuiscripted questionnaire of responsibility for health, spiritual health and interpersonal relationships, based on the standard health and lifestyle questionnaire HPLPII (health-promoting lifestyle profile II) and components of the theory of planned behavior which will be valid and reliable. Data will gather from two groups and analysis. educational intervention will be designed Based on the results and will be explemented in 5 sessions for 60 to 75 minutes with a sensitive method, lecture, group discussion, role playing, SMS, leaf let,individual counceling and some competitions in case group along with some programs for their friends, teachers ans families.One month and three months post-intervention questionnaires will be completed again in two groups. Data will be analysis and comparie.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014042615650N3
Registration date: 2014-05-05, 1393/02/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-05-05, 1393/02/15
Registrant information
Name
Mahnaz Solhi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 9928
Email address
solhi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Health, Tehran University of Medical SciencesCenter for Community Based Participatory Research, Institute reducing risk behaviors
Expected recruitment start date
2013-01-03, 1391/10/14
Expected recruitment end date
2013-10-06, 1392/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of educational intervention based on planned actionTheory about promotion of health responsibility, spirtual health and interpersonal communications in girl second year high school students in Tabriz
Public title
An educational intervention for improving responsibility for health, spiritual health and interpersonal relationships in girl students
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: girl second year high school students in Tabriz, Iran; voluntarily participate in the research; provide written consent. Exclusion criteria: not satisfied for participation and retention of students in research; change their school or change their location in the next 4 months.
Age
From 14 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice-chancellor for research, Tehran University of Medical Sciences
Street address
Central University Biulding, Ghods St., Keshavars Blvd
City
Tehran
Postal code
1471613151
Approval date
2012-12-18, 1391/09/28
Ethics committee reference number
240/4840

Health conditions studied

1

Description of health condition studied
Responsibility
ICD-10 code
F00-F99
ICD-10 code description
Mental and behavioural disorders

2

Description of health condition studied
Spirtual Health
ICD-10 code
F00-F99
ICD-10 code description
Mental and behavioural disorders

3

Description of health condition studied
Interpersonal communications
ICD-10 code
F00-F99
ICD-10 code description
Mental and behavioural disorders

Primary outcomes

1

Description
Attitude
Timepoint
One month and three months after intervention
Method of measurement
Questionnaire

2

Description
Behavioral Intension
Timepoint
One month and three months after intervention
Method of measurement
Questionnaire

3

Description
Subjectives Norms
Timepoint
One month and three months after intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Responsibility
Timepoint
One month and three months after intervention
Method of measurement
Questionnaire

2

Description
Spirtual Health
Timepoint
One month and three months after intervention
Method of measurement
Questionnaire

3

Description
Interpersonal Communications
Timepoint
One month and three months after intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Inervention in case group:An intervention will be planned based on the results of the completion of the initial questionnaire in two groups and it will provide only in the case group with in 5 sessions for 60 to 75 min with some methoths such as sensitive methods,lecture, group discussion, role playing, SMS, giving pamphlets, individual counseling and hold a design competition. Some programs will be provided for their friends and their families in case group too.
Category
Lifestyle

2

Description
No intervention do not apply for control group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Learning and Training Organization
Full name of responsible person
Afsaneh Rezazadeh
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice- Chancellor for Health, Tehran University of Medical Sciences
Full name of responsible person
Dr.Masoud Younesian
Street address
Central building of Tehran University of Medical Sciences,Ghodes St., Keshavars Blvd., Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice- Chancellor for Health, Tehran University of Medical Sciences
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Center for Community Based Participatory Research, Institute of reducing risk behaviors
Full name of responsible person
Dr. Fatemeh Rajabi
Street address
1547 No. Ghol Biulding,Ghods St., Keshavars Blvd, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Center for Community Based Participatory Research, Institute of reducing risk behaviors
Proportion provided by this source
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
School of Health, Tehran University of Medical Sciences
Full name of responsible person
Afsaneh Rezazadeh
Position
MSc. Student
Other areas of specialty/work
Street address
Poursina St., Ghods St., Keshavarz Blnd, Tehran
City
Tehran
Postal code
Phone
+98 21 8898 9128
Fax
Email
Afsane_resazadeh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Health, Iran University of Medical Sciences
Full name of responsible person
Mahnaz Solhi
Position
PhD in Health Education and Health Promotion
Other areas of specialty/work
Street address
Health Services and Health Education Department, School of Health,Near Milad Hospital, Shahid Hemmat highway
City
Tehran
Postal code
1449614535
Phone
+98 21 8670 4756
Fax
Email
solhi.m@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Solhi
Position
PhD in Health Education and Health Promotion/Associate Prof.
Other areas of specialty/work
Street address
Department of Health services and Health Education, School of Health, Iran University of Medical Sciences, Near Milad Hpspital, Shahid Hemmat highway, Tehran
City
Tehran
Postal code
1449614535
Phone
+98 86704756
Fax
+98 88779487
Email
solhi.m@iums.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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